First-of-Its-Kind High-Throughput Diagnostic Test for Infectious Vaginitis Uses Only One Swab

Accurate diagnosis of bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and Trichomonas vaginalis (TV) is vital in determining the proper treatment and reducing the possibilities of associated complications and the buildup of drug resistance. Now, a comprehensive diagnostic test directly detects the three most common infectious causes of vaginitis using a high-throughput molecular diagnostic platform for large laboratories.

Becton, Dickinson and Company’s (BD, Franklin Lakes, NJ, USA) BD Vaginal Panel is the first microbiome-based polymerase chain reaction (PCR) assay that uses a single swab and test to simultaneously detect organisms associated with BV, VVC and TV, and reports a clear positive or negative result for each condition separately. The BD Vaginal Panel obtained initial marketing authorization for the BD MAX System in 2016, and has now secured clearance from the U.S. Food and Drug Administration (FDA) on the BD COR System. If a test is positive for VVC (commonly referred to as a "yeast infection"), the BD Vaginal Panel is the only FDA-cleared Nucleic Acid Amplification Test (NAAT) that provides separate results for C. glabrata and C. krusei - two Candida species that carry resistance to traditional antimicrobials. This allows healthcare practitioners to prescribe the appropriate treatment regimen with the knowledge that antibiotic resistance will be addressed effectively.

This 510(k) clearance for the BD Vaginal Panel on the BD COR System is the first high-throughput version of the test. The BD COR System is the only high-throughput, fully integrated preanalytical and analytical system on the market, granting access to critical women's health and STI testing by enhancing both laboratory operations and patient management with advanced molecular diagnostic capabilities. The BD COR System enables 1,700 specimens to be loaded at a time, with onboard capacity for reagents and samples that provide over eight hours of uninterrupted system processing. The system can deliver close to 2,000 sample results in 24 hours, eliminating multiple manual interactions per shift that were required traditionally.

"Most women have a vaginal infection during their lifetime and millions of them receive inadequate treatment," said Nikos Pavlidis, vice president of Diagnostics for BD. "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."

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