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

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

doi:10.1016/j.diagmicrobio.2024.116677

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

Diagn Microbiol Infect Dis. 2024 Dec 30;111(3):116677. doi: 10.1016/j.diagmicrobio.2024.116677. Online ahead of print.

Authors

Affiliations

¹ Department of Infectious Diseases, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Victoria, 3000, Australia; Victorian Infectious Diseases Reference Laboratory, Royal Melbourne Hospital at the Peter Doherty Institute for Infection and Immunity, Victoria, 3000, Australia. Electronic address: [email protected].
² Department of Infectious Diseases, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Victoria, 3000, Australia.
³ Rodolphe Merieux Laboratory, University of Health Sciences, Phnom Penh, 12201, Cambodia.
⁴ Grant Management Office, University of Health Sciences, Phnom Penh, 12201, Cambodia.
⁵ Clinton Health Access Initiative, Inc., USA.
⁶ National Center for Laboratory and Epidemiology, Lao People's Democratic Republic.
⁷ Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea.
⁸ National Serology Reference Laboratory, Fitzroy, Australia.
⁹ Rectorate, University of Health Sciences, Phnom Penh, 12201, Cambodia.
¹⁰ Foundation for Innovative New Diagnostics, Geneva, Switzerland.
¹¹ Kirby Institute, UNSW, Sydney, Australia.
¹² Kirby Institute, UNSW, Sydney, Australia; St Vincent's Hospital Sydney, Sydney, Australia.
¹³ Department of Infectious Diseases, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Victoria, 3000, Australia; Victorian Infectious Diseases Reference Laboratory, Royal Melbourne Hospital at the Peter Doherty Institute for Infection and Immunity, Victoria, 3000, Australia.

PMID: 39818183
DOI: 10.1016/j.diagmicrobio.2024.116677

Abstract

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.

Keywords: Antigen tests; COVID-19; External quality assessment; Quality assurance; Rapid diagnostic tests.