Clinical and Interpretive

This assay is used in the detection of Trichomonas vaginalis.

Trichomonas vaginalis (TV) is a protozoan parasite that commonly infects the genital tract of men and women. It is now considered to be the most common curable sexually transmitted disease (STD) agent, with an estimated 3.7 million infected individuals in the United States. Although up to 70% of infected individuals are asymptomatic, infections may be associated with vaginitis, urethritis, and cervicitis in women, and urethritis and prostatitis in men. Patients that are infected with Trichomonas vaginalis have an increased risk of acquiring other sexually transmitted infections such as HIV, while infections in pregnant women are associated with premature labor, low-birth-weight offspring, premature rupture of membranes, and post-hysterectomy/post-abortion infection.

Symptoms of Trichomonas vaginalis overlap considerably with other sexually transmitted infections, and therefore laboratory diagnosis is required for definitive diagnosis. The most commonly used method for detection is microscopic examination of a wet-mount preparation of vaginal secretions. However, this method has only 35% to 80% sensitivity compared with culture. Culture also suffers from relatively low sensitivity (38%-82%) when compared to molecular methods. Culture is also technically challenging and takes 5 to 7 days to complete. Molecular methods, such as the APTIMA Trichomonasvaginalis Assay, offer the highest sensitivity and specificity for detection of trichomoniasis. The APTIMA test utilizes target capture, transcription-mediated amplification (TMA), and hybridization protection assay (HPA) technologies for detection of Trichomonas vaginalis ribosomal RNA (rRNA).A positive result is considered indicative of current or recent Trichomonas vaginalis infection (trichomoniasis).

The effects of tampon use, douching, and specimen collection variables have not been assessed for their impact on the detection of Trichomonas vaginalis.To ensure proper endocervical sampling, excess mucus should first be removed.