West Nile Virus NAT Testing
In September 2016, the FDA issued a new guidance document that addresses the intent to reduce the risk of transmission of West Nile Virus (WNV) from living donors of HCT/Ps and recommends the use of an FDA-licensed NAT to test living donors for evidence of active infection with WNV. For facilities within the United States (all 50 states and the District of Columbia), WNV-NAT testing is recommended on HCT/Ps recovered from June 1st through October 31st every year. For facilities outside of the United States intending to import HCT/Ps into the United States, the FDA recommends that donors be tested year-round for WNV by NAT. ViroMed offers comprehensive donor testing panels that include an FDA-cleared WNV test.
HTLV I/II Supplemental Testing
ViroMed will begin using the MP Diagnostics HTLV Blot 2.4 test kit for HTLV I/II supplemental testing beginning May 9, 2016. This kit is currently the only FDA-licensed test on the market for use as a supplemental test to confirm the presence of anti-HTLV I/II antibodies in serum or plasma. Additionally, this kit will differentiate between HTLV type-1 and HTLV type-2 infections.
To ensure compliance with the new FDA guidance document entitled Use of Donor Screening Tests to Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products for Infection with Treponema pallidum (Syphilis), ViroMed Laboratories will no longer offer the Rapid Plasma Reagin (RPR) test alone or reflexed to the Fluorsecent Treponemal Antibody tests (FTA-ABS) assay (tests 139278 and 139425). We will continue to offer the CAPTIA™ Syphilis (T pallidum)-G assay (139280) manufactured by Trinity Biotech for screening HCT/P donors for syphilis. This test has been cleared by the FDA as a donor screening assay. Client letters explaining this change have been mailed.
Test Methodology Change
ViroMed Laboratories is making a change to its test offerings for Hepatitis B Virus, Hepatitis C Virus, and Human Immunodeficiency Virus Types 1 and 2 on September 29, 2015. Tests on living donor samples will be performed using the Abbott Diagnostics PRISMnEXT (PRISM) system. The test methodology for samples from cadaveric tissue donors will not change. Client letters explaining this change have been mailed.
ViroMed Laboratories Earns Accreditation to ISO 15189 from CAP
ViroMed Laboratories, located in Burlington, NC, has received CAP 15189℠ reaccreditation to the International Standards Organization 15189:2007 Standard for laboratories from the College of American Pathologists. This reaccreditation recognizes the laboratory’s technical competence, management and continual improvement. It focuses on improved patient safety and risk reduction, outlining standards for quality, and competence particular to medical laboratories.
ViroMed Laboratories Transfers Operations to Burlington, NC
On October 1, 2013, ViroMed Laboratories transferred its donor testing laboratory operations to Burlington, NC. Our dedicated laboratory is located within the recently expanded and enhanced LabCorp York Court campus.
This is a change in our address only. Our quality, expertise, and customer commitment remain the same. We look forward to continuing to be your premier FDA-licensed resource for donor testing.