ArticleJournal of clinical virology : the official publication of the Pan American Society for Clinical Virology2022
Importance of external quality assessment for SARS-CoV-2 antigen detection during the COVID-19 pandemic.
Article in Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
6 citing papers in PubMed, 16 citations in OpenAlex.
- Behind the scenes of EQA – characteristics, capabilities, benefits and assets of external quality assessment (EQA): Part V – Benefits for stakeholders other than participantsClinical chemistry and laboratory medicine · 2025Review
- Piloting an external quality assurance program (QAP) for COVID-19 antigen rapid diagnostic tests (Ag-RDTs): findings and lessons learned from Cambodia.BMJ open quality · 2025Article
- Ignoring SARS-CoV-2 testing performance during COVID-19.The Lancet. Microbe · 2023Article
- SARS-CoV-2 antigen tests for screening of healthcare workers; experience with over 48,000 combined antigen tests and RT-PCR tests.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2023Article
- Ensuring diagnostic testing accuracy for patient care and public health- COVID-19 testing scale-up from an EQA provider's perspective.PLOS global public health · 2023Article
- Progress in Biosensors for the Point-of-Care Diagnosis of COVID-19.Sensors (Basel, Switzerland) · 2022Review
Corrections and comments
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Authors and funding
11 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAntigen testing has become an essential part of fighting the ongoing COVID-19 pandemic. With the continual increase in available tests, independent and extensive comparative evaluations using data from external quality assessment (EQA) studies to evaluate test performance between different users are required.
objectivesAn EQA scheme was established to assess the sensitivity of antigen tests and the potential impact of circulating SARS-CoV-2 strains on their performance. STUDY
designPanels were prepared for three challenges in 2021 containing inactivated SARS-CoV-2-positive samples of various genetic strains (including variants of concern, VOCs) at different concentrations, and negative samples. Data was analysed based on qualitative testing results in relation to the antigen test used.
resultsParticipants registered for each individual challenge in any combination. In total, 258 respondents from 27 countries worldwide were counted submitting 472 datasets. All core samples were correctly reported by 76.7 to 83.1% at participant level and by 73.5 to 83.8% at dataset level. Sensitivity differences could be shown in viral loads and SARS-CoV-2 strains/variants including the impact on performance by a B.1.1.7-like mutant strain with a deletion in the nucleoprotein gene. Lateral flow rapid antigen tests showed a higher rate of false negatives in general compared with automated point-of-care tests and laboratory ELISA/immunoassays.
conclusionsEQA schemes can provide valuable data to inform participants about weaknesses in their testing process or methods and support ongoing assay evaluations for regulatory approval or post-market surveillance.
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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.