Director, USAMRAA, 820 Chandler St, Fort Detrick, MD 21702-5014

A -- FDA-APPROVED IN VITRO DIAGNOSTIC DEVICE FOR THE DETERMINATION OF MALARIA SOL CBD-MRDD-122199 DUE 020100 POC Mrs. Patricia M. McAllister, 301-619-7360 WEB: Click here to view other USAMRMC opportunities., http://www-usamraa.army.mil. E-MAIL: Click here to contact the Contracting Officer via, pat.mcallister@amedd.army.mil. Request for information/Interest: The U.S. Army Medical Research and Materiel Command (USAMRMC) requires a U.S. Food and Drug Administration (FDA) approved in vitro diagnostic device for the determination of malaria infection using peripheral blood samples. The malaria rapid diagnostic device (MRDD) should use the immunochromatographic strip format and technology and be capable of discriminating P. falciparum from P. vivax or other non-falciparum Plasmodia infections within 30 minutes. The MRDD must function as a stand-alone device, that is, not require any additional equipment to prepare, operate, or interpret test outcome. The devices must have or be capable of achieving a 2-year shelf life when stored at tropical ambient temperature (35oC), and must operate at the same ambient temperature. Furthermore, the manufacturer must be willing to investigate and define the effect of high and low temperature extremes on the performance and shelf life of the device. In symptomatic patients, the device must have a specificity of at least 85% for P. falciparum. For P. falciparum infections, it must have sensitivity, at different concentrations of parasitemia, as follows: 97% sensitivity for parasitemia >5000 parasites/microliter; 95% sensitivity for parasitemia >1000-5000 parasites/microliter; 90% sensitivity for parasitemia of >500-1000/microliter. Although specific performance criteria for identification of P. vivax have not been set, high sensitivity and specificity for P. vivax will confer selective advantage for a competing product. The USAMRMC is seeking manufacturers who have either marketed products or advanced prototypes, and have a clear record of meeting the specified performance requirements in field evaluations. This is not a request for proposals. The intent of this announcement is for the USAMRMC to enter into Cooperative Research and Development Agreements (CRDAs)-not contracts-with interested, qualified manufacturers of MRDDs with the goal of obtaining FDA approval for the product. The companies must be willing to assemble and submit an appropriate PMA for the FDA. Interested companies should submit their name to Pat McAllister, Contracting Officer via fax (301-619-2937), e-mail (Pat.McAllister@amedd.army.mil) or letter NLT 1 Feb 00. Tentative Schedule: Questions and pertinent comments must be submitted to the Contracting Officer by 15 Feb 00. Both parties must sign a CRDA by 1 Mar 00. Posted 12/21/99 (W-SN410455). (0355)

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