Detect and quantify BK virus in blood.
Quantitative Real-Time Polymerase Chain Reaction
Lavender (EDTA), pink (K2EDTA), or serum separator tube
Transport 1 mL whole blood, serum or plasma in a sterile container. (Min: 0.5 mL).
Urine (refer to BK Virus, Quantitative PCR, Urine, ARUP test code 2002310). Heparinized specimens.
Specimen source required.
Ambient: 24 hours; Refrigerated: 72 hours; Frozen: 1 month
The quantitative range of this assay is 2.6-8.6 log copies/mL (390-390,000,000 copies/mL).
A negative result (less than 2.6 log copies/mL or less than 390 copies/mL) does not rule out the presence of PCR inhibitors in the patient specimen or BK virus DNA concentrations below the level of detection of the assay. Inhibition may also lead to underestimation of viral quantitation.
No international standard is currently available for calibration of this assay. Caution should be taken when interpreting results generated by different assay methodologies.
Compliance Statement A: For laboratory developed tests using a manufacturer labeled ASR as the reagent providing the specificity of the assay. Analyte Specific Reagent. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, the FDA has determined that such clearance or approval is not necessary.
The limit of quantification for this DNA assay is 2.6 log copies/mL (390 copies/mL). If the assay DID NOT DETECT the virus, the test result will be reported as "< 2.6 log copies/mL (< 390 copies/mL)." If the assay DETECTED the presence of the virus but was not able to accurately quantify the number of copies, the test result will be reported as "Not Quantified."
|Component Test Code*||Component Chart Name||LOINC|
|2002305||BK Virus (cpy/mL), Blood||48309-9|
|2002307||BK Virus Source, Blood||31208-2|
|2002308||BK Virus (log cpy/mL), Blood||43201-3|
|2002309||BK Virus Interp, Blood||63475-8|
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