The Effectiveness of a Point of Care Test for Syphilis in Local Health Clinics

Background:  Local health departments sometimes rely on outside laboratories to process syphilis confirmation tests which can cause a breakdown in services, ranging from deferred treatment, over-treatment and delayed public health investigations.  This pilot measured the effectiveness of using a point of care syphilis test in a clinical setting for the diagnosis of potential syphilis infection.

Methods: Four independent Sexually Transmitted Disease (STD) clinic labs were selected to participate.  These labs met the following criteria: associated with an STD clinic, performed stat Rapid Plasma Reagin (RPR) tests, experienced at least a one day delay in receiving treponemal test results from a non-clinic lab, CLIA-approved to run moderately complex lab tests, and interested in participating.  All sites continued their standard practices of submitting specimens for traditional treponemal testing.

Results: The four clinic labs conducted 313 tests and the results were evaluated by an independent laboratory consultant. The ability to identify biologic false positives (BFPs) saves staff time and program resources.  Waiting for confirmatory tests may cause a delay in treatment and additional resources to locate the persons to ensure s/he receives treatment and partner services, and some persons are lost to follow up.  Differences in the amount of time between confirmation labs received, treatment and partner services were noted.

Conclusions: The data suggest that Syphilis Health Check (SHC) would not be suitable to replace the RPR test or the combination of the RPR and Treponema pallidum Particle Agglutination Test (TPPA).  The data suggested SHC would be a suitable substitute to replace the TPPA.  This test could replace the TPPA using the current syphilis screening algorithm.  The product met the intended use in conjunction with a non-treponemal test (RPR).