Name: BK Virus, Quantitative by PCR, Urine
Test Name: BK Virus, Quantitative by PCR, Urine
Health Link Test Code: HCBKPCR
LIS Test Code: BKPCR
CPT Code(s): 87799
Methodology: Real-Time PCR
Detect and quantify BK virus in urine.
Days Performed: Mon-Fri.
In-Lab Turnaround Time: 2 - 3 days.
Stat In-Lab Turnaround Time: Not available stat.
Specimen: Random urine
Collection Container: Sterile screw cap container
First morning void is preferred.
Collection Volume: 5 - 10 mL
Pediatric Collection Volume: 2 mL
Sample Analyzed: Urine aliquot
Testing Volume: 2 mL
Pediatric Testing Volume: 1.2 mL
Transport specimen to Laboratory.
Pediatrics: not detected.
Adults: < 1 x 107
Interpretation Type: Expected Results
Analytical Measurement Range is 500 copies/mL to 1 x 109 copies/mL (2.70-9.00 log10 copies/mL) of urine.
For urine samples in which BKV DNA is detected and between the analytical measurement range (AMR) of 500 copies/mL to 1 x 109 copies/mL (2.70-9.00 log10 copies/mL) of urine, a quantitative value (copies/mL or log copies/mL) will be reported. If BKV DNA is detected outside the analytical measurement range (AMR) a result for <500 copies/mL or>1 x 109 copies/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. 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.
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.