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ViroMed offers comprehensive infectious disease testing for cord blood donors. In addition to infectious disease marker (IDM) testing, ViroMed performs product sterility testing for cord blood collections.
Donations of reproductive tissues (including oocytes, semen, and embryos) are tested in accordance with the FDA Code of Federal Regulations (21 CFR 1271) and current FDA guidance.
ViroMed has a national reputation for expertise in the tissue donor industry. We have earned customer trust though more than a decade of service in the tissue donor industry.
Recently awarded a National Marrow Donor Program® contract for IDM testing, ViroMed performs infectious disease testing for donors of hematopoietic stem/progenitor cells, including minimally manipulated bone marrow and peripheral blood stem cells.
Working With ViroMed
ViroMed Laboratories Highlights
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). Read more..
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, 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. Read more..