The U.S. Food and Drug Administration has granted marketing authorization for the first at-home syphilis test.
The over-the-counter First To Know Syphilis Test, made by NOWDiagnostics in Arkansas, detects antibodies for Treponema pallidum (syphilis), according to a press release.
The test, which does not require a prescription, takes about 15 minutes to administer using only a drop of blood — “like a finger prick,” the company said.
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Results will be positive for those experiencing a current syphilis infection — as well as for those who have been previously diagnosed, even if they were successfully treated.
The test results are not sufficient to diagnose syphilis alone, however, and should be followed by additional testing from a provider to confirm the diagnosis, according to the FDA.
A clinical study of 1,270 people found the product “easy to use,” a press release from NOWDiagnostics noted.
The study results showed that the …