Innovating Quality Control and External Quality Assurance for HIV-1 Recent Infection Testing: Empowering HIV Surveillance in Lao PDR

Abstract

Quality assurance programs are critical to ensuring the consistency and reliability of point-of-care surveillance test results. In 2022, we launched Laos' inaugural quality control (QC) and external quality assessment (EQA) program for national HIV recent infection surveillance. Our study aims to implement the first QC and EQA program for national HIV recent infection surveillance in Laos, utilizing non-infectious dried tube specimens (DTS) for quality control testing. This initiative seeks to monitor and assure the quality of HIV infection surveillance. We employed the Asante HIV-1 Rapid Test for Recent Infection (HIV-1 RTRI) point-of-care kit, using plasma specimens from the Thai Red Cross Society to create dried tube specimens (DTS). The DTS panels, including HIV-1 negative, HIV-1 recent, and HIV-1 long-term samples, met ISO 13528:2022 standards to ensure homogeneity and stability. These panels were transported from the Thai National Institute of Health (Thai NIH) to the Laos National Center for Laboratory and Epidemiology (NCLE) and subsequently shipped to 12 remote laboratories at ambient temperature. The laboratory results were electronically transmitted to Thai NIH 15 days after receiving the panel for performance analysis. The concordance results with the sample types were scored, and laboratories that achieved 100% concordance across all sample panels were considered to have satisfactorily met the established standards. Almost all laboratories demonstrated satisfactory results with 100% concordance across all sample panels during all three rounds of QC: 11 out of 12 (92%) in June, 10 out of 12 (83%) in July, and 11 out of 12 (91%) in August. The two rounds of EQA performed in June and August 2022 were satisfied by 8 out of 11 (72%) and 5 out of 10 (50%) laboratories, respectively. QC and EQA monitoring identified errors such as testing protocol mistakes and insufficient DTS panel dissolution, leading to improvements in HIV recency testing quality. Laboratories that reported errors were corrected and implemented further preventive actions. The QC and EQA program for HIV-1 RTRI identified errors in HIV recent infection testing. Implementing a specialized QC and EQA program for DTS marks a significant advancement in improving the accuracy and consistency of HIV recent infection surveillance. Continuous assessment is vital for addressing recurring issues.

Keywords: HIV recent infection surveillance; dried tube specimens; external quality assessment; quality control.