Clinical Research Support for Tropical Fever Diagnostic Evaluation

The Department of the Navy Naval Supply Systems Command, through NAMRU EURAFCENT, is seeking clinical research support services to conduct a diagnostic evaluation study at Komfo Anokye Teaching Hospital in Ghana. The contractor must provide comprehensive personnel, equipment, supplies, and facilities to execute a clinical study assessing the diagnostic performance of the Xpert Tropical Fever test on the GeneXpert Edge X system for identifying multiple fever-causing pathogens including Plasmodium species, Dengue virus, Zika virus, Chikungunya virus, and Leptospira species. Key requirements include project management, regulatory compliance with local IRB approvals and Good Clinical Practice standards, patient enrollment and screening, blood sample collection and processing, on-site diagnostic testing, comparator analysis using the Biofire Global Fever Panel, data management with quality assurance, and monthly status reporting. Capability statements submitted by interested contractors must address company profile information, past performance on relevant infectious disease clinical trials and in vitro diagnostic device evaluations with West African experience, and technical and management capability demonstrating personnel recruitment capabilities, BSL-2 equivalent laboratory facilities, Ghanaian IRB regulatory expertise, and logistics management proficiency. The deadline for submitting capability statements is March 12, 2026 at 2:00 PM Central European Time, with responses not to exceed 10 pages.

No set-aside designations apply to this procurement, and no incumbent contractors or potential award values are identified in the pre-solicitation notice. The clinical study will enroll approximately 300 patients with suspected tropical fever presenting at the Ghana-based teaching hospital over an anticipated 12-month base year with one optional 6-month extension period. The Government will provide the GeneXpert Edge X system, test kits, cartridges, and specified sample collection and shipping supplies, with the contractor responsible for all other personnel, equipment, facilities, and support services. This Sources Sought Notice is issued for market research purposes only and explicitly disclaims any solicitation intent or government obligation to award a contract; interested parties should submit capability statements to the four listed points of contact by the specified deadline.