BD (Becton, Dickinson and Company) has received the US Food and Drug Administration (FDA) 510(k) approval for BD Vaginal Panel to directly detect the three most common causes of infectious vaginitis.
The diagnostic test is designed to run on BD COR System, the company’s high-throughput molecular diagnostic platform for large laboratories.
It can detect bacterial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas vaginalis (TV) and deliver a clear positive or negative result for each condition.
BD Vaginal Panel is the first microbiome-based PCR assay that uses a single swab and test to simultaneously detect multiple infectious micro-organisms, said the medical device firm.
BD diagnostics vice president Nikos Pavlidis said: “Most women have a vaginal infection during their lifetime and millions of them receive inadequate treatment.
“A recent study showed that four out of 10 women didn’t receive the appropriate diagnosis and treatment for their vaginitis symptoms after an initial physician visit, which led to four out of 10 women having to schedule a new appointment because of persistent symptoms.
“The BD Vaginal Panel can help end the cycle of repeat visits, misdiagnosis and ineffective treatment for the millions of women suffering from vaginitis.”
According to BD, accurate diagnosis of BV, VVC and TV is important for choosing proper treatment regimens and lowering the risk related to complications and treatment resistance.
The company said that its BD Vaginal Panel is the only FDA-approved nucleic acid amplification test (NAAT) that provides separate results for C. glabrata and C. krusei.
C. glabrata and C. krusei are two Candida species known to carry resistance to traditional antimicrobial treatments.
BD Vaginal Panel is the third assay approved for use on the BD COR System in the US, following the BD Onclarity HPV assay, and the BD CTGCTV2 molecular assay.
The BD COR System is a high-throughput, fully integrated preanalytical and analytical system that offers advanced molecular diagnostic capabilities.
It allows for loading 1,700 specimens at a time, with onboard capacity for reagents and samples that provide more than eight hours of the unrestricted system processing.
The system can deliver nearly 2,000 sample results within 24 hours, eliminating multiple manual interactions per shift that were traditionally required, said BD.
