ArticleBMJ (Clinical research ed.)2022
Diagnostic accuracy of covid-19 rapid antigen tests with unsupervised self-sampling in people with symptoms in the omicron period: cross sectional study.
Article in BMJ (Clinical research ed.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 26 papers, 5 of them syntheses that pooled it.
What it found
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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.
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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
26 citing papers in PubMed, 5 syntheses or guidelines pooled it.
- Acceptability of self-sampling and self-testing for infections: a rapid systematic review on public users' views.BMC public health · 2025Pooled it
- Effectiveness of COVID-19 vaccines against SARS-CoV-2 infection and severe outcomes in adults: a systematic review and meta-analysis of European studies published up to 22 January 2024.European respiratory review : an official journal of the European Respiratory Society · 2025Pooled it
- Performance of self-performed SARS-CoV-2 rapid antigen test: a systematic review and meta-analysis.Frontiers in public health · 2024Pooled it
- Comparing SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing/self-sampling with molecular and professional-use tests: a systematic review and meta-analysis.Scientific reports · 2023Pooled it
- COVID-19 rapid antigen tests approved for self-testing in Australia: published diagnostic test accuracy studies and manufacturer-supplied information. A systematic review.The Medical journal of Australia · 2023Pooled it
- Communicating the Imperfect Diagnostic Accuracy of COVID-19 Rapid Antigen Self-Tests: An Online Randomized Experiment.Medical decision making : an international journal of the Society for Medical Decision Making · 2024Trial
- COVID-19 Rapid Antigen Tests With Self-Collected vs Health Care Worker-Collected Nasal and Throat Swab Specimens: A Randomized Clinical Trial.JAMA network open · 2023Trial
- Evolution with age of the relationship between sex and post-COVID symptoms: a population-based cohort study.BMC medicine · 2026Article
- The virology of Omicron: pathophysiology, immune regulation, and clinical impact of SARS-CoV-2 sub variants.Virology journal · 2025Review
- Dutch participatory surveillance framework for evaluating evolutionary changes on SARS-CoV-2 affecting rapid diagnostic test sensitivity in 2022 - 2023.BMC infectious diseases · 2025Article
- Comparison of the analytical and clinical sensitivities of 34 rapid antigen tests with prevalent SARS-CoV-2 variants of concern during the COVID-19 pandemic in the UK.Microbiology spectrum · 2025Article
- The Performance of a Rapid Coronavirus Disease 2019 Antigen Test in Rural Gabon.The American journal of tropical medicine and hygiene · 2025Article
- Health and Economic Impact of COVID-19 Surveillance Testing in Seattle Homeless Shelters: A Cost-Effectiveness Analysis.AJPM focus · 2025Article
- A Truncated Multi-Thiol Aptamer-Based SARS-CoV-2 Electrochemical Biosensor: Towards Variant-Specific Point-of-Care Detection with Optimized Fabrication.Biosensors · 2025Article
- Development and characterization of monoclonal antibodies recognizing nucleocapsid protein of multiple SARS-CoV-2 variants.Heliyon · 2024Article
- Wide Real-Life Data Support Reduced Sensitivity of Antigen Tests for Omicron SARS-CoV-2 Infections.Viruses · 2024Article
- Estimating the impact of COVID-19 self-test availability and modifications in test-strategy on overall test uptake using an experimental vignette study.Scientific reports · 2024Article
- Public health-focused use of COVID-19 rapid antigen and PCR tests.Scientific reports · 2024Article
- Article
- Self-tests for COVID-19: What is the evidence? A living systematic review and meta-analysis (2020-2023).PLOS global public health · 2024Article
Corrections and comments
- Erratum issued
Authors and funding
20 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo assess the performance of rapid antigen tests with unsupervised nasal and combined oropharyngeal and nasal self-sampling during the omicron period.
designProspective cross sectional diagnostic test accuracy study.
settingThree public health service covid-19 test sites in the Netherlands, 21 December 2021 to 10 February 2022.
participants6497 people with covid-19 symptoms aged ≥16 years presenting for testing.
interventionsParticipants had a swab sample taken for reverse transcription polymerase chain reaction (RT-PCR, reference test) and received one rapid antigen test to perform unsupervised using either nasal self-sampling (during the emergence of omicron, and when omicron accounted for >90% of infections, phase 1) or with combined oropharyngeal and nasal self-sampling in a subsequent (phase 2; when omicron accounted for >99% of infections). The evaluated tests were Flowflex (Acon Laboratories; phase 1 only), MPBio (MP Biomedicals), and Clinitest (Siemens-Healthineers).
main outcome measuresThe main outcomes were sensitivity, specificity, and positive and negative predictive values of each self-test, with RT-PCR testing as the reference standard.
resultsDuring phase 1, 45.0% (n=279) of participants in the Flowflex group, 29.1% (n=239) in the MPBio group, and 35.4% ((n=257) in the Clinitest group were confirmatory testers (previously tested positive by a self-test at own initiative). Overall sensitivities with nasal self-sampling were 79.0% (95% confidence interval 74.7% to 82.8%) for Flowflex, 69.9% (65.1% to 74.4%) for MPBio, and 70.2% (65.6% to 74.5%) for Clinitest. Sensitivities were substantially higher in confirmatory testers (93.6%, 83.6%, and 85.7%, respectively) than in those who tested for other reasons (52.4%, 51.5%, and 49.5%, respectively). Sensitivities decreased from 87.0% to 80.9% (P=0.16 by χ
conclusionsSensitivities of three rapid antigen tests with nasal self-sampling decreased during the emergence of omicron but was only statistically significant for Clinitest. Sensitivities appeared to be substantially influenced by the proportion of confirmatory testers. Sensitivities of MPBio and Clinitest improved after the addition of oropharyngeal to nasal self-sampling. A positive self-test result justifies prompt self-isolation without the need for confirmatory testing. Individuals with a negative self-test result should adhere to general preventive measures because a false negative result cannot be ruled out. Manufacturers of MPBio and Clinitest may consider extending their instructions for use to include combined oropharyngeal and nasal self-sampling, and other manufacturers of rapid antigen tests should consider evaluating this as well.
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