FDA approves first home test for syphilis. What you should know

This week, the Food and Drug Administration (FDA) cleared the way for the first over-the-counter home test to detect syphilis antibodies in human blood.

Test kits to detect syphilis have been available for several years, but none of the tests on the market have received FDA “marketing approval.”

The new test kits come from the company NOWDiagnostics. The name of the kit is “First-to-Know Syphilis Test”.

Here’s what you should know:

What is syphilis?

Syphilis is a sexually transmitted disease caused by the bacterium Treponema pallidum.

The FDA stated that if left untreated, the disease can cause severe damage to the heart and brain and “can lead to blindness, deafness and paralysis. If transmitted during pregnancy, it can cause miscarriages, lifelong health problems and death of the child.”

Syphilis is on the rise in the USA

Between 2018 and 2022, reported syphilis cases in the United States increased by 80% (from 115,000 to over 207,000), continuing a decades-long upward trend, according to the U.S. Centers for Disease Control and Prevention (CDC).

Congenital syphilis, which occurs when a mother with syphilis transmits the infection to her baby during pregnancy, increased by 30.6%, representing 3,700 cases in 2022.

Although the number of cases is increasing, people do not seem to be too worried about this sexually transmitted disease, according to experts.

“From a public health perspective, we’ve always been very concerned about it … but from a patient perspective, I think syphilis is fading away,” Dr. Peter Leone, a professor of medicine in the division of infectious diseases at the University of North Carolina School of Medicine, told USA Today earlier this year. “It’s a big deal, and it’s a big deal because there are consequences that I think people forget about.”

What you should know about home tests for syphilis

Knowing if you have syphilis is one of the best ways to stop the spread.

According to the FDA, the new test delivers a result in about 15 minutes. The FDA emphasized that a visit to a doctor should follow the home tests.

“We continue to see advances in testing, particularly testing for sexually transmitted infections, that can give patients more information about their health in the privacy of their own home,” Michelle Tarver, MD, Ph.D., deputy director of the FDA’s Center for Devices and Radiological Health, said in a press release. “Access to home testing can help improve initial screening for syphilis, including among individuals who may be hesitant to see their healthcare provider about possible exposure to sexually transmitted infections. This may lead to increased laboratory testing to confirm the diagnosis, which can lead to increased treatment and a reduction in the spread of infection.”

The main risk of the test is that you might get a false result, the FDA said. Confirmation from a doctor helps reduce the risk.

Do you need a prescription for the test kits?

No, they are available without a prescription.

What is syphilis?

Syphilis is on the rise in the USA

What you should know about home tests for syphilis

Do you need a prescription for the test kits?

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