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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 Laboratories will add Zika virus detection to our test menu. Nucleic Acid testing (NAT) testing for living tissue donor screening will be performed using Roche Diagnostics assay on the cobas® 6800/8800 test platform. Zika is not required per FDA guidance for HCT/P donor testing but this kit is a FDA licensed test for Zika.
ViroMed Laboratories has made changes to our test offerings for CMV , Syphilis, ABO/Rh, West Nile Virus and HIV/HCV/HBV effective January 2, 2019. Tests on living donor samples for CMV, Syphilis and ABO/Rh will be performed on the Beckman Coulter PK® 7300 Test System. Tests on living and cadaveric donor samples for HIV/HCV/HBV and West Nile Virus will be performed using Roche Diagnostics assay on the cobas® 6800/8800 test platform. Client letters explain this change were mailed in November, 2018. You may call ViroMed Account Management with any questions at 800-582-0077.
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. Read more.
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..