SAM #20260001558

Clinical Evaluation of Xpert Tropical Fever Test on GeneXpert Edge X System in Ghana

This procurement supports a clinical evaluation of the Xpert Tropical Fever test on the GeneXpert Edge X system in Ghana for the U.S. Navy Medical Research Unit Europe, Africa, Central (NAMRU EURAFCENT). - Government Buyer: - U.S. Department of Defense - Naval Medical Research Unit Europe, Africa, Central (NAMRU EURAFCENT) - Contracting through NAVSUP Fleet Logistics Center Sigonella – Naples - OEMs and Vendors: - Cepheid (OEM for GeneXpert Edge X system and Xpert tests) - University of Ghana Medical Centre (UMGC) (site and sole source contractor) - Products/Services Requested: - Clinical evaluation of the Xpert Tropical Fever test on the GeneXpert Edge X system - Testing of approximately 100 patient samples (capillary and venous whole blood) - Pathogens targeted: Plasmodium spp. (Malaria), Dengue, Zika, Chikungunya, Leptospira - Use of government-furnished GeneXpert machine and test supplies - Sample collection, testing, data entry, regulatory compliance, and reporting - Personnel roles: Principal Investigator, Phlebotomists, BioFire Operators, Data Entry - Unique/Notable Requirements: - Sole source award to UMGC for in-country clinical evaluation - All necessary personnel, equipment, supplies, and facilities provided by contractor - Government provides GeneXpert system and test kits - Results and samples to be shared with Noguchi Memorial Institute of Medical Research for further analysis - Period of Performance: - Base period of 12 months with a 6-month option period - Place of Performance: - University of Ghana Medical Centre, Accra, Ghana

Description

Pre-Solicitation Notice of Intent to Issue a Sole Source Contract Award

Issuing Agency: Naval Supply Systems Command (NAVSUP) Fleet Logistics Center Sigonella – Naples (FLCSI-N)

Requiring Agency:  Navy Medical Research Unit Europe, Africa, Central (NAMRU EURAFCENT)

Introduction:   NAVSUP FLSCI-N, on behalf of NAMRU EURAFCENT, provides notification of its intent to issue a sole source, firm-fixed price purchase order to the University of Ghana Medical Center (UMGC).  The contract is in support of a clinical evaluation of the Xpert® tropical fever test on the GeneXpert® Edge X system using venous and capillary whole blood specimens.  The contract period of performance will be for a base period with a six-month option period.

Nature of the Acquisition:  This contract is for a scientific study title “258C2: Clinical Evaluation of the Xpert® tropical fever test on the GeneXpert® Edge X system using venous and capillary whole blood specimens”, which has been approved to be conducted at the University of Ghana Medical Centre (UMGC).  The Xpert® Tropical Fever test is an automated, multiplex real-time PCR assay intended for the qualitative in vitro identification of nucleic acids from multiple fever-causing pathogens, including: Plasmodium species, Dengue virus, Zika virus, Chikungunya virus, and Leptospira species. 

Contractor Requirements:  The contractor shall provide all necessary personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other non-personal services to perform sample collection and testing for protocol 258C2, as defined in the attached Performance Work Statement.  The contractor is responsible for meeting all standards set forth in the contract terms, conditions, and standards issued by NAVSUP FLCSI-N.

Additional Information:

This acquisition is being conducted under the authority of Part 12 of the Revolutionary FAR Overhaul (RFO).

This is a notice of intent and not a request for competitive proposals. The Government will consider all capability statements from responsible sources that believe they can meet the requirement.  All capability statements must be received by 9 April 2026, 4:00 PM Central European Time (CET) to be considered. Responses shall be submitted via email to the Point of Contact (POC) identified in this notice. The statement must provide clear and convincing evidence of the interested party's ability to meet the Government's requirements as defined herein. The Government will not compensate interested parties for any costs related to the preparation or submission of a capability statement.

Point of Contract:

Tricia Folts, Contracting Officer | NAVSUP FLCSI-N | patricia.r.folts.civ@us.navy.mil

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