Cepheid has announced clinical study results showing that its Xpert Xpress MVP test improved appropriate treatment decisions for women with vaginal symptoms when used at the point of care.
The study compared Xpert Xpress MVP against usual diagnostic approaches, which often include symptom-based assessment and microscopy. It found that 89.6 per cent of women tested with Xpert Xpress MVP received appropriate treatment within 24 hours, compared with 51.9 per cent in the usual care group.
The study also showed that among symptomatic women with no detectable infection, 50.0 per cent in the usual care arm received unnecessary antimicrobial treatment, compared with 27.1 per cent in the Xpert Xpress MVP arm. This matters because unnecessary antimicrobial use can contribute to resistance, disrupt the vaginal microbiome, cause side effects and increase costs.
The trial was described as the first randomised clinical study evaluating the utility of a multiplex molecular test for vaginitis at the point of care. It was led by investigators at Magee-Womens Research Institute and the University of Pittsburgh, with support from an investigator-initiated grant from Cepheid.
Xpert Xpress MVP is an FDA-cleared, CLIA-waived PCR test. It uses a single vaginal swab specimen, either clinician-collected or self-collected in a clinical setting, and detects the causative agents of bacterial vaginosis, vulvovaginal candidiasis and trichomoniasis, including co-infections, in women aged 14 years and older.
The test runs on Cepheid’s GeneXpert and GeneXpert Xpress systems and provides results in approximately one hour. This turnaround time is important because same-visit results can support evidence-based prescribing before the patient leaves the clinic.
The study also reported positive provider perceptions. Most healthcare providers with patients randomised to Xpert Xpress MVP were satisfied with turnaround time and workflow, and 87 per cent indicated they would like to incorporate this type of testing into routine clinical practice.
