Establishing quality assurance for COVID-19 antigen tests in the Indo Pacific Region: A multi-site implementation study.

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Tác giả: Liza Cabuang, Philip Cunningham, Bouaphanh Khamphaphongphane, Jessica Markby, Marilyn Ninan, Boualay Norchaleun, Chan Leakhena Phoeung, Jacqueline Prestedge, Kirsten Ridley, Vonthanak Saphonn, Kennarey Seang, Pamela J Toliman, Andrew Vallely, Deborah A Williamson, Garrett Young

Ngôn ngữ: eng

Ký hiệu phân loại:

Thông tin xuất bản: United States : Diagnostic microbiology and infectious disease , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 730446

BACKGROUND: Quality assurance programs (QAPs) are used to evaluate the analytical quality of a diagnostic test and provide feedback to improve quality processes in testing. Rapid diagnostic tests were used in both laboratory and non-laboratory settings to diagnose COVID-19, although varied in reported performance. We aimed to design and implement a QAP for antigen rapid diagnostic tests (Ag-RDTs) for COVID-19 in Cambodia, Lao PDR, and Papua New Guinea. METHODS: Inactivated SARS-CoV-2 material derived from cell culture of Wildtype, Delta, and Omicron isolates were used to manufacture 435 quality control (QC) panels (consisting of a single positive and negative sample) and 36 external quality assessment (EQA) panels for use across 15 sites in accordance with provided training and protocols. RESULTS: In total, 369 QC results and 112 EQA results were submitted by electronic reporting or paper forms by two countries. 19·3 % (34/176) positive and 99·5 % (192/193) negative samples were correctly reported in the QC, and 37·5 % (30/80) positive and 97·5 % (39/40) negative samples were correctly reported in the EQA. CONCLUSION: This QAP demonstrates the importance of operator training and the design of QAP materials, which may have contributed to the high rate of false-negative interpretations in known COVID-19 positive samples. The implementation of this project, to our knowledge the first of its kind in the region and one of only a few globally, emphasised the importance of quality assurance principles, including non-laboratory community testing sites, to promote diagnostic quality for COVID-19 testing.
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