News

— Single-use test correctly identified positive samples over 97% of the time The FDA on Friday granted marketing authorization to the first at-home test for diagnosing chlamydia, gonorrhea, and trichomoniasis in females. In people with or without symptoms, the single-use test correctly identified a negative or positive case of one of the three sexually transmitted infections (STIs) over 97% of the time: Chlamydia trachomatis: 98.8% of negative and 97.2% of positive samples Neisseria gonorrhoeae: 99.1% and 100%, respectively Trichomonas vaginalis: 98.5% and 97.8% Home tests can give people information about their health from the privacy of their home. Risks of the new test include the usual: the possibility of false positives (unnecessary and/or incorrect treatment) and false negatives (treatment delays, spread of infection). Subsequent home STI tests of a similar nature can be cleared with the 510(k) pathway if they demonstrate substantial equivalence to Visby Medical Women's Sexual Health Test, the FDA said."