BK Virus (BKV) Quantitative Real-time PCR
Some specimen types for this assay are reported as qualitative results; please see our Specimen Information section below for more information.
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.
About BK Virus
BKV reactivation following renal transplantation may cause nephropathy in renal transplant recipients receiving immunosuppressive therapy, resulting in renal dysfunction and graft loss. BKVAN typically occurs several months after transplant, and affects 1 to 10% of recipients, leading to graft loss in 15 to 80% of cases.1-4 Progression of BKVAN often occurs with nonspecific clinical symptoms and is often misdiagnosed as acute rejection or drug toxicity.4-5
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 Eurofins' 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.
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.
Same day (within 8 - 12 hours from receipt of specimen), Monday through Saturday.
|Specimen Type||Order Code||CPT Code||NY Approved||Volume||Assay Range||Special Instructions|
|CSF||2503||87799||Yes||2 mL (min. 0.5 mL)||
52 copies/mL to 1x1010 copies/mL
|plasma||2501||87799||Yes||2 mL (min. 0.5 mL)||39 copies/mL to 1x1010 copies/mL||
2 mL (min. 0.5 mL)
39 copies/mL to 1x1010 copies/mL
|tissue [Qual]||2506||87798||Yes||5 mg fresh tissue (approximately ½ of a pencil eraser size)||Detected/Not Detected||
|tissue [Quant]||2505||87799||Yes||5 mg fresh tissue (approximately ½ of a pencil eraser size)||
56 copies/mg to 1x109 copies/mg
|urine||2502||87799||Yes||2 mL (min. 0.5 mL)||500 copies/mL to 1x1010 copies/mL||
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 Eurofins test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Viracor Eurofins, 1001 NW Technology Dr, Lee's Summit, MO 64086
Whole blood frozen, specimens beyond their acceptable length of time from collection as listed in the specimen handling or specimens other than those listed.
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 Eurofins' 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 Eurofins 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.
1 Hirsch HH, Brennan DC, Drachenberg CB, et al. Polyomavirus-associated nephropathy in renal transplantation: interdisciplinary analyses and recommendations. Transplantation. 2005 May 27;79(10):1277-86.
2 Brennan DC, Agha I, Bohl DL, et al. Incidence of BK with tacrolimus versus cyclosporine and impact of preemptive immunosuppression reduction. Am J Transplant. 2005 Mar;5(3):582-94.
3 Hirsch HH. BK virus: opportunity makes a pathogen. Clin Infect Dis. 2005 Aug 1;41(3):354-60. Epub 2005 Jun 14.
4 Bechert CJ, Schnadig VJ, Payne DA, Dong J. Monitoring of BK viral load in renal allograft recipients by real-time PCR assays. Am J Clin Pathol. 2010 Feb;133(2):242-50.
5 Mischitelli M, Bellizzi A, Anzivino E, et al. Complications post renal transplantation: literature focus on BK virus nephropathy and diagnostic tools actually available. Virol J. 2008 Mar 3;5:38.