Clinical Evaluation of 2 Point-of-Care Lateral Flow Tests for the Diagnosis of Syphilis

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Abstract

A diagnostic performance study comparing the only Food and Drug Administration–approved, point-of-care (POC) treponemal test (Syphilis Health Check) and the World Health Organization pre-qualified SD Bioline POC treponemal test against a treponemal hemagglutination test (TPHA) and a sequential algorithm of nontreponemal rapid plasma reagin and TPHA found both POC tests had >85% sensitivity compared with the TPHA and >85% sensitivity and >95% specificity compared with the rapid plasma reagin and TPHA standards.

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