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The First To Know Syphilis Test is a qualitative rapid membrane immunochromatographic assay for the detection of Treponema pallidum (syphilis) antibodies in human whole blood (capillary). This test is intended for over the counter (OTC) consumer use in individuals suspected of syphilis. Positive test results with the First To Know Syphilis Test alone are not sufficient to diagnose syphilis infection and must be followed by additional laboratory testing through a health care provider to confirm a diagnosis of syphilis. This test is not a substitute for visits to a healthcare provider. The information provided by this product should not be used to start, stop or change any treatments without a healthcare provider. Results of testing with the First To Know Syphilis Test will likely be positive for individuals previously diagnosed with syphilis, even if they were successfully treated. The First To Know Syphilis Test cannot determine whether there has been re-infection with syphilis.

The First To Know Syphilis Test is a single-use, lateral-flow, visually-read test that is intended for over-the-counter use by lay persons. All components of the test are contained in the cassette; no additional reagents are required to run the test. Procedure controls are intrinsic to the cassette. A single [~40 uL] drop of human capillary whole blood is added to the cassette. No software or instrumentation is required for use of the test. There are no accessories required to use the test. The test is a chromatographic immunoassay that delivers results in 15 minutes.