Vancomycin
Vancomycin
Vancomycin
Rx Only
ANNUAL REVIEW
Reviewed by Date Reviewed by Date
PRINCIPLE
INTENDED USE
VANC reagent, when used in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Vancomycin
Calibrator set, is intended for quantitative determination of vancomycin concentration in human serum or plasma.
CLINICAL SIGNIFICANCE
Vancomycin is a glycopeptide antibiotic. It is primarily used in the treatment of infections due to β-lactam or
methronidazole-resistant gram positive cocci and bacilli.1 It may also be used prophylactically in some patients who are
at risk for endocarditis or when methicillin-resistant Staphylococcus aureus or Staphylococcus epidermidis is a risk.2
Since individual patients exhibit a high degree of variability in absorption and metabolism of vancomycin, therapeutic
monitoring is recommended in certain patients.1 The major toxic reactions include "red-man syndrome", nephrotoxicity,
and ototoxicity when very high levels of drug are present in the circulation.
METHODOLOGY
VANC reagent is used to measure analyte concentration by a particle enhanced turbidimetric inhibition immunoassay
method.3 Particle-bound drug (PBD) binds to the analyte specific antibody (Ab) resulting in the formation of insoluble
aggregates causing light scatter. Non-particle-bound analyte in the patient sample competes with the PBD for the
antibody binding sites, inhibiting the formation of insoluble aggregates. The rate and amount of particle aggregation
is inversely proportional to the concentration of analyte in the sample.
The SYNCHRON System(s) automatically proportions the appropriate sample and reagent volumes into a cuvette. The
ratio used is one part sample to 104 parts reagent. The System monitors the aggregate formation by measuring the
change in absorbance at 340 nanometers. This change in absorbance is inversely proportional to the concentration
of VANC in the sample and is used by the System to calculate and express the VANC concentration based upon a
multi-point calibration curve.
SPECIMEN
TYPE OF SPECIMEN
Biological fluid samples should be collected in the same manner routinely used for any laboratory test.4 Freshly drawn
serum or plasma are the preferred specimens. Acceptable anticoagulants are listed in the PROCEDURAL NOTES
section of this chemistry information sheet. Whole blood or urine are not recommended for use as a sample.
Serial samples should be collected using the same sample type (i.e., serum or plasma).
1. Tubes of blood are to be kept closed at all times and in a vertical position. It is recommended that the serum or
plasma be physically separated from contact with cells within two hours from the time of collection.5
2. Separated serum or plasma should not remain at room temperature longer than 8 hours. If assays are not
completed within 8 hours, serum or plasma should be stored at +2°C to +8°C. If assays are not completed within
48 hours, or the separated sample is to be stored beyond 48 hours, samples should be frozen at -15°C to -20°C.
Frozen samples should be thawed only once. Analyte deterioration may occur in samples that are repeatedly
frozen and thawed.5
Additional specimen storage and stability conditions as designated by this laboratory:
SAMPLE VOLUME
A filled 0.5 mL sample cup is the optimum volume. For optimum primary sample tube volumes in primary tube samples
and minimum volumes, refer to the Primary Tube Sample Template for your system.
Refer to the PROCEDURAL NOTES section of this chemistry information sheet for information on unacceptable
specimens.
Criteria for sample rejection as designated by this laboratory:
SPECIMEN HANDLING
REAGENTS
CONTENTS
Sample Volume 3 µL
ORDAC Sample Volume 2 µL
Total Reagent Volume 312 µL
Cartridge Volumes
A 230 µL
B 50 µL
C 32 µL
REACTIVE INGREDIENTS
REAGENT CONSTITUENTS
Vancomycin Particle Reagent 8 mL
Monoclonal anti-vancomycin Antibody (mouse) 5 mL
Vancomycin Reaction Buffer 54 mL
Also non-reactive chemicals necessary for optimal system performance.
REAGENT PREPARATION
NOTICE
Failure to mix the reagent will result in erroneous values.
The acceptability of a reagent is determined by successful calibration and by ensuring that quality control results are
within your facility's acceptance criteria.
VANC Reagent when stored unopened at +2°C to +8°C, will remain stable until the expiration date printed on the cartridge
label. Once opened, the reagent is stable for 42 days at +2°C to +8°C unless the expiration date is exceeded. DO NOT
FREEZE. Do not expose reagent to temperatures above +35°C or to direct sunlight.
Reagent storage location:
CALIBRATION
CALIBRATOR REQUIRED
CALIBRATOR PREPARATION
No preparation is required.
SYNCHRON Systems Vancomycin Calibrator set is stable until the expiration date printed on the calibrator bottle if stored
capped in the original container at +2°C to +8°C.
Calibrator storage location:
CALIBRATION INFORMATION
1. The system must have a valid calibration curve in memory before control or patient samples can be run.
TRACEABILITY
QUALITY CONTROL
At least two levels of control material should be analyzed daily. In addition, these controls should be run with each new
calibration, with each new reagent cartridge, and after specific maintenance or troubleshooting procedures as detailed
in the appropriate system manual. More frequent use of controls or the use of additional controls is left to the discretion
of the user based on good laboratory practices or laboratory accreditation requirements and applicable laws.
The following controls should be prepared and used in accordance with the package inserts. Discrepant quality control
results should be evaluated by your facility.
TESTING PROCEDURE(S)
1. If necessary, load the reagent onto the system.
2. After reagent load is completed, calibration may be required.
3. Program samples and controls for analysis.
4. After loading samples and controls onto the system, follow the protocols for system operations.
For detailed testing procedures, refer to the UniCel DxC 600/800 System Instructions For Use (IFU) manual.
REPORTING RESULTS
Equivalency between the SYNCHRON LX and UniCel DxC 600/800 Systems has been established. Chemistry results
between these systems are in agreement and data from representative systems may be shown.
REFERENCE INTERVALS
The reference intervals listed below were taken from the literature.1,2,6,7
PROCEDURAL NOTES
ANTICOAGULANT TEST RESULTS
The following anticoagulants were assessed by Deming regression analysis with a minimum of 50 paired serum and
plasma samples. Values of serum (X) ranging from 4.2 to 49.0 µg/mL were compared with the values from plasma (Y)
yielding the following results:
LIMITATIONS
None identified
INTERFERENCES
1. The following substances were tested for interference with this methodology:
2. Interference may occur with serum samples from patients diagnosed as having plasma cell dyscrasias and
lymphoreticular malignancies associated with abnormal immunoglobulin synthesis, such as multiple myeloma,
Waldenström`s macroglobulinemia, and heavy chain disease.11 Results for these samples are typically
suppressed. If using the dilution protocol for results less than the analytical range, results from patients with these
disease states usually do not approximate the known value. These samples should be run by an alternate method.
3. For assays employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies
(HAMA) in the sample. Human anti-mouse antibodies may be present in samples from patients who have received
immunotherapy or diagnostic procedures utilizing monoclonal antibodies or in individuals who have been regularly
exposed to animals.12,13 Additionally, other heterophile antibodies, such as human anti-goat antibodies may be
present in patient samples. Interpretation of results should be done in the context of the overall clinical presentation
of the patient, including symptoms, clinical history, data from additional tests and other appropriate information.
4. Refer to References (14,15,16) for other interferences caused by drugs, disease and preanalytical variables.
SPECIFICITY
The following list of substances were added at the concentration listed to separate aliquots of a serum pool containing
15 µg/mL vancomycin. In most cases the value shown approximates maximum physiological concentrations. The
recovered values were subtracted from the serum pool value. If the recovered results were within ± 2X the within-run
precision specifications there was no significant interference. If the recovered results were more than ± 2X the within-run
precision specifications the difference is listed under observed effect.
The SYNCHRON LX Systems method for the determination of vancomycin provides the following analytical range. It is
recommended that the Auto ORDAC feature be enabled.
SENSITIVITY
Sensitivity is defined as the lowest measurable concentration which can be distinguished from zero with 95% confidence.
Sensitivity for VANC determination is 3.5 µg/mL (2.4 µmol/L).
EQUIVALENCY
Equivalency was assessed by Deming regression analysis of patient samples to accepted clinical methods.
PRECISION
A properly operating SYNCHRON System(s) should exhibit precision values less than or equal to the following:
NOTICE
These degrees of precision and equivalency were obtained in typical testing procedures
on a SYNCHRON LX System and are not intended to represent the performance
specifications for this reagent.
SHIPPING DAMAGE
If damaged product is received, notify your Beckman Coulter Clinical Support Center.
REVISION HISTORY
Revision AG
Revised Quality Control section, and removed the sodium azide warning.
Revision AH
Updated corporate address; updated OSHA precaution and removed EDTA as an Acceptable Anticoagulant claim.
Revision AJ
Added Reagent Preparation visual aid to the Reagent Preparation section.
Revision AK
Added Revision History
Revision AL
Added new language requirement: Czech, and Korean.
Revision AM
Removed references to CX and LX systems as they are discontinued effective 12/2013.
Added Beckman Coulter trademark statement and disclaimer.
Revision AN
Revised Interferences section.
Revision AP
Added GHS Classification information
Revision AR
Updates to comply with requirements per Beckman Coulter Global Labeling Policy.
Revision AT
Additional changes to comply with requirements per Beckman Coulter Global Labeling Policy.
Revision AU
Updated REAGENT CONSTITUENTS to correct volume of Vancomycin Reaction Buffer.
Table 10.0
2. Burtis, C. A., Ashwood, E. R., eds., "Specimen Collection and Processing: Sources of Biological Variation", Tietz
Textbook of Clinical Chemistry, 3rd Edition, W. B. Saunders, Philadelphia PA (1999).
3. Newman, D. J., Henneberry, H., Price, C. P., "Particle Enhanced Light Scattering Immunoassay", Ann. Clin .
Biochem., 29:22 42 (1992).
4. Tietz, N. W., "Specimen Collection and Processing; Sources of Biological Variation", Textbook of Clinical
Chemistry, 5th Edition, W. B. Saunders, Philadelphia, PA (2005).
5. National Committee for Clinical Laboratory Standards, Procedures for the Handling and Processing of Blood
Specimens Approved Guideline, NCCLS publication H18-A, Villanova, PA (1990).
6. The National Academy of Clinical Biochemistry, Standards of Laboratory Practice, Guidelines for Therapeutic Drug
Monitoring Services (1999).
7. Tietz, N. W., Clinical Guide to Laboratory Tests, 3rd Edition, W. B. Saunders Company, Philadelphia, PA (1995).
8. National Committee for Clinical Laboratory Standards, How to Define, Determine, and Utilize Reference Intervals
in the Clinical Laboratory Approved Guideline, NCCLS publication C28-A, Villanova, PA (1995).
9. Tietz, N. W., ed., Fundamentals of Clinical Chemistry, 6th Edition, W. B. Saunders, Philadelphia, PA (2007).
10. Henry, J. B., Clinical Diagnosis and Management by Laboratory Methods, 22nd Edition, W. B. Saunders Company,
Philadelphia, PA (2006).
11. Burtis, C.A. and Ashwood, E.R., ed., Tietz Textbook of Clinical Chemistry 3rd Edition, pages 510 and 511, W.B.
Saunders, Philadelphia, PA (1999).
12. Bjerner, J., et al., "Immunometric Assay Interference: Incidence and Prevention", Clin. Chem. 48:613 621 (2002).
13. Kricka, L. J., "Interferences in Immunoassays-Still a Threat", Clin. Chem., 46:1037 1038 (2000).
14. Young, D. S., Effects of Drugs on Clinical Laboratory Tests, 5th Edition, AACC Press, Washington, D. C. (2000).
15. Friedman, R. B., Young, D. S.,Effects of Disease on Clinical Laboratory Tests, 4th Edition, AACC Press,
Washington, D.C. (2001).
16. Young, D. S., Effects of Preanalytical Variables on Clinical Laboratory Tests, 3rd Edition, AACC Press,
Washington, D. C. (2007).
17. National Committee for Clinical Laboratory Standards, Method Comparison and Bias Estimation Using Patient
Samples Approved Guideline, NCCLS publication EP9-A, Villanova, PA (1995).
18. National Committee for Clinical Laboratory Standards, Precision Performance of Clinical Chemistry Devices, 2nd
Edition, Approved Guideline, Vol. 19, No. 2, NCCLS publication EP5-A, Villanova, PA (1999).
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