Special Precautions/Comments:

N.B. This procedure is for testing endocervical and vaginal swabs. Any samples received in non-COBAS tubes will be discarded.

cobas® TV/MG has not been evaluated in patients <14 years of age.

cobas® TV/MG has not been evaluated with patients who were currently being treated with antimicrobial agents active against TV or MG as well as patients with a history of hysterectomy.

Interferences: Detection of vaginalis and 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 T. vaginalis and M. genitalium strains.

Urogenital specimens from patients who have used the over-the-counter Metronidazole vaginal gels Replens^TM and RepHresh^TM produced false negative or invalid results.

Products containing carbomer(s), including vaginal lubricants and creams may interfere with the test and should not be used prior/during specimen collection

Method:  Real-time polymerase chain reaction (PCR). Calibration: cobas® 6800/8800 system. EQA scheme: QCMD. IQC: cobas® commercial preparations.

Interpretation: Results are reported as NOT detected, Inconclusive, or DETECTED by PCR. A negative result does NOT fully exclude infection. POSITIVE results must be discussed with Sexual Health; please refer to local sexual health service for treatment, other essential testing and follow up.

Additional Information:

Background information: Trichomonas vaginalis (TV) is the most common non-viral sexually transmitted infection (STI) in the world. TV is a parasitic protozoan that primarily infects the squamous epithelial cells and erythrocytes, residing in the lower genital tract of females and in the urethra and prostate of males. Humans are the only known host for TV, and the pathogen is primarily sexually transmitted. Infection may persist for long periods (months to years) in women, but in males, it generally persists less than ten days. Women who are symptomatic for a TV infection complain of vaginal discharge, pruritus, and irritation. Other signs of infection include malodour, oedema, and/or erythema. TV is also known to cause urethritis in men who have sex with women. Men with trichomoniasis may feel itching or irritation inside the penis or burning after urination or ejaculation or have some discharge from the penis.

Mycoplasma genitalium (MG) 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.