BD Diagnostics, a segment of BD
(Becton, Dickinson and Company) BDX, a leading global medical
technology company, announced today the U.S. Food and Drug Administration
clearance and launch of the BD ProbeTec™ Trichomonas vaginalis Q^x 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. This
assay has been CE-marked to the In Vitro Diagnostic Directive (98/79/EC).
Trichomoniasis is the most common curable sexually transmitted infection
(STI). Worldwide, more than 180 million cases are estimated to occur
annually.[i] 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 (i.e., women who have new or multiple partners, have a history
of STIs, exchange sex for payment, or use injection drugs).^
The BD ProbeTec Trichomonas vaginalis Q^x 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 Q^x 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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