Lateral Flow Assay (LFA) validation and manufacturing
ID: HCKBG-2025-00447Type: Sources Sought
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFCENTERS FOR DISEASE CONTROL AND PREVENTIONCDC OFFICE OF ACQUISITION SERVICESATLANTA, GA, 30333, USA

NAICS

Analytical Laboratory Instrument Manufacturing (334516)

Original Source

https://sam.gov/opp/05082b6f019b4c09a94d31c66d42b7ca/view
Timeline
    Description

    The Department of Health and Human Services, specifically the Centers for Disease Control and Prevention (CDC), is seeking qualified sources for the validation and manufacturing of lateral flow assays (LFA) aimed at diagnosing HIV antiretroviral usage in point-of-care settings. The CDC requires an established medical device company capable of producing 25,000 lateral flow devices, which will be utilized in pre-clinical and clinical studies, with the contractor responsible for adapting the provided technical design to their production pipeline and optimizing test performance. This initiative is part of the broader effort to enhance HIV prevention and treatment strategies, emphasizing the need for rapid and cost-effective assays to monitor drug levels. Interested parties must submit their responses, including organizational details and relevant project experience, to Mark Wirtz at mag8@cdc.gov by January 31, 2025, at 12:00 p.m. EST, as this notice is for market research purposes only and does not constitute a solicitation for proposals.

    Point(s) of Contact
    Mark Wirtz
    mag8@cdc.gov
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    Lateral Flow Assay (LFA) validation and manufacturing
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