# Establishing Quality Assurance for HIV-1 Rapid Test for Recent Infection in Thailand through the Utilization of Dried Tube Specimens

## TL;DR

This study developed a reliable method using dried blood samples to ensure quality testing for recent HIV infections in Thailand.

## Contribution

A cold-chain independent DTS method was developed and validated for quality assurance of HIV-1 RTRI testing.

## Key findings

- DTS panels showed satisfactory performance ranging from 96% to 100% across health regions.
- The method was successfully distributed to multiple sites in Thailand for quality monitoring.
- DTS preparation and testing met ISO/Guide 35 standards for homogeneity and stability.

## Abstract

The present study focuses on establishing the quality assurance of laboratories for recent infections (RTRI) in Thailand. We developed a cold-chain independent method, using fully characterized plasma obtained from the Thai Red Cross Society, and prepared as dried tube specimens (DTS). Twenty microliters of HIV-seronegative, recent, and long-term infected samples were aliquoted into individual tubes and dried at room temperature, 20–30 degrees Celsius, in a biosafety cabinet overnight to ensure optimal preservation. The DTS external quality control and external quality assessment were tested for homogeneity and stability following the ISO/Guide 35 guidelines. The DTS panels were distributed to 48 sites (FY 2022) and 27 sites (FY 2023) across 14 and 9 provinces, respectively, in Thailand. The results from participating laboratories were collected and evaluated for performance. The results were scored, and acceptable performance criteria were defined as the proportion of panels correctly tested, which was set at 100%. The satisfactory performance ranged from 96% to 100% and was not significantly different among the 13 health regions. The developed and implemented DTS panels can be used to monitor the quality of RTRI testing in Thailand.