Evidence map›Paper›PMID 39762057›Full record

ArticleBMJ open quality2025

Piloting an external quality assurance program (QAP) for COVID-19 antigen rapid diagnostic tests (Ag-RDTs): findings and lessons learned from Cambodia.

Chan Leakhena Phoeung, Jacqueline Prestedge, Marilyn Ninan, Philip Cunningham, Sothavireak Bory, Kennarey Seang, Kanika Heng, Deborah Williamson, Jessica Markby, Andrew Valley and 2 more

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Article in BMJ open quality, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

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5 · Who and what money

Authors and funding

12 authors.

Chan Leakhena PhoeungUniversity of Health Sciences, Phnom Penh, Cambodia p_chanleakhena@uhs.edu.kh.ORCID http://orcid.org/0000-0002-6538-3597
Jacqueline PrestedgeThe Peter Doherty Institute for Infection and Immunity, University of Melbourne, Melbourne, Victoria, Australia.
Marilyn NinanThe Peter Doherty Institute for Infection and Immunity, University of Melbourne, Melbourne, Victoria, Australia.
Philip CunninghamThe Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.
Sothavireak BoryFaculty of Pharmacy, University of Health Sciences, Phnom Penh, Cambodia.
Kennarey SeangGrant Management Office, University of Health Sciences, Phnom Penh, Cambodia.
Kanika HengFaculty of Pharmacy, University of Health Sciences, Phnom Penh, Cambodia.
Deborah WilliamsonThe Peter Doherty Institute for Infection and Immunity, University of Melbourne, Melbourne, Victoria, Australia.
Jessica MarkbyFoundation for Innovative New Diagnostics, Geneva, Genève, Switzerland.
Andrew ValleyThe Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.
John KaldorThe Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.
Vonthanak SaphonnRectorate, University of Health Sciences, Phnom Penh, Cambodia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Rapid antigen diagnostic tests (Ag-RDTs) that quickly and accurately identify SARS-CoV-2 are an essential part of the COVID-19 response, but multiple factors can affect the validity of Ag-RDTs results. In Cambodia, several commercial Ag-RDTs have become available since the COVID-19 outbreak, but quality control (QC) and external quality assurance (EQA) of these rapid tests have yet to be fully and systematically implemented. We collaborated with laboratory experts in Australia and piloted an EQA programme of the commonly used COVID-19 Ag-RDTs at the University of Health Sciences' MERIEUX Laboratory (Tier 1 site-responsible for the in-country receipt and distribution of QA material) and four other participating laboratories (Tier 2-healthcare facility based) between November 2021 and November 2022. The preimplementation training including the Khmer-translated documentation was conducted virtually for Tier 1 laboratories and in-person for Tier 2 laboratories. All QC (n=290) and EQA (n=60) specimens were distributed to the laboratories and testing was performed according to the frequency of Ag-RDTs use in each laboratory. All National Reference Laboratory-provided EQA and QC specimens were tested and results were submitted via the EDCNet portal using QR code scanning. The Tier 1 laboratory reported 100% concordance with the EQA reference result, while some of Tier 2 laboratories' results were discordant. While continued capacity building and support with troubleshooting have been key to the successful EQA piloting at the UHS laboratory, the programme experienced delays in the shipping/delivery of EQA and QC panels due to customs and border requirements, which could have hindered implementation and potentially impacted the quality of the QA materials. The pilot EQA programme demonstrated potential scalability and provided data on the reliability of test results at the site. However, to ensure sustainability and practicability of this activity, in-country EQA panel preparation may need to be considered.

Indexed as

COVID-19Quality Assurance, Health CareSARS-CoV-2Antigens, ViralCambodiaCOVID-19 Serological TestingDiagnostic Tests, RoutineHumansPilot ProjectsQuality ControlRapid Diagnostic TestsAntigens, ViralCOVID-19Health professions educationPerformance measuresQuality improvement

Identifiers

PMID39762057
PMCPMC12056633

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.