Molecular Diagnostics Analyzer and Reagents for detection of the Antibodies and Pathogens
ID: W81K0225QA047Type: Sources Sought
Overview

Buyer

DEPT OF DEFENSEDEPT OF THE ARMYW40M MRCO PACIFICFORT SHAFTER, HI, 96858-5098, USA

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

PSC

MEDICAL AND SURGICAL INSTRUMENTS, EQUIPMENT, AND SUPPLIES (6515)

Original Source

https://sam.gov/opp/cdbeffb15ae74a44b2e33930589d7d55/view
Timeline
    Description

    The Department of Defense, specifically the Department of the Army, is seeking sources for a contract to provide a Molecular Diagnostics Analyzer and Reagents for the detection of antibodies and pathogens, including Herpes simplex virus (HSV 1 and 2), congenital cytomegalovirus (CMV), Candida auris, and Varicella Zoster Virus (VZV). The procurement aims to enhance diagnostic capabilities at the Joint Base Lewis McChord Health Contracting Branch by acquiring FDA-approved systems that can perform qualitative nucleic acid amplification testing (NAAT) with rapid results and minimal downtime. This initiative is critical for improving patient care and operational efficiency in public health laboratories. Interested parties are encouraged to submit their capabilities statements and relevant information to Cindy Means at cindy.j.means.civ@health.mil by the specified deadline, as this sources sought notice is for market research purposes and does not constitute a formal solicitation.

    Point(s) of Contact
    Cindy Means
    cindy.j.means.civ@health.mil
    George Rutt
    george.r.rutt.civ@health.mil
    Files
    Title
    Posted
    Salient Characteristics Draft.pdf
    The document outlines specifications for an FDA-approved molecular diagnostic system capable of performing qualitative nucleic acid amplification testing (NAAT) for various pathogens, including Herpes simplex virus (HSV-1/2), Cytomegalovirus (CMV), Candida auris (C. auris), and Varicella Zoster Virus (VZV). Key requirements include direct specimen amplification, rapid results within 1.5 hours, and the capacity to process at least eight samples per run. The system must feature automated sample identification, barcoding, liquid detection, and a bi-directional interface for integration with Laboratory Information Systems. Additional specifications involve emergency support, staff training, system validation, and operation within designated environmental conditions. The overarching goal is to enhance productivity in the Molecular Diagnostics Section, reduce reagent waste, and eliminate the need for user intervention during tests. This RFP serves to procure an advanced diagnostic tool for public health laboratories, aiming for improved diagnostic capabilities and compliance with federal standards.
    SOW DRAFT.pdf
    The Department of Pathology at Madigan Army Medical Center (MAMC) is soliciting a contract for molecular diagnostic systems to test for Herpes simplex virus (HSV 1 and 2), congenital cytomegalovirus (CMV), Candida auris, and Varicella Zoster Virus (VZV). The proposal includes a nucleic acid testing analyzer with FDA-approved assays, equipment, and ongoing maintenance for five years starting October 1, 2025. The contractor must ensure timely patient care through proper installation, training, and emergency support. The testing system must have the capability for future expansion, operate with minimal downtime, and integrate with laboratory information systems. It should adhere to clinical standards, produce results in under 1.5 hours, and manage multiple samples without waste. Specific performance criteria are set for assay validation, support services, and reagent delivery. Compliance with security and training regulations is mandated for contractor personnel. The project highlights the MAMC’s continued commitment to enhancing diagnostic capabilities and patient care through state-of-the-art technology.
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