Trial reportEBioMedicine2022
Accuracy and ease-of-use of seven point-of-care SARS-CoV-2 antigen-detecting tests: A multi-centre clinical evaluation.
Trial report in EBioMedicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 3 of them syntheses that pooled 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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
27 citing papers in PubMed, 3 syntheses or guidelines pooled it, 50 citations in OpenAlex.
- Clinical accuracy of instrument-based SARS-CoV-2 antigen diagnostic tests: a systematic review and meta-analysis.Virology journal · 2024Pooled it
- Assessment of the detection accuracy of SARS-CoV-2 rapid antigen test in children and adolescents: An updated meta-analysis.Journal of the Chinese Medical Association : JCMA · 2023Pooled it
- Investigation of the diagnostic performance of the SARS-CoV-2 saliva antigen test: A meta-analysis.Journal of microbiology, immunology, and infection = Wei mian yu gan ran za zhi · 2022Pooled it
- How to identify respiratory pathogens in primary health care - a review on the benefits, prospects and pitfalls in using point of care tests.Infection · 2025Review
- Rapid and highly sensitive immunoassay using an ultra-thin immuno-wall microfluidic device with a sequential fluorescence signal increment method.Analytical and bioanalytical chemistry · 2025Article
- Innate Immune Cell Functions Contribute to Spontaneous HIV Control.Current HIV/AIDS reports · 2024Review
- Clinical Evaluation and Comparison of Two Microfluidic Antigenic Assays for Detection of SARS-CoV-2 Virus.Microorganisms · 2023Article
- [Diagnostic performance of two antigen-tests compared to one PCR-Test to detect SARS-CoV-2 in an emergency department and emergency service].Die Anaesthesiologie · 2023Article
- Clinical performance of SARS-CoV-2 antigen-detection rapid diagnostic test using SERS-based lateral flow immunoassay.Heliyon · 2023Article
- Multicenter Diagnostic Evaluation of OnSite COVID-19 Rapid Test (CTK Biotech) among Symptomatic Individuals in Brazil and the United Kingdom.Microbiology spectrum · 2023Article
- The spread of the omicron variant: Identification of knowledge gaps, virus diffusion modelling, and future research needs.Environmental research · 2023Article
- SARS-CoV-2 multi-variant rapid detector based on graphene transistor functionalized with an engineered dimeric ACE2 receptor.Nano today · 2023Article
- Variable detection of Omicron-BA.1 and -BA.2 by SARS-CoV-2 rapid antigen tests.Medical microbiology and immunology · 2023Article
- Evaluation of the performance of a rapid antigen test (Roche) for COVID-19 diagnosis in an emergency setting in Sweden.Journal of medical virology · 2023Article
- Article
- Evaluation of Four Strategies for SARS-CoV-2 Detection: Characteristics and Prospects.Microbiology spectrum · 2022Article
- Article
- Risk-based decision-making related to preprocedural coronavirus disease 2019 testing in the setting of GI endoscopy: management of risks, evidence, and behavioral health economics.Gastrointestinal endoscopy · 2022Review
- SARS-CoV-2 Spatiotemporal Genomic and Molecular Analysis of the First Wave of the COVID-19 Pandemic in Macaé, the Brazilian Capital of Oil.International journal of molecular sciences · 2022Article
- Clinical Performance of Self-Collected Nasal Swabs and Antigen Rapid Tests for SARS-CoV-2 Detection in Resource-Poor Settings.Biomedicines · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
39 authors at 8 institutions in 5 countries.
Funding
Abstract
backgroundAntigen-detecting rapid diagnostic tests (Ag-RDTs) for SARS-CoV-2 are important diagnostic tools. We assessed clinical performance and ease-of-use of seven Ag-RDTs in a prospective, manufacturer-independent, multi-centre cross-sectional diagnostic accuracy study to inform global decision makers.
methodsUnvaccinated participants suspected of a first SARS-CoV-2 infection were recruited at six sites (Germany, Brazil). Ag-RDTs were evaluated sequentially, with collection of paired swabs for routine reverse transcription polymerase chain reaction (RT-PCR) testing and Ag-RDT testing. Performance was compared to RT-PCR overall and in sub-group analyses (viral load, symptoms, symptoms duration). To understandusability a System Usability Scale (SUS) questionnaire and ease-of-use (EoU) assessment were performed.
findings7471 participants were included in the analysis. Sensitivities across Ag-RDTs ranged from 70·4%-90·1%, specificities were above 97·2% for all Ag-RDTs but one (93·1%).Ag-RDTs, Mologic, Bionote, Standard Q, showed diagnostic accuracy in line with WHO targets (> 80% sensitivity, > 97% specificity). All tests showed high sensitivity in the first three days after symptom onset (≥87·1%) and in individuals with viral loads≥ 6 log
interpretationVariability in test performance is partially explained by variable viral loads in population evaluated over the course of the pandemic. All Ag-RDTs reach high sensitivity early in the disease and in individuals with high viral loads, supporting their role in identifying transmission relevant infections. For easy-to-use tests, performance shown will likely be maintained in routine implementation.
fundingMinistry of Science, Research and Arts, State of Baden-Wuerttemberg, Germany, internal funds from Heidelberg University Hospital, University Hospital Charité - Universitätsmedizin Berlin, UK Department of International Development, WHO, Unitaid.
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Registered trials
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.