Clinical Evaluation: Tropical Fever Testing & Support

The Naval Supply Systems Command (NAVSUP) Fleet Logistics Center Sigonella – Naples (FLCSI-N) intends to issue a sole source contract to the University of Ghana Medical Center (UMGC) for a clinical evaluation of the Xpert Tropical Fever test on the GeneXpert Edge X system using venous and capillary whole blood specimens. The contractor will 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. The contract period of performance will be for one base year with a six-month option period. • The contractor will conduct study procedures as described in protocol 258C2. • The contractor will obtain Institutional Review Board (IRB) approval for the protocol and Informed Consent Form (ICF). • The contractor will collect capillary and venous blood samples from approximately 100 patients presenting with clinical suspicion of one of the fever-causing pathogens for Tropical Fever. • The contractor will perform laboratory analysis on the Edge X and GXDX on-site on a portion of the venous blood and perform Biofire Global Fever Panel comparator testing and discrepant analysis with use of bi-directional sequencing at sites performing lab (NMIMR).