Specimen Collection Manual and Test Catalog

5mL random (unpreserved) urine. NO SHARED SPECIMENS.

Non-GMC sites- Aliquot a minimum of 5 mL unpreserved urine into a 15 mL conical tube. Each molecular test ordered for viral quantitation requires its own aliquot tube.

GMC- Transfer a minimum of 4.3mL of urine in the cobas PCR Urine Media tube using a sterile pipet.  For low volume urines do not aliquot into cobas PCR Urine Media tube, please deliver urine to Molecular Diagnostic Laboratory.

Transport urine specimens immediately at 2 to 30°C.

Urine is stable for 24 hours at 2 to 30°C. Urine stabilized in cobas PCR Media is stable for 90 days at 2 to 30°C.

Urine specimens must be transferred to cobas PCR Urine Media within 24 hours of collection, or they will be rejected. Urine must be stored at 2 to 30°C for no longer than 24 hours before transferred to cobas PCR Urine Media. Untested urine specimens must show the top of the liquid level between the two black lines on the cobas® PCR Media tube label window. If the liquid level is above or below these lines, the specimen has not been collected properly and cannot be used for testing. Urine stabilized in cobas PCR Media is stable for 90 days at 2 to 30°C, otherwise stability limits are exceeded. Shared or comingled specimens will be rejected.

Negative IU/mL.

Normal volume of specimen tested is 650 uL of urine. When 650 uL of urine is tested, the linear range of the assay is 200 IU/mL to 100,000,000 IU/mL. Positive results less than 200 IU/mL will be reported as: BKV DNA detected but is not quantifiable: below the lower limit of quantification (LLoQ) of the assay. Interpret results with the context of other clinical data and should not be the sole basis for treatment decisions.

BKV, BK Virus, BKVDNA, BKV Quantitation, BK Viral Load, BKV Quant, BK DNA Viral Load, Polyomavirus

The BKV assay detects and quantifies BKV DNA, in human plasma and urine samples. Detection of BKV DNA indicates that the virus is replicating and therefore is evidence of active infection. BKV infection may cause severe disease in immunocompromised persons, including transplant patients. Kidney transplant patients are at higher risk for BKV associated complications compared to recipients of other transplant types, including polyoma virus nephropathy (PVN) and ureteral stenosis.