Clinical Research Support for Tropical Fever Diagnostic Evaluation
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The Department of the Navy, NAVSUP Fleet Logistics Center (FLCI), intends to award a firm-fixed-price, sole-source contract to Komfo Anokye Teaching Hospital (KATH) in Kumasi, Ghana, for Clinical Research Support for Tropical Fever Diagnostic Evaluation. This action, valued at an estimated $199,787.50, is for clinical evaluation services supporting Protocol 258C2. While this is an intent to sole source, responsible sources may submit capability statements by April 2, 2026, 2:00 PM CET.
Scope of Work
The requirement is for clinical evaluation services as defined in Protocol 258C2 for the Naval Medical Research Unit Europe, Africa, Central (NAMRU EURAFCENT). This involves evaluating the Xpert® tropical fever test on the Genexpert® Edge X system using venous and capillary whole blood specimens from approximately 300 human subjects in Kumasi, Ghana. Key tasks include patient enrollment, sample collection and processing, diagnostic testing, comparator analysis, data management, and reporting, adhering to Good Clinical Practice (GCP) and regulatory standards. The contractor will provide personnel, equipment, supplies, and facilities, while the Government will furnish the GeneXpert machine and associated test kits.
Justification for Sole Source
Market research confirmed KATH as the only source capable due to:
- Unique Patient Access: Established infrastructure and collaborative history with NAMRU EURAFCENT, providing access to specific patient populations for tropical disease research.
- Existing Regulatory Approvals: Holds necessary Institutional Review Board (IRB) and ethical approvals from Ghanaian authorities, preventing delays.
- Specialized Facilities & Personnel: Possesses required laboratory facilities, biosafety infrastructure, and trained personnel with experience using the mandatory Cepheid GeneXpert® diagnostic equipment.
- Compliance & Trust: An established partner uniquely positioned to perform testing in compliance with U.S. and Ghanaian research ethics standards.
Contract & Timeline
- Type: Pre-Solicitation (Intent to Award Sole Source), Firm-Fixed-Price
- NAICS: 541715 (Research and Development in the Physical, Engineering, and Life Sciences)
- PSC: AN42 (Health R&D Services; Health Care Other; Applied Research)
- Estimated Value: $199,787.50
- Period of Performance: April 2026 to October 2027
- Place of Performance: Komfo Anokye Teaching Hospital (KATH), Kumasi, Ghana
- Set-Aside: None (Sole Source)
- Capability Statement Due: April 2, 2026, 2:00 PM Central European Time (CET)
- Published: March 18, 2026
Submission Details
This is not a request for competitive proposals. However, any responsible source capable of meeting the requirement may submit a capability statement electronically to Terry Herbert (terry.l.herbert3.civ@us.navy.mil). The statement must provide clear and convincing evidence of capability.
Additional Notes
A determination by the Government not to compete this proposed contract based on responses is solely at its discretion.