Mycoplasma genitalium screen and resistance assay
The Cobas® Mycoplasma Genitalium (MG) assay is a qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection of MG DNA in male and female urine, clinician-instructed self-collected vaginal swab specimens, clinician-collected vaginal swab specimens, endocervical swab specimens, clinician-instructed self-collected meatal swab specimens, clinician-collected meatal swab specimens, all collected in cobas® PCR media (Roche Molecular Systems, Inc.), and cervical specimens collected in PreservCyt® Solution.
This test is intended as an aid in the diagnosis of MG caused disease in both symptomatic and asymptomatic individuals.
The Elitech resistance assay detects the macrolide resistance gene and will be performed on all samples that have tested positive for MG on the Cobas MG assay.
Mycoplasma genitalium is a fastidious bacterium first isolated in 1980 from the urethral swabs of two symptomatic men with non-gonococcal urethritis (NGU). Infections caused by this bacterium have been associated with male and female urethritis, balanoposthitis, prostatitis, cervicitis, pelvic inflammatory disease, and male and female infertility. Additional complications, such as preterm delivery and extra-genital infections, have been reported.
Positive with resistance gene detection
|Sample & container required||Urine or urogenital swab. Roche M.genitalium collection kit|
|Sample volume||10ml if sending urine|
See Notes section below for guides to PCR Media Urine Collection Kit; PCR Media Swabs Guide; PCR Clinician Collected Vaginal and Endocervical Samples
|Transport storage||Transport to Infection and Immunity Laboratory, Charing Cross Hospital, 9th Floor|
|Turnaround time||4 days|
This test was previously referred externally to Micropathology.
The Elitech macrolide resistance assay is awaiting UKAS accreditation due to a change in assay platform