The U.S. Food and Drug Administration (FDA) has licensed an over-the-counter rapid test for three sexually transmitted infections for self-administration at home, the agency said in a press release. The test system, Women's Sexual Health Test by Visby Medical, has received a registration certificate. It is intended for women with or without symptoms of STIs and detects chlamydia, gonorrhea, and trichomoniasis.
The diagnostic kit contains disposable tools for self-collection of a vaginal smear and an electronic analytical device that transmits results to a smartphone app. The diagnostic process takes about 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.
