TY - JOUR
T1 - Establishing quality assurance for COVID-19 antigen tests in the Indo Pacific Region
T2 - a multi-site implementation study
AU - Prestedge, Jacqueline
AU - Ninan, Marilyn
AU - Phoeung, Chan Leakhena
AU - Seang, Kennarey
AU - Young, Garrett
AU - Khamphaphongphane, Bouaphanh
AU - Norchaleun, Boualay
AU - Toliman, Pamela J
AU - Cabuang, Liza
AU - Saphonn, Vonthanak
AU - Markby, Jessica
AU - Ridley, Kirsten
AU - Vallely, Andrew
AU - Cunningham, Philip
AU - Williamson, Deborah A
N1 - Funding: Support for this program was provided through funding from The Foundation for Innovative New Diagnostics (FIND), the global alliance for diagnostics, in the context of their broader role in the ACT Accelerator.
PY - 2025/3
Y1 - 2025/3
N2 - 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.
AB - 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.
KW - COVID-19
KW - Rapid diagnostic tests
KW - Antigen tests
KW - Quality assurance
KW - External quality assessment
U2 - 10.1016/j.diagmicrobio.2024.116677
DO - 10.1016/j.diagmicrobio.2024.116677
M3 - Article
C2 - 39818183
SN - 0732-8893
VL - 111
SP - 1
EP - 8
JO - Diagnostic Microbiology and Infectious Disease
JF - Diagnostic Microbiology and Infectious Disease
IS - 3
M1 - 116677
ER -