Test Information

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BK Virus (BKV) Quantitative Real-time PCR

Test Code: 2500

Cpt Code:

87799 (x1)

Clinical Utility

BKV has emerged as an important pathogen in nephropathy in kidney transplant patients and hemorrhagic cystitis in hematopoietic stem cell transplantation patients. Early diagnosis of BK nephropathy has been shown to positively impact organ survival. Early diagnosis can be accomplished through a regular monitoring program for reactivation of BKV. Monitoring is effectively accomplished through the use of quantitative BKV DNA PCR of both blood and urine specimens. Quantitative PCR can also be used to track the course of infection and monitor response to treatment.

Procedure

Extraction of BK Viral DNA from specimen followed by amplification and detection using real-time, quantitative PCR. An internal control is added to ensure the extraction was performed correctly and the PCR reaction was not inhibited. Viracor-IBT's assay design includes multiple targets to account for viral mutations, which significantly reduces the chance of false negative results. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.

Specificity

Designed to detect all strains of BKV. The primers and probes used in this assay are specific for all known BKV strains based on similarity search algorithms. Additionally, no cross reactivity was detected when tested against adenoviruses, CMV, EBV, HSV-1, HSV-2, HHV-6, HHV-7, HHV-8, JCV, parvovirus B19, SV-40, and VZV.

Causes For Rejection

Whole blood frozen, specimens beyond their acceptable length of time from collection as listed in the specimen handling or specimens other than those listed.

Turnaround Time

Same day (within 8 to 12 hours of receiving specimen), Monday through Saturday.

Shipping

Ship Monday through Friday. Friday shipments must be labeled for Saturday delivery. All specimens must be labeled with patient's name and collection date. A Viracor-IBT test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Viracor-IBT Laboratories, 1001 NW Technology Dr, Lee's Summit, MO 64086

Specimen Information

2503 CSF

NY approved. Assay Range: 52 copies/mL to 1x1010 copies/mL. 2 mL collected in a sterile, screw top tube (minimum volume 0.5 mL). Store frozen and ship on dry ice for overnight delivery to Viracor-IBT.

2501 plasma

NY approved. Assay Range: 39 copies/mL to 1x1010 copies/mL. Collect 4-5 mL whole blood in EDTA or ACD tube, centrifuge and transfer 2 mL plasma to sterile, screw top tube (minimum volume 0.5 mL). Can be shipped ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

2510 serum

NY approved. Assay Range: 39 copies/mL to 1x1010 copies/mL. 2 mL (minimum) collected in red-top or SST (minimum volume 0.5 mL). Separate serum from cells by centrifugation. Transfer serum to screw-cap tube for shipment. If specimen was collected in SST, the entire tube can be shipped following centrifugation. Can be shipped ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

2506 tissue [Qual]

NY approved. (CPT Code:87798 X 1) Assay Range: (Detected/Not Detected). Place fresh tissue in a sterile, screw top container. The preferred handling is to not add water, saline or other fluid media to the tissue container; however, fluid media filled containers will be accepted for qualitative results. Store frozen and ship on dry ice for overnight delivery to Viracor-IBT. Formalin fixed, paraffin embedded tissue will not be accepted.

2505 tissue [Quant]

NY approved. Assay Range: 56 copies/mg to 1x109 copies/mg. Place a minimum of 5 mg fresh tissue (approximately ½ of a pencil eraser size) in a sterile, screw top container. Do not add water, saline or other fluid media to container. Store frozen and ship on dry ice for overnight delivery to Viracor-IBT. Formalin fixed, paraffin embedded tissue will not be accepted.

2502 urine

NY approved. Assay Range: 500 copies/mL to 1x1010 copies/mL. 2 mL sample collected in a sterile urinalysis container then transferred to sterile, screw top tube for shipment (minimum volume 0.5 mL). Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

Disclaimer

Specimens are approved for testing in New York only when indicated in the Specimen Information field above.

The CPT codes provided are based on Viracor-IBT's interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Viracor-IBT assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

PCR tests are performed pursuant to a license agreement with Roche Molecular Systems, Inc.

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