Centers for Disease Control and Prevention (CDC), Procurement & Grants Office, Program Acquisition Branch, 255 East Paces Ferry Rd, NE, Rm 500, Atlanta, GA 30305

B -- EVALUATION OF NEW DIAGNOSTIC TESTS IN SCREENING PATIENTS WITH SUSPECTED TUBERCULOSIS SOL 200-97-0623(P) DUE 061597 POC Susan B. Kiddoo, Contract Specialist, (404) 842-6635 The Centers for Disease Control and Prevention contemplates awarding more than one contract to identify and enroll approximately 500-1000 patients (for each contract) undergoing initial evaluation for suspected pulmonary tuberculosis. Upon enrollment of the patients, the successful offeror(s) will be responsible to prospectively collect historical and clinical and cost information; obtain blood samples and perform PPD-tuberculin skin testing; and perform nucleic acid amplification tests (NAA tests) on respiratory samples submitted to the laboratory during the course of each patient's evaluation. To be considered eligible for this acquisition, offerors must meet the following absolute eligibility criteria. Each offeror must: (1) be a public or private academic institution, medical center, or health department in the United States or Canada; (2) have the ability to coordinate and conduct a scientifically rigorous study involving close cooperation between clinical, laboratory, infection control, and public health components; (3) have access to patients and laboratory facilities for an adult inpatient service that evaluates patients with a suspected diagnosis of pulmonary tuberculosis, and be able to collect follow-up information after patient discharge; (4) be able to interview patients, obtain and process blood specimens, perform NAA assays, obtain supplemental information regarding clinical decisions from care providers, and collect and transmit data for CDC use; (5) have the capacity to enroll adequate numbers of patients with suspected tuberculosis, culture-positive smear-positive tuberculosis, culture-positive smear-negative tuberculosis, and clinically defined culture-negative tuberculosis, and obtain adequate follow-up including links with public health department registry numbers; and (6) demonstrate access to a patient population in which offeror can reasonably predict ability to identify, and recruit into a study of tuberculosis diagnostics, 500 to 1000 adult subjects with suspected tuberculosis including at least 100 with demonstrable culture-proven tuberculosis over a 2-year enrollment period. The scheduled issue date is approximately May 1, 1997. No telephone requests will be accepted; ONLY WRITTEN REQUESTS FOR THIS SOLICITATION WILL BE HONORED. Requests should cite RFP No. 200-97-0623(P). Requests for the solicitation may be faxed to (404) 842-6727, Attn: Susan B. Kiddoo. All responsible sources that meet the above requirements may submit a proposal which will be considered by the Agency. (0100)

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