Specifications include, but are not limited to: A. Test Platform Specifications 1. The test platform shall be one system that is fully automated, computer-controlled, and FDA-approved for the liquid-based culture to support the growth of Mycobacteria species in a variety of specimens obtained from human patients. 2. Documentation shall be provided to support FDA-approval for mycobacterial culture using liquid media, including all specimen collection, handling, storage, and transportation statements. The vendor shall provide all specimen transport requirements, including the following: specimen collection processes, including any tube handling requirements such as centrifugation; specimen storage condition and storage time between collection and test performance; specimen storage condition and storage time after test completion; number of times specimen can undergo freeze-thaw conditions.
