Detect and quantitate BK virus in blood.

Testing is performed Monday-Friday in batched runs. Specimens received by the Molecular Diagnostic lab by 8:30am will be run same day. If received after 8:30am it will be held to following day.

For optimal specimen, separate cell-free plasma from whole blood and transfer plasma to a sterile polypropylene or Inpeco tube within 6 hours of collection. EDTA plasma may  be stored at either 2°C to 8°C for up to 72 hours or frozen at -20°C for up to 7 days.

Transport whole blood or separated plasma at room temperature to Laboratory using priority overnight delivery only.

Transport specimen to Laboratory immediately. If frozen, transport separated plasma on dry ice and keep frozen.

LIMIT: One specimen every 48 hours.

Not detected

The reported concentration of BK virus particles in blood may indicate viremia levels and treatment efficacy.

Analytical measurement range for this test is 200-10,000,000 IU/mL (2.30-7.00 log₁₀ IU/mL) of plasma. 

Inadequate specimen collection, processing and storage may invalidate test results. This test should not be used as the only criterion to form a clinical conclusion; instead, results should be correlated with other test results, patient symptoms and clinical presentation.

For plasma samples in which BKV DNA is detected and between the analytical measurement range (AMR) of 200-10,000,000 IU/mL (2.30-7.00  log₁₀  IU/mL), a quantitative value (IU/mL) will be reported. If BKV DNA is detected outside the analytical measurement range (AMR) a result of <200 IU/mL or >10,000,000 IU/mL will be reported. If BKV DNA is not detected, a result of "Not Detected" will be reported. 

A result of "Not Detected" does not rule out the presence of BKV DNA or the absence of infection.  False negative results may be due to the suppression of viral replication to levels below the detection threshold, or to inhibitory substances that may be present in the specimen.  Inadequate specimen collection, processing and storage may invalidate test results.  This test should not be used as the only criterion to form a clinical conclusion.  Instead, results should be correlated with other test results, patient symptoms and clinical presentation. 

DNA sequence polymorphisms in BKV strains may underestimate viral levels.  The presence of variation in BKV DNA sequences are monitored in the real-time PCR assay.  This assay does not genotype the virus, and consequently does not provide any information with regard to BKV drug resistance. 

The performance characteristics of this test were validated by UWHC Clinical Laboratories. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test; however, FDA approval or clearance is currently not required for clinical use of this test. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. The UWHC Clinical Laboratories is authorized under Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing.