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Drugmaker Pfizer is warning doctors that it expects to run low on supplies of Bicillin L-A, a long-acting injection of the ...
Test-kits for syphilis for the disease have been available for several years, but none of the tests on the market have been granted "marketing authorization" from the FDA.
The First To Know Syphilis Test is now available for purchase nationwide to be used for at-home testing of suspected syphilis infection.
The first at-home syphilis test has been approved for sale in the US as the worsening epidemic and decades-long rise in cases continues.
FDA authorizes 1st over-the-counter, at-home test for syphilis Syphilis cases have increased nearly 80% from 2018 to 2022, CDC data shows.
The at-home test can inform people of current and past infections but positive tests should still be taken to a healthcare provider for additional testing.
The Food and Drug Administration on Friday authorized the first at-home syphilis test amid surging cases of the bacterial infection and calls from federal health officials for innovative ...
The first at-home, over-the-counter syphilis antibody test has been granted marketing authorization by the FDA. Experts weigh in on the significance of accessible testing as STI cases rise in the U.S.
If the test is positive, additional testing must be done to confirm a diagnosis. Results of the at-home test will be positive for individuals previously diagnosed and/or treated for syphilis.
This new test will be available without a prescription and inform the user of their status within 15 minutes, according to the FDA. The test is just an indicator of syphilis antibodies, however.
The first at-home, over-the-counter antibody test for syphilis received marketing authorization from the U.S. Food and Drug Administration (FDA) on Friday.