CLN Article

CE Mark Given to Mologic for Rapid, POC Bacterial Vaginosis Test

Regulatory Roundup: November 2017

Mologic has been awarded the CE mark for BVPro, a 15-minute point-of-care test for patients presenting with symptoms of bacterial vaginosis (BV). The test is designed in a lateral flow immunoassay format, similar to a pregnancy test, with a visual result that is easy for healthcare providers to interpret. Performed using vaginal fluid collected with a sterile swab, the test detects the activity of the sialidase enzyme, which is produced by bacterial pathogens in the vagina and is a well-established clinical marker of BV. BVPro identifies sialidase activity by supplying the enzyme—which typically degrades sugars—with an artificial substrate. If sialidase-producing bacteria are present, the enzyme will modify the substrate which is then captured on the test strip using specific antibodies, producing a red line. A control line is also included to indicate that the assay has been performed correctly.  

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