BK Virus (BKV) Quantitative Real-time PCR

Test Code: 2500

Some specimen types for this assay are reported as qualitative results; please see our Specimen Information section below for more information.

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Clinical and Procedure
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.

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

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. Eurofins  Viracor 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.

Turnaround Time

Same day (within 8 - 12 hours from receipt of specimen), Monday through Saturday, with the exception of Tissue specimens. Tissue specimens are expected to report within 18-24 hours from receipt of specimen, Monday-Saturday.

Specimen Information
Specimen Type Test Code CPT Code NY Approved Volume Assay Range Special Instructions
plasma 2501 87799 Yes

2 mL (min. 0.8 mL)

 33 IU/mL to 3.30E+08 IU/mL
  • Collect 4-5 mL whole blood in EDTA or ACD tube.
  • Avoid using gel separator tubes; samples collected in gel separator tubes have increased rate of PCR inhibition.
  • Centrifuge and transfer 2 mL plasma to sterile, screw top tube.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient temperature must be received within 96 hrs. of collection.
  • If you plan to have more than one PCR test performed on a sample, please ensure you send adequate volume. See the ID Volume Calculator on the website to confirm you are sending enough sample.
urine 2502 87799 Yes

2 mL (min. 0.8 mL)

70 IU/mL to 6.90E+08 IU/mL
  • Collect in a sterile urinalysis container then transfer to sterile, screw top tube for shipment
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient temperature must be received within 96 hrs. of collection.
  • If you plan to have more than one PCR test performed on a sample, please ensure you send adequate volume. See the ID Volume Calculator on the website to confirm you are sending enough sample.
CSF 2503 87799 Yes

2 mL (min. 0.5 mL)

52 copies/mL to 1x1010 copies/mL
  • Collect in a sterile, screw top tube.
  • Store frozen and ship on dry ice for overnight delivery.
Fresh Frozen Tissue [Quant] 2505 87799 Yes 5 mg fresh tissue (approximately ½ of a pencil eraser size)

56 copies/mg to 1x109 copies/mg
  • Place fresh tissue 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.
  • Formalin fixed, paraffin embedded tissue will not be accepted.
Fresh Frozen Tissue [Qual] 2506 87798 Yes 5 mg fresh tissue (approximately ½ of a pencil eraser size) 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.
  • Formalin fixed, paraffin embedded tissue will not be accepted.
serum 2510 87799 Yes

2 mL (min. 0.8 mL)

33 IU/mL to 3.30E+08 IU/mL
  • Collect 4-5 mL whole blood in red top tube or SST.
  • Avoid using gel separator tubes; samples collected in gel separator tubes have increased rate of PCR inhibition.
  • Centrifuge and transfer 2 mL serum to sterile, screw top tube.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient temperature must be received within 96 hrs. of collection.
  • If you plan to have more than one PCR test performed on a sample, please ensure you send adequate volume. See the ID Volume Calculator on the website to confirm you are sending enough sample.
Shipping

Ship Monday through Friday. Friday Eurofins Viracor test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Eurofins Viracor, 18000 W 99th St. Ste, #10, Lenexa, KS 66219

Causes for Rejection

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

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 Eurofins Viracor'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. Eurofins Viracor assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

References

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.

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