This test is intended to be used for the detection and quantitation of BK virus in urine specimens as an aid in the diagnosis and management of BK virus infections.

• Patient should not have urinated for at least one (1) hour prior to sample collection
• Female patients must not clean the labial area prior to sample collection

Screw cap plastic container (sterile)

Urine sample must be transferred to the Cobas PCR Urine Sample Kit immediately.

• Use the disposable pipette included with the kit to add urine to the media tube until the volume falls between the two black lines (Fill Area)
• Cap the tube tightly and invert 5 times to mix the sample

If the urine cannot be transferred immediately, it can be stored, refrigerated, for up to 24 hours

Cobas PCR Urine Sample Kit

Stabilized in Cobas PCR media:

Refrigerated  (preferred) - 90 days

Ambient - 90 days

Frozen - NO

• Insufficient quantity for analysis (QNS)
• Excessive blood in the sample
• Leaking or broken tube
• Inadequate storage or transport
• Urine not submitted in a Cobas PCR media tube
• Under-filled or over-filled Cobas media tube

Real-time polymerase chain reaction (PCR)

Negative

• The linear range of the assay is 200 - 100,000,000 IU/mL
• The analytical sensitivity is 12.2 IU/mL