Implementation of Syphilis Health Check in New York State Clia-Waived Point of Care Testing Sites

Background:  Primary and secondary syphilis in New York State (NYS) have risen (2011-14) with increased cases among men who have sex with men.  The (2014) FDA-approved Syphilis Health Check (SHC), the first CLIA-waived rapid syphilis test, has little data available from agencies targeting high-risk individuals and the impact of SHC on prevention.  Multisite assessments of program outcomes were conducted of NYS CLIA-waived testing sites using SHC fingerstick whole blood.

Methods:  Screening and supplemental testing outcomes were collected from NYS CLIA-waived sites targeting high-risk men with prevention, while SHC utilization and issues were assessed during advisory calls with members from each site.  Screening data were collected from 4 NYS community based organizations (CBOs) using the AIDS Institute Reporting System (January 2015 – June 2016).   One STD clinic manually collected data (July 2015 – June 2016).   Supplemental testing information on reactive results (RR) were obtained as additional testing and clinical evaluation are required for diagnosis.

Results:  The CBOs conducted 372 SHC tests.  Of those with RR (N=26), 3 were true positives, 2 were false positives, 17 tests had unresolved results with inconsistent tests performed (RPR-, EIA-, CIA-, FTA-) based on reverse sequence algorithm (RSA) testing, and 4 with no additional testing.  One false negative was identified from parallel testing (SHC-/EIA+, RPR-, TPPA+).  The STD clinic conducted 88 SHC tests.  Of those with RR (N=9), 1 was true positive and 8 were CIA-.

Conclusions:  The National Coalition of STD Directors supports the use of the RSA in their SHC pamphlet.  In our assessment, 29 of the 35 initially RR did not have RSA confirmatory test/s completed.  The unresolved infection status in these individuals could potentially lead to unintended disease transmission.  A lack of strong recommendations, standards, policies, and protocol for confirmatory testing following SHC RR highlights a clear need for guidance to sites using SHC.