Establishing a Quality Assurance Program for Syphilis Serology

Background: Early detection and treatment of pregnant women infected with HIV and/or syphilis is an essential component of basic antenatal care, and critical for current global and regional initiatives for eliminating mother-to-child transmission (MTCT) of HIV and syphilis.  The government of Zambia plans a syphilis national reference program to provide expertise in diagnostic testing and oversee the quality of testing via administration of a proficiency testing quality assurance program.  Zambia invited CDC to support the national laboratory to develop such a program.

Methods: CDC laboratory scientists conducted an initial laboratory assessment exercise at the proposed site for the syphilis national reference laboratory. They assessed existing laboratory practices and documentation; evaluated availability of reagents, equipment and supplies; conducted competency assessments with laboratory staff on qualitative RPR; and provided training on quantitative RPR and TPPA assays.   Model approaches on syphilis testing quality assurance were presented; and facilitated discussion was provided about the roles and responsibilities of a national syphilis reference laboratory.

Results: The laboratory had developed standard operating protocols (SOPs) relevant to techniques for HIV, but lacked documents specific to syphilis testing. Laboratorians did not have direct control of the source or manufacturer of tests ordered, causing inconsistencies and limited access to needed supplies. At the time of the evaluation, only qualitative RPR was performed on samples received for syphilis testing. RPR competency assessment found the staff competent with minor corrections. All staff were successfully trained on quantitative RPR and qualitative TPPA.  

Conclusions:The assessment identified that Zambia’s national laboratory requires essential supplies, SOPs, and additional training. Zambia’s commitment through an external PT program, with periodic assessments, would ensure sustainability and scalability of a national syphilis proficiency testing program. If successful, the capacity building approach used for Zambia could serve as a model for other resource-poor countries.