BKV Quantitative PCR

Message
Not approved by FDA.
This test employs a real time polymerase chain reaction (PCR) for the amplification of a well conserved region of BKV VP2 gene. This test was developed and it's performance characteristics determined by CompuNet Clinical Laboratories. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be considered as investigational or for research. This Laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity testing.

Test Code
74788

Alias/See Also
BK Virus DNA, QN; Transplant BKV PCR Quant; Transplant BKV QPCR; BKV Quant; BK Quant; BKV Quantitative Real Time PCR

CPT Codes
87799

Preferred Specimen
2 mL EDTA Plasma (lavender top)

Minimum Volume
0.5 mL Plasma
0.5 mL Whole Blood

Other Acceptable Specimens
1 mL Whole Blood collected in a sterile tube containing EDTA--Transport refrigerated
1 mL Whole Blood collected in sterile tube with ACD--Transport refrigerated

Instructions
Centrifuge the tube for at least 10 minutes. Transfer plasma to a completely labeled plastic transport tube within 6 hours of collection. Freeze plasma pour off.

Transport Container
EDTA (lavender top) tube, Sterile plastic pour off tube

Transport Temperature
Plasma - Frozen or refrigerated
Whole Blood - refrigerated

Specimen Stability
Plasma
     Room Temperature = unacceptable
     Refrigerated = 8 hours (24 hours after first thaw)
     Frozen = 5 days
Whole Blood
     Room Temperature = 8 hours
     Refrigerated = 5 days
     Frozen = unacceptable

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Plasma received at room temperature
Whole blood received frozen

Methodology
Real-time Polymerase Chain Reaction

Setup Schedule
Monday - Wednesday - Friday

Report Available
48 - 72 hours

Performing Laboratory
CompuNet Clinical Laboratories, LLC
2308 Sandridge Drive
Moraine, OH 45439



The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.