Notice of Intent - Nucleic Acid Testing

Added: Mar 24, 2017 9:28 am The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (IAW FAR Part 13.106-1(b) (2)). The proposed source is Grifols Diagnostic Solutions Inc., 4560 Horton St, Emeryville, CA 94608-2916. United States Naval Hospital (USNH) Okinawa, Japan has a requirement for test kits of Procleix TIGRIS analyzer system for blood screening. WEST NILE VIRUS 5k reagent Kits to test for West Nile Virus (WNV), ULTRIO1k Reagent Kits to test for HIV-1 and hepatitis C Virus and Hepatitis B Virus, ULTRIO and additional reagents and consumables. Procleix Ultrio Assay is intended for use in testing individual samples from living donors of whole blood, blood components, or source plasma, other living donors and heart-beating organ donors, and for testing individual blood specimens from cadaveric (non-heart-beating) donors. It is also intended for use in testing pools of human plasma comprised of equal aliquots of not more than 16 individual donations from donors of whole blood, blood components, or source plasma. This assay is intended to be used in conjunction with licensed tests for detecting antibodies to HIV-1, HCV, and hepatitis B core antigen (anti-HBc), and with licensed tests for hepatitis B surface antigen (HBsAG). The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of WNV RNA in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors. It is also intended for use in testing plasma specimens to screen organ donors when specimens are obtained while the donor's heart is still beating, and in testing blood specimens to screen cadaveric (no-heart-beating) donors.