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Certification of a Standard Reference Material for BK viral load


BK virus originally described in 1971[1]  is common but generally asymptomatic in adults[2].  Transplant patients and other immune compromised individuals can develop disease.  In renal transplant patients active infection can leading to organ rejection.

[1] Lancet. 1971 June 19;1(7712):1253-7. New human papovavirus (B.K.) isolated from urine after renal transplantation. Gardner SD, Field AM, Coleman DV, Hulme B.

[2] J Infect Dis. 2009 January 27. [Epub ahead of print] Prevalence of Polyomavirus BK and JC Infection and Replication in 400 Healthy Blood Donors. Egli A, Infanti L, Dumoulin A, Buser A, Samaridis J, Stebler C, Gosert R, Hirsch HH.



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.  

To produce sufficient quantities the entire BK virus genome will be inserted into a cloning vector, which can then be propagated in Escherichia coli.

The material will be pure DNA in buffer certified for number of copies of the genome per volume (e.g. copies per microliter). The sequence of each genome will be determined so that users will know about mutations under the primer and probe binding sites.

Major Accomplishments:

  • Acquired DNA from six clinical isolates from common genotypes (Ia, Ic, III, IV, V, VI)
  • Using long range PCR, amplified each of the BK virus genomes in preparation for cloning
Image of the BK virus.

Start Date:

December 1, 2010

End Date:


Lead Organizational Unit:



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. Jo Lynne Harenza

Mr. Ross J. Haynes


Dr. Jo Lynne Harenza



Mr. Ross J. Haynes