SECTION 1: INTRODUCTION



MANUAL OF LABORATORY TESTS AND SERVICESMASSACHUSETTS DEPARTMENT OF PUBLIC HEALTHBUREAU OF INFECTIOUS DISEASE AND LABORATORY SCIENCESMA STATE PUBLIC HEALTH LABORATORY BOSTON, MASSACHUSETTSSeventh Edition, (June 2018)Table of Contents TOC \o "1-3" \h \z \u SECTION 1: INTRODUCTION PAGEREF _Toc517262318 \h 3SECTION 2: LABORATORY TESTING SERVICES PAGEREF _Toc517262319 \h 4BACTERIAL GENREAL, BIOLOGICAL THREAT AGENTS, AND FUNGAL AND PARASITIC REFERRALS PAGEREF _Toc517262320 \h 4BACTERIAL STI PAGEREF _Toc517262321 \h 16CHEMICAL ILLNESS PAGEREF _Toc517262322 \h 20FOODBORNE ILLNESS PAGEREF _Toc517262323 \h 27TUBERCULOSIS PAGEREF _Toc517262324 \h 31VIRAL ILLNESS PAGEREF _Toc517262325 \h 35SECTION 3: SPECIMEN INFORMATION PAGEREF _Toc517262326 \h 58SPECIMENS SUBMISSION- GENERAL INFORMATION PAGEREF _Toc517262327 \h 58MA STATE PUBLIC HEALTH LABORATORY PAGEREF _Toc517262328 \h 59SPECIMEN OUTFITS AND SUPPLIES PAGEREF _Toc517262329 \h 59SECTION 4: PACKAGING AND SHIPPING SPECIMENS PAGEREF _Toc517262330 \h 60SESCTION 5: MANDATORY REPORTING OF DISEASE AND SPECIMEN SUBMISSION PAGEREF _Toc517262331 \h 61SECTION 6: LABORATORY DIRECTORY PAGEREF _Toc517262332 \h 62SECTION 1: INTRODUCTIONThe Massachusetts State Public Health Laboratory’s (MA SPHL) Manual of Laboratory Tests and Services (MLTS) describe our services.The Massachusetts Department of Public Health’s (MDPH) Bureau of Infectious Disease and Laboratory Sciences (BIDLS) is located at the DPH Jamaica Plain Campus. Within the BIDLS, the MA SPHL provides comprehensive public health laboratory services for diagnosis, surveillance, investigation and prevention. These services address public health priorities in Massachusetts and complement local and regional laboratory activities.Core functions listed below provide direct benefits to the health of our citizens:Diagnostic testingReference testingLaboratory-based surveillanceConsultation for laboratory test interpretation and useEnvironmental chemical analysis and diagnosis of chemical illness in humans due to chemical exposureInfectious disease outbreak identification, surveillance, and responseFood safetyEmergency response testing for biological and chemical Threat, foodborne illness, and emerging infectious diseasesHealth studiesPartnerships with the U.S. Centers for Disease Control and Prevention (CDC), the National Laboratory Response Network (LRN), Food Emergency Response Network (FERN) and other federal and state agenciesTraining and outreach in laboratory science and related subject matter expertiseThe MLTS provides details of services and contact information for our staff. This manual can be found at the MA SPHL’s website by accessing dph/bls.Sandra C. Smole, PhDDirector, MA State Public Health Laboratory Bureau of Infectious Disease and Laboratory Sciences305 South StreetJamaica Plain, MA 02130sandra.smole@state.ma.us 617-983-4362 (phone)617-983-6211 (fax)SECTION 2: LABORATORY TESTING SERVICES BACTERIAL GENREAL, BIOLOGICAL THREAT AGENTS, AND FUNGAL AND PARASITIC REFERRALSTest Name:Bacillus anthracis, Culture and PCRLab and Phone:BioThreat Response Laboratory 617-590-6390 (24hr/7days) Call the BioThreat Response Laboratory to report when a Bacillus anthracis cannot be ruled out by sentinel lab protocol. Prior to submitting specimen(s), instructions on packaging and shipping requirements will be provided.Use of Test:Rule out infection by Bacillus anthracis causative agent of anthrax.Test Includes:Isolation and identification from primary specimen. Isolated organism identification.Rapid screening by PCR for presumptive identification may be performed on a case-by-case basis.Reference Range/ Expected Results:Bacillus anthracis not found.Bacillus anthracis DNA not detected by PCR.Availability:24/7 after prior consultation with the BioThreat Response Laboratory.Turnaround Time:< 1 to 5 daysSample:1.????? Primary specimen- aseptically collected lesions or eschars, whole blood, tissue, tissue biopsies in screw-capped tube (with or without swab used to collect sample).2.????? Subculture- pure growing on an appropriate agar slant in a screw capped tube.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:After receiving packaging and shipping instructions, transport primary specimens or subcultures to the SPHL.????Test Name:Bacterial Culture Identification- Reportable pathogensLab and Phone:Clinical Microbiology Laboratory 617-983-6607Use of Test:Bacterial isolates causing reportable diseases. Definitive identification of bacteria of public health significance (see Limitations listed below).Test Includes:Identification of bacteria of public health significance.Limitations:Isolates collected from sterile sites causing reportable diseases include the following organisms: Bacillus anthracis, Bordetella spp., Brucella spp., Corynebacterium diphtheriae, Francisella tularensis, Haemophilus influenzae, Listeria monocytogenes, Neisseria meningitidis, Yersinia spp, and Vibrio spp.Availability:Monday through FridayTurnaround Time:2 days to 1 monthSample:Pure actively growing culture on suitable agar slant.Form Required:SPHL Specimen Submission Form and submitting laboratory’s work-up and results information.Shipping Requirements:Prior to transport, contact the Clinical Microbiology Laboratory for specimen category guidance and corresponding packaging and shipping ments:Additional tests recommended: Serogrouping/Serotyping of bacteria for use in epidemiological studies.????Test Name:Bacterial Culture Identification, Serotyping (Non-enteric)(N. meningitidis H. influenzae, L. pneumophila, etc.)Lab and Phone:Clinical Microbiology Laboratory 617-983-6607Use of Test:To serotype or serogroup common pathogens for use in treatment selection and/or epidemiological studies.Test Includes:Serogrouping of Neisseria meningitidis, Legionella pneumophila, and beta hemolytic Streptococcus spp.; serotyping of Haemophilus influenzae and Streptococcus pneumoniae (only isolates from sterile sources in patients ≤18 years of age.Limitations:Only done on organisms listed above.Availability:Monday through FridayTurnaround Time:1 to 3 daysSample:Submitting laboratory’s identification of Neisseria meningitidis and Haemophilus influenzae is required.Pure actively growing culture on suitable agar slant. Ship at ambient temperature.Form Required:SPHL Specimen Submission Form and submitting laboratory’s work-up and results information.Shipping Requirements:Ship as UN3373- Biological Substances, Category B.If culture is N. meningitidis, print “DO NOT REFRIGERATE” on the outside of the outer packing.Test Name:Bordetella pertussis and other Bordetella spp. CultureLab and Phone:Clinical Microbiology Laboratory 617-983-6607Use of Test:Diagnosis and confirmation of Bordetella pertussis?Culture is indicated for:1.? All patients with cough duration < 2 weeks.2.? Patients < 11 years of age with any cough duration.3.? Patients recently vaccinated with Tdap with any cough duration.?Serology is indicated for:Patients > 11 years of age with cough > 2 weeks and no recent history of Tdap.Test Includes:Isolation and identification of B. pertussis and other Bordetella species.Reference Range/ Expected Results:B. pertussis or other Bordetella species not found.?Culture positive for B. pertussis or other Bordetella species.Culture is most sensitive for specimens collected within the first 2 weeks after onset of cough. Beyond this period, false negative results become more likely.Availability:Monday through FridayTurnaround Time:3 -12 days.Sample:Charcoal transport agar slant inoculated with sample from nasopharyngeal swab, according to instructions included in the kit. Moisten swab in 1% CAS and roll over the charcoal transport slant. Submit slant for culture. Discard the nasopharyngeal swab and glass tube with the remaining 1% CAS solution as biohazard waste after use.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Sample Test Kit:SPHL Pertussis Culture kit. Instructions and all materials needed for culture are provided in the Pertussis Culture Kit. Call (617) 983-6640 to order kits.Shipping Requirements:Ship as UN-3373- Biological Substances, Category B. Same day delivery is recommended. Overnight priority mail with coolant is acceptable if sme day delivery is not possible.Test Name:Bordetella pertussis SerologyLab and Phone:Virus Serology Laboratory 617-983-6396Use of Test:To determine the presence of IgG antibody to pertussis toxin, which is consistent with an ongoing or recent infection with Bordetella pertussis.Test Includes:Serologic, single serum testing for the presence of IgG antibody to pertussis toxin.Reference Range/ Expected Results:< 20 ?g/mL IgG antibody to Bordetella pertussis toxin.Limitations:For use in patients > 11 years with cough duration 14-56 days inclusive. This test is not interpretable in children < 11 years of age and in patients who received Tdap vaccine within the preceding 3 years. Results of < 20?g/mL may occur in individuals who have pertussis, particularly if the blood is drawn < 14 days after cough onset. This test can NOT be used to evaluate immunity to pertussis.Availability:Monday through FridayTurnaround Time:2 to 14 days. Repeat testing and time of year may affect turnaround time.Sample:Serum (> 1 mL) preferred, or whole blood (5-10 mL) collected in a red top or serum separator tube (SST). Allow the blood to clot at least 30 minutes. Separate the serum if a centrifuge is available. Serum may be shipped at ambient temperature, cold or frozen. Whole blood must be maintained at 2°C - 27°C.Do not send both serology and culture specimen without prior approval.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Sample Test Kit:Single Mailing Outfit. Call (617) 983-6640 to order kits.Shipping Requirements:Ship as UN3373-Biological Substances, Category B.Test Name:Brucella, Culture and PCRLab and Phone:BioThreat Response Laboratory 617-590-6390 (24hr/7days)Call the BioThreat Response Laboratory to report when a Brucella cannot be ruled out by sentinel lab protocol. Prior to submitting specimen(s), instructions on packaging and shipping requirements will be provided.Use of Test:To detect infections caused by Brucella spp. causative agent for Bang’s disease, Malta fever, Undulant fever.Test Includes:Isolation and identification from primary specimen. Isolated organism identification.Rapid screening by PCR for presumptive identification may be performed on a case-by-case basis.Reference Range/ Expected Results:Brucella spp. not found.Brucella spp. DNA not detected by PCR.Availability:24/7 after prior consultation with BioThreat Response Laboratory.Turnaround Time:< 1 day to 3 weeks. Preliminary report may be obtained earlier.Sample:1. Primary specimen- aseptically collected bone marrow, body fluids, abscesses, exudates, whole blood (PCR only; no culture), tissue (spleen, liver) in screw-capped tube (with or without swab used to collect sample)2. Subculture- pure growing on an appropriate agar slant in a screw capped tube.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:After receiving packaging and shipping instructions, transport primary specimens or subcultures to the ments:Additional tests recommended: Brucella spp. serology.Test Name:Brucella spp., Serology (non-specific for Brucella abortus)Lab and Phone:BioThreat Response Laboratory 617-590-6390 (24hr/7days) CDC Sendout.Call the BioThreat Response Laboratory prior to submitting specimen(s), instructions on packaging and shipping requirements will be provided.Use of Test:This assay can provide presumptive evidence of brucellosis due to B. abortus, B. melitensis and B. suis.Test Includes:Brucella microagglutination test (Total Antibody and IgG Titer)Reference Range/ Expected Results:1. Serology can provide presumptive evidence of brucellosis, but laboratory confirmation requires the direct detection of Brucella spp. in the patient specimen. Serology results should be considered in combination with other clinical, laboratory, and epidemiologic findings.2. This assay does not measure antibodies to B. canis or other non-smooth (rough) types, such as B. abortus RB51, a vaccine strain deficient in LPS O-side chain.3. Cross-reactions have been observed with serum from individuals with Afipia clevelandensis, Escherichia coli 0:157, Francisella tularensis, Vibrio cholerae, Yersinia enterolitica serotype 0:9, and other antigenically related species, and especially from persons vaccinated against Vibrio cholerae.Availability:Mon-Fri, after prior consultation with BioThreat Response Laboratory.Turnaround Time:Several weeksSample:Serum, collect 5 to 10 mL of whole blood aseptically from patient. Paired serum specimens, (acute and convalescent phase) obtained at least 14 days apart should be collected. Allow blood to clot, centrifuge, and obtain the serum with a Pasteur pipette. If serum is not free of erythrocytes, clarify by centrifugation. DO NOT HEAT. Specimen must be clear and free of visible fat. It must be free of excessive hemolysis and not bacterially contaminated.Serum specimens less than or equal to 7 days from collection date should be stored and transported at 2-8oC. If shipping is delayed greater than 7 days from collection date, serum should be stored and shipped frozen.Ambient temperature shipments are also acceptable.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:Transport as UN3373- Biological Substances, Category B.Test Name:Burkholderia mallei, Culture and PCRLab and Phone:BioThreat Response Laboratory 617-590-6390 (24hr/7days)Call the BioThreat Response Laboratory to report when a Burkholderia cannot be ruled out by sentinel lab protocol. Prior to submitting specimen(s), instructions on packaging and shipping requirements will be provided.Use of Test:Rule out infection by Burkholderia mallei the causative agent of glanders.Test Includes:Isolation and identification from primary specimen. Isolated organism identification.Rapid screening by PCR for presumptive identification may be performed on a case-by-case basis.Reference Range/ Expected Results:Burkholderia mallei not found.Burkholderia mallei DNA not detected by PCR.Availability:24/7 after prior consultation with BioThreat Response Laboratory.Turnaround Time:< 1 day to 5 daysSample:1. Primary specimen - aseptically collected bone marrow, exudates, body fluids, whole blood (PCR only; no culture), tissue aspirates, urine in sterile screw capped tube (with or without swab used to collect sample) .2. Subculture- pure growing on appropriate agar slant in a screw capped tube.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:After receiving packaging and shipping instructions, transport specimen to the SPHL.Test Name:Burkholderia pseudomallei, Culture and PCRLab and Phone:BioThreat Response Laboratory 617-590-6390 (24hr/7days)Call the BioThreat Response Laboratory to when a that Burkholderia cannot be ruled out by sentinel lab protocol. Prior to submitting specimen(s), instructions on packaging and shipping requirements will be provided.Use of Test:Rule out infection by Burkholderia pseudomallei causative agent of meliodosis.Test Includes:Subculture identification Isolated organism identification.Rapid screening by (PCR) for presumptive identification may be performed on a case-by-case basis.Reference Range/ Expected Results:Burkholderia pseudomallei not found.Burkholderia pseudomallei DNA not detected by PCR.Availability:24/7 available after prior consultation with BioThreat Response Laboratory.Turnaround Time:< 1 day to 5 daysSample:1. Primary specimen- Aseptically collected bone marrow, exudates, body fluids, whole blood (PCR only; no culture), tissue aspirates, or urine in sterile screw capped tube (with or without collection swab). Throat, nasal or sputum specimens are not diagnostic, but may be used in special situations with prior consultation.2.? Subculture pure growing on appropriate agar slant in a screw capped tube.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:After receiving packing and shipping instructions, transport specimens to the SPHLTest Name:CDC Culture Identification, BacteriologyLab and Phone:Clinical Microbiology Laboratory 617-983-6607Before sending specimens, call the Clinical Microbiology Laboratory for specimen requirements for the specific organism requested.Test Includes:Primary specimen or culture isolate sent to CDC for specialized bacteria culture and/or identification procedure.Availability:Monday through FridayTurnaround Time:VariableSample:Primary specimen, or pure culture isolate sent with prior consultation with Clinical Microbiology Laboratory.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:Ship as UN3373- Biological Substances, Category B.Test Name:CDC Serology-Bacterial/FungalLab and Phone:Clinical Microbiology Laboratory 617-983-6607 Before sending specimens, call the Clinical Microbiology Laboratory for specimen requirements for the specific organism requested.Generally all fungal and parasitology specimens are referred to the CDC.Test Includes:Extensive testing menu is available for qualitative and/or quantitative assays for various bacterial and fungal organisms performed by the CDC, Atlanta, GA.Availability:Monday through Friday.Turnaround Time:2 to 4 weeks.Sample:Serum and/or cerebrospinal fluid.Call Clinical Microbiology Laboratory for specific volumes required.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:Ship as UN3373- Biological Substances, Category B.Test Name:CDC Serology ParasiticLab and Phone:Parasitology specimens are to be sent directly from the clinical lab to the CDC parasitology lab.Test Includes:Extensive testing menu is available for qualitative and/or quantitative assays for various parasitic organisms performed by the CDC, Atlanta, GA.Availability:Monday through FridayTurnaround Time:2 to 4 weeksSample:Serum and/or cerebrospinal fluid.Form Required:CDC Dash form Requirements:Ship as UN3373- Biological Substances, Category B.Call the MDPH Clinical Microbiology Lab at 617-983-6607 for questions pertaining to shippingTest Name:Coxiella burnetii, PCRLab and Phone:BioThreat Response Laboratory 617-590-6390 (24hr/7days) Call the BioThreat Response Laboratory to report that Coxiella cannot be ruled out by sentinel lab protocol. Prior to submitting specimen(s), instructions on packaging and shipping requirements will be provided.Use of Test:Rule out infection by Coxiella burnetii causative agent of Q fever.Test Includes:Rapid screening by PCR for presumptive identification will be performed on a case-by-case basis.Reference Range/ Expected Results:Coxiella burnetii DNA not detected by PCR.Availability:24/7 after prior consultation with the BioThreat Response Laboratory.Turnaround Time:< 1 to 2 daysSample:Primary specimen- blood, fluids, trans-tracheal or bronchial washings, tissue aspirates, swabs of lesions and nasopharyngeal swabs in a sterile screw-capped tube collected (with or without swab used to collect sample).Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:After receiving packaging and shipping instructions, transport specimen to the SPHL.Test Name:Diphtheria, CultureLab and Phone:Clinical Microbiology Laboratory 617-983-6607Use of Test:Rule out Corynebacterium diphtheriae as causative agent of infection.Test Includes:Culture for C. diphtheriae. Screens for C. diphtheriae only.If culture positive, the specimen will be forwarded to CDC for toxin testing.Reference Range/ Expected Results:C. diphtheriae not found.Availability:Monday through FridayTurnaround Time:24-hour preliminary report, if suspicious; final report in 3 to 4 days.SampleSwab from the inflamed areas of the membranes in throat and nasopharynx, skin lesion and material from wounds removed by swab or aspiration. Swab shipped dry in a sterile tube or in a special packet containing a desiccant such as silica gel provided by the user. A transport medium may be used if the sample is being delivered by courier the same day as collected.Form Required:SPHL Specimen Submission Form Shipping Requirements:Ship as UN3373- Biological Substances, Category B. Same day delivery is recommended.Test Name:Francisella tularensis, Culture and PCRLab and Phone:BioThreat Response Laboratory 617-590-6390 (24hr/7days) Call the BioThreat Response Laboratory to when a that Francisella cannot be ruled out by sentinel lab protocol. Prior to submitting specimen(s), instructions on packaging and shipping requirements will be provided.Use of Test:Rule out infections caused by Francisella tularensis causative agent of tularemia (Rabbit fever, Deer-fly fever).Test Includes:Isolation and identification from primary specimens. Isolated organism identification.Rapid screening by PCR for presumptive identification may be performed on a case-by-case basis.Reference Range/ Expected Results:Francisella tularensis not found.Francisella tularensis DNA not detected by PCR.Availability:24/7 after prior consultation with the BioThreat Response Laboratory.Turnaround Time:< 1 day to 7 daysSample:1.? Primary specimen- Aseptic collection of lesion, tissue biopsy and aspirate (lymph node, spleen, liver), whole blood (PCR only; no culture), sputum, tracheal, pleural aspirates. in a sterile screw cap tube (with or without swab used to collect sample)2.? Subculture pure growing on appropriate agar slant in a screw capped tube.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:After receiving packaging and shipping instructions, transport specimen to the ments:Additional tests recommended: Francisella tularensis serology.Test Name:Francisella tularensis, SerologyLab and Phone:BioThreat Response Laboratory 617-590-6390 (24hr/7days)CDC Sendout.Call the BioThreat Response Laboratory prior to submitting specimen(s), instructions on packaging and shipping requirements will be provided.Use of Test:To perform Francisella tularensis presumptive or confirmatory testing on human and/or suspect mammalian serum samples. Results may be used for purposes of confirming exposure (infection and vaccination) and serosurveillance studies. Causative agent of tularemia (Rabbit fever, Deer-fly fever).Test Includes:Quantitative microagglutination test for assaying titer of homologous agglutinins.Reference Range/ Expected Results:1.? Single serum specimen with a titer greater or equal to 1:128 is reported as a presumptive positive reaction to F. tularensis.2.? Paired (from same source) serum specimens taken greater or equal to 14 days apart giving a greater or equal to 4 fold increase or decrease in titer, with at least 1 titer being greater or equal to 1:128, is reported as confirmed for F. tularensis reaction.A negative result does not preclude an active infection. Conversely, a positive result may not be diagnostic since the serum may exhibit a rise in heterologous agglutinins due to a different febrile infection.Limitations:This test is useful for screening purposes but should not be used as a substitute for conventional isolation and identification.1.? The test results are determined by subjective reading.2.? Non-specific cross-reactivity with Brucella spp. And Legionella spp. antigens have been reported.3.? This test does not differentiate between early and late antibody response. Seroreactivity, including IgM antibodies, may last for years after initial exposure.Availability:Monday- Friday after prior consultation with BioThreat Response LaboratoryTurnaround Time:Several weeks.Sample:Serum, collect 5 to 10 mL of whole blood aseptically from patient. Paired serum specimens, (acute and convalescent phase) obtained at least 14 days apart should be collected. Allow blood to clot, centrifuge, and obtain serum with a Pasteur pipette.If serum is not free of erythrocytes/hemolysis, clarify by re-centrifugation. DO NOT HEAT. Serum must be clear and free of visible fat. It must be free of excessive hemolysis and not bacterially contaminated.Serum specimens less than or equal to 7 days from collection date should be stored and transported at 2-8oC. If shipping is delayed greater than 7 days from collection date, serum should be stored and shipped frozen. Ambient temperature shipments are also acceptable.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:After receiving packaging and shipping instructions, transport specimen to the SPHL as UN3373 Biological substances, Category B.”Comments:Additional tests recommended: Francisella tularensis culture and PCRTest Name:Haemophilus influenzae CultureLab and Phone:Clinical Microbiology Laboratory 617-983-6607Use of Test:To serotype isolate for use in treatment selection and/or epidemiological studies.Test Includes:Serotyping of Haemophilus influenzae.Limitations:Testing performed only on organisms isolated from normally sterile sites unless prior consultation is arranged.Availability:Monday through FridayTurnaround Time:1 to 2 daysSample:Prior correct identification of Haemophilus influenzae is required. Pure young culture on chocolate agar slant.Ship at room temperature.Form Required:SPHL Specimen Submission Form, complete "Additional Patient Information" section.Shipping Requirements:Ship as UN3373 - Biological Substances, Category BMark "DO NOT REFRIGERATE" on outside of package.Test Name:Legionella CultureLab and Phone:Clinical Microbiology Laboratory 617-983-6607Use of Test:Confirm diagnosis of Legionnaire’s Disease in the acute phase of illness.Test Includes:Primary isolation and identification of Legionella spp. from lung tissue, pleural fluid, trans-tracheal aspirate, and lower respiratory secretions (sputum bronchial wash etc.).Subculture identification, confirmation, and serogrouping. Soluble antigen studies on all specimens are not offered.Reference Range/ Expected Results:Legionella not found.Availability:Monday through FridayTurnaround Time:4 to 10 daysSample:Lung tissue, pleural fluid, trans-tracheal aspirate, and lower respiratory secretions (sputum bronchial wash etc.). Sputum, trans-tracheal aspirate and lung tissue have the highest yield. Pleural fluid has the lowest yield.Collect pea-sized piece of tissue or 5-30 mL of secretions. Specimens should be held at 4-8° C and should not be allowed to dry out. Add a small amount of sterile distilled water to lung tissue if necessary. Do not use sterile saline for specimen collections as Legionella spp. are inhibited by saline.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Sample Test Kit:Legionella Specimen Kit. To order, call 617-983-6640.Shipping Requirements:Same day transport by courier is recommended. If same day transport is not possible, freeze the specimen and send it overnight priority mail in dry ice. Ship as UN3373- Biological Substances, Category ments:Additional testing: Legionella serology.Test Name:Listeria monocytogenes CultureLab and Phone:Clinical Microbiology Laboratory 617-983-6607Use of Test:Epidemiological studies.Test Includes:Isolated organism identification.Availability:Monday through FridayTurnaround Time:3 to 7daysSample:Pure, actively growing culture on agar slant.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:Ship as UN3373- Biological Substances, Category B.Test Name:Malaria, Direct SmearLab and Phone:Virus Isolation Laboratory 617-983-6382/6853Samples are sent to CDC. Contact laboratory prior to collecting or shipping specimens to the Public Health Laboratory.Use of Test:Diagnosis of malaria, rule out other causative organisms.Test Includes:Examination of blood smears.Availability:Monday through FridayTurnaround Time:2 to 4 weeksSample:Thick and thin peripheral blood smearsForm Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:Ship as UN3373- Biological Substances, Category ments:Malaria serology is available as a CDC send out. Call Virus Isolation Laboratory for specimen submission informationTest Name:Meningitis (Neisseria meningitidis) Confirmation and SerogroupingLab and Phone:Clinical Microbiology Laboratory 617-983-6607Use of Test:To serogroup isolate for use in treatment selection and/or epidemiological studies.Test Includes:Serogrouping of Neisseria meningitidis.Limitations:Testing performed only on organisms isolated from normally sterile sites unless prior consultation is arranged.Availability:Monday through FridayTurnaround Time:1 to 2 daysSample:Prior correct identification of Neisseria meningitidis is required. Pure young isolate on agar slant. Do not refrigerate during transport.Form Required:SPHL Specimen Submission FormShipping Requirements:Ship as UN3373- Biological Substances, Category B. Mark “DO NOT REFRIGERATE” on outside of package.Test Name:Mycoplasma pneumoniae Antibody IgMLaband Phone:Virus Serology Laboratory 617-983-6396Use of Test:Diagnosis of current Mycoplasma pneumoniae infection.Test Includes:M. pneumoniae IgM EIA AssayReference Range/ Expected Results:Presence of IgM indicates recent or current infection.Limitations:If testing a particular specimen occurs early during the primary infection, no detectable IgM may be evident and a second sample may be requested.Availability:Monday through FridayTurnaround Time:3 to 5 daysSample:2 mL of serumAcute sample collected within 7 days after onset. Convalescent serum at least 14 days after onset.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Test Name:Staphylococcus aureus, Streptococcus pyogenes Culture for Toxin TestingLab and Phone:Clinical Microbiology Laboratory 617-983-6607If S. aureus stool culture on food handlers is desired, prior consultation is required by calling laboratory.Use of Test:To determine if isolate is responsible for Toxic Shock Syndrome or a “flesh eating” Group A Streptococcus.Test Includes:Confirmation of S. aureus and S. pyogenes and submitted to the CDC for toxin testing on cultures that are confirmed with prior consultation.Limitations:Foods will be examined for S.aureus only if the clinical and epidemiologic information is compatible with S.aureus foodborne disease.Availability:Monday through FridayTurnaround Time:3 weeks to several monthsSample:Pure culture on an agar slant. Ship at ambient temperature.Form Required:SPHL Specimen Submission FormShipping Requirements:Ship as UN3373- Biological Substances, Category B.Test Name:Streptococcus pneumoniae SerotypingLab and Phone:Clinical Microbiology Laboratory 617-983-6607Consult with Reference Bacteriology at 617-983-6607 for CDC referral.Use of Test:To determine serotype of S. pneumoniae isolates from usually sterile sites from patients ≤ 18 years. For surveillance purposes.Test Includes:Serotyping of S. pneumoniae at Boston Medical Center.Limitations:S. pneumoniae isolates from usually sterile sites from patients ≤ 18 years.Availability:Monday through FridayTurnaround Time:3 weeks to several months.Sample:Pure culture on an agar slant.Test Name:Yersinia pestis, Culture and PCRLab and Phone:BioThreat Response Laboratory 617-590-6390 (24hr/7days) Call the BioThreat Response Laboratory to report when a Yersinia cannot be ruled out by sentinel lab protocol. Prior to submitting specimen(s), instructions on packaging and shipping requirements will be provided.Use of Test:Rule out infection by Yersinia pestis causative agent of Plague (Bubonic and Pneumonic).Test Includes:Isolation and identification from primary specimen. Isolated organism identification..Rapid screening by PCR for presumptive identification may be performed on a case-by-case basis.Reference Range/ Expected Results:Yersinia pestis not found.Yersinia pestis DNA not detected by PCR.Availability:24/7 after prior consultation with the BioThreat Response Laboratory.Turnaround Time:< 1 to 5 daysSample:1.? Primary specimen- Aseptically collected tissue biopsy or aspirates (lymph node, bone marrow, spleen, liver, lung); whole blood, bronchial wash and trans-tracheal aspirates (>1mL) in a sterile screw-capped tube (with or without swab used to collect sample).Sputum not recommended due to contamination by normal flora.2.?? Subculture pure growing on appropriate agar slant in a screw capped tube.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:After receiving packaging and shipping instructions, transport specimen to the SPHL.BACTERIAL STITest Name:Chlamydia trachomatis and Neisseria gonorrhoeae (CT/GC) Nucleic Acid Amplification Test (NAAT)Lab and Phone:STI Laboratory 617-983-6372 Testing performed for pre-approved program sites only.Use of Test:Screening of individuals at risk for sexually transmitted infections (STI’s) Test Includes:Nucleic acid amplification test (NAAT)Reference Range/ Expected Results:Negative CT/GC: RNA not detected.Limitations:Testing only performed as a dual CT/GC assay. CT only or GC only cannot be performed.NAAT is not appropriate for medico-legal cases. Testing of specimens with methods for medico-legal purposes is not performed at the MA State Public Health Laboratory. NAAT is not recommended for post-treatment assessment (test-of-cure).Availability:Monday through FridayTurnaround Time:7 daysSample:Urine: must be submitted in approved UPT tube provided with collection kit.Vaginal swabs: clinician or self-collected. *Endocervical swabs: must be clinician collected.Rectal swabs: clinician or self-collected. *Phanyngeal swab: clinician collected. ** Submitted only by agencies pre-approved for this specimen type.Form Required:CT/GC Specimen Submission Form with appropriate 2D barcode required. Forms are completed electronically via training protocol provided by the Office of HIV/AIDS.Sample Test Kit:Single or Multiple Mailing or Courier kits for transport of swab and urine samples.Call 617-983- 6389 to order kits.Shipping Requirements:Ship as UN3373-Biological Substances, Category B. Specimens must be shipped on day of specimen collection to laboratory via UPS CampusShip or approved courier, and received by laboratory within 1 week post collection.Test Name:Gonorrhea (Neisseria gonorrhoeae) CultureLab and Phone:Clinical Microbiology Laboratory 617-983-6607 Testing on primary cultures is available only on specimens from assigned clinics. Assigned clinics are specific sites selected to monitor disease prevalence throughout Massachusetts.Use of Test:Screening and confirmation of Neisseria gonorrhoeae.Test Includes:Isolation and identification of Neisseria species recovered from primary specimens or isolates. Isolates of Neisseria gonorrhoeae are tested for susceptibility to ceftriaxone, ciprofloxacin, and other antibiotics.Genus and species identification will be performed for any Neisseria species submitted as suspect for Neisseria gonorrhoeae.Limitations:Culture is limited by the quality of the specimen obtained and the handling of the specimen prior to receipt in the laboratory.Availability:Monday through FridayTurnaround Time:1 to 5 daysSample:Swabs of affected areas streaked on Thayer Martin selective agar in a "Z" pattern (covering up to half of the plate), then cross-streaked, and incubated at 35°-36°C under 2-10% CO2 for a minimum of 16 hours before transport. Cultures should be maintained in a CO2 environment (candle extinction jar, Gonopak, etc).Referred isolates: subcultured on Thayer Martin slant. Ship presumptive positive specimens at ambient temperatureForm Required:SPHL Specimen Submission FormShipping Requirements:Transport by same day courier, or by carrier to arrive the next day as UN3373- Biological Substances, Category B.Test Name:Syphilis, Treponemal AssayLab and Phone:STI Laboratory 617-983-6372Testing performed for pre-approved program sites only.Use of Test:Screening for syphilis. To detect treponemal antibodies.Will only be tested as part of integrated testing along with HIV and Hepatitis C.Test Includes:Qualitative screening for treponemal antibodiesReference Range/ Expected Results:Non-reactiveLimitations:Availability:Monday to FridayTurnaround Time:7 daysSample:Samples must be collected in 2 x 8.5 mL SST, spun prior to submission.Form Required:HIV/HCV - Syphilis Specimen Submission Form with appropriate 2D barcode required. Forms are completed electronically via training protocol provided by the Office of HIV/AIDS.Sample Test Kit:Single or Multiple Mailing or Courier kits. Call 671-983-6389 to order kits.Shipping Requirements:Ship as UN3373-Biological Substances, Category B. Specimens must be shipped on day of specimen collection to laboratory via UPS CampusShip or approved courier, and received by the laboratory within 48 hours post ments:Positive results will reflex to RPR or TP-PA when indicated.Test Name:Rapid Plasma Reagin Card Test (RPR), Non-treponemal Syphilis SerologyLab and Phone:STI Laboratory 617-983-6614Use of Test:To detect non-treponemal (reagin) antibodies. This test is also used to quantitate levels of non-treponemal antibodies to monitor efficacy of syphilis treatment.Test Includes:Qualitative screening for syphilis. Quantitative testing performed only on positive RPR.Reference Range/ Expected Results:Non-reactiveLimitations:Yaws, pinta, and other treponemal diseases may cause a reactive RPR. False positive RPR results may occur in specimens from persons with autoimmune disease or other conditions. Persons treated during latent or late stages of syphilis may remain seropositive. Prozone reactions can occur in the screening tests and may result in false negative results.Availability:Monday through FridayTurnaround Time:7 daysSample:Serum (> 3 mL) is preferred. Alternatively, 5-10 mL whole blood in a red top or serum separator tube. Allow blood to clot at least 30 minutes before centrifuging. Serum may be shipped at room temperature, cold or frozen. Whole blood must be maintained at 2°C - 27°C.The RPR test cannot be used with cerebrospinal fluid (CSF). For CSF test requests, order VDRL test instead.Form Required:SPHL Specimen Submission FormSample Test Kit:Single or Multiple Mailing or Courier kit. Call 617-983-6389 to order kits.Shipping Requirements:Ship as UN3373- Biological Substances, Category B. Send to laboratory as soon as possible post ments:For pre-approved program sites, refer to Syphilis, Treponemal Assay Test Name:Syphilis VDRL, Cerebrospinal Fluid (CSF)Lab and Phone:STI Laboratory 617-983-6372Use of Test:To provide serologic evidence of neurosyphilis.Test Includes:Qualitative screening of non-treponemal antibodies in spinal fluid. Quantitative titers are performed on positive screening samples.Reference Range/ Expected Results:Non-reactiveA negative result can occur in some neurosyphilis patients.Limitations:Small amounts of blood or serum may cause a false positive result.Availability:Once per weekTurnaround Time:10 daysSample:Cerebrospinal Fluid only. Submit 1 to 3 mL of cerebrospinal fluid from a lumbar puncture. Use leakproof tubes with securely closed tops.Form Required:SPHL Specimen Submission FormSample Test Kit:Single or Multiple Mailing or Courier Kit. Call 617-983-6389 to order kits.Shipping Requirements:Ship as UN3373-Biological Substances, Category B. Ship at ambient temperatures as soon as possible post collection or frozen at -20C.Test Name:Treponema pallidum Particle Agglutination Antibody (TP-PA)Lab and Phone:STI Laboratory 617-983-6372Use of Test:Detection of antibodies to Treponema pallidum. Test is used for confirmation of specimens that are reactive on RPR or other non-treponemal tests.Test Includes:Detection of antibodies to Treponema pallidum.Reference Range/ Expected Results:Non-reactiveLimitations:False positives may occur in a small percentage of healthy individuals. Positives may occur in individuals from areas where yaws or pinta was/is endemic.Note: Treponemal test results may remain positive for life and cannot be used to evaluate response to treatment or confirm reinfection.Availability:Monday through FridayTurnaround Time:1 to 5 daysSample:Serum (> 3 mL) is preferred. Alternatively, 5-10 mL whole blood in a red top or serum separator tube. Allow blood to clot at least 30 minutes before centrifuging. Serum may be shipped at room temperature, cold or frozen. Whole blood must be maintained at 2°C - 27°C.Form Required:SPHL Specimen Submission FormSample Test Kit:Single or Multiple Mailing or Courier kit. Call 617-983-6389 to order kits.Shipping Requirements:Ship as UN3373- Biological Substances, Category B. Send to laboratory as soon as possible post ments:For pre-approved program sites, refer to Syphilis, Treponemal AssayCHEMICAL ILLNESSTest Name:Abrine and Ricinine, UrineLab and Phone:Chemical Threat Laboratory 617-839-1283 (24hr/7days) Call the Chemical Threat Laboratory for guidance on submitting clinical urine specimens for the presence of abrine or ricinine. Prior to submitting specimen(s), instructions on packaging and shipping requirements will be provided.Use of Test:To measure acute exposure to abrin or ricin by analyzing for the biomarkers, abrine and ricinine, respectively.Method of Analysis:Solid Phase Extraction Liquid Chromatography - Tandem Mass Spectrometry (LC-MS/MS)Turnaround Time:5 working daysSampling Instructions:Call the Chemical Threat Laboratory for sampling and storage guidelines.Form Required:Chemical Exposure Clinical Specimen FormShipping Requirements:Call the Chemical Threat Laboratory for packaging and shipping instructions and to coordinate specimen transport to the ments:Further characterization or identification may be performed at the discretion of the laboratory and/or after consultation with the CDC.Test Name:Arsenic, WaterLab and Phone:Environmental Chemistry Laboratory 617-983-6657/6654Use of Test:To measure arsenic in drinking water as a possible source of exposure.Method of Analysis:Acid digestion followed by graphite furnace atomic absorption spectroscopy.Reference Range/ Expected Results:< 15 ?g /LAvailability:Monday through FridayTurnaround Time:7 to 10 working daysSample:Three 1000 mL compliance samples, collected over time, (standing, two minutes running and five minutes running).Form Required:Drinking Water Submission Form containing documentation of provider, occupant, water source, and exact location of tap.To order, call 617-983-6654.Sample Test Kit:Arsenic sample collection kit. EPA approved containers packaged for chain-of- custody supplied by laboratory. Each kit includes 3 containers for collection of compliance and instructions for collecting compliance samples. To order, call 617-983-6654Shipping Requirements:Secure covers to containers to prevent any leakage. Ship to laboratory in carton provided within 10 days of collection. Carton must have labels of orientation and handling to ensure safe delivery.Test Name:Cyanide, Whole BloodLab and Phone:Chemical Threat Laboratory 617-839-1283 (24hr/7days) Call the Chemical Threat Laboratory for guidance on submitting clinical specimens (whole blood) for the presence of cyanide. Prior to submitting specimen(s), instructions on packaging and shipping requirements will be provided.Use of Test:To measure acute exposure to cyanideMethod of Analysis:Headspace Gas Chromatography/Mass Spectrometry (GC/MS)Turnaround Time:5 working daysSampling Instructions:Call the Chemical Threat Laboratory for sampling, storage and transport procedures.Form Required:Chemical Exposure Clinical Specimen FormShipping Requirements:Call the Chemical Threat Laboratory for packaging and shipping instructions and to coordinate specimen transport to the ments:Further characterization or identification may be performed at the discretion of the laboratory and/or after consultation with the CDC.Test Name:Lead, WaterLab and Phone:Environmental Chemistry Laboratory 617-983-6654Use of Test:To measure lead in drinking water as a possible source of exposure.Method of Analysis:Acid extraction followed by Inductively Coupled Plasma Mass Spectrometry.Reference Range/ Expected Results:< 15 ?g /LAvailability:Monday through FridayTurnaround Time:7 to 10 working daysSample:Three compliance samples, collected over time, (standing, two minutes running and five minutes running).Form Required:Drinking Water Submission Form containing documentation of provider, water source, and exact location of tap.To order, call 617-983-6654.Sample Test Kit:Lead sample collection kit. EPA approved containers packaged for chain-of- custody supplied by laboratory. Each kit includes 3 containers for collection of compliance and instructions for collecting compliance samples. To order, call 617-983-6654.Shipping Requirements:Secure covers to containers to prevent any leakage. Ship to laboratory in carton provided within 10 days of collection. Carton must have labels of orientation and handling to ensure safe delivery.Fee:$ 80.00 per kit. Testing fees are waived for families of lead poisoned children.Test Name:Lead, Whole BloodLab and Phone:Childhood Lead Screening Laboratory 617-983-6665Use of Test:Identification and monitoring of children with elevated lead body burden.Test Includes:Graphite furnace atomic absorption spectroscopy.Reference Range/ Expected Results:Children 0 to 5 ?g/dL Adults 0 to 40 ?g /dLAvailability:Monday through FridayTurnaround Time:1-2 working daysForm Required:Childhood Lead Screening Specimen Submission FormSamples:Call 617-983-6665 for collection instructions.?Capillary fingerstick - 150 ?L whole blood; collect with EDTA. EDTA is the preferred anticoagulant. Heparin is also acceptable. Place biohazard label on microcuvette.?Venous blood - 2 mL of whole blood collected in EDTA (lavender top tube). EDTA is the preferred anticoagulant. Heparin (green top tube) is also acceptable. Place biohazard label on blood tube.Sample Test Kits:Call 617-983-6665 to order kits for:Capillary fingerstick- Microcuvette capillary collection system with EDTA and specimen collection instructions.Shipping Requirements:Keep samples refrigerated before submitting. Avoid exposing samples to extreme temperatures during shipping. Ship as Exempt Human Specimens.Test Name:Lewisite Metabolite, UrineLab and Phone:Chemical Threat Laboratory 617-839-1283 (24hr/7days) Call the Chemical Threat Laboratory for guidance on submitting clinical urine specimens for the presence of lewisite metabolite. Prior to submitting specimen(s), instructions on packaging and shipping requirements will be provided.Use of Test:To measure acute exposure to lewisite by analyzing for the presence of the lewisite metabolite: 2- chlorovinylarsonous acid in urine.Method of Analysis:Liquid Chromatography - Inductively Coupled Plasma / Mass Spectrometry (LC- ICP/MS)Turnaround Time:5 working daysSampling Instructions:Call the Chemical Threat Laboratory for sampling, storage and transport procedures.Form Required:Chemical Exposure Clinical Specimen FormShipping Requirements:Call the Chemical Threat Laboratory for packaging and shipping instructions and to coordinate specimen transport to the ments:Further characterization or identification may be performed at the discretion of the laboratory and/or after consultation with the CDC.Test Name:Mercury, UrineLab and Phone:Environmental Chemistry Laboratory 617-983- 6657/6654Use of Test:To measure acute mercury exposure in urine.Method of Analysis:Extraction followed by flow injection atomic spectroscopy.Reference Range/ Expected Results:< 5 ?g /g creatinineToxic Concentration:>35 ?g /g creatinineAvailability:Call the laboratory prior to sample submission for test availability and turn around times.Turnaround Time:1-10 working days.Sample:100 mL urine. Use trace metal free urine specimen collection container. Submit single first void sample, or an aliquot of a 24-hour urine collection. For 24-hour collection, measure total volume and record the volume on required laboratory form. Mix urine well, then pour off an aliquot to submit to the SPHL. Sample must be submitted to the laboratory for preservation within 24 hours of collection. Secure container to avoid sample loss.?Call 617-983-6654 for sampling instructions and container.Form Required:SPHL Specimen Submission Form, complete the “Additional Patient Information” section.Shipping Requirements:Keep sample refrigerated until submitted. Secure container to avoid sample loss. Ship as Exempt Human Specimen.Test Name:Nitrogen Mustard Metabolites, UrineLab and Phone:Chemical Threat Laboratory 617-839-1283 (24hr/7days) Call the Chemical Threat Laboratory for guidance on submitting clinical urine specimens from patients with suspected exposure to nitrogen mustard. Prior to submitting specimen(s), instructions on packaging and shipping requirements will be provided.Use of Test:To measure acute exposure to nitrogen mustard by analyzing for the N- ethyldiethanolamine (EDEA) and N-methyldiethanolamine (MDEA) metabolites in urine.Method of Analysis:Solid Phase Extraction Liquid Chromatography - Tandem Mass Spectrometry (LC-MS/MS)Turnaround Time:5 working daysSampling Instructions:Call the Chemical Threat Laboratory for sampling, storage and transport procedures.Form Required:Chemical Exposure Clinical Specimen FormShipping Requirements:Call the Chemical Threat Laboratory for packaging and shipping instructions and to coordinate specimen transport to the ments:Further characterization or identification may be performed at the discretion of the laboratory and/or after consultation with the CDC.Test Name:Organophosphate Nerve Agent Metabolites, UrineLab and Phone:Chemical Threat Laboratory 617-839-1283 (24hr/7days) Call the Chemical Threat Laboratory for guidance on submitting clinical urine specimens from patients with suspected exposure to organophosphate nerve agents such as sarin, soman, cyclosarin, Russian VX, and VX. Prior to submitting specimen(s), instructions on packaging and shipping requirements will be provided.Use of Test:To measure acute exposure to the nerve agents sarin, soman, cyclosarin, Russian VX, and VX by analyzing for the presence of esters of the methylphosphonic acid metabolites for each agent in urine.Method of Analysis:Solid Phase Extraction Liquid Chromatography - Tandem Mass Spectrometry (LC-MS/MS)Turnaround Time:5 working daysSampling Instructions:Call the Chemical Threat Laboratory for sampling, storage and transport procedures.Form Required:Chemical Exposure Clinical Specimen FormShipping Requirements:Call the Chemical Threat Laboratory for packaging and shipping instructions and to coordinate specimen transport to the ments:Further characterization or identification may be performed at the discretion of the laboratory and/or after consultation with the CDC.Test Name:Sulfur Mustard Metabolite, UrineLab and Phone:Chemical Threat Laboratory 617-839-1283 (24hr/7days) Call the Chemical Threat Laboratory for guidance on submitting clinical urine specimens from patients with suspected exposure to sulfur mustard (“mustard gas”). Prior to submitting specimen(s), instructions on packaging and shipping requirements will be provided.Use of Test:To measure acute exposure to sulfur mustard by analyzing for the presence of the 1,1-sulfonylbis-[2-methylthio] ethane (SBMTE) metabolite in urine.Method of Analysis:Solid Phase Extraction Liquid Chromatography - Tandem Mass Spectrometry (LC-MS/MS)Turnaround Time:5 working daysSampling Instructions:Call the Chemical Threat Laboratory for sampling, storage and transport procedures.Form Required:Chemical Exposure Clinical Specimen FormShipping Requirements:Call the Chemical Threat Laboratory for packaging and shipping instructions and to coordinate specimen transport to the ments:Further characterization or identification may be performed at the discretion of the laboratory and/or after consultation with the CDC.Test Name:Tetramine, UrineLab and Phone:Chemical Threat Laboratory 617-839-1283 (24hr/7days) Call the Chemical Threat Laboratory for guidance on submitting clinical urine specimens from patients with suspected exposure to tetramine. Prior to submitting specimen(s), instructions on packaging and shipping requirements will be provided.Use of Test:To measure acute exposure to (Tetramine) tetramethylene disulfotetramine in urine.Method of Analysis:Solid-Phase Extraction Gas Chromatography / Mass Spectrometry (GC/MS)Turnaround Time:5 working daysSampling Instructions:Call the Chemical Threat Laboratory for sampling, storage and transport procedures.Form Required:Chemical Exposure Clinical Specimen FormShipping Requirements:Call the Chemical Threat Laboratory for packaging and shipping instructions and to coordinate specimen transport to the ments:Further characterization or identification may be performed at the discretion of the laboratory and/or after consultation with the CDC.Test Name:Tetranitromethane Metabolite (HNPAA), UrineLab and Phone:Chemical Threat Laboratory 617-839-1283 (24hr/7days) Call the Chemical Threat Laboratory for guidance on submitting clinical urine specimens from patients with suspected exposure to tetranitromethane.Prior to submitting specimen(s), instructions on packaging and shipping requirements will be provided.Use of Test:To measure acute exposure to tetranitromethane by analyzing for the 4-hydroxy 3-nitrophenylacetic acid (HNPAA) metabolite in urine.Method of Analysis:Liquid Chromatography - Tandem Mass Spectrometry (LC-MS/MS)Turnaround Time:5 working daysSampling Instructions:Call the Chemical Threat Laboratory for sampling, storage and transport procedures.Form Required:Chemical Exposure Clinical Specimen FormShipping Requirements:Call the Chemical Threat Laboratory for packaging and shipping instructions and to coordinate specimen transport to the ments:Further characterization or identification may be performed at the discretion of the laboratory and/or after consultation with the CDC.Test Name:Trace Metals, UrineLab and Phone:Chemical Threat Laboratory 617-983-6657Use of Test:To measure acute exposure to any or all of the following: arsenic, barium, beryllium, cadmium, lead, thallium, and uranium by detection in urine.Method of Analysis:Inductively Coupled Plasma/ Mass Spectrometry (ICP/MS)Turnaround Time:5 working daysSampling Instructions:Call the Chemical Threat Laboratory for sampling, storage and transport procedures.Form Required:Chemical Exposure Clinical Specimen FormShipping Requirements:Call the Chemical Threat Laboratory for packaging and shipping instructions and to coordinate specimen transport to the ments:Trace metal levels in urine are corrected for creatinine, if requested.Test Name:Trace Metals, Whole BloodLab and Phone:Chemical Threat Laboratory 617-839-1283 (24hr/7days) Call the Chemical Threat Laboratory for guidance on submitting clinical specimens (whole blood) from patients with suspected exposure to cadmium, lead, and mercury. Prior to submitting specimen(s), instructions on packaging and shipping requirements will be provided.Use of Test:To measure acute exposure to any or all of the following: cadmium, lead, and mercuryMethod of Analysis:Inductively Coupled Plasma / Mass Spectrometry (ICP/MS)Turnaround Time:5 working daysSampling Instructions:Call the Chemical Threat Laboratory for sampling, storage and transport procedures.Form Required:Chemical Exposure Clinical Specimen FormShipping Requirements:Call the Chemical Threat Laboratory for packaging and shipping instructions and to coordinate specimen transport to the ments:Further characterization or identification may be performed at the discretion of the laboratory and/or after consultation with the CDC.Test Name:Unknown powders/liquidsLab and Phone:Chemical Threat Laboratory 617-839-1283 (24hr/7days) Call the Chemical Threat Laboratory for guidance on submitting unknown environmental powders and liquids for identification. Prior to submitting specimen(s), instructions on packaging and shipping requirements will be provided.Use of Test:To identify unknown drugs, toxic or household compounds in suspect powdersMethod of Analysis:FTIR, RAMAN, GC-MS, and or XRDTurnaround Time:2 daysSampling Instructions:Call the Chemical Threat Laboratory for sampling, storage and transport procedures.Form Required:Biological/Chemical Specimen Specimen FormShipping Requirements:Call the Chemical Threat Laboratory for packaging and shipping instructions and to coordinate specimen transport to the ments:Some samples may be triaged to the Chemical Threat Laboratory following screening for the presence of biological agents by the BioThreat Response Laboratory (617-590-6390 (24hr/7days)). Further characterization or identification may be performed at the discretion of the laboratory and/or after consultation with the CDC.Test Name:Volatile Organic Compounds, Whole BloodLab and Phone:Chemical Threat Laboratory 617-839-1283 (24hr/7days) Call the Chemical Threat Laboratory for guidance on submitting clinical samples (whole blood) for exposure to one or more of the following: 1,2- dichloroethane, benzene, carbon tetrachloride, chloroform, ethylbenzene, m- & p-xylene, o-xylene, styrene, tetrachloroethylene, and toluene. Prior to submitting specimen(s), instructions on packaging and shipping requirements will be provided.Use of Test:To measure acute exposure to 1,2-dichloroethane, benzene, carbon tetrachloride, chloroform, ethylbenzene, m- & p-xylene, o-xylene, styrene, tetrachloroethylene, and/or toluene in whole blood.Method of Analysis:Solid Phase Micro-extraction Gas Chromatography/Mass Spectrometry (SPME GC/MS)Turnaround Time:5 working daysSampling Instructions:Call the Chemical Threat Laboratory for sampling, storage and transport procedures.Form Required:Chemical Exposure Clinical Specimen FormShipping Requirements:Call the Chemical Threat Laboratory for packaging and shipping instructions and to coordinate specimen transport to the ments:Further characterization or identification may be performed at the discretion of the laboratory and/or after consultation with the CDC.FOODBORNE ILLNESSTest Name:Bacterial Typing, Pulsed Field Gel Electrophoresis (PFGE)Lab and Phone:PFGE Laboratory 617-983-6612Use of Test:To determine if enteric and other isolates from different sources (i.e., patient and environmental isolates) may have a common origin. All isolates of Salmonella spp., Shigella spp, shiga-toxigenic E. coli, and Listeria monocytogenes are routinely analyzed by PFGE. Other isolates are analyzed as needed for outbreak investigations.Test Includes:Bacterial strain typing using restriction endonuclease digestion of bacterial chromosomal DNA.Reference Range/ Expected Results:Isolates with matching PFGE patterns require supporting epidemiologic data to support related ness.Availability:Monday through Friday. Prior approval required for isolates other than Salmonella, Shigella, and STEC.Turnaround Time:1 week for pure cultures. Turnaround time is delayed if the isolate submitted is in mixed culture.Sample:Pure actively growing isolate on suitable agar slant. Transport at ambient temperature.Form Required:SPHL Specimen Submission Form, and submitting laboratory’s work-up and results.Shipping Requirements:Depending on the organism, ship asUN3373-Biological Substances, Category B or UN2814- Infectious Substances, Category A.Call the PFGE Laboratory for specimen shipping category information.Test Name:Botulism Culture, Stool, Food, or Reference CultureLab and Phone:All botulism testing must be approved by the MDPH Bureau of Infectious Disease617-983-6800Call the BioThreat Response Laboratory to arrange for submission of samples. 617-590-6390Use of Test:For clinical diagnosis of botulism or infant botulism.Test Includes:Culture for Clostridium botulinum.Confirmatory methods include ELISA, PCR and MALDI-TOF.Contraindications:Test is performed only on patients who exhibit neurological symptoms suggestive of botulism or infant botulism, on patients who have consumed food suspected to contain botulinum toxin, or on foods highly suspected to contain botulinum toxin.Availability:24/7 after prior consultation with MDPH Bureau of Infectious Disease.Turnaround Time:Minimum 1 week.Sample:Sufficient specimen amount must be submitted. DO NOT FREEZE.Stool- 25 to 50 grams (no preservative needed).Food- 25 to 200 grams preferred. Sterile, leakproof container and insulated box with coolant.Reference culture- pure isolate in screw-capped tube.Form Required:Stool- SPHL Specimen Submission Form, complete “Additional Patient Information” section.Food Environmental Sample Submission Form Clinical Microbiology culture- SPHL Specimen Submission Form, and submitting laboratory’s work-up and results.Shipping Requirements:Shipment by courier as soon as possible. If overnight, use coolant such as prefrozen gel packs. DO NOT FREEZE.Ship as UN3373- Biological Substances, Category B.Test Name:Botulism Toxin, SerumLab and Phone:All botulism testing must be approved by the MDPH Bureau of Infection Disease 617-983-6800Call the BioThreat Response Laboratory to arrange for submission of samples. 617-590-6390Use of Test:For clinical diagnosis of botulism or infant botulism.Test Includes:Clostridium botulinum neurotoxins A through G by PCR.Contraindications:Assay performed only on patients who exhibit neurological symptoms suggestive of botulism or infant botulism or on patients who have consumed food suspected to contain botulinum toxin.Availability:24/7 after prior consultation with MDPH Bureau of Infectious Disease.Turnaround Time:Minimum 1 week.Sample:Sufficient specimen amount must be submitted, ie, 10 to 15 mL of serum. Keep refrigerated. DO NOT FREEZE.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:Shipment by courier as soon as possible. If overnight, ship with coolant such as prefrozen gel packs. DO NOT FREEZE.Ship as UN3373- Biological Substances, Category ments:Additional tests recommended: Botulism Culture, Stool, Food, or Reference CultureTest Name:Enteric Pathogens, Culture FoodLab and Phone:Food Bacteriology Laboratory 617-983-6610 Food samples must be submitted through local or state public health agencies and implicated in an outbreak (one or more ill consumers). Call the Food Protection Program at 617-983-6712 prior to submission.Use of Test:To associate a food source with human illness.Test Includes:Isolation and identification of enteric pathogens (including Salmonella spp, Shigella spp, shiga-toxin-producing E. coli, Listeria monocytogenes, Campylobacter spp) .Limitations:Foods will be examined only if the clinical and epidemiologic information is compatible with enteric foodborne disease.Availability:Monday through FridayTurnaround Time:3 to 14 daysSample:At least 100 grams is preferred, but lesser amounts are acceptable with original sample container as submitted by inspector. Alternatively, collect food aseptically and place in sterile whirlpack bags or other sterile, leak-proof container. Keep all samples under refrigeration except samples received frozen which should be maintained in the frozen state.Form Required:Environmental Sample Submission Form. Forms are available from the MDPH Food Protection Program at 617-983-6712, the local board of health, or the Food Laboratory. Collection is to be coordinated by the MDPH Food Protection Program.Shipping Requirements:Transport samples on ice or on pre-frozen cold packs, in appropriate ments:Additional Tests Recommended: Enteric Pathogens, Routine Culture HumanTest Name:Enteric Pathogens, Referred Culture HumanLab and Phone:Clinical Microbiology Laboratory 617-983-6607Use of Test:Identification of genus and species of isolates associated with bacterial diarrheal disease.Test Includes:Genus and species identification of pathogenic isolates in the Enterobacteriaceae, and Campylobacteraceae families, including Salmonella sp., Shigella sp.,E. coli O157:H7 and other Shigatoxin-producing E. coli isolates, Campylobacter sp (other than Campylobacter jejuni for which submission is not mandatory) .Tests include serotyping and subtyping of all isolatesAvailability:Monday through FridayTurnaround Time:Enterobacteriaceae- 1 to 4 days Campylobacteriaceae-1 to 5 daysSamplePure culture on appropriate medium (screw capped tube media preferred).Media should be inoculated and incubated for 24 hours prior to shipping.Ship at ambient temperature.For Campylobacteriaceae, pure culture and timely submission are imperative.Sufficient growth must be obtained prior to sending sample to the SPHL.Form Required:SPHL Specimen Submission Form, Complete “Additional Patient Information” section, and submitting laboratory’s work-up and results.Shipping Requirements:E. coli O157:H7, other suspected Shigatoxin producing E. coli isolates, and Shigella dysenteriae Type 1 must be shipped as UN2814-Infectious Substances Affecting Humans, Category A?All other isolates and original stool specimens can be shipped as UN3373- Biological Substances, Category B.Test Name:Enteric Pathogens, Routine Culture HumanLab and Phone:Clinical Microbiology Laboratory 617-983-6607Use of Test:Screen for bacterial causes of diarrheal disease.Test Includes:Culturing for Salmonella, Shigella, Campylobacter, Yersinia, Vibrio, and/or Shigatoxigenic E. coli including E. coli O157:H7. Culturing for Bacillus cereus, Clostridium perfringens, and Staphylococcus aureus is limited to outbreak situations in which the organism has been isolated and quantified in significant numbers from food samples.Reference Range/ Expected Results:Enteric pathogens not found.Limitations:Culture yield may be reduced if specimens are not submitted under optimal conditions (see below).Availability:Monday through Friday. Daily for significant outbreaks.Turnaround Time:72 hours to 1 weekSample:Preferred Method: Submit stool specimen using SPHL Enteric kit. Add stool to Para-Pak C&S transport vial to bring the liquid level up to the “Add specimen to this line” mark on the vial (approximately 1 gram of stool). DO NOT OVERFILL. Specimen jars must be tightly closed and not leaking when received. Urine or other foreign material must not be mixed with the stool material. The time interval between collection of the specimen and receipt in the lab must ≤ 5 days. Vibrio sp. must be delivered to the lab as soon as possible.Call Clinican Microbiology Lab prior to submission if Vibrio cholerae is suspected. Ship Enteric Kit at room temperature.?Fresh stool: In a sterile screw cap plastic specimen collection container is acceptable if delivered on ice the same day as collected. If a stool specimen is not available, rectal swabs are NOT acceptable.Sample Test Kit:SPHL Enteric kit. Call (617) 983-6640 to order kits.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section. In outbreak situations, indicate on the submission form specific outbreak identification and whether specimen is from a food-handler, other employee, or from a consumer.Shipping Requirements:Ship as UN3373- Biological Substances, Category B.Test Name:Shiga Toxin (Verotoxin) AssayLab and Phone:Clinical Microbiology Laboratory 617-983-6607Use of Test:Confirm presence of Shiga toxin. Isolate Shigatoxigenic organism(s) for subsequent identification.Test Includes:Test for Shiga toxin(s) by enzyme-immunoassay. Isolation of Shigatoxigenic organism from mixed positive specimens for subsequent identification.Reference Range/ Expected Results:Negative for Shiga toxin.Limitations:Mixed cultures and stool specimens must be submitted in a timely manner to prevent overgrowth by normal bacterial flora.Availability:Monday through FridayTurnaround Time:2 to 7 days for confirmation of mixed culture and/or stool specimen.Isolation of the Shigatoxigenic organism can take a few days longer. If specimen must be forwarded to CDC for final confirmation and/or serotyping, turnaround time may exceed 1 month.Sample:Pure isolate on an agar slant in a screw cap tube, broth culture in screw cap tube, selected broth medium (GN broth; MAC broth), or fresh stool in sterile collection container on cool packs, or stool in SPHL Enteric kit at room temperatureForm Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Sample Test Kit:SPHL Enteric kit. Call (617) 983-6640 to order kits.Shipping Requirements:Pure cultures- ship as UN2814- Infectious Substances Affecting Humans, Category A.Mixed cultures, fresh stools, and specimens in Enteric kits- ship as UN3373- Biological Substances, Category B.TUBERCULOSISTest Name:Mycobacteriology, NAAT for Mycobacterium tuberculosis, and if positive, possible resistance to RifampinLab and Phone:Mycobacteriology Laboratory 617-983-6381 Questions about testing and/or sample requirements should be directed to 617 983 6381.To request NAAT on smear negative respiratory specimens please call the lab. Patient specimens must be decontaminated within 24 hours after collection.Sediments must be analyzed within 72 hours after decontamination.Use of Test:To detect, using nucleic acid amplification, the presence of Mycobacterium tuberculosis complex DNA in acid-fast (AFB) smear positive concentrated sediments prepared from sputum, bronchial specimens or tracheal aspirates only. Only for the detection of members of the M. tuberculosis complex using sediments prepared following the NALC-NaOH and NaOH procedures recommended by CDC. NAAT should always be performed in conjunction with mycobacterial culture. This test is performed on specimens from first time, smear-positive patients that have not had a previous M. tuberculosis complex infection, upon physician request on smear-negative specimens, highly suspect TB cases, and on first time submissions of respiratory specimens from high risk providers.Test Includes:Identification of M. tuberculosis and Rifampin Resistance by nucleic acid amplication.Reference Range/ Expected Results:M. tuberculosis not detected.A negative test does not exclude the possibility of isolating an M. tuberculosis complex organism from the specimenAvailability:Monday through FridayTurnaround Time:24 hoursSample:Patient specimen or sediment of a sputum, bronchial specimen or tracheal aspirate.Form Required:SPHL Specimen Submission Form Sample Test Kit:SPHL TB Culture Kit. Call 617-983-6358 to order kits.Shipping Requirements:Ship as “UN3373- Biological Substances, Category ments:Additional tests recommended: Mycobacteriology culture.Test Name:Mycobacteriology (TB) Identification, Referred CultureLab and Phone:Mycobacteriology Laboratory 617-983-6381Use of Test:To determine the species of mycobacteria.Test Includes:Confirmation or identification to the complex or species level by MALDILimitations:Pure isolate.Availability:Monday through FridayTurnaround Time:< 30 daysSample:Pure isolate. Liquid cultures are acceptable.Mixed or contaminated cultures may take longer and identification may not be possible.Form Required:SPHL Specimen Submission Form Sample Test Kit:SPHL TB Culture kit. Call 617-983-6358 to order kits.Shipping Requirements:Ship as UN2814- Infectious Substance Affecting Humans, Category A.If M.tuberculosis has been ruled out, ship as UN3373- Biological Substances, Category B.Test Name:Mycobacteriology (TB) SmearLab and Phone:Mycobacteriology Laboratory 617-983-6381Use of Test:Presumptive diagnosis of mycobacterial disease; rapid identification of most infectious cases, e.g. those that are smear positive; to follow progress of tuberculosis patient on chemotherapy; to evaluate if patient may be discharged from hospital or return to gainful employment. The laboratory strongly recommends this test be done in conjunction with a culture.Test Includes:Acid fast smear only.Reference Range/ Expected Results:No AFB found.Limitations:Much less sensitive than culture for detecting mycobacteriaAvailability:Monday through FridayTurnaround Time:24 hoursSample:Prepared slide or 1- 3 mL of specimen.Form Required:SPHL Specimen Submission Form Sample Test Kit:SPHL TB Culture Kit. Call 617-983-6358 to order ments:Additional test recomenned: Mycobacteria CultureTest Name:Mycobacteriology (TB) Smear and CultureLab and Phone:Mycobacteriology Laboratory 617-983-6381Use of Test:Determine presence or rule out Mycobacteria. If present, identify the species using MALDITest Includes:Acid Fast Smear and Culture.Reference Range/ Expected Results:No Mycobacteria sp foundAvailability:Monday through FridayTurnaround Time:Smear 24 hours; culture 1 to 8 weeks.Form Required:SPHL Specimen Submission Form Sample Test Kit:SPHL TB Culture Kit. Call 617-983-6358 to order kits.Collect samples prior to drug therapy. If applicable, perform sterile preparation of site.SampleVolumeLimitationsSpecial instructionsBody fluids containing blood (collected in tube)10 mL??Body fluids not containing blood10-15 mL??Blood (collected in tube)10 mL??Bone marrow (collected in tube)1-10 mL??Cerebrospinal (CSF) fluid66294060960000> 2 mLCSF submitted in the original collection tubes may leak during transport. Transfer CSF to container in TB Culture Kit.?Gastric aspirate/washing5-10 mLSpecimens not neutralized (buffered) are unacceptable.Collect fasting specimen soon after patient awakens in order to obtain sputum swallowed during sleep. Collect 3 specimens on different days. Neutralize immediately and submit on day of collection and indicate on requisition form that the specimen has been neutralized.SampleVolumeLimitationsSpecial instructionsSkin lesion material1 cubic centimeterDo not wrap in gauze. Do not freeze. 1-2 mL sterile slaine may be used to keep tissue moist. Swabs not recommended as negative results obtained are not reliable.?Sputum5-10 mL24 hour pooled specimens or saliva are unacceptable.Submit on each day of collection, 3 first morning sputa which have been collected on different days.Tissue biopsy1 cubic centimeterDo not wrap in gauze. Do not freeze. 1-2 mL sterile slaine may be used to keep tissue moist. Swabs not recommended as negative results obtained are not reliable.?Urine20 mL24 hour pooled specimens are unacceptable.Collect 3-5 first morning clear voided midstream specimens on different days. Submit each sample on the day of collection.Shipping Requirements:Transport samples to the laboratory as soon as possible. Refrigerate if a delay in submitting is anticipated. Ship as UN3373- Biological Substances, Category BComments:Drug susceptibility testing is performed on all M. tuberculosis complex isolates.??Test Name:Mycobacteriology (TB) SusceptibilityLab and Phone:Mycobacteriology Laboratory 617-983-6381Use of Test:To determine the in vitro susceptibility of mycobacteria antimicrobial agents.Test Includes:Proportion method of testing mycobacterial isolates against streptomycin, isoniazid, ethambutol, rifampin, ethionamide, capreomycin, cycloserine, ciprofloxacin and kanamycin.Reference Range/ Expected Results:Pattern of susceptibility varies based on isolate.Availability:Monday through FridayTurnaround Time:Primary specimens usually 7 to 8 weeks. Referred cultures usually 3 to 4 weeks.Sample:Pure isolate, only done on pathogensForm Required:SPHL Specimen Submission Form Sample Test Kit:SPHL TB Culture Kit. Call 617-983-6358 to order kits.Shipping Requirements:Primary specimens- ship as UN3373- Biological Substances, Category B. Mycobacterium tuberculosis isolates- ship as UN-2814- Infectious Substance Affecting Humans, Category A.??Test Name:Mycobacteriology (TB) Susceptibility, RapidLab and Phone:Mycobacteriology Laboratory 617-983-6381Use of Test:To determine the in vitro susceptibility of M. tuberculosis complex organisms to first line drugs.Test Includes:Rapid susceptibility testing by MGIT, for isoniazid, ethambutol, rifampin and pyrazinamide.Reference Range/ Expected Results:M. tuberculosis complex organisms susceptible to mycobacteria antimicrobial agents.Availability:Monday-FridayTurnaround Time:Results are available 7 to 12 days after inoculation.Sample:Pure isolate, only done on M. tuberculosis complex organisms.Form Required:SPHL Specimen Submission Form Sample Test Kit:SPHL TB Culture Kit. Call 617-983-6358 to order kits.Shipping Requirements:Primary specimens- ship as UN3373- Biological Substances, Category B. Mycobacterium tuberculosis isolates- ship as UN-2814- Infectious Substance Affecting Humans, Category A.??VIRAL ILLNESSTest Name:Adenovirus CultureLab and Phone:Virus Isolation Laboratory 617-983-6382/6853Use of Test:To support respiratory virus surveillance efforts by the MDPH Epidemiology Program.Limitations:Asymptomatic shedding of adenoviruses frequently occurs in stool and throat.Availability:Individual testing available upon special request.Turnaround Time:2 to 10 daysSample:Call the laboratory for collection instructions. Do not use cotton tip wood shaft swab.Eye swab, throat, and/or nose nares (nasopharyngeal swab), stool, urine, cerebrospinal fluid, and tissue.Maintain sample at 4°C and transport to the laboratory within 24 hours at 4°C. Courier transport of CSF specimens is recommended.Form Required:SPHL Specimen Submission Form , complete “Additional Patient Information” section.Sample Test Kit:SPHL Respiratory Virus Test Kit. Call 617-983-6800 to order kits.Shipping Requirements:Ship as UN3373-Biological Substances, Category ments:Culture for additional viruses may be performed at the discretion of the laboratory. Serotyping of adenovirus isolates may be performed at CDC in outbreak situations.Test Name:Arbovirus Antibody IgM, HorsesLab and Phone:Virus Serology Laboratory 617-983-6396Use of Test:Serodiagnosis of a recent or current infection with Eastern Equine Encephalitis or West Nile Virus.Test Includes:Screening EIA IgM assays specific for Eastern Equine Encephalitis and West Nile Virus followed by confirmatory plaque reduction neutralization test (PRNT), as necessary.Reference Range/ Expected Results:Specific arbovirus IgM antibody not found.Presence of IgM indicates recent or current infection.Test cannot differentiate between natural infection and recent vaccination.Availability:Upon approval of Arbovirus Surveillance Program and State Public Health Veterinarian.Turnaround Time:3 or 4 daysSample:3 mL of serum, no additives and at least 1 mL of cerebrospinal fluid (CSF) collected aseptically. Transport at 4°C. Courier transport of CSF specimens is recommended.?Acute serum (> 3mL) and CSF (> 1 mL) should be collected within the first 14 days following onset of symptoms and sent immediately to the SPHL.?For samples collected before day 8 after onset of symptoms and negative by EIA test, a second serum is recommended to be drawn 10-14 days after onset of symptoms.Form Required:Animal Submission Form, complete the “Vaccination” and “Epidemiological Information” sections.Shipping Requirements:Ship as UN3373 - Biological Substances, Category BTest Name:Arbovirus Antibody IgM and IgG, HumanLab and Phone:Virus Serology Laboratory 617-983-6396Use of Test:Serodiagnosis of a recent or prior infection or vaccination with Eastern Equine Encephalitis, West Nile Virus or St. Louis Encephalitis.Test Includes:Screening EIA IgM assays specific for Eastern Equine Encephalitis and West Nile Virus followed by confirmatory plaque reduction neutralization test (PRNT), as necessary. Specific IgG assays will be performed on a case-by-cases basis.Reference Range/ Expected Results:Specific arbovirus IgM and/or IgG antibodies not found.Presence of IgM indicates recent or current infection or vaccination.In the absence of symptoms and when the IgM results are negative, IgG positive test results can be used as an indicator of past infection.For negative samples collected before day 8 after onset of symptoms and negative by EIA test, a second serum is recommended to be drawn 10-14 days after onset of symptoms.Availability:As requested. Testing is restricted to illness onsets between May and October unless provided with a travel history to an endemic area. Consult the laboratory from November through April.Turnaround Time:3 to 4 daysSample:At least 3 mL of serum, no additives and/or at least 1 mL of cerebrospinal fluid (CSF) collected aseptically. Maintain samples at 4°C and transport to the laboratory within 24 hours at 4°C. Courier transport of CSF specimens is recommended.?Acute serum and CSF should be collected within the first 14 days following onset of symptoms and sent immediately to the SPHL.Convalescent serum is recommended to be drawn 10-14 days after onset of symptoms.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:Ship as UN3373-Biological Substances, Category ments:Additional tests recommended: For cases of meningitis, encephalitis, or meningoencephalitis where a cerebrospinal fluid (CSF) has been submitted on ice (prefrozen ice packs) in sufficient volume and tests negative for EEE and WNV, the CSF will be tested for enterovirus.With MDPH Epidemiology Program approval and a travel history and clinical symptoms, sample(s) may be forwarded to CDC for further serological testing for agents such as: California Encephalitis, Chikungunya, Dengue Fever, Flavivirus, Japanese Encephalitis, Powassan, Ross River Virus, St Louis Encephalitis, Tick- borne Encephalitis, Western Equine Encephalitis, and Yellow Fever.Test Name:Arbovirus Culture and PCR, HumanLab and Phone:Virus Isolation Laboratory 617-983-6382/6853Use of test:To support clinical diagnosis of a current infection with Eastern Equine Encephalitis (EEE) or West Nile Virus (WNV).Test Includes:Depending on sample type, volume and collection date, testing for EEE or WNV by either culture and/or PCR will be performed on a case-by-case basis.?For cases of meningitis, encephalitis, or meningoencephalitis where a patient’s cerebrospinal fluid (CSF) has been submitted on ice (prefrozen cool packs) in sufficient volume and tests negative for EEE and WNV, the CSF will be tested for enterovirus.Reference Range/ Expected Results:By culture, specific arbovirus not found.By PCR, specific arbovirus RNA not detected. Presence of virus and/or viral RNA indicates recent or current infection.?For virus culture, only live virus will be detected. Stage of illness, specimen choice, specimen collection technique and specimen handling and transport will affect the sensitivity of the test. Negative results do not rule out infection.Laboratory results must be interpreted in light of overall patient information.Availability:As requested. Testing is restricted to illness onsets between May and October unless provided with a travel history to an endemic area. Consult the laboratory from November through April.Turnaround Time:4 to 6 hours (PCR), and 3 to 7 days (culture)Sample:Call Laboratory for specimen collection instructions. Submit 2 mL of aseptically collected cerebrospinal fluid, or post-mortem tissue from brain or spinal cord. Maintain sample at 4?C and transport to the laboratory within 24 hours at 4?C. Courier transport of CSF specimens is recommended.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:Ship as UN3373-Biological Substances, Category ments:Additional tests recommended: For cases of meningitis, encephalitis, or meningoencephalitis where a patient’s cerebrospinal fluid (CSF) has been submitted on ice (prefrozen ice packs) in sufficient volume and tests negative for EEE and WNV, the CSF will be tested for enterovirus.With MDPH Epidemiology Program approval and as indicated by travel history related to endemic areas and clinical symptoms, patient sample(s) may be forwarded to CDC for further testing for agents such as: California Encephalitis, Chikungunya, Dengue Fever, Flavivirus, Japanese Encephalitis, Powassan, Ross River Virus, St Louis Encephalitis, Tick-borne Encephalitis, Western Equine Encephalitis, and Yellow Fever.Test Name:Arbovirus Culture and PCR, Other AnimalLab and Phone:Virus Isolation Laboratory 617-983-6382/6853Use of test:To support clinical diagnosis of current infection with either Eastern Equine Encephalitis (EEE) or West Nile Virus (WNV) in non-horse or non-human specimens.Test Includes:Isolation of Eastern Equine Encephalitis (EEE) or West Nile Virus (WNV) by cell culture. Rapid screening by PCR for presumptive identification of EEE or WNV will be performed on a case-by-case basis and will be dependent on sample type and collection date.Limitations:Isolates presumptive positive for virus other than EEE or WNV may be forwarded to CDC for identification.Reference Range/ Expected Results:By culture, specific arbovirus not detected.By PCR, specific virus RNA not detected. Presence of virus and/or viral RNA indicates recent or current infection.Availability:Upon approval of Arbovirus Surveillance Program and State Public Health Veterinarian.Turnaround Time:4 to 6 hours (PCR), and 3 to 7 days (culture)Sample:Call the Laboratory for specimen collection instructions. Type of specimen varies depending on species.Maintain sample at 4°C and transport to the laboratory within 24 hours at 4°C.Form Required:Animal Submission Form, complete the “Vaccination” and “Epidemiological Information” sections.Shipping Requirements:Ship as UN3373-Biological Substances, Category ments:Additional tests recommended: Depending upon species, serology may be preferred, (Eastern Equine Encephalitis antibody, West Nile Virus antibody). Note: Culture for additional viruses may be performed at the discretion of the LaboratoryTest Name:Arbovirus PCR, Mosquito VectorsLab and Phone:Arbovirus Surveillance Laboratory 617-983-6792Use of test:To support detection of EEE and WNV in mosquito vectors for surveillance purposes.Test includes:Rapid screening by PCR for RNA from Eastern Equine Encephalitis (EEE) and West Nile Virus (WNV) in mosquito vectors.Availability:Upon approval of Arborvirus Surveillance Program.Turnaround Time:< 2 daysSample:Varies, depending upon species. Call the Arbovirus Field Program Manager at 617-983-6792 for information on sample types and mosquito pools.Form Required:Mosquito Collection form is provided to authorized submitters.Sample Collection:Call the laboratory for instructions prior to collecting sample. Maintain sample at 4°C and transport to the laboratory ASAP at 4°C.Shipping Requirements:Ship as UN3373-Biological Substances, Category B.Test Name:Arbovirus Plaque Reduction Neutralization Test –Antibody (PRNT)Lab and Phone:Virus Isolation Laboratory 617-983-6382/6853Use of Test:To provide diagnostic confirmation of infection with WNV or EEE.Test includes:Confirmation of the presence of antibody specific to either WNV, EEE or St Louis Encephalitis virus (SLE).Availability:As requested. Testing is restricted to illness onsets between May and October unless provided with a travel history to an endemic area. Consult the laboratory from November through April.Turnaround Time:3 to 7 daysSample:2 mL of serum, and at least 1 mL of cerebrospinal fluid collected aseptically.?Maintain sample at 4°C and transport to the laboratory within 24 hours at 4°C. Courier transport of CSF specimens is recommended.Form Required:SPHL Specimen Submission Form or Animal Specimen Submission FormSample Collection:Call the laboratory for instructions prior to collecting sample.Shipping Requirements:Ship as UN3373-Biological Substances, Category ments:Additional tests recommended: Serology (Eastern Equine Encephalitis EIA antibody, West Nile Virus EIA antibody).Note: PRNT confirmation for antibody and for other arboviral agents may be performed at the discretion of the laboratory.Test Name:CDC Serology- Viral and Arthropod IllnessLab and Phone:Virus Serology Laboratory 617-983-6396 Before sending specimens, contact the Virus Serology Laboratory for specimen requirements for the specific testing requested.Test Includes:Extensive testing menu for viral and arthropodborne illness available at the CDC in Atlanta, Puerto Rico or Colorado, includes, but not limited to:Viral- California encephalitis,chickungunya, dengue fever, flavivirus, hantavirus, Jamestown fever, japanese encephalitis, junin virus, lymphocytic choriomeningitis (LCM), powassan, Ross river, Q fever, viral hemorrhagic fever, western equine encephalitis, yellow fever.Arthropod (including Tick)- Babesia, colorado tick fever, erlichia, lyme disease, rickettsia, rocky mountain spotted fever, typhus.Availability:Monday through FridayTurnaround Time:4 to 8 weeksSample:Serum and/or CSF. Usually acute and convalescent samples.Call Virus Serology Laboratory for specific volumes required and paired sample information.Maintain sample at 4°C and transport to the laboratory within 24 hours at 4°C.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:Ship as UN3373- Biological Substances, Category B.Test Name:Cytomegalovirus CultureLab and Phone:Virus Isolation Laboratory 617-983-6382/6853Use of Test:To rule out infection caused by cytomegalovirus.Test Includes:Shell vial and conventional culture tubes inoculation followed by immunofluorescence detection.Reference Range/ Expected Results:CMV not detected by cell culture.Availability:Monday through FridayTurnaround Time:2 to 28 days for positive report, and 28 days for negative report.Sample:Call laboratory prior to collection. Urine, cerebral spinal fluid, tissue, peripheral blood buffy coat.?Maintain sample at 4°C and transport to the laboratory within 24 hours at 4°C. Courier transport of CSF specimens is recommended.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:Ship as UN3373- Biological Substances, Category ments:Culture for additional viruses may be performed at the discretion of the laboratory.Test Name:Ebola virus PCRLab and Phone:Molecular Diagnostics Laboratory 617-983-6411Notify MDPH Immunization Program (24/7) at 617-983-6800 for all suspect Ebola virus cases to coordinate sample collection, transport and rapid testing.Use of Test:To rule out suspect Ebola virus cases meeting the case definition; support public health measures.Test Includes:Rapid screening by PCR for presumptive identification of Ebola virus.Reference Range/ Expected Results:Ebola virus RNA not detected by PCR.Availability:Available (24/7) year-round after prior consultation with MDPH Epidemiologists and Molecular Diagnostics Laboratory.Turnaround Time:4 to 6 hours (PCR).Sample:Call 617-983-6800 for sample collection instructions. Two tubes of whole blood (lavender top) are required. Maintain samples at 4°C and transport to the laboratory immediately at 4°C.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:For all specimens/cases, testing and transport arrangements must be coordinated through the MDPH Epidemiology Program at 617-983-ments:Refer to the MDPH or CDC website for the most up to date information. Confirmatory testing will be performed by CDC.Test Name:Enterovirus CultureLab and Phone:Virus Isolation Laboratory 617-983-6382/6853Use of Test:Detection of coxsackieviruses, echoviruses, polioviruses and other viruses.Test includes:Isolation of coxsackieviruses, echoviruses, polioviruses and other viruses.Reference Range/ Expected Results:Enterovirus not detected by cell culture.?Enteroviruses may be recovered from stools of asymptomatic patients. Vaccine strain polioviruses may be recovered from stools of recently vaccinated individuals or their contacts. This test is usually performed in the context of an outbreak.Availability:As requested.Turnaround Time:2 to 10 days for positive report, and 10 days for negative report.SampleCall the laboratory for sample collection instructions. Throat swab in viral transport media (VTM) or universal transport media (UTM), stool, cerebrospinal fluid, tissue, vesicular fluid.?Maintain sample at 4°C and transport to the laboratory within 24 hours at 4°C.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:Ship as UN3373- Biological Substances, Category ments:Culture for additional viruses may be performed at the discretion of the laboratory. Typing of poliovirus performed but serotyping of other isolates is performed only at CDC under special circumstances.Test Name:Hepatitis C AntibodyLab and Phone:STI Laboratory 617-983-6389Testing performed for pre-approved program sites only.Use of Test:Screening for Hepatitis C (HCV) infection. Will be tested as part of integrated testing along with HIV and Syphilis. Test Includes:Qualitative screening for Hepatitis C antibodies. Reference Range/ Expected ResultsNegative for HCV antibodyAvailability:Monday through FridayTurnaround Time:7daysSample:Samples must be collected in 2x8.5 mL SST, spun prior to submission.Form Required:HIV/HCV Specimen Submission Form with appropriate 2D barcode required. Forms are completed electronically via training protocol provided by the Office of HIV/AIDS.Sample Test Kit:Single or Multiple Mailing or Courier kit. Call 617-983-6389 to order kits.Shipping Requirements:Ship as UN3373-Biological Substances, Category B. Specimens must be shipped on day of specimen collection to laboratory via UPS CampusShip or approved courier, and received by laboratory within 2 days post ments:Positive results will reflex to HCV NAATTest Name:Herpes Simplex Virus CultureLab and Phone:Virus Isolation Laboratory 617-983-6382/6853Use of Test:To support clinical diagnosis of herpes simplex types 1 or 2 virus during an outbreak investigation.Test Includes:Identification of herpes simplex types 1 or 2 by cell culture followed by immunofluorescence detection.Reference Range/ Expected Results:Herpes simplex virus not found by cell culture.Availability:As requestedTurnaround Time:2 to 10 days for positive report, and 10 days for negative report.Sample:Call Laboratory for specimen collection instructions. Lesion swab (oral, skin), eye swab, cerebrospinal fluid, tissue, respiratory tract specimens.Maintain sample at 4°C and transport to the laboratory within 24 hours at 4°C. Courier transport of CSF specimens is recommended.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:Ship as UN3373- Biological Substances, Category ments:Culture for additional viruses may be performed at the discretion of the laboratory.Test Name:HIV Antigen/AntibodyLab and Phone:STI Laboratory 617-983-6372Testing performed for preapproved program sites only.Use of Test:Detection of HIV-1 p24 antigen or antibodies to Human Immunodeficiency Virus (HIV-1 and HIV-2). Testing is provided only for approved for submitting agenciesTest Includes:Qualitative screening for HIV-1/2 antibodies and HIV-1 p24 antigen. Reference Range/ Expected Results:No antigen or antibody to HIV detected. HIV-1 p24 antigen negativeAvailability:Monday through FridayTurnaround Time:7 daysSample:Samples must be collected in 2x8 mL SST, spun prior to submission.Form Required:HIV/HCV Specimen Submission Form with appropriate 2D barcode required. Forms are completed electronically via training protocol provided by the Office of HIV/AIDS.Sample Test Kit:Single or Multiple Mailing or Courier kit. Call 617-983-6389 to order kits.Shipping Requirements:Ship as UN3373-Biological Substances, Category B. Specimens must be shipped on day of specimen collection to laboratory via UPS CampusShip or approved courier, and received by laboratory within 2 days post ments:Positive results will reflex to HIV – 1/2 antibody differentiation and NAAT as indicated.Test Name:Influenza/ Parainfluenza Virus Culture and SubtypingLab and Phone:Virus Isolation Laboratory 617-983-6382/6853 Notify MDPH Immunization Program (24/7) at 617-983-6800 for all suspect pandemic, avian or novel influenza cases to prioritize and coordinate testing.Use of Test:To support public health virologic surveillance efforts.Test Includes:Culture and typing/subtyping of primary specimens or isolates by hemagglutination inhibition assay (HAI) and immunofluorescence detection.Reference Range/ Expected Results:Virus not detected in tissue culture.?Only live virus will be detected. Stage of illness, specimen choice, specimen collection technique and specimen handling and transport will affect the sensitivity of the test. Negative results do not rule out infection.Laboratory results must be interpreted in light of overall patient information.Availability:Available year-round; contact the Virus Isolation Laboratory prior to sending samples to the laboratory from June through September.Turnaround Time:2 to 10 daysSample:Call Laboratory for sample collection instructions, or use Respiratory Virus Test kit instructions. Do not use cotton tip wood shaft swab.Primary specimens- Nasopharyngeal swab (preferred specimen)or throat swab placed into viral transport media (VTM) or universal transport media (UTM), bronchial wash, or other respiratory specimen.Isolates- exhibiting hemadsorption or any preliminary positive results by a rapid influenza test.Maintain sample at 4°C and transport to the laboratory within 24 hours at 4°C.Form Required:Respiratory Surveillance Specimen Submission Form, complete “Additional Patient Information” section.Sample Test Kit:SPHL Respiratory Virus Test kit. Call 617-983-6800 to order.Shipping Requirements:Call 617-983-6800 for courier pickup. Ship as UN3373- Biological Substances, Category ments:Culture for additional viruses may be performed at the discretion of the laboratory.Test Name:Influenza Virus, Molecular Typing/Subtyping PCRLab and Phone:Virus Isolation Laboratory 617-983-6382/6853 Notify MDPH Immunization Program (24/7) at 617-983-6800 for all suspect pandemic, avian or novel influenza cases to prioritize and coordinate testing.Use of Test:To rule out suspect novel influenza strains or to rapidly subtype influenza A or type B strains for outbreak investigations.Test Includes:Rapid screening by PCR for identification of influenza types A, B and A subtypes: (2009) H1, H1 and H3 (H5 and EuH7 special request only).Reference Range/ Expected Results:Viral RNA not detected.Availability:Available (24/7) year-round after prior consultation with MDPH Epidemiologists and Virus Isolation Laboratory.Turnaround Time:4 to 6 hours (PCR).H1 and H3 subtypes will be confirmed by in house conventional culture and subtyping. Un-subtypable, or novel subtypes will be shipped to CDC ASAP for urgent, confirmatory testing.Sample:Call Laboratory for sample collection instructions, or use Respiratory Virus Test kit instructions. Do not use cotton tip wood shaft swab.Nasopharyngeal swab, and/or pharyngeal swab placed into viral transport media (VTM) or universal transport media (UTM).Maintain sample at 4°C and transport to the laboratory within 24 hours at 4°C.Form Required:Respiratory Surveillance Specimen Submission Form, complete “Additional Patient Information” section.Sample Test Kit:SPHL Respiratory Virus Test kit. Call 617-983-6800 to order.Shipping Requirements:Call 617-983-6800 for courier pickup.Ship as UN3373- Biological Substances, Category ments:Culture for additional viruses may be performed at the discretion of the laboratory.Test Name:Influenza Virus, Shell Vial CultureLab and Phone:Virus Isolation Laboratory 617-983-6382/6853 Notify MDPH Immunization Program (24/7) at 617-983-6800 for all suspect pandemic, avian or novel influenza cases to prioritize and coordinate testing.Use of Test:To support public health virologic surveillance efforts, isolation and subtyping of influenza samples from sentinel surveillance sites and hospital sentinel surveillance sites are essential.Test Includes:Isolation and typing of influenza virus by shell vials.Reference Range/ Expected Results:Virus not detected.?Only live virus will be detected. Stage of illness, specimen choice, specimen collection technique and specimen handling and transport will affect the sensitivity of the test. Negative results do not rule out infection. Laboratory results must be interpreted in light of overall patient information.This procedure is not as sensitive as conventional tissue culture, specimens testing negative are not reported until conventional culture results are finalized.Availability:Available year-round after prior consultation with MDPH Epidemiologists and Virus Isolation Laboratory.Turnaround Time:1 to 2 days for preliminary positive report. Positives are confirmed by conventional culture and subtyping.Sample:Call Laboratory for sample collection instructions, or use Respiratory Virus Test kit instructions. Do not use cotton tip wood shaft swabs. Other acceptable specimen types include: throat swab or nasopharyngeal swab in viral transport media (VTM) or universal transport media (UTM), bronchial wash or other respiratory specimen.Maintain sample at 4°C and transport to the laboratory within 24 hours at 4°C.?Form Required:Respiratory Surveillance Specimen Submission Form, complete “Additional Patient Information” section.Sample Test Kit:SPHL Respiratory Virus Test kit. Call 617-983-6800 to order.Shipping Requirements:Call 617-983-6800 for courier pickup.Ship as UN3373- Biological Substances, Category ments:Culture for additional viruses may be performed at the discretion of the laboratory.Test Name:Measles Antibody IgGLab and Phone:Virus Serology Laboratory 617-983-6396Notify MDPH Immunization Program (24/7) at 617-983-6800 to prioritize and coordinate measles testing during outbreak investigations.Use of Test:To support serodiagnosis of measles outbreak public health investigations.Test Includes:IgG antibody to measles (rubeola).Reference Range/ Expected Results:Negative for IgG antibody.?Positive IgG antibody (single convalescent serum), or four-fold increase in titer (paired sera).Availability:Monday through FridayTurnaround Time:2 days upon receipt of convalescent serum.Sample:2 mL of serum: collect convalescent specimen ?14 days after the acute specimen.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:Ship as UN3373- Biological Substances, Category ments:Additional tests recommended: Measles Antibody IgMTest Name:Measles Antibody IgMLab and Phone:Virus Serology Laboratory 617-983-6396Notify MDPH Immunization Program (24/7) at 617-983-6800 to prioritize and coordinate measles testing during outbreak investigations.Use of Test:To support measles outbreak public health investigations.Test Includes:Measles (Rubeola) IgM Capture EIA.Reference Range/ Expected Results :? Negative IgM, Negative IgG antibody indicates probable non-measles rash or sample collected too early. IgM may be negative if the specimen is collected prior to the appearance of or before the fourth day after rash onset. Convalescent specimen should be submitted to rule out measles infection.? Positive IgM indicates current or recent measles infection or vaccination.? Negative IgM, Positive IgG antibody indicates possible measles convalescence, prior vaccination or past infection.?Cannot distinguish between antibody produced in response to vaccine versus wild strain measles. This vaccination is performed in conjunction with measles PCR.Availability:Monday through FridayTurnaround Time:1 to 3 daysSample:2 mL of serum: aute serum collected ≥4 days after the appearance of rash.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:Ship as UN3373- Biological Substances, Category ments:Additional tests recommended: Throat and/or NP swab collected in parallel and submitted for measles virus culture and PCR.Test Name:Measles Virus CultureLab and Phone:Virus Isolation Laboratory 617-983-6382/6853Notify MDPH Immunization Program (24/7) at 617-983-6800 to prioritize and coordinate measles testing during outbreak investigations.Use of Test:To support measles outbreak public health investigations by isolation of the viral agent. Original specimens and isolates are used to determine the viral strains in circulation and are forwarded to the CDC for genetic characterization.Test Includes:Cell culture followed by immunofluorescence detection. Reference Range/ Expected Results:For virus culture, measles virus is rarely isolated from clinical specimens.?This test is performed in conjunction with IgM serology. Stage of illness, specimen choice, specimen collection technique, specimen handling and transport will affect the sensitivity of culture results. Negative results do not rule out infection. Laboratory results must be interpreted in light of clinical information including vaccine status.Availability:Monday through FridayTurnaround Time:Positive results 3-14 days; at least 14 days for negative results. PCR: 6 hrs.Sample:Call the laboratory for sample collection instructions. Nasopharyngeal swab (preferred) or throat swab in viral transport media (VTM) or universal transport media (UTM), urine.Maintain sample at 4°C and transport to the laboratory within 24 hours at 4°C.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:Ship as UN3373- Biological Substances, Category ments:Additional tests required: IgM serology must also be performed for measles diagnosis. Parvovirus and rubella antibody and/or PCR testing may be necessary for differential diagnosis. Culture for additional viruses may be performed at the discretion of the laboratory.Test Name:Measles and Rubella PCRLab and Phone:Molecular Diagnostics Laboratory 617-983-6411Notify MDPH Immunization Program (24/7) at 617-983-6800 for all suspect measles cases to prioritize and coordinate testing during outbreak investigations. Due to similar clinical presentation, suspect measles samples are also tested for rubella virus.Use of Test:To support measles outbreak public health investigations by isolation of the viral agent. Original specimens and isolates are used to determine the viral strains in circulation and are forwarded to the CDC for genetic characterization.Test Includes:PCR Panel includes both measles RNA and rubella RNA detection by PCR.Reference Range/ Expected Results:For PCR Panel, measles virus RNA not detected/ rubella virus RNA not detected.?Stage of illness, specimen choice, specimen collection technique, specimen handling and transport will affect the sensitivity of PCR results. Negative results do not rule out infection. Laboratory results must be interpreted in light of clinical information including vaccine status.Availability:Monday through FridayTurnaround Time:PCR: 6 hrs.Sample:Call the laboratory for sample collection instructions. Nasopharyngeal swab (preferred) or throat swab in viral transport media (VTM) or universal transport media (UTM), urine. Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:Maintain sample at 4°C and transport to the laboratory within 24 hours at 4°C. Ship as UN3373- Biological Substances, Category ments:Additional tests required: IgM serology must also be performed for measles diagnosis. Parvovirus and rubella antibody and/or PCR testing may be necessary for differential diagnosis. Culture for additional viruses may be performed at the discretion of the laboratory.Test Name:MERS-CoV PCRLab and Phone:Molecular Diagnostics Laboratory 617-983-6411Notify MDPH Immunization Program (24/7) at 617-983-6800 for all suspect Middle East Respiratory Syndrome Coronavirus (MERS-CoV) cases to prioritize samples and coordinate rapid testing.Use of Test:To rule out suspect Middle East Respiratory Syndrome Coronavirus (MERS-CoV) cases meeting the case definition; support public health measures.Test Includes:Rapid screening by PCR for presumptive identification of Middle East Respiratory Syndrome-coronavirus (MERS-CoV).Reference Range/ Expected Results:MERS-CoV RNA not detected by PCR.Availability:Available (24/7) year-round after prior consultation with MDPH Epidemiologists and Molecular Diagnostics Laboratory.Turnaround Time:4 to 6 hours (PCR).Sample:Call 617-983-6800 for sample collection instructions. Lower respiratory tract specimens are recommended over upper respiratory tract specimens. Stool and serum may be requested. Maintain samples at 4°C and transport to the laboratory within 24 hours at 4°C.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:Maintain samples at 4°C and transport to the laboratory within 24 hours at 4°C.For all specimens/cases, testing and transport arrangements must be coordinated through the MDPH Epidemiology Program at 617-983-ments:Refer to the MDPH or CDC website for the most up to date information. Confirmatory testing will be performed by CDC.Test Name:Mumps Antibody IgGLab and Phone:Virus Serology Laboratory 617-983-6396Notify MDPH Immunization Program (24/7) at 617-983-6800 to prioritize and coordinate mumps testing during outbreak investigations.Use of Test:To support mumps outbreak public health investigations by providing clinical serodiagnosis of mumps infection convalescence.Test Includes:Quantitative indirect fluorescence Antibody (IFA) testing for IgG antibody to mumps.Reference Range/ Expected Results:Negative for IgG antibody.Positive IgG antibody (single convalescent serum), or four-fold increase in titer (paired sera).Availability:Monday through FridayTurnaround Time:2 to 5 days upon receipt of convalescent serum.Sample:2 mL of serum: collect convalescent specimen ?14 days after the acute specimen.?Maintain sample at 4°C and transport to the laboratory within 24 hours at 4°C.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:Ship as UN3373- Biological Substances, Category ments:Additional tests recommended: Mumps antibody IgM testing for acute serum collected ?5 days after appearance of symptom onset.Test Name:Mumps Antibody IgMLab and Phone:Virus Serology Laboratory 617-983-6396Notify MDPH Immunization Program (24/7) at 617-983-6800 to prioritize and coordinate mumps testing during outbreak investigations.Use of Test:To support mumps outbreak public health investigations by providing clinical diagnosis of a current or recent mumps infection.Test Includes:Mumps antibody IgM EIAReference Range/ Expected Results:Negative IgM indicates probable non-mumps cause or possibility that the specimen was collected too early.Positive IgM indicates probable current or recent mumps infection.?30% of primary mumps may be sub-clinical. Mumps infection can occur without parotitis. Parotid swelling may have other viral/bacterial causes (coxsackievirus, echovirus, parainfluenza, influenza A, herpes simplex virus, varicella zoster virus, and S. aureus). Parotid pain or swelling may have non-infectious cause.Availability:Monday through FridayTurnaround Time:1 to 3 daysSample:2 mL of serum: acute serum collected ?5 days after appearance of symptom onset.?Maintain sample at 4°C and transport to the laboratory within 24 hours at 4°C.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:Ship as UN3373- Biological Substances, Category ments:Additional tests recommended:Collect convalescent specimen ??14 days after the acute specimen. Buccal or throat swab in VTM or UTM, or saliva should be collected ≤ 5 days in parallel and submitted for mumps virus culture and PCR.Test Name:Mumps virus CultureLab and Phone:Virus Isolation Laboratory 617-983-6382/6853Notify MDPH Immunization Program (24/7) at 617-983-6800 to prioritize and coordinate mumps testing during outbreak investigations.Use of Test:To support mumps virus outbreak public health investigations by providing clinical diagnosis of a current mumps infection.Test Includes:Cell culture followed by immunofluorescence detection. Reference Range/ Expected Results:For culture, mumps virus not detected. ?Stage of illness, specimen choice, specimen collection technique and specimen handling and transport will affect the sensitivity of culture and PCR results.Negative results do not rule out infection. Laboratory results must be interpreted in light of overall patient information.?30% of primary mumps may be sub-clinical. Mumps infection can occur without parotitis. Parotid swelling may have other viral/bacterial causes (coxsackievirus, echovirus, parainfluenza, influenza A, herpes simplex and varicella zoster virus, and S. aureus). Parotid pain or swelling may have a non- infectious cause.Availability:Monday through FridayTurnaround Time:5 to 15 daysSample:Call the laboratory for sample collection instructions. Buccal swab (preferred) or throat swab in viral transport media (VTM) or universal transport media (UTM), saliva, urine, cerebrospinal fluid, or tissue.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:Maintain samples at 4°C and transport to the laboratory within 24 hours at 4°C. Ship as UN3373- Biological Substances, Category ments:Additional Tests required: Mumps antibody IgM and IgG.Culture for additional viruses may be performed at the discretion of the laboratory.Test Name:Mumps virus PCRLab and Phone:Molecular Diagnostics Laboratory 617-983-6411Notify MDPH Immunization Program (24/7) at 617-983-6800 for all suspect mumps cases to prioritize and coordinate testing during outbreak investigations. Use of Test:To support mumps virus outbreak public health investigations by providing clinical diagnosis of a current mumps infection.Test Includes:PCR test includes mumps virus RNA detection by PCR.Reference Range/ Expected Results:For PCR, mumps virus RNA not detected.?Stage of illness, specimen choice, specimen collection technique and specimen handling and transport will affect the sensitivity of PCR results.Negative results do not rule out infection. Laboratory results must be interpreted in light of overall patient information and vaccine status.?30% of primary mumps may be sub-clinical. Mumps infection can occur without parotitis. Parotid swelling may have other viral/bacterial causes (coxsackievirus, echovirus, parainfluenza, influenza A, herpes simplex and varicella zoster virus, and S. aureus). Parotid pain or swelling may have a non- infectious cause.Availability:Monday through FridayTurnaround Time:5 to 15 daysSample:Call the laboratory for sample collection instructions. Buccal swab (preferred) or throat swab in viral transport media (VTM) or universal transport media (UTM).Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:Maintain samples at 4°C and transport to the laboratory within 24 hours at 4°C. Ship as UN3373- Biological Substances, Category ments:Additional Tests required: Mumps antibody IgM and IgG.Culture for additional viruses may be performed at the discretion of the laboratory.Test Name:Non-variola orthopoxvirus PCRLab and Phone:Molecular Diagnostics Laboratory 617-983-6411Notify MDPH Immunization Program (24/7) at 617-983-6800 to prioritize and coordinate testing, and for specimen collection and shipping instructions for all pustular rash illness symptoms suspicious for non-variola (smallpox) orthopoxviruses such as vaccinia or monkeypox.Use of Test:To support public health investigations of adverse vaccine reactions or accidental inoculation. To provide rapid presumptive results for vaccinia and monkeypox virus.Test includes:Rapid screening by PCR for presumptive identification of monkeypox virus or vaccinia performed on a case-by-case basis. Additional testing may be required by CDC.Reference Range/ Expected Results:Non-variola orthopoxvirus DNA not detected by PCR.Availability:Upon approval of the MDPH Epidemiology Program.Turnaround Time:4-6 hrsSample:Vesicular material, scab specimens, biopsy lesions.Maintain samples at 4°C and transport to the laboratory within 24 hours at 4°C.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:Ship as UN3373- Biological Substances, Category B.Test Name:Norovirus PCRLab and Phone:Molecular Diagnostics Laboratory 617-983-6411 Notify MDPH Immunization Program (24/7) at 617-983-6800 to prioritize and coordinate norovirus testing during outbreak investigations.Use of Test:To provide rapid testing for norovirus in support of outbreaks.Test Includes:Rapid screening by PCR for identification of norovirus (genogroup I or II).Reference Range/ Expected Results:Norovirus RNA not detected by PCR.Availability:Upon approval of the MDPH Epidemiology Program.Turnaround Time:6-8 hoursSample:Primary specimen for identification: stool?Maintain samples at 4°C and transport to the laboratory within 24 hours at 4°C.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:For outbreak investigations, transport arrangements must be coordinated through the MDPH Epidemiology Program at 617-983-6800.Test Name:Orthopoxvirus PCRLab and Phone:Molecular Diagnostics Laboratory 617-983-6411Notify MDPH Immunization Program (24/7) at 617-983-6800 to prioritize and coordinate testing, and for specimen collection and shipping instructions for all pustular rash illness symptoms suspicious for orthopoxvirus variola (smallpox).Use of Test:To provide rapid rule out of smallpox in moderate to high risk specimens.Test Includes:Rapid screening by PCR for presumptive differential identification of several orthopoxviruses including variola (smallpox), and non-variola orthopoxviruses including vaccinia, cowpox and monkeypox.?Rapid screening by PCR for presumptive identification will be performed on a case-by-case basis in consultation with MDPH Epidemiologists and the testing laboratory. Confirmatory testing will be performed by CDC.Reference Range/ Expected Results:Orthopoxvirus DNA not detected by PCR.Availability:Upon approval of the MDPH Epidemiology Program.Turnaround Time:4-6 hoursSample:Primary specimen for identification: vesicular material, scab specimens, and lesion biopsies.?Maintain samples at 4°C prior and during transport to the laboratory.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:For moderate to high risk specimens/cases transport arrangements must be coordinated through the MDPH Epidemiology Program at 617-983-6800.Test Name:Rabies Testing, HumanLab and Phone:Rabies Laboratory 617-983-6385Notify MDPH Epidemiology Program (24/7) at 617-983-6800 to coordinate testing of all rabies suspect human cases.?Note: Individuals whom have been exposed to rabies suspect animals should notify their physician as it may be necessary to start rabies post-exposure prophylaxis (PEP) immediately.Use of Test:To support clinical diagnosis of human rabies virus infection.Test Includes:Human diagnostic testing will be performed by CDC and may consist of antigen detection, cell culture, PCR and/or serology.Availability:Available after prior consultation and approval from the State Epidemiologist or State Public Health Veterinarian.Turnaround Time:Within 1-2 weeks of receipt at CDC.Sample:Contact the MDPH Epidemiology Program for sample collection instructions. All four specimen types [nuchal biopsy (back of neck hair follicle and nerve), CSF, serum and saliva] must be submitted simultaneously.?Maintain samples at 4°C and transport to the laboratory ASAP at 4°C.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section, and a CDC Specimen Submission Form.Shipping Requirements:Ship as UN3373- Biological Substances, Category B.Test Name:Rabies, Antigen Detection, Non-HumanLab and Phone:Rabies Laboratory 617-983-6385Notify MDPH Epidemiology Program (24/7) at 617-983-6800 to report all human exposures to rabies suspect animals.?Note: Individuals whom have been exposed to rabies suspect animals should notify their physician as it may be necessary to start rabies post-exposure prophylaxis (PEP) immediately.Use of Test:To determine whether post-exposure prophylaxis should be administered to exposed individuals by rapidly identifying rabies virus infection in wild and domestic animals.Test Includes:Direct fluorescent antibody (DFA) testing to detect rabies virus in brain tissue.Reference Range/ Expected Results:Rabies virus antigen not detected by DFA.?Testing is dependent on the availability and quality of the brain tissue.Inconclusive results can occur , with unsatisfactory specimens (co-mingled/indistinguishable anatomy, decomposed or gross bacterial contamination, or when brain stem and cerebellum are missing).Availability:Routine testing performed Monday- Friday. Urgent testing available (24/7) after consultation with MDPH Epidemiology Program.Turnaround Time:Same day on specimens received before 12:00 pm Monday through Friday. Next working day for specimens received after 12:00 pm.Results are reported immediately upon completion of testing.Sample:Contact the Rabies laboratory for sample submission and packaging instructions. Only send head, or intact brain stem and brain of animal.Do not send live animals or whole bodies (except for bats).Package/bag sample separately, place in leak proof container and use prefrozen cool packs to place outside of the sample packaging.Do not use ice cubes as coolant.Form Required:Specimen Request Form for Rabies Testing Shipping Requirements:Ship as UN3373- Biological Substances, Category B.Test Name:Respiratory Panel, Viral Culture and PCRLab and Phone:Virus Isolation Laboratory 617-983-6382/6853 Notify MDPH Immunization Program (24/7) at 617-983-6800 to prioritize and coordinate testing for outbreak or surveillance purposes.Use of Test:To diagnose respiratory pathogens in support of public health surveillance and/or outbreak investigation activities.Test Includes:Culture for viral agents (adenovirus, influenza/parainfluenza, and respiratory syncytial virus) followed by immunofluorescence detection.?Multiplex PCR Panel includes RSV, adenovirus, parainfluenza 1-4, human metapneumo- virus, coronavirus – 229E, HKU1, NL63, OC43, human rhinovirus/enterovirus, Bordetella pertussis, Chlamydophila pneumorniae, and Mycoplasma pneumoniae detection by PCR.Reference Range/ Expected Results:For virus culture, no virus not found.For PCR, virus and/or bacterial nucleic acid not detected. Only NP swabs are approved for the PCR assay.?Stage of illness, specimen choice, specimen collection technique and specimen handling and transport will affect the sensitivity of the test. Negative results do not rule out infection. Laboratory results must be interpreted in light of overall patient information.Availability:Available year-round; contact the Virus Isolation Laboratory prior to sending samples to the laboratory from June through September.Turnaround Time:2 to 10 daysSample:Call Laboratory for sample collection instructions, or use Respiratory Virus Test kit instructions. Do not use cotton tip wood shaft swab.Primary specimens for virus culture only- Nasopharyngeal swab (preferred specimen) or throat swab in viral transport media (VTM) or universal transport media (UTM), bronchial wash, or other respiratory specimen.Primary specimens for PCR Panel: Nasopharyngeal swab ONLY in viral transport media (VTM).Isolates- exhibiting hemadsorption or any preliminary positive results by a rapid influenza test.?Maintain samples at 4°C and transport to the laboratory within 24 hours at 4°C.Form Required:Respiratory Surveillance Specimen Submission Form, complete “Additional Patient Information” section.Sample Test Kit:SPHL Respiratory Virus Test kit. Call 617-983-6800 to order.Shipping Requirements:Call 617-983-6800 for courier pickup.Ship as UN3373- Biological Substances, Category ments:Viruses, not included in the panel, may be identified resulting in additional testing being performed at the discretion of the laboratory.Test Name:Respiratory Syncytial Virus (RSV) CultureLab and Phone:Virus Isolation Laboratory 617-983-6382/6853 Notify MDPH Immunization Program (24/7) at 617-983-6800 to prioritize and coordinate testing for outbreak or surveillance purposes.Use of Test:To support influenza-like illness outbreak public health investigations and to support routine public health virus surveillance efforts.Test Includes:Cell culture followed by immunofluorescence detection.Reference Range/ Expected Results:RSV not found by cell culture.?Only live virus will be detected. Stage of illness, specimen choice, specimen collection technique and specimen handling and transport will affect the sensitivity of the test. Negative results do not rule out infection. Laboratory results must be interpreted in light of overall patient information.Availability:Available year-round; contact the Virus Isolation Laboratory prior to sending samples to the laboratory from June through September.Turnaround Time:2 to 10 daysSample:Call Laboratory for sample collection instructions, or use Respiratory Virus Test kit instructions. Do not use cotton tip wood shaft swab. Nasopharyngeal swab in viral transport media (VTM).?Maintain samples at 4°C and transport to the laboratory within 24 hours at 4°C.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Sample Test Kit:SPHL Respiratory Virus Test Kit. Call 617-983-6800 to order.Shipping Requirements:Ship as UN3373- Biological Substances, Category ments:Culture for additional viruses may be performed at the discretion of the laboratory.Test Name:Rubella Antibody, IgMLab and Phone:Virus Serology Laboratory 617-983-6396 Notify MDPH Immunization Program (24/7) at 617-983-6800 to prioritize and coordinate testing for all suspect rubella cases.Use of Test:To support rubella outbreak public health investigations by providing clinical diagnosis of a current or recent rubella infection.Test Includes:Rubella IgM EIAReference Range/ Expected Results:Negative IgM indicates probable non-rubella rash, or sample collected prior to the appearance of or before the third day after rash onset. Convalescent serum should be submitted to rule out rubella infection.?Positive IgM indicates current or recent rubella infection.Cannot distinguish between antibodies produced in response to vaccine versus wild strain rubella.Availability:Monday through FridayTurnaround Time:1 to 3 daysSample:2 mL of serum: acute specimen collected ? 4 days after appearance of rash.?Maintain samples at 4°C and transport to the laboratory within 24 hours at 4°C.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:Ship as UN3373- Biological Substances, Category ments:Additional tests recommended: Total Rubella Antibody. Collect convalescent specimen ? 14 days after the acute specimen. Measles IgM testing may also be performed at the Laboratory’s discretion for differential diagnosis.Test Name:Rubella Antibody, Total (IgG and IgM)Lab and Phone:Virus Serology Laboratory 617-983-6396 Notify MDPH Immunization Program (24/7) at 617-983-6800 to prioritize and coordinate testing for all suspect rubella cases.Use of Test:Confirmation of rubella infection.Test Includes:Total Rubella antibody testing by latex agglutination.Reference Range/ Expected Results:Negative for total Rubella Antibody.Positive total antibody (single convalescent serum), or four-fold increase in titer (paired sera).?Test cannot distinguish between antibody produced in response to vaccination versus wild strain rubella infection.Availability:Monday through FridayTurnaround Time:2 days upon receipt of convalescent serum.Sample:2 mL of serum: convalescent specimen collected ? 14 days after the acute specimen.?Maintain samples at 4°C and transport to the laboratory within 24 hours at 4°C.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:Ship as UN3373- Biological Substances, Category ments:Additional tests recommended: Rubella Antibody IgM test for acute specimen collected ≥ 4 days after appearance of rash.Test Name:Rubella Virus Culture Lab and Phone:Virus Isolation Laboratory 617-983-6382/6853 Notify MDPH Immunization Program (24/7) at 617-983-6800 to prioritize and coordinate testing for all suspect rubella cases.Use of Test:To support rubella outbreak public health investigations by providing clinical diagnosis of the viral agent. Original specimens and isolates are invaluable for determining the viral strains in circulation and will be forwarded to the CDC for genetic characterization.Test Includes:Cell culture followed by immunofluorescence detection. Reference Range/ Expected Results:For culture, rubella virus not detected.For PCR Panel, rubella virus RNA not detected/ measles virus RNA not detected.?Rubella virus is rarely isolated from clinical specimens. Serology is recommended. Stage of illness, specimen choice, specimen collection technique and specimen handling and transport will affect the sensitivity of the test. Negative results do not rule out infection. Laboratory results must be interpreted in light of overall patient information.Availability:Monday through FridayTurnaround Time:Approximately one monthSample:Nasopharyngeal (preferred) or throat swabs in viral transport media (VTM) or universal transport media (UTM), nasal wash (nasopharyngeal aspirate) in VTM and urine (less optimal).?Maintain samples at 4°C and transport to the laboratory within 24 hours at 4°C.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:Ship as UN3373- Biological Substances, Category ments:Additional tests recommended: Rubella Total and IgM serology is the recommended test for evidence of Rubella virus infection. Culture for additional viruses may be performed at the discretion of the Laboratory.Test Name:Vaccinia Virus, Shell Vial Culture and PCRLab and Phone:Virus Isolation Laboratory 617-983-6382/6853 Notify MDPH Immunization Program (24/7) at 617-983-6800 to prioritize and coordinate testing, and for specimen collection and shipping instructions for all pustular rash illness symptoms suspicious for vaccinia virus.Use of Test:To support investigation and clinical diagnosis of adverse vaccine events or inadvertent inoculation by vaccinia virus.Test includes:Isolation by shell vial cell culture followed by immunofluorescence detection.Reference Range/ Expected Results:By cell culture, vaccinia virus not detected. By PCR, vaccinia virus not detected.?Only live virus will be detected. Stage of illness, specimen choice, specimen collection technique and specimen handling and transport will affect the sensitivity of the test. Negative results do not rule out infection.Laboratory results must be interpreted in light of overall patient information.Availability:Available after prior consultation with the Virus Isolation Laboratory.Turnaround Time:48 hoursSample:Vesicular material, scab specimens, biopsy lesions.?Maintain samples at 4°C and transport to the laboratory within 24 hours at 4°C.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:Ship as UN3373- Biological Substances, Category ments:Additional tests recommended: Non-orthpoxvirus PCR: rapid presumptive identification by PCR may be performed on a case-by-case basis.Test Name:Varicella Zoster Virus, Culture and PCRLab and Phone:Virus Isolation Laboratory 617-983-6382/6853 Notify MDPH Epidemiology Program (24/7) at 617-983-6800 to prioritize and coordinate testing for all pustular rash illness symptoms suspicious for Varicella zoster virus (VZV).Use of Test:To support investigation and clinical diagnosis of Varicella Zoster virus.Test includes:Isolation by conventional tube and shell vial cell culture followed by virus identification using immunofluorescence detection. Detection of VZV DNA by PCR may be performed on a case-by-case basis.Reference Range/ Expected Results :By virus culture, varicella zoster virus not detected. By PCR, varicella zoster virus DNA not detected.Only live virus will be detected. Stage of illness, specimen choice, specimen collection technique and specimen handling and transport will affect the sensitivity of the test. Negative results do not rule out infection.Laboratory results must be interpreted in light of overall patient information.Availability:Monday through FridayTurnaround Time:6 to 48 hoursSample:Vesicular material, scab specimens, biopsy lesions.?Maintain samples at 4°C and transport to the laboratory within 24 hours at 4°C.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:Ship as UN3373- Biological Substances, Category B.Test Name:Zika Antibody IgM, HumanLab and Phone:Virus Serology Laboratory 617-983-6396Test Name:Consult the current Zika Clinical Advisory on the MA DPH website or contact the MDPH Division of Epidemiology and Immunization at 617-983-6800 for Zika consultations. Samples must be pre-approved prior to submission for testing.Use of Test:To diagnose suspect Zika cases in pregnant women, fetuses or infants of infected women or atypical presentations (microcephaly and other severe fetal brain defects, Guillain-Barré syndrome); in support of public health measures.Test Includes:Screening EIA IgM assays specific for Zika virus and chikungunya or dengue viruses (if applicable) followed by confirmatory plaque reduction neutralization test (PRNT) for reactive or inconclusive IgM results.Reference Range/ Expected Results:Specific arbovirus IgM antibodies not found.Presence of IgM indicates recent or current infection or vaccination.?For negative samples collected before day 8 after onset of symptoms and negative by EIA test, a second serum is recommended to be drawn 10-14 days after onset of symptoms.Availability:Pre-approval by MDPH Epidemiology Program. Turnaround Time:3 to 4 daysSample:At least 3 mL of serum, no additives, collected aseptically. Maintain samples at 4°C and transport to the laboratory within 24 hours at 4°C.Acute serum and CSF should be collected within the first 14 days following onset of symptoms and sent immediately to the SPHL.Convalescent serum is recommended to be drawn 10-14 days after onset of symptoms.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:Ship as UN3373-Biological Substances, Category ments:Refer to the MDPH website for the most up to date information on Zika. Samples must include the following detailed clinical information: dates and location of travel, evidence of mosquito exposure, symptoms clinically consistent with Zika virus, date of symptom onset, and any previous exposure to dengue virus, yellow fever vaccine or Japanese encephalitis vaccine. This information must be provided when calling for testing approval AND on the specimen submission form accompanying the sample.Test Name:Zika, chikungunya, and dengue virus (Trioplex) PCRLab and Phone:Molecular Diagnostics Laboratory 617-983-6411Consult the current Zika Clinical Advisory on the MA DPH website or contact the MDPH Division of Epidemiology and Immunization at 617-983-6800 for Zika consultations. Samples must be pre-approved prior to submission for testing.Use of Test:To diagnose suspect Zika cases in pregnant women, fetuses or infants of infected women or atypical presentations (microcephaly and other severe fetal brain defects, Guillain-Barré syndrome); in support of public health measures.Test Includes:Rapid screening by PCR for presumptive identification of Zika, chikungunya or dengue viruses in serum, urine, whole blood, amniotic fluid, or semen (prior approval required).Reference Range/ Expected Results:Zika, chikungunya, and/or dengue virus RNA not detected by PCR.Availability:Available (24/7) year-round after prior consultation with MDPH Epidemiologists.Turnaround Time:24 hours (PCR).Sample:Call 617-983-6800 for sample collection instructions. Serum, urine, amniotic fluid, or semen (prior approval required) are possible sample types. Paired serum and urine are recommended.Maintain samples at 4°C and transport to the laboratory within 24 hours at 4°C; Samples must be stored and shipped frozen (-20C) if they are not shipped the same day of collection.Form Required:SPHL Specimen Submission Form, complete “Additional Patient Information” section.Shipping Requirements:For all specimens/cases, testing and transport arrangements must be coordinated through the MDPH Epidemiology Program at 617-983-ments:Refer to the MDPH website for the most up to date information on Zika. Samples must include the following detailed clinical information: dates and location of travel, evidence of mosquito exposure, symptoms clinically consistent with Zika virus, date of symptom onset, and any previous exposure to dengue virus, yellow fever vaccine or Japanese encephalitis vaccine. This information must be provided when calling for testing approval AND on the specimen submission form accompanying the sample.Test Name:Zika Plaque Reduction Neutralization Test –Antibody (PRNT)Lab and Phone:Virus Isolation Laboratory 617-983-6382/6853Use of Test:To provide diagnostic confirmation of infection with Zikavirus or recent exposure to an undetermined flavivirus infection (dengue).Test includes:Confirmation of the presence of antibody specific to either Zika, dengue serotype 1, or dengue serotype 2 viruses.Availability:As requested. Testing is restricted to illness onsets between May and October unless provided with a travel history to an endemic area. Consult the laboratory from November through April.Turnaround Time:3 to 7 daysSample:2 mL of serum, and at least 1 mL of cerebrospinal fluid collected aseptically.?Maintain sample at 4°C and transport to the laboratory within 24 hours at 4°C. Courier transport of CSF specimens is recommended.Form Required:SPHL Specimen Submission Form or Animal Specimen Submission FormSample Collection:Call the laboratory for instructions prior to collecting sample.Shipping Requirements:Ship as UN3373-Biological Substances, Category ments:Additional tests recommended: Serology (Eastern Equine Encephalitis EIA antibody, West Nile Virus EIA antibody).Note: PRNT confirmation for antibody and for other arboviral agents may be performed at the discretion of the laboratory.SECTION 3: SPECIMEN INFORMATIONSPECIMENS SUBMISSION- GENERAL INFORMATIONTips for successful sample collection and submission:Sample collectionReview the MLTS test listings for requirements- sample type, volume required, specimen submission form, sample container, specimen kit, and shipping requirements.It is the responsibility of the shipper to submit good quality samples for testing.Use only a specific specimen outfit (kit) for its intended purpose. Example: use TB Culture Outfit for TB sample only.All samples submitted for analysis should be properly labeled for identification. The name on the primary, leakproof, sterile container (the sample collection tube or vial) and the name on the laboratory submission form must be the same.Specimens should be collected at the appropriate times noted in the test listing.Do not hold onto specimens for long periods. Transport or ship the samples to the laboratory as soon as possible. Avoid mailing specimens on weekends or holidays. Where applicable, keep samples refrigerated until shipping.Follow instructions for temperature control. Do not expose samples to extreme temperatures as this may affect the sample integrity and the test results.Do not use wet ice (ice cubes) when shipping because the sample and/or the shipping container temperature control will be compromised by water from melt down, and/or appear to be leaking which will prevent acceptance or delay transport by a courier or USPS mailing. Maintain cool temperatures where noted by using pre-frozen cold packs.Specimen submission formEach form must contain completed contact information.Use only the most current laboratory specimen submission forms when submitting samples. Discard all old pleted specimen submission form with all required information must accompany each specimen submitted.Missing information may delay testingPlace the submission form between the secondary and outer container. Do not attach the form to the sample or wrap the submission form around the primary sample container.Use recommended packing materials according to appropriate packing regulations when shipping. Do not transport any specimens in materials that do not qualify as secondary or outer packings (such as paper cups or paper bags).Use of Specimen Outfit Container:The SPHL provides Specimen Outfits to physicians, hospital laboratories, clinics and boards of health throughout Massachusetts for transporting specimens to the SPHL for analysis. These containers are the property of the MDPH/SPHL and are not to be used for purposes other than shipping specimens to the SPHL. The SPHL does not supply blood collection tubes. The Specimen Outfit containers supplied by the SPHL meet U.S. Postal Service (USPS) and Department of Transportation (USDOT) regulations for triple packaging of patient specimens and biological substances up to and including UN3373- Biological Substances, Category B. Triple packaging provides the most effective containment of pathogens in preventing the risk of exposure during transport. The Childhood Lead Whole Blood collection kits meet the regulations for Exempt Human Specimens.IMPORTANT: For reasons of confidentiality, safety and security do not write the name of a patient or organism on the outside of any package containing laboratory specimens. This includes any package containing Exempt Human or Animal specimens, Biological Substances-Category B, or Infectious Substances-Category A.It is the shipper’s (specimen submitter’s) responsibility to package the specimen properly to meet the shipping regulations. Depending on the type of specimen and patient history, specimens that are sent to the SPHL may fall in several categories (proper shipping names) including:Exempt Human or Animal Specimen,UN3373 Biological Substances- Category B,UN2814 Infectious Substances Affecting Humans and Animals- Category A, andUN2900 Infectious Substances Affecting Animals- Category A.MA STATE PUBLIC HEALTH LABORATORYSPECIMEN OUTFITS AND SUPPLIESSpecimen outfits and supplies are available for the purpose of sending samples via USPS, commercial carrier, or courier. Call or fax orders to the contact for each item. When ordering, specify whether the outfits will be for “pick-up” at the State Public Health Laboratory by the requestor, or “ship to” the requestor. Specimen Outfits and MaterialsContactPhone(617)Fax(617)Fee per kitEntericDivision of Microbiology983-6640983-6618NoneMultiple Mailing Outfits (9 or 12)STI Lab983-6389983-6227NoneSingle Mailing OutfitsSTI Lab983-6389983-6227NoneCT/GC NAAT (specify specimen type: vaginal, urine, multi)Division of Microbiology983-6389983-6227NoneLegionella TransportDivision of Microbiology983-6640983-6618NonePertussis CultureDivision of Microbiology983-6640983-6618NoneRespiratory Virus(influnzae, parainflu, adenovirus, RSV)BCDC, Division of Epidemiology & Immunization983-6800983-6840NoneMultiple Mailing Outfits (9 or 12)Division of Microbiology983-6640983-6618NoneSingle Mailing OutfitsDivision of Microbiology983-6640983-6618NoneTB Culture CourierMycobacteriology Lab983-6358983-6399NoneTB Culture MailingMycobacteriology Lab983-6358983-6399NoneNorovirus (for Foodborne Outbreaks)BCDC, Division of Epidemiology & Immunization983-6800983-6840NoneBlood Lead Screening Supplies:Lead, Microcuvette Capillary Collection TubesChildhood Lead Screening983-6665983-6677NoneLead, Blood Requisition FormChildhood Lead Screening983-6665983-6677NoneSpecimen Shipping containersChildhood Lead Screening983-6665983-6677NoneEnvironmental Test Kits:Lead, WaterEnvironmental Chemistry Lab983-6654983-6662$80.00Lead, Sodium Sulfide (Provided to State Licensed Lead Inspectors and Code Enforcement Agents Only).Environmental Chemistry Lab983-6654983-6662NoneSPHL Forms Available: ( refer to for available current versions)Animal Specimen SubmissionChemical Exposure Clinical SpecimenFood Environmental Sample SubmissionHepatitis/ HIV Barcodes and Specimen Submission Forms (Select Clinics Only)Respiratory Surveillance Specimen SubmissionLead, Order Form for Environmental KitsLead, Paint WorksheetLead, Soil WorksheetRabies Specimen for TestingSpecimen SubmissionSECTION 4: PACKAGING AND SHIPPING SPECIMENSFor information and guidance regarding the packaging and shipping of specimens, including the Division 6.2 Infectious Materials, to the Massachusetts State Public Health Laboratory refer to “Packing and Shipping” section of the MA SPHL Sentinel Laboratory Blue Book: 5: MANDATORY REPORTING OF DISEASE AND SPECIMEN SUBMISSIONFor the list of isolates required to be submitted to the State Public Health Laboratory (refer to the 105 CMR 300 document, section 300.172) and list of diseases reportable by Healthcare Providers and Laboratories, refer to Reportable Disease and Surveillance Information () State public health officials rely on local boards of health, healthcare providers, laboratories and other public health personnel to report the occurrence of notifiable diseases as required by law (Massachusetts General Laws, Chapter 111, sections 3, 6, 7, 109, 110, 111 and 112 and Chapter 111D, Section 6). These laws are implemented by regulation under Chapter 105, Code of Massachusetts Regulations (CMR), Section 300.000: Reportable Diseases, Surveillance, and Isolation & Quarantine Requirements.SECTION 6: LABORATORY DIRECTORYPhone (617) 983-Director, MA State Public Health Laboratory4362Responsible Official, Select Agent Program4362Associate Director, MA State Public Health Laboratory6601Director, Division of Analytical Chemistry6203Chemical Threat Response Laboratory(24/7) 617-839-1283Chemical Threat Response Laboratory Coordinator6550Childhood Lead Screening Laboratory6665Environmental Chemistry Laboratory6657Director, Division of Microbiology6619Administration6600BioThreat Response Laboratory(24/7) 617-590-6390BioThreat Response Laboratory Coordinator6664Clinical Microbiology Laboratory6609Environmental Microbiology; Dairy Lab6616Environmental Microbiology; Food Lab6610Laboratory Response Network (LRN) Coordinator/ Packaging and Shipping Coordinator6664Laboratory Supervisor; Environmental Microbiology and Foodborne Outbreak Response6647STI Laboratory6614/ 6389STI Laboratory Supervisor6372Mycobacteriology (TB) Laboratory6374Foodborne Outbreak Response Section, PFGE (Pulse-Field Gel Electrophoresis) Laboratory6612Director, Division of Molecular Diagnostics and Virology6966Arbovirus Surveillance Laboratory6792/4364Molecular Diagnostics Laboratory6411Rabies Laboratory6385Virus Isolation Laboratory6382/6853Virus Serology Laboratory6396Director, Division of Quality Assurance6236Central Laboratory Services (Glassware, Kits, Media, Specimen Receiving) Supervisor6675Specimen Kit Orders6640 ................
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