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For In Vitro Diagnostic Use. The Rheonix STI TriPlex™ Assay, as performed on the Rheonix Encompass MDx® Workstation, is an automated DNA extraction and multiplex PCR amplification test system intended for the direct, qualitative detection of DNA from Chlamydia trachomatis (CT), and/or Neisseria gonorrhoeae (NG), and/or Trichomonas vaginalis (TV) in male urine specimens collected with the Rheonix Urine Specimen Collection Kit. The test is indicated to aid in the diagnosis of chlamydial urogenital disease, gonococcal urogenital disease and trichomoniasis in asymptomatic male individuals.

The Rheonix Encompass MDx® Workstation and the Rheonix STT TriPlex™ Assay are comprised of an instrument with associated hardware and accessories, disposable microfluidic CARD cartridges, master mixes and reagent components used to extract, amplify, and detect DNA using end point PCR. In addition, all male urine specimens in this system must be collected using the Rheonix Urine Specimen Collection Kit. The process is fully automated with the user intervention required only for loading and unloading the samples and disposable assay components. The Rheonix Encompass MDx Workstation's software automatically interprets test results which may be called as POS (positive), NEG (negative), or IND (indeterminate) for each of the assay's three targets. In addition, if the instrument encounters an error during the performance of the assay, it will report an ERR code. If either an IND or ERR code results, the same specimen should be reanalyzed for the presence of the target for which the indeterminate or error code occurred. Each assay has a built-in process control that assures that the individual steps of the entire process occurred properly. The user may also include external positive and/or negative controls to monitor the assay performance.