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
Negative

See Notes section below for guides to PCR Media Urine Collection Kit; PCR Media Swabs Guide; PCR Clinician Collected Vaginal and Endocervical Samples

Please click here to view collection guide – cobas PCR Media Urine Collection Kit

Please click here to view collection guide – cobas PCR Media Swabs Guide

Please click here to view collection guide – cobas PCR Clinician Collected Vaginal and Endocervical Samples

• Reliable results depend on proper sample collection, storage and handling procedures.
• The cobas® MG assay has been validated for use with male and female urine, clinician-instructed self-collected vaginal swab specimens, clinician-collected vaginal swab specimens, clinician-instructed self-collected meatal swab specimens, clinician-collected meatal swab specimens, and endocervical swab specimens, all collected in cobas® PCR Media (Roche Molecular Systems, Inc.) and cervical specimens collected in PreservCyt® Solution. Assay performance has not been established with other collection media and/or specimen types. Use of other collection media and/or specimen types may lead to false positive, false negative or invalid results.
• The cobas® MG assay has not been evaluated in patients younger than 14 years of age.
• Detection of M. genitalium is dependent on the number of organisms present in the specimen and may be affected by specimen collection methods, patient factors (i.e., age, history of STD, presence of symptoms), stage of infection and/or infecting M. genitalium strains.
• The cobas® MG assay for urine testing is recommended to be performed on first catch urine specimens (defined as the first 10 to 50 mL of the urine stream). The effects of other variables such as first-catch vs. mid-stream, post-douching, etc. have not been evaluated.
• The effects of other potential variables such as vaginal discharge, use of tampons, douching, etc. and specimen collection variables have not been evaluated.
• The cobas® MG assay has not been evaluated with patients who were currently being treated with antimicrobial agents active against MG as well as patients with a history of hysterectomy.
• Urogenital specimens from patients who have used the over-the-counter products ReplensTM Long-Lasting Vaginal Moisturizer, RepHreshTM Clean Balance or used Metronidazole Vaginal Gel (Sandoz) may generate invalid or false negative results. In general the presence of PCR inhibitors may cause false negative or invalid results.
• Though rare, mutations within the highly conserved regions of the genomic DNA of M. genitalium covered by cobas® MG primers and/or probes may result in failure to detect the presence of the bacterium.