Suparak Supaporn, Unpol Petai, Ngueanchanthong Kanokwan, Chisholm Sirilada Pimpa, Jomjunyoung Siriphailin, Thanyacharern Wipawee, Smanthong Nitis, Pinrod Pojaporn, Srithanaviboonchai Kriengkrai, Yingyong Thitipong, Tasaneeyapan Theerawit, Nookhai Somboon, Rojanawiwat Archawin, Northbrook Sanny
Department of Medical Sciences, Ministry of Public Health, Nonthaburi 11000, Thailand.
Research Institute for Health Sciences, Chiang Mai University, Chiang Mai 50200, Thailand.
Diagnostics (Basel). 2024 Jun 9;14(12):1220. doi: 10.3390/diagnostics14121220.
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.
本研究聚焦于确立泰国近期感染（RTRI）实验室的质量保证。我们开发了一种独立于冷链的方法，使用从泰国红十字会获得的经过充分表征的血浆，并制备成干管标本（DTS）。将20微升HIV血清阴性、近期感染和长期感染的样本分装到各个试管中，在生物安全柜中于20至30摄氏度的室温下干燥过夜，以确保最佳保存。按照ISO/指南35的准则对DTS外部质量控制和外部质量评估进行了均匀性和稳定性测试。DTS样本分别分发给泰国14个省的48个地点（2022财年）和9个省的27个地点（2023财年）。收集参与实验室的结果并对其性能进行评估。对结果进行评分，可接受的性能标准定义为正确检测的样本比例，设定为100%。令人满意的性能范围为96%至100%，在13个卫生区域之间没有显著差异。所开发和实施的DTS样本可用于监测泰国RTRI检测的质量。
