BD Diagnostics, BD ProbeTec™ Trichomonas vaginalis Qx Amplified DNA Assay gets FDA clearance
Global medical technology company, BD Diagnostics, a segment of BD (Becton, Dickinson and Company) announced Tuesday the U.S. Food and Drug Administration clearance and launch of the BD ProbeTec™ Trichomonas vaginalis Qx Amplified DNA Assay for the direct qualitative detection of T. vaginalis DNA in endocervical and vaginal samples as well as neat urine specimens to aid in the diagnosis of trichomoniasis on the BD Viper™ System with XTR™ Technology.
Trichomonas vaginalis
Image/DPDx–CDC
Trichomoniasis is the most common curable sexually transmitted infection (STI). Worldwide, more than 180 million cases are estimated to occur annually.
“The global prevalence of trichomoniasis is on the rise and there are more asymptomatic cases than previously thought,” said Chris Demiris, Worldwide Group Marketing Manager, BD Diagnostics – Diagnostic Systems, Women’s Health and Cancer. “The availability of an automated platform is especially important as clinical and public health communities embrace the need for a test that provides timely and accurate diagnosis of trichomoniasis when screening high-risk populations.”
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 samples in panel mode for T. vaginalis, C. trachomatis and N. gonorrhea or in batch mode for chlamydia and gonorrhea, trichomonas and herpes on the same automated platform.
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