Special Precautions/Comments:

N.B. The patient should not have urinated for at least 1 hour prior to sampling and should provide a first catch urine sample (first 10 – 50mL of urine stream). Please fill between fill-lines indicated on cobas® PCR Urine tube.

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: Urine samples that are under- or over-filled will not be processed.

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.