The Centers for Disease Control and Prevention is looking for a source to provide a nucleic acid amplification system for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae in a homogeneous, real-time detection format allowing for a one-hour assay time with high throughput capability and a simple workflow. The technology must qualitatively detect C. trachomatis and N. gonorrhoeae DNA in endocervical swabs, male urethral swabs, and in female and male urine specimens as evidence of infection with C. trachomatis, N. gonorrhoeae, or of co-infection with both C. trachomatis and N. gonorrhoeae. Built-in amplification controls and an option for inhibition testing must also be available with the system. The in vitro noninvasive diagnostic instrument must be FDA-approved for patient test management, and must meet the requirements for proficiency testing (PT) such as the College of American Pathologists (CAP) Surveys and Anatomic Pathology Education Programs. The storage and handling requirements for the instrument, equipment, and supplies must be stable at room temperatures. Consumables must be ready-to-go reagents. There should be minimal to no facility modifications for the instrument space requirements: bench top location preferred in only one room. Financially, the estimated value of the equipment should not exceed $50,000.00 and the estimated cost of consumables that would be required under a 5 year agreement should not exceed $25,000.00. This announcement serves as a solicitation; no other will be issued. Interested persons may identify their interest and capability to respond to this requirement. This procurement is not set-aside for small business. For contractual questions contact Linda M. Young.
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