The U.S. Food and Drug Administration (FDA) has licensed an over-the-counter, rapid test for three sexually transmitted infections for home use, according to a press release from the agency. The test system, the Women's Sexual Health Test from Visby Medical, has received marketing authorization. It is intended for women with or without STI symptoms and detects chlamydia, gonorrhea, and trichomoniasis.
The diagnostic kit contains disposable instruments for self-collection of a vaginal swab and an electronic analysis device that transmits results to a smartphone app. The diagnostic process takes approximately 30 minutes, and its accuracy, according to testing, is 97.2–100 percent. The FDA previously approved an over-the-counter syphilis test for self-diagnosis in women and men using a drop of blood from a finger.
