This infectivity assay, without using non-infectivity assays such as PCR, has the ability to detect viable BPyV in 3 weeks or less, with increased specificity and sensitivity compared with other assays on the market.
"Guidance from The European Medicines Agency Committee has suggested for many years that all bovine serum going into manufacture of human medicines be tested for BPyV," said Dr. Richard Jones, Vice President of ABR. "However, testing for live BPyV has traditionally taken 6 weeks. Our rapid 3 week test enables customers to comply with the EMA guidance and get their product to market within their standard rhythm of business."
ABR’s BPyV assay employs proprietary testing methods and an antibody based detection strategy that results in sensitivity of 1 virion. The virus can be detected by immunofluorescence, and cytopathic effect.
"Contamination with BPyV is a major concern in manufacturing biological products for human and animal use," said Dr. Chungwon Chung, VP of R&D.
"The potential for tumorigenicity makes BPyV contamination of bovine serum, biologicals seeds and other raw materials used for manufacture of veterinary and human products a cause for concern."
In addition to testing for BPyV, ABR also offers many other virus assays, as well as testing for mycoplasma, bacteria, fungi, and endotoxins. ABR is the services division of VMRD.
VMRD was founded in 1981 by D. Scott Adams, DVM, PhD, and currently employs approximately 50 researchers, lab technicians and support personnel. From its site in Pullman, WA VMRD develops and manufactures diagnostic test kits and related reagents for distribution in more than 55 countries.
