The biotechnology company’s NOWDiagnostics diagnostic will take the user just 15 minutes and a single drop of blood.
The U.S. Food and Drug Administration on Friday approved the use of over-the-counter home tests for syphilis for the first time. Until now, people who suspected they had a sexually transmitted infection had to go to a doctor to get tested. With a tremendous increase in the number of syphilis cases, biotechnology company NOWDiagnostics can now determine whether a person has syphilis in just 15 minutes and with just one drop of blood.
However, the FDA says the home kit is only to rule out or confirm your suspicion and if someone tests positive for syphilis, they should visit a doctor to confirm the diagnosis and get treatment promptly.
The company said the test will be available in the second half of 2024 and is expected to cost $29.98.
“We continue to see advances in testing, particularly testing for sexually transmitted infections, that can give patients more information about their health from the privacy of their own home,” said Dr. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, in a press release. “Access to at-home testing can help increase initial detection of syphilis, even in people who may be reluctant to consult their health care provider about possible exposure to sexually transmitted infections. This can lead to increased laboratory testing to confirm the diagnosis, which can result in increased treatment and reduced spread of infection,” she added.
The alarming rise of syphilis
Syphilis, a sexually transmitted infection, can permanently damage the heart, brain, muscles, bones and eyes if not treated early, experts say. Doctors say the infection, which is transmitted by bacteria, had been almost eliminated in the 1990s, but numbers have risen dramatically in recent times.
According to the Centers for Disease Control and Prevention, there has been an 80% increase in the number of cases, including among newborns, between 2018 and 2022. Data from the U.S. Centers for Disease Control and Prevention (CDC) indicate that newborn cases were more than ten times higher in 2022 than ten years ago.
Home kit for detecting syphilis has shown 93 percent accuracy in tests
Experts say the test kit received FDA clearance after clinical trial data showed the First To Know Syphilis Test identified a positive sample 93.4 percent of the time. NOWDiagnostics said it hopes its test will have a significant impact on public health and help improve access to early detection and treatment, particularly with cases rising in underserved populations.
Who can get syphilis?
Doctors say anyone who is sexually active can get the bacterial infection, but the risk is higher if:
- Having unprotected sex, especially if you have multiple partners.
- You are a man who has sex with men
- He has HIV
- You have had sexual relations with someone who tested positive for syphilis.
- They have tested positive for other sexually transmitted infections.
Signs and symptoms of syphilis
According to doctors, the symptoms of syphilis vary depending on the stage of infection. While the early stages are the most contagious, it is when signs can be noticed that develop mainly on the genitals.
- Sores on the genitals
- Eruptions
- Flu-like symptoms
- Fatigue and tiredness
- High fever
- Sore throat
- muscle pains
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