The US Food and Drug Administration (FDA) has granted 510(k) clearance to Roche’s cobas BV/CV assay, a molecular diagnostic test that can identify bacterial vaginosis (BV) and Candida vaginitis (CV) from a single vaginal swab. According to the filing, the assay is intended for professional laboratory use, based on a clinician’s order.
The test uses real-time polymerase chain reaction technology to identify the specific bacteria and yeast species responsible for BV and CV in symptomatic patients. Roche stated that the assay is designed to support faster, more accurate diagnosis than syndromic evaluation alone.
BV and CV are among the most common causes of vaginal symptoms in the United States, and both conditions can present with overlapping symptoms that complicate clinical diagnosis based on history and examination alone.
Guidance on the diagnosis and treatment of these conditions is provided by the CDC’s STI Treatment Guidelines. The guidelines note that most women will experience at least one vaginal infection during their lifetime, making diagnosis and treatment key.
The cobas BV/CV assay detects DNA targets for BV-associated organisms, including Gardnerella vaginalis, Atopobium vaginae, and Lactobacillus spp. It also detects Candida species associated with CV, including C. albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis, and C. dubliniensis.
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The sample is collected via a clinician-collected or clinician-instructed self-collected vaginal swab in cobas PCR Media, in a health care setting. This sample can be used for extended testing with the cobas CT/NG and cobas TV/MG assays, streamlining the diagnostic process.
BV and CV frequently present with similar symptoms, making misdiagnosis common in clinical practice.
Roche plans to add the cobas 5800 system to the assay via the FDA’s Reagent Replacement and Instrument Family Policy. The commercial launch is expected later this year, according to the company, and will provide healthcare professionals with a valuable tool for diagnosing and treating these conditions.
The CDC’s STI Treatment Guidelines do not call for Candida speciation before first-line therapy is initiated. Additional speciation or susceptibility testing becomes relevant only in cases of persistent or recurrent CV.
The cobas BV/CV assay is a valuable tool in diagnosing and treating these conditions, providing healthcare professionals with a fast and accurate means of diagnosis.
