ArticleEClinicalMedicine2021
Validation of a rapid antigen test as a screening tool for SARS-CoV-2 infection in asymptomatic populations. Sensitivity, specificity and predictive values.
Article in EClinicalMedicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 49 papers, 6 of them syntheses that pooled it.
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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.
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Who cites it
49 citing papers in PubMed, 6 syntheses or guidelines pooled it, 91 citations in OpenAlex.
- Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection.The Cochrane database of systematic reviews · 2025Pooled it
- The Asymptomatic Proportion of SARS-CoV-2 Omicron Variant Infections in Households: A Systematic Review.Influenza and other respiratory viruses · 2024Pooled it
- The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Antigen Testing (January 2023).Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Guideline
- An Elaboration on Sample Size Planning for Performing a One-Sample Sensitivity and Specificity Analysis by Basing on Calculations on a Specified 95% Confidence Interval Width.Diagnostics (Basel, Switzerland) · 2023Guideline
- Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection.The Cochrane database of systematic reviews · 2022Pooled it
- Accuracy of rapid point-of-care antigen-based diagnostics for SARS-CoV-2: An updated systematic review and meta-analysis with meta-regression analyzing influencing factors.PLoS medicine · 2022Pooled it
- Daily testing for contacts of individuals with SARS-CoV-2 infection and attendance and SARS-CoV-2 transmission in English secondary schools and colleges: an open-label, cluster-randomised trial.Lancet (London, England) · 2021Trial
- Development and multi-institutional validation of a deep learning algorithm for predicting cervical cord compression using dynamic cervical lateral radiographs.Scientific reports · 2026Article
- Diagnostic accuracy of point-of-care testing methods for SARS-CoV-2 detection in community quarantine and isolation settings.Infection prevention in practice · 2026Article
- Clinical Evaluation of the Healgen Rapid COVID-19 Antigen Test as a Point-of-Care Diagnostic Tool.Immunity, inflammation and disease · 2025Article
- Symptoms Six Weeks After COVID-19 Are Reduced Among US Health Care Personnel Receiving Additional Vaccine Doses During the Omicron Period, December 2021-April 2022.Open forum infectious diseases · 2024Article
- How Much Does SARS-CoV-2 Infection during Pregnancy Affect the Neonatal Brain, Heart, and Kidney? A Parallel between COVID-19, Vaccination, and Normal Pregnancy.Life (Basel, Switzerland) · 2024Article
- Development and External Validation of Clinical Features-based Machine Learning Models for Predicting COVID-19 in the Emergency Department.The western journal of emergency medicine · 2024Article
- Evaluation of Multiplex Rapid Antigen Tests for the Simultaneous Detection of SARS-CoV-2 and Influenza A/B Viruses.Biomedicines · 2023Article
- Accuracy of Rapid Antigen Screening Tests for SARS-CoV-2 Infection at Correctional Facilities in Korea: March - May 2022.Infection & chemotherapy · 2023Article
- Capillary flow-driven immunoassay platform for COVID-19 antigen diagnostics.Analytica chimica acta · 2023Article
- Behavioral and Personal Characteristics Associated With Risk of SARS-CoV-2 Infection in a Spanish University Cohort.American journal of epidemiology · 2023Article
- Analytical sensitivity of COVID-19 rapid antigen tests: A case for a robust reference standard.Talanta open · 2023Article
- Post COVID-19 symptoms are common, also among young adults in the general population.Scientific reports · 2023Article
- LightR-YOLOv5: A compact rotating detector for SARS-CoV-2 antigen-detection rapid diagnostic test results.Displays · 2023Article
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Authors and funding
5 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEarly diagnosis of SARS-CoV-2 infection is essential to reduce disease spread. Rapid antigen tests have not been sufficiently evaluated in asymptomatic patients to be used as massive population screening tools.
methodsHead-to-head evaluation of Roche SARS-CoV-2 Rapid Antigen Test and real-time reverse transcription polymerase chain reaction (RT-PCR) as SARS-CoV-2 screening tools performed in asymptomatic adults from a semi-closed community in University of Navarra (Spain) from November 2020 to January 2021. Sensitivity, specificity and predictive values were calculated using RT-PCR as reference method.
findingsRoche SARS-CoV-2 Rapid Antigen Test was performed on 2542 asymptomatic adults in a community with a SARS-CoV-2 incidence of 1·93%. It showed a sensitivity of 71·43% (CI 95%: 56·74 - 83·42) and a specificity of 99·68% (CI 95%: 99·37 - 99·86). Positive Predictive Value was 81·4 (CI 95% 66·6 - 91·61) and Negative Predictive Value was 99·44 (CI 95% 99·06 - 99·69). Test sensitivity was related to viral load, with higher sensitivity in RT-PCR cycle threshold (Ct) values under 25 (93·75%, CI 95%: 71·96 - 98·93), that dropped to 29·41% (CI 95%: 10·31- 55·96) in RT-PCR Ct values above 25.
interpretationThis study suggests that rapid antigen tests are less effective in asymptomatic population, when compared with RT-PCR. Further studies are needed to evaluate different options to improve screenings based on rapid antigen test, such as the use of clinical questionnaires to select higher risk-participants, the confirmation of negative results with RT-PCR or the use of repetitive sequential testing.
fundingThis research received no external funding.
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