Clinical Evaluation: Tropical Fever Testing & Support

Closed Pre-Solicitation Posted

Solicitation number
20260001558
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Place of performance
Ghana

Notice details come from SAM.gov. Updated .

About this opportunity

The Naval Supply Systems Command (NAVSUP) Fleet Logistics Center Sigonella-Naples, on behalf of Navy Medical Research Unit Europe, Africa, Central (NAMRU EURAFCENT), intends to issue a sole source, firm-fixed price contract to conduct a clinical evaluation of the Xpert tropical fever test on the GeneXpert Edge X system. This study will assess the performance of an automated, multiplex real-time PCR assay designed to identify nucleic acids from fever-causing pathogens including Plasmodium species, Dengue virus, Zika virus, Chikungunya virus, and Leptospira species using both venous and capillary whole blood specimens. The contractor must provide all necessary personnel, equipment, supplies, facilities, transportation, supervision, and materials to perform sample collection and testing in accordance with Protocol 258C2, Good Clinical Practice, Good Laboratory Practice, and Safe Laboratory Practice guidelines. The contractor is expected to meet specific performance standards including 98% protocol compliance, 100% training compliance, zero deviation from Institutional Review Board (IRB) standards, 95% sample testing success rate, and greater than 98% equipment operational uptime. The pre-solicitation notice was posted on March 26, 2026, with a response deadline of April 9, 2026.

The University of Ghana Medical Center (UMGC) has been identified as the intended sole source awardee for this acquisition. This pre-solicitation notice is not a competitive solicitation but rather a notice of intent, issued under the authority of Part 12 of the Revolutionary FAR Overhaul. The contract will involve the collection of capillary and venous blood samples from approximately 100 patients presenting with clinical suspicion of tropical fever pathogens and with travel or residence history in endemic regions within the preceding three months. The period of performance consists of a 12-month base year with one optional 6-month extension period. The Government will furnish the GeneXpert machine, test pouches, sample collection supplies, shipping materials, and Personal Protective Equipment through Cepheid, while the contractor is responsible for providing laboratory space and other operational requirements to support the clinical study.

Notice text

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

Files

File Type Posted
PWS - NAMRU Ghana.pdf PDF

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