The European Union has granted CE mark certification to BD Diagnostics’ molecular detection assay, designed to diagnose Trichomonas vaginalis in women who are considered to be at high risk of HIV infection.
The BD ProbeTec Trichomonas vaginalis Qx Amplified DNA assay, which is designed for use on the company’s BD Viper system, uses urine specimens of asymptomatic and symptomatic females for the qualitative detection of T. vaginalis DNA.
The assay reduces human intervention and associated variables, while improving speed to results, when compared to wet mount microscopy and culture.
Automated DNA extraction and simultaneous amplification and detection maximises laboratory efficiency and quality of results, according to the company.
BD Diagnostics women’s health and cancer group marketing manager Chris Demiris said the global prevalence of trichomoniasis, which is the most common curable sexually transmitted infection, is on the rise, and there are more asymptomatic cases than previously thought.
"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," Demiris said.
In addition to Trichomonas, the BD Viper system is used to test for chlamydia, gonorrhea and herpes on the same automated platform.