The regulator has said that treatment decisions should not be made based on the results of this test alone
The USFDA, which is the drug regulator in the United States of America has approved the first over the counter syphilis test that can be administered at home. However the results of this test cannot be the basis of treatment decisions and a confirmatory test is required.
Syphilis is a bacterial infection and one of the most common sexually transmitted infections in the world. If left untreated, syphilis can seriously damage the heart and brain and can cause blindness, deafness and paralysis. When transmitted during pregnancy, it can cause miscarriage, lifelong medical issues and infant death.
This is the first over the counter syphilis test. It looks in the blood for antibodies to the Trepanoma pallidum – the organism that causes syphilis – to decide whether or not a person has caught the infection. It takes about 15 minutes to arrive at a result but users are expected to take it to a physician to decide on the next course of action including the administration of a confirmatory test.
“We continue to see advancements in tests, particularly tests for sexually transmitted infections, which can give patients more information about their health from the privacy of their own home,” said Michelle Tarver, M.D., Ph.D., acting director of the FDA’s Center for Devices and Radiological Health. “Access to home tests may help increase initial screening for syphilis, including in individuals who may be reluctant to see their health care provider about possible sexually transmitted infection exposure. This can lead to increased lab testing to confirm diagnosis, which can result in increased treatment and reduction in the spread of infection.”
The United States has been seeing a surge in numbers of the infection in recent years with an almost 80% increase reported between 2018 and 2022.
