BK virus, originally described in 1971 , is a 5kb polyomavirus which shares roughly 75% of its DNA sequence with JC virus. Nearly 80% of the population is infected with the virus and although it disseminates into the urinary tract and kidneys, it usually remains latent . However, immunocompromised patients, such as those undergoing kidney or multiple organ transplants , severe reactions as a result of BKV infection may occur. The infection presents itself in the clinic as renal dysfunction and abnormal urinalysis. If the BK virus replicates within the new graft, BK-associated nephropathy (BKVAN) may arise . BKVAN is thought to occur as a result of high doses of immunosuppressants administered to transplant patients that also have BKV infections (1-10% of kidney transplant patients). The devastating consequence of BKVAN is graft rejection, which occurs in up to 80% of infected patients. Therefore, in order to determine an optimal immunosuppressant dosing regimen, accurate measurement of BK viral load in transplant patients is needed. Providing a DNA reference material for BK virus will not only allow this, but also enable commutability of measurements among laboratories across the world.
 Gardner SD, et al, 1971. "New human papovavirus (B.K.) isolated from urine after renal transplantation". Lancet. 1 (7712): 1253-7.
 Egli A, et al, 2009. "Prevalence of Polyomavirus BK and JC Infection and Replication in 400 Healthy Blood Donors". Journal of Infectious Disease. 199: 837-46. Gupta, G, et al, 2006. “Low Incidence of BK Virus nephropathy after simultaneous kidney pancreas transplantation”. Transplantation. 82 (3): 382-8.
 Fishman, JA, 2002. "BK Virus Nephropathy - Polyomavirus Adding to Injury". New England Journal of Medicine. 347 (7) 527-530.
The goal of this project is to provide a SI-traceable reference material for use by calibrant and reagent manufacturers in production of their own calibrants and standards. Clinical laboratories with in-house methods would be able to use the reference material for production of their own quality control materials which would be traceable to a NIST standard.
The entire BK virus genome will be inserted into a cloning vector and propagated in Escherichia coli.
The final material will be pure DNA in buffer certified for number of copies of the genome per volume (e.g. copies per microliter). The genome will be sequenced and provided as information in the certificate of analysis.
Start Date:December 1, 2010
Lead Organizational Unit:mml
Clinical testing community, Invitro device industry, Organizations: Quality Control for Molecular Diagnostics, Association for Molecular Pathology, National Institute of Biological Standards and Control (UK), University of Washington.
Dr. Peter M. Vallone