The Health and Human Services National Syphilis and Congenital Syphilis Syndemic Federal Trask Force has created a Implementation of Point of Care Tests for Syphilis document to address the challenges in diagnosis and treatment of syphilis. This document emphasizes the often-asymptomatic nature of the infection and discusses the implementation of Point of Care (POC) tests to facilitate rapid diagnosis and treatment during the same visit.
POC tests for syphilis differs from the traditional laboratory-based serologic testing primarily in specimen collection, time to result, need for confirmation, and sensitivity/specificity. While POC tests offers rapid results using whole blood from a fingerstick, it lacks the comprehensive assessment provided by laboratory-based tests, requiring confirmation and follow-up. It also underscores that laboratory-based testing remains the preferred option, particularly for individuals with a history of syphilis and low-risk individuals. Despite lower sensitivity and specificity, POC tests can be valuable, especially in settings with high incidence rates or where access to healthcare is limited.
Over the past decade, syphilis rates and case numbers in the U.S. have increased across all populations. Syphilis infection can be difficult to diagnose. People are often asymptomatic, which makes screening a crucial step in diagnosis. Most current syphilis testing in the U.S. is done through laboratory-based serologic (i.e., antibody) tests that need to be sent from the provider to a laboratory which can delay diagnosis and treatment. The Food and Drug Administration (FDA) has authorized many such laboratory-based serologic tests and has authorized two Clinical Laboratory Improvement Amendments (CLIA)-waived point-of-care (POC) tests for syphilis to detect antibodies to Treponema pallidum.
Click here to review the document.
Read more about the Task Force here.
