Vancomycin II - ILEX Medical

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Vancomycin II

5B75

34-3919/R6

Vancomycin II

Customer Service United States: 1-877-4ABBOTT International: Call your Abbott Representative

This package insert must be read carefully prior to product use. Package insert instructions must be followed accordingly. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert.

Read Highlighted Changes Revised November, 2005

List Number

Key to symbols used

Expiration Date

?1996, 2005 Abbott Laboratories

For In Vitro Diagnostic Use Store at 2-8?C

Lot Number

Control Low, Medium, High (L, M, H)

Store at 15-30?C

Sample Cups

CAUTION: Handle human sourced materials as potentially infectious. Consult instructions for use. (Infection Risk)

Consult instructions for use

Reagent Pack

Standard Calibrator (A-F)

Reaction Vessels

ABBOTT Max-Planck-Ring 2 65205 Wiesbaden Germany +49-6122-580

Legal Manufacturer

Authorized Representative

See REAGENTS section for a full explanation of symbols used in reagent component naming.

Abbott Laboratories Diagnostics Division Abbott Park, IL 60064 USA

1

Printed in USA

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Colors: Black

Editor: Don DTP: Joe

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NAME

CALIBRATORS

Vancomycin II

AxSYM Vancomycin II Standard Calibrators (5B75-01)

INTENDED USE The AxSYM Vancomycin II assay is a reagent system for the quantitative measurement of vancomycin, an antibiotic drug, in serum or plasma. The measurements obtained are used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.

6 Bottles (6 mL A, 4 mL each B-F) of AxSYM Vancomycin II Standard Calibrators. Standard Calibrator A is buffered dextrose and stabilizers. Standard Calibrators B-F contain accurately measured amounts of vancomycin prepared in buffered dextrose and stabilizers to yield the following concentrations:

Vancomycin Concentration

SUMMARY AND EXPLANATION OF TEST The AxSYM Vancomycin II assay utilizes Fluorescence Polarization Immunoassay (FPIA) technology.1,2 Refer to the AxSYM System Operations Manual, Section 3, under Principles of Operation for a discussion of this technology.

Vancomycin is a glycopeptide antibiotic which is bactericidal against many gram-positive and some gram-negative cocci. It is useful in therapy of severe staphylococcal (including methicillin-resistant staphylococci) infections in patients who cannot receive or who have failed to respond to the penicillins and cephalosporins. Vancomycin HCl has been used successfully alone in the treatment of staphylococcal (including methicillinresistant staphylococci) endocarditis.3-5 Because of its ototoxicity, vancomycin should be used with care in patients with renal insufficiency. Concurrent and sequential use of other neurotoxic and/or nephrotoxic antibiotics, particularly streptomycin, neomycin, kanamycin, gentamicin, cephaloridine, paromomycin, viomycin, polymyxin B, colistin, tobramycin and amikacin, requires careful monitoring of vancomycin.3,6-8

BIOLOGICAL PRINCIPLES OF THE PROCEDURE

Bottle

(?g/mL & mg/L) 0.00 5.00 10.00

25.00 50.00 100.00

(?mol/L) 0.00 3.45 6.90 17.25

34.50 69.00

Preservative: ProClin? 300

CONTROLS AxSYM Vancomycin II Controls (5B75-10) 3 Bottles (8 mL each) of AxSYM Vancomycin II Controls contain vancomycin prepared in buffered dextrose and stabilizers to yield the following concentration ranges:

The AxSYM Vancomycin II assay is based on Fluorescence Polarization Immunoassay (FPIA) technology. The AxSYM Vancomycin II Reagents and sample are pipetted in the following sequence:

SAMPLING CENTER

Bottle

Vancomycin

Concentration

Range

(?g/mL & mg/L) (?mol/L) (?g/mL & mg/L) (?mol/L)

? Sample and all AxSYM Vancomycin II Reagents required for one test are pipetted by the sampling probe into various positions of a Reaction Vessel (RV).

? Sample and Solution 4 (Line Diluent) are pipetted into one well of the RV.

? The pretreatment solution and Solution 4 (Line Diluent) are transferred to the cuvette of the RV.

The RV is immediately transferred into the Processing Center. Further pipetting is done in the Processing Center with the processing probe. PROCESSING CENTER ? An aliquot of the predilution mixture and Solution 4 (Line Diluent) are

transferred to the cuvette of the RV and the blank intensity of the sample is measured. ? A second aliquot of the predilution mixture is transferred to the cuvette along with the Vancomycin II Antiserum (antibody) and the Vancomycin II Fluorescein Tracer. ? Vancomycin from the sample and the Vancomycin II Fluorescein Tracer compete for binding sites on the antibody molecule. ? The intensity of polarized fluorescent light is measured by the FPIA optical assembly. For further information, refer to the AxSYM System Operations Manual, Section 3.

REAGENTS REAGENT PACK, 100 TESTS AxSYM Vancomycin II Reagent Pack (5B75-20)*

? 1 Bottle (15.0 mL) < 25% Vancomycin II Antiserum (Mouse, Monoclonal) in buffer with protein stabilizers. Preservative: Sodium Azide. (Reagent Bottle 1)

? 1 Bottle (8.6 mL) Pretreatment Solution. Surfactant in TRIS buffer. Preservative: Sodium Azide. (Reagent Bottle 2)

? 1 Bottle (15.1 mL) < 0.01% Vancomycin II Fluorescein Tracer in buffer containing surfactant and stabilizers. Preservative: ProClin? 300. (Reagent Bottle 3)

*5B75-99 includes an AxSYM Vancomycin II Reagent Pack (100 Tests) and Reaction Vessels (100 each). 5B75-20 includes these items for international shipments.

7.00 35.00 75.00

4.83 5.20 - 8.80 3.59 - 6.07 24.15 30.00 - 40.00 20.70 - 27.60 51.75 62.00 - 88.00 42.78 - 60.72

Preservative: ProClin? 300

Abbott manufactures internal reference standards using Vancomycin Hydrochloride (USP Reference Standard). Vancomycin calibrators are manufactured gravimetrically and tested against these internal reference standards.

OTHER REAGENTS

AxSYM Probe Cleaning Solution (9A35-05)

2 Bottles (220 mL each) AxSYM Probe Cleaning Solution containing 2% Tetraethylammoniumhydroxide (TEAH).

Solution 4 (Line Diluent) (8A46)

1 Bottle (10 L) Solution 4 (Line Diluent) containing 0.1M Phosphate Buffer. Preservatives: Sodium Azide and Antimicrobial Agent.

WARNINGS AND PRECAUTIONS For In Vitro Diagnostic Use.

SAFETY PRECAUTIONS

? CAUTION: This product requires the handling of human specimens. It is recommended that all human sourced materials are considered potentially infectious and be handled in accordance with the OSHA Standard on Bloodborne Pathogens13. Biosafety Level 214 or other appropriate biosafety practices15,16 should be used for materials that contain or are suspected of containing infectious agents.

? The AxSYM Probe Cleaning Solution (2% TEAH) may cause mild eye irritation. If this solution comes in contact with eyes, rinse immediately with water. If irritation persists, seek medical attention.

? This product contains sodium azide; for a specific listing, refer to the REAGENTS section. Contact with acids liberates very toxic gas. This material and its container must be disposed of in a safe way.

? The Tracer, Standard Calibrators A-F and Controls L, M, H contain methylisothiazolones which are components of ProClin 300 and are classified per applicable European Community (EC) Directives as: Irritant (Xi). The following are the appropriate Risk (R) and Safety (S) phrases.

R43 May cause sensitization by skin contact.

S24 Avoid contact with skin.

S35 This material and its container must be disposed of in a safe way.

S37 Wear suitable gloves.

S46 If swallowed, seek medical advice immediately and show this container or label.

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For product not classified as dangerous per European Directive 1999/45/EC as amended - Safety data sheet available for professional user on request.

45 Selected Result Concentration Units > ?g/mL 46 Selected Result Decimal Places > 2 62 Blank I-Max background intensity: *

HANDLING PRECAUTIONS

? Do not use kits beyond the expiration date or a maximum of 112 cumulative hours on-board the AxSYM System.

? Do not mix reagents from different reagent packs.

? AxSYM Vancomycin II Reagents are susceptible to bubbles/foaming and require inspection and removal of bubbles before loading. If bubbles are present, refer to the AxSYM System Operations Manual, Section 9, for instructions on removing bubbles from reagent packs.

Refer to the AxSYM System Operations Manual, Sections 7 and 8, for a more detailed discussion of the safety and handling precautions during system operation, including disposal of sodium azide containing solutions.

63 Min Tracer-Min net intensity: * 73 Low Limit-Normal/Therapeutic Range lower limit > 0.00 74 Hi Limit-Normal/Therapeutic Range upper limit > 0.00 75 Low Extreme Value > 3.00 76 High Extreme Value > 1000.00 91 Low Range Undiluted: * 92 High Range Undiluted: * 96 Low Range Dil1: * 97 High Range Dil1: *

STORAGE INSTRUCTIONS

101 Low Range Dil2: *

The AxSYM Vancomycin II Reagent Pack must be stored at 2-8?C. The AxSYM Vancomycin II Reagent Pack may be used immediately after removal from the refrigerator. Do not freeze the AxSYM Vancomycin II Reagent Pack. Calibrators and controls should be returned to 2-8?C storage immediately after use. The AxSYM Vancomycin II Reagent Pack may be on-board the AxSYM System for a maximum of 112 cumulative hours; for example, 14 eight hour shifts. Refer to the AxSYM System Operations Manual, Sections 2, 5 and Appendices, for further information on tracking on-board time. Reagents are stable until the expiration date when stored and handled as directed.

The AxSYM Probe Cleaning Solution and Solution 4 (Line Diluent) must be stored at 15-30?C.

INSTRUMENT PROCEDURE Assay File Installation

The AxSYM Vancomycin II Assay File must be installed on the AxSYM System from one of the following software disks, prior to performing the Vancomycin II assay: ? 2C44-01, or higher (112 hours on-board Stability) ? 3D53-01, or higher (112 hours on-board Stability) Refer to the AxSYM System Operations Manual, Section 2, for proper installation procedures. AxSYM Vancomycin II Assay Parameters

The default values for the assay parameters used for the AxSYM Vancomycin II assay are listed below. Assay parameters that can be edited contain a (>) symbol. These parameters can be displayed and edited according to the procedure in the AxSYM System Operations Manual, Section 2. In order to obtain values for the parameters with (*), review the specific Assay Parameter screen. Press PRINT to print the assay parameters.

102 High Range Dil2: *

NOTES:

1. Parameter 45: Selected result concentration unit can be edited to the alternate results units ?mol/L or mg/L.

2. Values associated with the low and high extreme flags, Assay Parameters #75 and #76 are assay specific and should not be edited.

SAMPLE COLLECTION AND PREPARATION FOR ANALYSIS ? Serum or plasma (collected in sodium heparin, citrate, EDTA, or

oxalate collection tubes) may be used in the AxSYM Vancomycin II assay. Follow the manufacturer's processing instructions for serum or plasma collection tubes.

? The AxSYM System does not provide the capability of verifying sample type. It is the responsibility of the operator to verify the correct sample type(s) is(are) used in the Vancomycin II assay.

? Ensure that complete clot formation has taken place prior to centrifugation. Some samples, especially those from patients receiving anticoagulant or thrombolytic therapy, may exhibit increased clotting time. If the sample is centrifuged before a complete clot forms, the presence of fibrin may cause erroneous results.

? Specimens containing particulate matter or red blood cells may give inconsistent results and should be centrifuged before testing (recommended 8,000-10,000 RCF* x 10 minutes).

? Samples may be stored for up to 24 hours at 2-8?C prior to being tested. If testing will be delayed more than 24 hours, the serum or plasma should be separated from the clot or red blood cells and stored frozen at -10?C or colder for up to 168 hours.

? To minimize the effects of evaporation, all samples (patients, controls and calibrators) should be tested within 3 hours of being placed on-board the AxSYM System. Refer to the AxSYM System Operations Manual, Section 5, for a detailed discussion of on-board sample storage constraints.

Assay Parameters 1 Long Assay Name (English): Vancomycin_II 6 Abbrev Assay Name (English): Vanco_II 11 Assay Number: 668 12 Assay Version: * 13 Calibration Version: * 14 Assay File Revision: * 15 Assay Enabled > ON 17 Assay Type: FPIA 18 Standard Cal Reps > 2 21 Cal A Concentration: 0.00 22 Cal B Concentration: 5.00 23 Cal C Concentration: 10.00 24 Cal D Concentration: 25.00 25 Cal E Concentration: 50.00 26 Cal F Concentration: 100.00 43 Default Dilution Protocol > UNDILUTED 44 Default Calibration Method > Standard Calibration

? Inspect all samples for bubbles. Remove bubbles prior to analysis.

? When shipped, samples must be packaged and labeled in compliance with applicable federal and international regulations covering the transport of clinical samples and etiologic agents.

* Relative Centrifugal Force.

SAMPLE VOLUME

The sample volume required to perform a single undiluted vancomycin test on the AxSYM System varies depending on the type of sample container used. For sample cups, a ROUTINE test requires 150 ?L and a STAT test requires 94 ?L. For every additional vancomycin test performed (ROUTINE or STAT) from the same sample container, an additional 44 ?L of sample is required.

The sample cup minimum volumes for both ROUTINE and STAT tests (undiluted or diluted) are calculated by the AxSYM System. They are displayed on the Order screen at the time the test(s) is(are) ordered.

When using Host Order Query, the Order screen information and Orderlist Report are not available. Refer to the AxSYM System Operations Manual, Section 5: Ordering Patient Samples, for a description of the Host Order Query option.

If the assay is configured for auto retest/auto dilution, the additional sample volume needed for the retest will not be displayed on the Order screen at the time the test(s) is(are) ordered. Therefore, the total sample volume should include an additional 44 ?L of sample.

For sample volume requirements in primary or aliquot tubes, and calibrator and control requirements for multiple reagent lots, refer to the AxSYM System Operations Manual, Section 5.

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To obtain the recommended volume requirements for AxSYM Vancomycin II Calibrators and Controls, hold the bottles vertically and dispense 4 drops of each calibrator or control into each respective sample cup.

AxSYM Vancomycin II PROCEDURE Materials Provided ? 5B75-99 AxSYM Vancomycin II Reagent Kit, containing:

Operator Verification An acceptable Vancomycin II calibration curve should meet the following criteria: a) Polarization Error (PERR) -3.00 to +3.00 for all calibrators. b) Root Mean Squared Error (RMSE) less than or equal to 2.00. c) L, M and H controls are all within the acceptable ranges.

AxSYM Vancomycin II

100

Materials Required But Not Provided

? 5B75-01 AxSYM Vancomycin II Standard Calibrators

? 5B75-10 AxSYM Vancomycin II Controls

? 8A46

? 9A35-05

? 8A76-01

? Pipettor and pipette tips (optional) to deliver the volumes specified on the Order screen.

CAUTION: ? For optimal performance it is important to follow the routine maintenance

procedures defined in the AxSYM System Operations Manual, Section 9. If your laboratory requires more frequent maintenance, follow those procedures. Assay Procedure

Sections 5 and 6 of the AxSYM System Operations Manual can be easily removed for use at the instrument. They contain detailed steps for performing assay calibration and sample testing procedures. Prior to ordering tests, confirm that the System inventory of Reaction Vessels (RVs), bulk solutions and waste levels are acceptable. The operator may obtain an Orderlist Report by pressing PRINT. The printout contains sample placement information and minimum STAT sample cup volume requirements for all tests ordered. When using Host Order Query the Orderlist Report is not available. Refer to the AxSYM System Operations Manual, Section 5: Ordering Patient Samples, for a description of the Host Order Query option. CAUTION: When operating the AxSYM System, always observe the following: ? The System status must be WARMING, PAUSED, READY or STOPPED

before adding or removing sample segments, reagent packs or Reaction Vessels (RVs). ? When only performing FPIA assays, the instrument homes all motors and may display "Error Code 5066 Matrix cell not detected, trap door, processing center". Select OK to proceed with testing the FPIA assays. ? Do not open the Interior Waste Door or the AxSYM Processing Center Cover while any test is in process. If opened, all processing will stop. Tests in process will be terminated and must be repeated. ? When testing is completed, it is recommended that samples and the AxSYM Vancomycin II Reagent Pack are removed from the Sampling Center to maximize the on-board reagent pack use. Store Reagent Pack at 2-8?C.

QUALITY CONTROL PROCEDURES CALIBRATION The AxSYM Vancomycin II assay must be calibrated using a Standard Calibration (6-point) procedure. Standard Calibration

To perform a Standard Calibration, test the AxSYM Vancomycin II Standard Calibrators A, B, C, D, E, and F in duplicate. A single sample of all levels of vancomycin controls must be tested as a means of evaluating the assay calibration. Once the AxSYM Vancomycin II calibration is accepted and stored, all subsequent samples may be tested without further calibration unless: ? A reagent pack with a new lot number is used. ? Control values are out of their specified range. Refer to the AxSYM System Operations Manual, Section 6, for: ? Setting up an assay calibration ? When recalibration may be necessary ? Calibration Verification The AxSYM System verifies that the results of an assay calibration meet the specifications assigned to selected validity parameters. An error message occurs when the calibration fails to meet a specification. Refer to the AxSYM System Operations Manual, Section 10, for an explanation of the corrective actions for the error code. Refer to the AxSYM System Operations Manual, Appendices, for an explanation of the calibration validity parameters that may be used by the AxSYM System.

NOTE: PERR's and RMSE's are to be used as guidelines only. If controls are within specified ranges, the calibration curve is acceptable.

QUALITY CONTROL

The recommended control requirement for an AxSYM Vancomycin II assay is a single sample of at least two different vancomycin control levels, which span the medical decision range, tested once every 24 hours, each day of use. Controls may be placed in any position in the Sample Carousel.

If the quality control procedures in your laboratory require more frequent use of controls to verify test results, follow those procedures.

Ensure that assay control values are within the concentration ranges specified in this package insert. Refer to the REAGENTS, CONTROLS section of this package insert for AxSYM Vancomycin II Control ranges.

INDICATIONS OF INSTABILITY OR DETERIORATION OF REAGENTS

When a control value is out of the specified range, it may indicate deterioration of the reagents or errors in technique. Associated test results may be invalid and require retesting. Assay recalibration may be indicated. Refer to the AxSYM System Operations Manual, Section 10, Subsection: Observed Problems, for further troubleshooting information.

The AxSYM System has a capability to generate a Levey-Jennings plot of each assay's quality control performance. Refer to the AxSYM System Operations Manual, Section 5, for further information. At the discretion of the laboratory, selected quality control rules may be applied to the quality control data.

RESULTS The AxSYM Vancomycin II assay utilizes a four parameter logistic curve fit method (4PLC, Y weighted) to generate a calibration curve. This curve is stored in memory and concentrations of drug in controls and unknown samples are calculated from this curve using polarization values generated.

Alternate Result Unit

The default result unit for AxSYM Vancomycin II is ?g/mL. When selecting the alternate result unit, mg/L, the conversion factor used by the AxSYM System is 1.00. When selecting the alternate result unit, ?mol/L, the conversion factor used by the AxSYM System is 0.69.

Flags

Some results may contain information in the Flags field. Samples flagged as low extreme values (LL), Assay Parameter #75, must be reviewed prior to reporting assay results. Results at or near the assay sensitivity should be verified prior to reporting drug concentrations. For a description of the flags that may appear in this field, refer to the AxSYM System Operations Manual, Section 1.

LIMITATIONS OF THE PROCEDURE As with all analyte determinations, the vancomycin value should be used in conjunction with information available from clinical evaluation and other diagnostic procedures.

SAMPLE DILUTION PROCEDURES

Automated Dilution Protocol

Patient samples with vancomycin concentrations reported as greater than 100.00 ?g/mL may be diluted using an automated dilution protocol. The AxSYM System automatically calculates the concentration of the diluted sample and reports the result. Refer to the AxSYM System Operations Manual, Section 5, for additional information on ordering sample dilutions.

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Manual Dilution Protocol

Patient samples with vancomycin concentrations reported as greater than 400.00 ?g/mL by the Automated Dilution Protocol may be diluted using a manual dilution of 1:10. Add one part of the patient sample to nine parts of the AxSYM Vancomycin II Calibrator A. Repeat the test using this manually diluted sample. The concentration reported by the AxSYM System must be multiplied by the manual dilution factor to obtain the final sample concentration.

Final Sample

Concentration = Reported Concentration x Manual Dilution Factor

Manual (Volume of Sample + Volume of Dilution Reagent)

Dilution Factor = Volume of Sample

EXPECTED VALUES Strong correlations have been shown between serum levels of vancomycin and both therapeutic effect and toxicity in specific patient types. Peak serum levels of vancomycin in the range of 20 to 40 ?g/mL and trough blood levels of 5-10 ?g/mL are suggested for optimal therapeutic effectiveness.9 In the presence of impaired renal function, unnecessarily high blood levels of vancomycin (approximately 90 ?g/mL) may damage the eighth cranial nerve and cause deafness.6,7

Refer to the drug manufacturer's package insert or the Physicians' Desk Reference? (PDR) for proper drug dosage and for vancomycin measurement sampling times.

SPECIFIC PERFORMANCE CHARACTERISTICS PRECISION

Precision was determined as described in National Committee for Clinical Laboratory Standards (NCCLS) protocol EP5-T210 (including an additional estimate of between day precision) using assay controls with 7.0, 35.0, and 75.0 ?g/mL of vancomycin added. Results from these studies typically yielded CV's of less than 7%. The following are representative results from pooled data from one reagent lot tested across four instruments for a total of twelve precision studies.

Target value

Concentration (?g/mL)

7.0

35.0

75.0

(n=80)

Mean

7.44

35.23

73.09

SD Within Run

0.32

0.92

2.55

CV Within Run (%)

4.25

2.61

3.49

SD Between Day

0.05

0.30

0.64

CV Between Day (%)

0.63

0.85

0.88

SD Total

0.32

1.04

2.97

CV Total (%)

4.26

2.94

4.06

ACCURACY BY RECOVERY

Recovery was determined by adding vancomycin to human serum and to buffer at concentrations of 5.0, 7.0, 10.0, 25.0, 35.0, 50.0, and 75.0 ?g/mL. The concentration of vancomycin was determined using the AxSYM Vancomycin II assay, and the resulting % recovery was calculated according to the following equation:

% Recovery = ("serum sample concentration" divided by "buffer sample concentration") x 100

Representative data are shown in the following table.

Added Concentration

(?g/mL)

Concentration in serum (?g/mL)

Concentration in Buffer (?g/mL)

Percent (%) Recovery

5.0

5.02

7.0

6.94

10.0

10.00

25.0

24.09

35.0

35.27

50.0

50.47

75.0

77.60

Average Recovery: 102.5 + 2.5%

4.76 7.02 10.02 23.06 34.58 48.44 75.33

105.5 98.9 99.8 104.5 102.0 104.2 103.0

SENSITIVITY

The sensitivity of the AxSYM Vancomycin II assay was calculated to be 2.00 ?g/mL. This sensitivity is defined as the lowest measurable concentration that can be distinguished from zero with 95% confidence.

SPECIFICITY

Cross-reactivity was tested for compounds whose chemical structure or concurrent usage could cause potential interference with the AxSYM Vancomycin II assay.

Cross-reactivity testing has demonstrated that vancomycin crystalline degradation product 1 (CDP-1) at concentrations of 10, 20 and 50 ?g/mL, cross-reacts less than the sensitivity of the assay in the absence of vancomycin. When CDP-1 is tested in the presence of vancomycin, at the same indicated concentrations (10-50 ?g/mL), the change in vancomycin measured is less than the assay sensitivity. CDP-1 may accumulate in patients with impaired renal function.11,12

The following compounds were tested in the absence of vancomycin up to 500 ?g/mL after adding a known quantity of each to human serum. Methotrexate was tested up to 227 ?g/mL. Each compound yielded results less than the sensitivity of the assay (2.00 ?g/mL).

Acetaminophen Amikacin Ampicillin Amphotericin B Bendroflumethiazide Caffeine Carbenicillin Cefamandole Nafate Cefazolin Cephacetrile Cephalexin Cephaloglycin Cephaloridine Cephalosporin C Cephalothin Chloramphenicol Chlorothiazide Ciprofloxacin Clindamycin Erythromycin Ethacrynic Acid Ethambutol 5-Fluorocytosine Fortimicin A Fortimicin B Furosemide Gentamicin Heparin Hydrochlorothiazide Ibuprofen Isoniazid

Kanamycin A Kanamycin B Lincomycin Methylprednisolone Methicillin Methotrexate Nalidixic Acid Naproxen Neomycin Netilmicin Nitrofurantoin Oxaprozin Oxytetracycline Penicillin G Penicillin V Phenacetin Polythiazide Prednisolone Rifampin Sagamicin Sulfate Salicylic Acid Seldomycin Factor 5 Spectinomycin Streptomycin Sulfadiazine Sulfamethoxazole Sulfisoxazole Tetracycline Ticarcillin Tobramycin Trimethoprim

INTERFERENCE

The compounds listed below, added to human serum, resulted in less than 10% error in detecting added drug when assayed with the AxSYM Vancomycin II assay.

Compound ? Bilirubin ? Hemoglobin ? Triglycerides ? Total Protein

Concentration Tested 20 mg/dL 1 g/dL

2300 mg/dL 3.0-10.0 g/dL

Results ................
................

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