FDA authorizes marketing of at-home, over-the-counter syphilis test
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The FDA has granted NOWDiagnostics authorization to market their at-home, over-the-counter antibody test that detects a potential syphilis infection, according to a press release.
The First to Know Syphilis Test (NOWDiagnostics) lets individuals know of a current or past infection, regardless of successful treatment, in 15 minutes using a drop of blood. Individuals with a positive result should seek further testing for confirmation of the infection because the test is “not sufficient to diagnose syphilis infection” by itself, the FDA said in press release.
The main risk individuals using the test should be aware of is the possibility of false positive and false negative results, according to the release.
“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,” Michelle Tarver, MD, PhD, acting director the FDA’s Center for Devices and Radiological Health, said in the release. “This can lead to increased lab testing to confirm diagnosis, which can result in increased treatment and reduction in the spread of infection.”
As Healio previously reported, members of the U.S. House of Representatives recently introduced H.R. 8839, the bipartisan Maternal and Infant Syphilis Prevention Act. This proposed bill would enable HHS to further address the congenital syphilis epidemic.
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