Molecular Diagnostics | BK Virus, Quantitative by PCR, Urine

UWHC Lab Test Details
Test NameBK Virus, Quantitative by PCR, Urine
Test Code(s)HCBKPCR
CPT Code(s)87799
MethodologyReal-Time PCR
Clinical Information

Detect and quantify BK virus in urine.

Days PerformedMon-Fri.
In-Lab Turnaround Time2 - 3 days.
Stat In-Lab Turnaround TimeNot available stat.
Collection Requirements
Patient Preparation

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.

SpecimenRandom urine
Collection Container
Collection ContainerSterile screw cap container
Collection Instructions

First morning void is preferred.

Collection Volume5 - 10 mL
Pediatric Collection Volume2 mL
Specimen Processing Requirements
Stability
Stability Ambient

4 days (96 hours)

Stability Refrigerated

7 days 

Stability Frozen

30 days

Sample AnalyzedUrine aliquot
Testing Volume2 mL
Pediatric Testing Volume1.2 mL
Specimen Transport

Transport specimen to Laboratory.

Interpretation
Test Limitations

Analytical Measurement Range is 200 IU/mL to 1 x 109 IU/mL (2.30-9.00 log10 IU/mL) of urine.

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.

Additional Information

For urine samples in which BKV DNA is detected and between the analytical measurement range (AMR) of 200 IU/mL to 1 x 109 IU/mL (2.30-9.00 log10 IU/mL) of urine, a quantitative value (IU/mL or log IU/mL) will be reported. If BKV DNA is detected outside the analytical measurement range (AMR) a result for <200 IU/mL or>1 x 109 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 threshhold, or to inhibitory substances that may be present in the specimen.

 

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.