(P326) Brazilian Ministry of Health quality assurance tools for rapid treponemal tests in public healthcare system

Background: Brazilian Ministry of Health (MoH) distributes around 14 million Rapid treponemal tests (RTT) annually and recommend it as main tool for syphilis diagnosis. Pregnant women and other high risk of loss to follow-up groups can be treated after a positive RTT. Quality assurance supports correct diagnosis for early treatment to reduce syphilis transmission and complications.

Methods: Brazilian MoH manages five quality tools for RTT (Figure 1). 2022 data from all tools were evaluated, including: technical criteria definition for RTT acquisition; adherence to distance RTT training provided by MoH (webinars and Telelab training platform); performance criteria verification results for lots acquired; participation in RTT External Quality Assessment (EQA) program; and Customer Service (CS) registers for RTT reactive post-marketing evaluation.

Results: All RTT acquired matched technical criteria, including registration at Brazilian Health Regulatory Agency, CS availability, ≥94.5% sensitivity, ≥93.0% specificity, kit and accessories features to improve usability. 2141 professionals from all 27 federal unities accessed webinars about quality assurance tools for RTT and a monthly average of 1300 were certified by Telelab for Syphilis Diagnosis. All 20 RTT lots analyzed were approved according to performance criteria. 3013 professionals performed the practical round of EQA and 94.5% were approved. Main reasons for disapproval were performance ≤69% or use of an expired RTT in EQA. 3011 performed the theoretical round and 84.9% were approved. Main mistakes were about diagnostic flowcharts in Brazilian Guidelines and results interpretation. 49 RTT nonconformity were reported by CS, representing 0,0003% of 14,3 million RTT distributed. 87.75% of the non-conformities were not replicated in manufacturer evaluation. Therefore, they may have occurred due to execution errors or sample inherent factors.

Conclusion: Defining procurement criteria and lots verification are important tools to ensure quality of RTT provided, reflected in the low number of reported non-conformities identified through reactive post-marketing evaluation tool. Educational platforms had high adherence, which reflected in better rapid testing performances. EQA is an efficient tool to evaluate main difficulties related to rapid testing and diagnosis algorithms. The results demonstrated high-quality level in rapid testing in Brazil, although an increase in EQA adherence is still needed.