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Test Name:
BK Virus, Quantitative, by PCR, Serum or Plasma
- SBMF No:
36156 - Performance Lab Name:
Flow Cytometry/Molecular Pathology - Test Mnemonic:
BKV QPCR - ABN:
Required – Not FDA-Approved - CPT Code:
87799 - LOINC Code:
41479-7 - Spec Type:
Serum - Spec Container:
Gold top (SST) or red top (serum) tube - Alt Spec Type:
Plasma - Alt Spec Container:
Lavender top (EDTA) or pale yellow top (ACD) tube - Pref Vol:
1.0 mL - Min Vol:
0.5 mL - Fasting:
No - Spec Collect:
Routine venipuncture - Spec Process:
Serum sample tubes, clot 30 minutes
Promptly centrifuge 15 minutes
Immediately transfer serum or plasma to sterile plastic tube - Spec Store Transport:
Refrigerated (3 days) or frozen - Spec Stability:
8 hours room temperature (20-30°C)
3 days refrigerated (2-8°C)
1 month frozen (-20°C) – Do not use frost-free units that undergo repeated freeze/thaw cycles - Spec Reject:
Clotted specimen
Heparinized plasma
Frozen whole blood - Methodology:
Polymerase Chain Reaction (PCR) - Use:
Detect the presence of BK virus and, if present, quantify and result as "copies/mL" or "Log copies/mL" - Clinical Significance:
BK Virus (BKV) is a member of polyoma viruses, a DNA virus in the family Polyomaviridae, which also includes other closely related viruses, JC virus and simian virus 40. BKV is a common cause of asymptomatic infection in immunocompetent individuals. Seroconversion occurs in approximately 70% of the population between the ages of 5 and 8. Human symptomatic infections usually occur in immunocompromised patients. BKV causes cystitis (non-hemorrhagic and hemorrhagic) and ureteral stenosis in bone marrow and solid organ transplant recipients, and polyomavirus-associated nephropathy (PVAN) in renal transplant recipients. The prevalence of PVAN in transplant recipients varies from 1 to 10%, and the rates of allograft loss range from 10 to 80%. - Reference Range:
Not detected - Additional Test Info:
This assay is able to quantify BK virus DNA in the linear range of 1000 to 1,000,000 copies/mL. A “not detected” result indicates either an absence of BK virus in the specimen or the presence of a viral load at a level that is below the assay detection limit. A result that indicates the presence of BK virus should be evaluated in conjunction with clinical presentation. Diagnosis of BK virus infection should not rely solely on the result of the PCR test.
A standardized international calibration is not currently available for BK virus PCR test. Caution should be taken when interpreting results obtained by different assay methodologies in different laboratories.
This test was developed and its performance characteristics were determined by SBMF Laboratory. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test. However, the FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes and should not be regarded as investigational or for research. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. SBMF is authorized under Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing.
This test is performed pursuant to an agreement with Roche Molecular Systems, Inc.
- Day Run:
Wed - Time Run:
If received by 8:00 am Wednesday - Time Reported:
Reported by the following Friday - Test Type:
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