Laboratory Tests



Indicate the appropriate result for each testTable 1 Blood Laboratory TestsResultUnits for test resultProposed test resultreference rangeAbnormal Result?NK Cell Activity**TBDTBD FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownErythrocyte sedimentation rate (ESR)mm/hr0-15 FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownHigh sensitivity C-reactive protein (hsCRP)mg/L0-10 FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownComplete blood count (CBC) with Differential:White Blood Cell (WBC) Countcells/LAdults: 3.8 – 11.0 x 10^3Age 6- 12 yr: 4.5 – 14.0 x10^3 FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownCBC with Differential: Lymphocyte Countcells/L1.00 – 4.8 x 10^3 FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownCBC with Differential: Neutrophil Countcells/L1.80 – 7.00 x 10^3 FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownCBC with Differential: Monocyte Countcells/L0.00 – 0.80 x 10^3 FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownCBC with Differential: Eosinophil Countcells/L0.00 – 0.50 x 10^3 FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownCBC with Differential: Basophil Countcells/LAdults: 0.00 -– 0.30 X 10^3Up to age 15 yr: 0.00 -– 0.20 X 10^3 FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownCBC with Differential: Red Blood Cell (RBC) Countcells/LMale adults: 4.32 – 5.72 x 10^6Female adults: 3.90-5.03 x 10^6 FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownCBC with Differential: Hemoglobin (Hgb)g/dLMale adults: 13.2 – 17.5Female adults: 12.0 – 16 FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownCBC with Differential: Hematocrit (HCT)% RBC/unitvolume of bloodMale adults: 40 – 52%Female adults: 37 – 46% FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownCBC with Differential: Mean Corpuscular Volume (MCV)femtoliters (fl)/cellMale adults: 81.2 – 95.1Female adults: 81.6 – 98.3 FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownCBC with Differential: Red Cell Distribution Width (RDW)% (reflects deviation of width of RBC in a blood sampleMale adults: 11.8 – 15.6Female adults: 11.9 – 15.5 FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownCBC with Differential: Platelet Countcells/LMale adults: 160 – 450 x10^3Female adults: 160 – 450 x10^3 FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownLymphocyte Subset Panel: T cells (CD3+, CD4+, CD5+, CD7+, CD8+), B cells (CD10+, CD19+, CD20+), NK cells (CD16+, CD56+, [CD3?/(CD16+/CD56+)]% of cell type/unitvolume of bloodTBD FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownImmunoglobulin isotypesTBDIgA _________IgE _________IgG _________IgM _________ FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownOther, specify: FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownTable 2A Infectious Disease Laboratory Tests – Serum antibodiesTestTest datePositive Result?Epstein-Barr virus (EBV): anti VCA IgM FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownEpstein-Barr virus (EBV): anti-VCA IgG FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownEpstein-Barr virus (EBV): anti-EA-D IgG FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownEpstein-Barr virus (EBV): anti-EBNA IgG FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownCytomegalovirus (CMV): IgM FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownCytomegalovirus (CMV): IgG FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownHuman herpes virus 6 (HHV6): IgM FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownHuman herpes virus 6 (HHV6): IgG FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownCoxsackie B virus (CBV): IgM FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownCoxsackie B virus (CBV): IgG FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownEchovirus: IgM FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownEchovirus: IgG FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownChlamydia pneumoniae: IgM FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownChlamydia pneumoniae: IgG FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownMycoplasma pneumoniae: IgM FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownMycoplasma pneumoniae: IgG FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownTick-borne diseases (TBD): IgM(Lyme disease/Borrelia burgdorferi, Anaplasma phagocytophilum, Coxiella burnetii, Babesia microti, Powassan virus) FORMCHECKBOX Yes (specify which TBD yielded positive results): FORMCHECKBOX No (specify which TBD were tested and found to be negative): FORMCHECKBOX UnknownTick-borne diseases (TBD): IgG(Lyme disease/Borrelia burgdorferi, Anaplasma phagocytophilum, Coxiella burnetii, Babesia microti, Powassan virus) FORMCHECKBOX Yes (specify which TBD yielded positive results) FORMCHECKBOX No (specify which TBD were tested and found to be negative) FORMCHECKBOX UnknownParvovirus: IgM FORMCHECKBOX Yes (specify which parvovirus strain yielded positive results): FORMCHECKBOX No (specify which parvovirus strains were tested and found to be negative): FORMCHECKBOX UnknownParvovirus: IgG FORMCHECKBOX Yes (specify which parvovirus strain yielded positive results): FORMCHECKBOX No (specify which parvovirus strains were tested and found to be negative): FORMCHECKBOX UnknownMycotoxin/fungal (IgE antibodies unless otherwise specified) FORMCHECKBOX Yes (specify which mycotoxins/fungi yielded positive results): FORMCHECKBOX No (specify which mycotoxins/fungi were tested and found to be negative): FORMCHECKBOX UnknownLipopolysaccharides (LPS): IgA, IgM or IgG FORMCHECKBOX Yes (specify bacterial source/type of LPS and whether IgA, IgM and/or IgG positive_________________________________) FORMCHECKBOX No (specify which were tested and whether IgA, IgM and/or IgG was found to be negative__________________________) FORMCHECKBOX UnknownTable 2B Infectious Disease Laboratory Tests – PCR, OtherTestTest TypeSample TypePositive Result?Epstein-Barr virus (EBV) FORMCHECKBOX PCR FORMCHECKBOX Other (specify_________) FORMCHECKBOX Unknown FORMCHECKBOX Serum FORMCHECKBOX PBMC FORMCHECKBOX Other (specify__________) FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownCytomegalovirus (CMV) FORMCHECKBOX PCR FORMCHECKBOX Other (specify_________) FORMCHECKBOX Unknown FORMCHECKBOX Serum FORMCHECKBOX PBMC FORMCHECKBOX Other (specify__________) FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownCoxsackie B virus (CBV) FORMCHECKBOX PCR FORMCHECKBOX Other (specify_________) FORMCHECKBOX Unknown FORMCHECKBOX Serum FORMCHECKBOX PBMC FORMCHECKBOX Other (specify__________) FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownHuman herpes virus 6 (HHV6) FORMCHECKBOX PCR FORMCHECKBOX Other (specify_________) FORMCHECKBOX Unknown FORMCHECKBOX Serum FORMCHECKBOX PBMC FORMCHECKBOX Other (specify__________) FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownEchovirus FORMCHECKBOX PCR FORMCHECKBOX Other (specify_________) FORMCHECKBOX Unknown FORMCHECKBOX Serum FORMCHECKBOX PBMC FORMCHECKBOX Other (specify__________) FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownChlamydia pneumoniae FORMCHECKBOX PCR FORMCHECKBOX Other (specify_________) FORMCHECKBOX Unknown FORMCHECKBOX Serum FORMCHECKBOX PBMC FORMCHECKBOX Other (specify__________) FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownMycoplasma pneumoniae FORMCHECKBOX PCR FORMCHECKBOX Other (specify_________) FORMCHECKBOX Unknown FORMCHECKBOX Serum FORMCHECKBOX PBMC FORMCHECKBOX Other (specify__________) FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownTick-borne diseases (TBD) FORMCHECKBOX PCR FORMCHECKBOX Other (specify_________) FORMCHECKBOX Unknown FORMCHECKBOX Serum FORMCHECKBOX PBMC FORMCHECKBOX Other (specify__________) FORMCHECKBOX Yes (specify which TBD yielded positive results) FORMCHECKBOX No (specify which TBD were tested and found to be negative) FORMCHECKBOX UnknownParvovirus FORMCHECKBOX PCR FORMCHECKBOX Other (specify_________) FORMCHECKBOX Unknown FORMCHECKBOX Serum FORMCHECKBOX PBMC FORMCHECKBOX Other (specify__________) FORMCHECKBOX Yes (specify which parvovirus strains yielded positive results) FORMCHECKBOX No (specify which parvovirus strains were tested and found to be negative) FORMCHECKBOX UnknownGiardia FORMCHECKBOX Antigen test FORMCHECKBOX PCR FORMCHECKBOX Other (specify_________) FORMCHECKBOX Unknown FORMCHECKBOX Stool FORMCHECKBOX Other (specify__________) FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownTable 3 Autoimmunological and Other Immune Profiling Laboratory TestsTestResultUnit for ResultAbnormal Result?Cytokines: TGFbetaTBDTBD FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownCytokines: Interleukin 6 (IL-6)TBDTBD FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownCytokines: Interleukin 1 beta (IL-1b)TBDTBD FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownCytokines: Tumor necrosis factor-alpha (TNF-alpha)TBDTBD FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownCytokines: Interferon gamma (IFN-gamma)TBDTBD FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownCytokines: Interleukin 8 (IL-8)TBDTBD FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownAntinuclear antibodies (ANA): IgMTBDTBD FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownAntinuclear antibodies (ANA): IgG FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownRheumatoid Factor (RF) antibodies: IgMTBDTBD FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownRheumatoid Factor (RF) antibodies: IgGTBDTBD FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownAntimitochondrial antibodies:anti-cardiolipin antibodies (ACA)TBDSpecify test type_________ (e.g., ELISA, complement fixation test) FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownAntimitochondrial antibodies:anti-M3 proteinTBDSpecify test type_________ (e.g., ELISA, complement fixation test) FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownAntimitochondrial antibodies:anti-M4 proteinTBDSpecify test type_________ (e.g., ELISA, complement fixation test) FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownAnti-muscarinic receptor antibodiesTBDSpecify test type_________ (e.g., ELISA, complement fixation test), specificity (which muscarinic receptor, if known) __________ and isotype (e.g., IgM, IgG) ___________TBD FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownAnti-beta-1 adrenergic antibodiesTBDSpecify test type_________ (e.g., ELISA, complement fixation test) and isotype (e.g., IgM, IgG) __________TBD FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownAnti-beta-2 adrenergic antibodiesTBDSpecify test type_________ (e.g., ELISA, complement fixation test) and isotype (e.g., IgM, IgG) __________TBD FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownAnti-streptolysin O antibodiesTBDTBD FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownAnti-DNase B antibodiesTBDTBD FORMCHECKBOX Normal FORMCHECKBOX Abnormal FORMCHECKBOX UnknownTable 4 Hypersensitivity Lab TestsTestResultUnit for ResultEosinophilsTBDTBDTryptaseTBDTBDFood-based IgG skin testTBDTBDFood-based IgE skin testTBDTBDGeneral InstructionsLaboratory tests are routinely administered in clinical trials of pharmacological interventions to assess subject safety. Laboratory tests may also be used to determine an individual’s eligibility for a study.Laboratory results may be received via electronic files directly from central study laboratories or recorded manually on case report forms if the study is using a local lab. In either scenario, it is recommended that the Laboratory Test form be used to record when samples were collected (date and time) so that the laboratory tests results can be matched with the samples collected for each subject.Important note: None of the data elements included on this CRF Module are considered Core (i.e., required for all ME/CFS studies to collect). All data elements are considered Supplemental (i.e., non-Core) and should only be collected if the research team considers them appropriate for their study, unless specified by an asterisk.**Element is classified as Supplemental – Highly RecommendedSpecific InstructionsPlease see the Data Dictionary for definitions for each of the data elements included in this CRF Module.Test – Indicate the name of each laboratory test that is run on the specimen. See the data dictionary for additional information on coding the test name using Logical Observation Identifiers Names and Codes (LOINC).Result – Record the numeric or alpha-numeric results for each laboratory test.Unit for Result – Record the units of the numeric results for each laboratory test are measured in. See the data dictionary for additional information on coding the unit of measure using Unified Code for Units of Measure (UCUM). ................
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