Establishing quality assurance for COVID-19 antigen tests in the Indo Pacific Region: A multi-site implementation study
Year: 2024
Type: article
Abstract: • COVID-19 rapid antigen tests were assessed through a quality assurance program. • Central and regional sites in Cambodia, Lao PDR, Papua New Guinea participated. • This training was an opportunity to embed quality processes across testing workflows. • False-negative results were frequently reported from known COVID-19 positive samples. • Variability of results showed quality control is needed even for simple antigen tests. 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. 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. 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. 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.
Institutions: The Royal Melbourne Hospital, The University of Melbourne, Victorian Infectious Diseases Reference Laboratory, Peter Doherty Institute, University of Health Science, Clinton Health Access Initiative, Papua New Guinea Institute of Medical Research, FIND, UNSW Sydney, Kirby Institute, St Vincent's Hospital Sydney
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,190
OpenAlex ID: W4405911108