FDA approves first syphilis home test

In view of the increasing number of syphilis cases in the United States, the American health authority FDA on Friday approved the first home test to detect the bacterial disease.

“This is the first over-the-counter home test to detect antibodies to Treponema pallidum (syphilis) in human blood,” the FDA said in a press release. “Results from this type of test alone are not sufficient to diagnose syphilis infection. Additional testing should be done to confirm the diagnosis of syphilis.”

To stop the spread of syphilis, there is an urgent need for faster diagnostic procedures.

According to the U.S. Centers for Disease Control and Prevention, the number of cases increased by 80% between 2018 and 2022 – from 115,000 to over 207,000 known cases of syphilis per year.

The disease is typically transmitted through sex.

“If left untreated, syphilis can cause serious damage to the heart and brain and can lead to blindness, deafness, and paralysis,” the FDA noted. “If transmitted during pregnancy, it can cause miscarriage, lifelong health problems, and death of the baby.”

NOWDiagnostics’ new self-administered blood test can provide results within 15 minutes, according to the agency.

However, the FDA stressed that test results should be viewed as a preliminary step toward a fully confirmed, laboratory-based diagnosis that can be made through a visit to a doctor or clinic.

People who have previously been infected with syphilis will test positive on a home test even if they have been successfully treated, the FDA noted. That’s one reason why follow-up testing in a clinic is so important.

“Access to home testing can help increase initial screening for syphilis, including among people who may be hesitant to see their doctor about possible sexually transmitted disease exposure,” said Dr. Michelle Tarver, deputy director of the FDA’s Center for Devices and Radiological Health.

“This may lead to increased laboratory testing to confirm the diagnosis, which in turn may lead to increased treatment and a reduction in the spread of infection,” she added in the FDA press release.

Like many diagnostic tests, the NOWDiagnostics test can produce false positive results (the person tests positive but is not infected) or false negative results (the test misses an actual infection).

“False negative test results can lead to delays in effective treatment, spread of illness, and spread of infection to others in your community,” the FDA noted. “False positive results could lead to additional unnecessary testing and a delay in getting a correct diagnosis.”

Here, too, all test results from NOWDiagnostics must be confirmed by a subsequent laboratory test, the agency explained.

The launch of the first over-the-counter home test for syphilis follows the approval of a similar home test for two other common sexually transmitted infections, chlamydia and gonorrhea, in 2023.

“We continue to see advances in testing, particularly testing for sexually transmitted infections, which can give patients more information about their health in the privacy of their own home,” Tarver said.

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