BD Diagnostics, Sparks, Md, announced the European launch of the BD ProbeTec™ Trichomonas vaginalis Qx Amplified DNA assay for the direct qualitative detection of T. vaginalis DNA in female urine specimens to aid in the diagnosis of trichomoniasis on the BD Viper™ System. This assay has been CE-marked to the In Vitro Diagnostic Directive (98/79/EC). BD plans to submit this product for FDA 510(k) approval.
Trichomoniasis is the most common curable sexually transmitted infection (STI). Worldwide, more than 180 million cases are estimated to occur annually. Genital inflammation caused by trichomoniasis can increase a woman’s susceptibility to HIV infection. In HIV-infected women, trichomoniasis may increase the likelihood of HIV transmission to sex partners. Furthermore, trichomoniasis is often asymptomatic. For these reasons, experts recommend screening for T. vaginalis in women considered to be at high risk for infection.
The BD ProbeTec Trichomonas vaginalis Qx Amplified DNA Assay is designed for use with the BD Viper System. Automated DNA extraction and simultaneous amplification and detection maximize laboratory efficiency and quality of results. Compared to wet mount microscopy and culture, the BD ProbeTec Trichomonas vaginalis Qx assay reduces human intervention and associated variables and improves speed to results. The BD Viper System allows laboratories to test other samples for chlamydia, gonorrhea, and herpes on the same automated platform.