The U.S. FDA has granted marketing authorization for the first over-the-counter PCR diagnostic test for chlamydia, gonorrhea, and trichomoniasis. This single-use PCR test is designed for females, with or without symptoms, and remarkably delivers results within 30 minutes.
Clinical evidence In clinical trials involving over 2,000 lay users, the diagnostic test correctly identified 98.8% of negative and 97.2% of positive Chlamydia trachomatis samples, 99.1% of negative and 100% of positive Neisseria gonorrhoeae samples, and 98.5% of negative and 97.8% of positive Trichomonas vaginalis samples. Notably, the test yielded results comparable in accuracy to traditional laboratory-based PCR machines. Device description Intended for single-use at-home testing Includes a vaginal collection kit and a powered testing device, which securely communicates with an app to display results The companion…
