For in vitro diagnostic use. RIDA®GENE Trichomonas vaginalis is a multiplex real-time PCR for the direct, qualitative detection of Trichomonas vaginalis from human genital swabs and urine.
The RIDA®GENE Trichomonas vaginalis real-time PCR is intended for use as an aid in diagnosis of Trichomoniasis caused by Trichomonas vaginalis.
Trichomonas vaginalis is a human pathogenic parasite that infects the genital area. It can lead to trichomoniasis where both sexual organs and also the urinary tract can be affected. Trichomoniasis is transmitted by sexual intercourse and is either transmitted through vaginal secretion or sperm indicating the infrection potential for both men and women. Worldwide, 120 million cases are described yearly, whereas a higher prevalence rate is known in women.
According to the Centers of Disease Control and Prevention (CDC), about 3 – 5 million people are infected with Trichomonas vaginalis in the US. However, only 30% of the infected show symptoms. Symptoms reach from discomfort in the vaginal area and with urination up to discharge. During a Trichomonas vaginalis infection in women, also a miscolonisation of the vaginal flora with other pathogens is observed. For example Gardnerella vaginalis or various stool pathogens often accompany a Trichomonas vaginalis infection. In pregnant women, an infection with Trichomonas vaginalis may lead to further complications such as premature labour or premature membrane rupture. Complications in men are amongst others infertility or prostatitis.
Besides the miscolonisation of the vaginal flora, Trichomonas vaginalis also plays an important role as co-factor during transmission of HIV. The gold standard for diagnosis is still culture, however sensitivity is only about 80% and with the time to result of up to 7 days it is not suitable for timely diagnosis.
|Test format||real-time PCR with 100 reactions|
|Shelf life||24 month after production|
|Sensitivity||Analytical Sensitivity : ≥ 10 DNA copies per reaction|
we have started to provide the documents for our products in an electronic format. These are the Instructions for Use (IFU), the Safety Data Sheets (SDS) and the Certificate of Analysis (CoA). For batches placed on the market after 01 January 2023, you can find our documents on the eIFU portal eifu.r-biopharm.com.