NA The contractor shall provide FDA-approved test kit (PACE 2) for the detection of ribosomal RNA (rRNA) for Chlamydia trachomatis and Neisseria gonorrhoeae. This method is a non-amplified, probe assay for the presence of sequence specific nucleic acids un ique to C. trachomatis and N. gonorrhoeae. Urethral or cervical specimens are collected on a swab using a specific male and female collection kit and transported to the laboratory for testing. The collection and transport kits are designed and FDA approv ed to specifically support this assay only. The instrumentation , the Leader 450I and the Leader 250, are the only instruments available to support these reagents.
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