Integrated Multi-Modality Transfusion-Transmitted Disease (TTD) Testing Systems for Armed Services Blood Bank Center-Europe (ASBBC-EUR), Landstuhl Regional Medical Center (LRMC), Germany
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Description
1. Purpose The Defense Health Agency (DHA) is conducting market research to identify capable sources that can provide a complete, integrated multi-modality Transfusion-Transmitted Disease (TTD) testing solution for the Armed Services Blood Bank Center-Europe (ASBBC-EUR) located at Landstuhl Regional Medical Center (LRMC), Germany. This is a Request for Information (RFI) for market research and planning purposes only. It does not constitute a Request for Proposals (RFP), Request for Quotations (RFQ), or an invitation for bids. 2. Requirement Overview The Government requires the supply, installation, validation, training, ongoing maintenance, software support and upgrades, technical support, and reagent/consumable support for three complementary testing platforms capable of performing the full suite of U.S. Food and Drug Administration (FDA) required blood-donor screening assays: Immunohematology / ABO-Rh, Syphilis, Cytomegalovirus (CMV), Antibody Titer (example platform class: Beckman Coulter PK7400 or equivalent) Serology (example platform class: Abbott Alinity s or equivalent) � Human Immunodeficiency Virus (HIV) Antigen/Antibody Combo, Anti-Hepatitis C Virus (Anti-HCV), Hepatitis B Surface Antigen (HBsAg), Human T-lymphotropic Virus (HTLV) I/II, Anti-Hepatitis B Core (Anti-HBc), Chagas Nucleic Acid Testing (NAT) (example platform class: Grifols Procleix Panther / Ultrio Elite or equivalent) � HIV, Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), West Nile Virus (WNV), Babesia Approximate annual volume is 6,000 whole-blood units (plus residual plasma and platelets as needed). All systems must be FDA Center for Biologics Evaluation and Research (CBER)-cleared/licensed for blood-donor screening. Dual-marked (FDA + CE) systems are preferred. FDA-only systems are acceptable provided they operate directly on German power sources (single-phase 230 V / 50 Hz) with no transformer required. Preferred approach: A single integrated multi-modality solution from one prime cont…