Test Summary

This qualitative molecular assay uses Transcription‑Mediated Amplification (TMA) for the detection of Mycoplasma genitalium and real‑time PCR for the detection of Mycoplasma hominis, Ureaplasma parvum, and Ureaplasma urealyticum. 
The Mycoplasma genitalium component of this panel utilizes an FDA‑cleared TMA‑based assay. Detection of M. hominis, U. parvum, and U. urealyticum is performed using a laboratory‑developed real‑time PCR assay. These laboratory‑developed components were developed, and their analytical performance characteristics were determined, by CompuNet Clinical Laboratories. The laboratory‑developed portions of this assay have been validated pursuant to CLIA regulations and are intended for clinical use

 

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