Meta-Analysis

. 2025 Nov 28;11(11):CD013705.

doi: 10.1002/14651858.CD013705.pub4.

Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection

Jacqueline Dinnes^{1

2}, Sarah Berhane^{1

2}, Jennifer Walsh³, Paul Reidy⁴, Aaron Doherty³, Bethany Hillier^{1

2}, Katie Scandrett^{1

2}, Dineshani Hettiarachchi⁵, Fahmida Islam⁶, Yasith Mathangasinghe⁷, Nicholas Nyaaba⁸, Melissa Taylor⁹, Praveen Weeratunga¹⁰, Dakshitha Wickramasinghe¹¹, Susanna S van Wyk¹², Jane Cunningham¹³, Clare Davenport^{1

2}, Sabine Dittrich¹⁴, Devy Emperador¹⁵, Lotty Hooft¹⁶, Mariska Mg Leeflang¹⁷, Matthew Df McInnes¹⁸, René Spijker^{16

19}, Jan Y Verbakel²⁰, Yemisi Takwoingi^{1

2}, Sian Taylor-Phillips²¹, Ann Van den Bruel²⁰, Jonathan J Deeks^{1

2}; Cochrane COVID-19 Diagnostic Test Accuracy Group²

Affiliations

¹ Biostatistics, Evidence Synthesis, Test Evaluation and prediction Models (BESTEAM), Department of Applied Health Sciences, University of Birmingham, Birmingham, UK.
² NIHR Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust and University of Birmingham, Birmingham, UK.
³ UCD National Virus Reference Laboratory, University College Dublin, Dublin, Ireland.
⁴ Dept of Clinical Medicine, Trinity College, Dublin, Ireland.
⁵ Department of Anatomy, Genetics & Biomedical Informatics, University of Colombo, Colombo, Sri Lanka.
⁶ Australia Regenerative Medicine Institute, Monash University, Melbourne, Australia.
⁷ Centre for Human Anatomy Education, Department of Anatomy and Developmental Biology, Monash University, Clayton, Australia.
⁸ Infectious Disease Unit, 37 Military Hospital, Cantonments, Ghana.
⁹ Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.
¹⁰ Department of Clinical Medicine, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
¹¹ Department of Surgery, University of Colombo, Colombo, Sri Lanka.
¹² Centre for Evidence-based Health Care, Epidemiology and Biostatistics, Department of Global Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
¹³ Global Malaria Programme, World Health Organization, Geneva, Switzerland.
¹⁴ Technische Hochschule Deggendorf, Rottal-Inn, Germany.
¹⁵ FIND, Geneva, Switzerland.
¹⁶ Cochrane Netherlands, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.
¹⁷ Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.
¹⁸ Department of Radiology, University of Ottawa, Ottawa, Canada.
¹⁹ Medical Library, Amsterdam UMC, University of Amsterdam, Amsterdam Public Health, Amsterdam, Netherlands.
²⁰ Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium.
²¹ Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.

PMID: 41312797
PMCID: PMC12661640
DOI: 10.1002/14651858.CD013705.pub4

Meta-Analysis

Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection

Jacqueline Dinnes et al. Cochrane Database Syst Rev. 2025.

. 2025 Nov 28;11(11):CD013705.

doi: 10.1002/14651858.CD013705.pub4.

Authors

Affiliations

¹ Biostatistics, Evidence Synthesis, Test Evaluation and prediction Models (BESTEAM), Department of Applied Health Sciences, University of Birmingham, Birmingham, UK.
² NIHR Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust and University of Birmingham, Birmingham, UK.
³ UCD National Virus Reference Laboratory, University College Dublin, Dublin, Ireland.
⁴ Dept of Clinical Medicine, Trinity College, Dublin, Ireland.
⁵ Department of Anatomy, Genetics & Biomedical Informatics, University of Colombo, Colombo, Sri Lanka.
⁶ Australia Regenerative Medicine Institute, Monash University, Melbourne, Australia.
⁷ Centre for Human Anatomy Education, Department of Anatomy and Developmental Biology, Monash University, Clayton, Australia.
⁸ Infectious Disease Unit, 37 Military Hospital, Cantonments, Ghana.
⁹ Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.
¹⁰ Department of Clinical Medicine, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
¹¹ Department of Surgery, University of Colombo, Colombo, Sri Lanka.
¹² Centre for Evidence-based Health Care, Epidemiology and Biostatistics, Department of Global Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
¹³ Global Malaria Programme, World Health Organization, Geneva, Switzerland.
¹⁴ Technische Hochschule Deggendorf, Rottal-Inn, Germany.
¹⁵ FIND, Geneva, Switzerland.
¹⁶ Cochrane Netherlands, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.
¹⁷ Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.
¹⁸ Department of Radiology, University of Ottawa, Ottawa, Canada.
¹⁹ Medical Library, Amsterdam UMC, University of Amsterdam, Amsterdam Public Health, Amsterdam, Netherlands.
²⁰ Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium.
²¹ Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.

PMID: 41312797
PMCID: PMC12661640
DOI: 10.1002/14651858.CD013705.pub4

Abstract

Background: Accurate rapid diagnostic tests for SARS-CoV-2 infection could help manage the COVID-19 pandemic by potentially increasing access to testing and speed detection of infection, as well as informing clinical and public health management decisions to reduce transmission. Previous iterations of this review provided clear and conclusive evidence of superior test performance in those experiencing possible signs and symptoms of Covid-19. However, test performance in asymptomatic individuals and sensitivity by setting and indication for testing remains unclear. This is the fourth iteration of this review, first published in 2020.

Objectives: To assess the diagnostic accuracy of rapid, point-of-care antigen tests (Ag-RDTs) for diagnosis of SARS-CoV-2 infection in asymptomatic population groups.

Search methods: We searched the COVID-19 Open Access Project living evidence database from the University of Bern (which includes daily updates from MEDLINE and Embase and preprints from medRxiv and bioRxiv) on 17 February 2022. We included independent evaluations from national reference laboratories, FIND and the Diagnostics Global Health website. We did not apply language restrictions.

Selection criteria: We included test accuracy studies of any design that evaluated commercially produced, rapid antigen tests in asymptomatic people tested because of known or suspected contact with SARS-CoV-2 infection, known SARS-CoV-2 infection or known absence of infection, or those who were being screened for infection. We included evaluations of single applications of a test (one test result reported per person). Reference standards for presence or absence of infection were any laboratory-based molecular test (primarily reverse transcription polymerase chain reaction (RT-PCR)).

Data collection and analysis: We used standard screening procedures with three reviewers. Two reviewers independently carried out quality assessment (using the QUADAS-2 tool) and extracted study results. Other study characteristics were extracted by one review author and checked by a second. We present sensitivity and specificity with 95% confidence intervals (CIs) for each test, and pooled data using the bivariate model. We investigated heterogeneity by including indicator variables in the random-effects logistic regression models. We tabulated results by test manufacturer and compliance with manufacturer instructions for use and according to symptom status.

Main results: We included 146 study cohorts (described in 130 study reports). The main results relate to 164 evaluations of single test applications including 144,250 unique samples (7104 with confirmed SARS-CoV-2) obtained from asymptomatic or mainly asymptomatic populations. Studies were mainly conducted in Europe (85/146, 58%), and evaluated 41 different commercial antigen assays (test kit). Only six studies compared two or more brands of test. Nearly all studies (96%) used RT-PCR alone to define presence or absence of infection. Risk of bias was high because of participant selection (13, 9%); interpretation of the index test (3, 2%); weaknesses in the reference standard for absence of infection (3, 2%); and participant flow and timing (46, 32%). Characteristics of participants (11, 8%) and index test delivery (117, 80%) differed from the way in which and in whom the test was intended to be used. Estimates of sensitivity varied considerably between studies, with consistently high specificities. Average sensitivity was 55.0% (95% CI 50.9%, 59.0%) and average specificity was 99.5% (95% CI 99.5%, 99.6%) across the 147 evaluations of Ag-RDTs reporting both sensitivity and specificity (149,251 samples, 7636 cases). Average sensitivity was higher when epidemiological exposure to SARS-CoV-2 was suspected (58.6%, 95% CI 51.4% to 65.5%; 43 evaluations; 15,516 samples, 1483 cases) compared to where COVID-19 testing was reported to be widely available to anyone on presentation for testing (53.0%, 95% CI 48.4% to 57.5%; 103 evaluations; 129,032 samples, 5660 cases); however CIs overlapped, limiting the inference that can be drawn from these data. Average specificity was similarly high for both groups (99.4% and 99.6%). Sensitivity was generally lower when used in a screening context (summary values from 40.6% to 42.1% for three of four screening settings) compared to testing asymptomatic individuals at Covid-19 test centres (56.7%) or emergency departments (54.7%). We observed a decline in summary sensitivities as measures of sample viral load decreased. Sensitivity varied between brands. When tests were used according to manufacturer instructions, average sensitivities by brand ranged from 36.3% to 78.8% in asymptomatic participants (14 assays with sufficient data for pooling). None of the assays met the WHO acceptable performance standard for sensitivity (of 80%) based on meta-analysis; however, sensitivities from individual studies (where meta-analysis was not possible) exceeded 80% for three assays. The WHO acceptable performance criterion of 97% specificity was met by all but four assays (based on individual studies or meta-analysis) when tests were used according to manufacturer instructions. At 0.5% prevalence using summary data for asymptomatic people, where testing was widely available and where epidemiological exposure to COVID-19 was suspected, resulting PPVs would be 40% and 33%, meaning that 3 in 5 or 2 in 3 positive results will be false positives, and between 1 in 2 and 2 in 5 cases will be missed.

Authors' conclusions: Evidence for antigen testing in asymptomatic cohorts has increased considerably since the publication of the previous update of this review. Average sensitivities remain lower for testing of asymptomatic when compared to symptomatic individuals; however, there is an indication that sensitivities may be higher where epidemiological exposure to SARS-CoV-2 is suspected compared to testing any asymptomatic individual regardless of indication. Sensitivities were particularly low when antigen tests were used in screening settings. Assays from different manufacturers also vary in sensitivity, indicating the need for appropriate clinical validation of a particular antigen test in a given intended use setting prior to more widespread deployment. Further research is needed to evaluate the effectiveness of screening programmes at reducing transmission of infection, whether mass screening or targeted approaches, including schools, healthcare setting and traveller screening.

Funding: This paper presents independent research supported by the NIHR Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust, and the University of Birmingham. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.

Registration: Protocol (2020) doi: 10.1002/14651858.CD013596.

PubMed Disclaimer

Conflict of interest statement

Jacqueline Dinnes: declares a grant from Evidence Synthesis Ireland (ESI) Fellowship agreement to supervise three fellows contributing to this review (paid to institution; JD does not benefit financially). JD is an Editor for the Cochrane DTA Editorial Team. She was not involved in the editorial process for this review. JD has published opinions on the topic: (1) Dinnes J, Davenport C. COVID‐19 rapid antigen testing strategies must be evaluated in intended use settings. Lancet Regional Health Western Pacific 2022;25:100542. doi: 10.1016/j.lanwpc.2022.100542; (2) Deeks JJ, Dinnes J, Davenport C, Takwoingi Y, McInnes M, Leeflang MM, et al. Letter to the Editor regarding Peto T; UK COVID‐19 Lateral Flow Oversight Team: COVID‐19: Rapid antigen detection for SARS‐CoV‐2 by lateral flow assay. EClinicalMedicine 2021;38; (3) Dinnes J. COVID‐19 rapid antigen testing strategies require careful evaluation. EBioMedicine 2021;70:103491; (4) Dinnes J, Davenport C. Do we have informed consent for asymptomatic COVID‐19 testing in schools? BMJ opinion. https://blogs.bmj.com/bmj/2021/03/16/do‐we‐have‐informed‐consent‐for‐asymptomatic‐testing‐in‐schools/, 2021.

Sarah Berhane: none known.

Jennifer Walsh works as a Consultant Microbiologist at Cork University Hospital. She has no known conflicts to declare.

Paul Reidy works as a health professional at Trinity College Dublin. He has no known conflicts to declare.

Aaron Doherty works as a Consultant Clinical Microbiologist, Cork University Hospital (HSE). At the time of writing this review, he was employed at UCD National Virus Reference Laboratory, Dublin, Ireland. He has no known conflicts to declare.

Bethany Hillier: none known

Katie Scandrett: none known

Dineshani Hettiarachchi: none known

Fahmida Islam: none known.

Praveen Weeratunga: none known

Yasith Mathangasinghe: none known

Nicholas Nyaaba works as General Nurse at the Connolly Hospital. At the time of writing this review, he was employed at 37 Military Hospital, Cantonments, Ghana. He has no known conflicts to declare.

Melissa Taylor: none known

Dakshithaw Wickramasinghe: none known

Susan van Wyk: none known

Jane Cunningham: no relevant interests; affiliated to WHO, which produces guidance on use of SARS‐CoV‐2 rapid tests.

Clare Davenport: no relevant interests. CD is a Senior Editor for the Cochrane Central Editorial Service. She was not involved in the editorial process for this review.

Sabine Dittrich: was employed by FIND (until June 2022 as part of senior management; 2024 consultancy to advise on grant writing activities), with funding from DFID and Australian Aid.

FIND is a global not‐for profit product development partnership and WHO Diagnostic Collaboration Centre. It is FIND’s role to accelerate access to high‐quality diagnostic tools for low‐resource settings and this is achieved by supporting both research and development and access activities for a wide range of diseases, including COVID‐19. FIND has several clinical research projects to evaluate multiple new diagnostic tests against published Target Product Profiles that have been defined through consensus processes. These studies are for diagnostic products developed by private sector companies who provide access to know‐how, equipment/reagents, and contribute through unrestricted donations as per FIND policy and external SAC review.

Devy Emperador: was employed by FIND, with funding from FCDO and CAN, during the write‐up of this review.

Lotty Hooft: no relevant interests. LH is a Professor of Evidence Synthesis & Knowledge Translation in Healthcare at Universitair Medisch Centrum Utrecht, and a member of the DTA Editorial Team and PMG implementation team. She was not involved in the editorial process for this review.

Mariska Leeflang: no relevant interests. ML is an Associate Professor at Academisch Medisch Centrum, and Contact Editor for the Cochrane DTA Editorial Team. She was not involved in the editorial process for this review. ML also declares a grant from Cochrane for finalising the DTA Handbook, on which she is an Editor and active proponent, and royalties from the sale of the Handbook (personal payment). ML also reports personal payment for expert testimony.

Matthew McInnes: none known. MMI is a Physician at Ottawa Hospital.

Rene Spijker: none known. RS is employed as an Information Specialist/Senior Scientist for three days per week at AmsterdamUMC. For two days per week, he is seconded to Cochrane Netherlands, which is hosted at Universitair Medisch Centrum, Utrecht. He was not involved in the editorial process for this review.

Jan Verbakel: none known

Yemisi Takwoingi: no relevant interests. YT declares that she is a member of the Cochrane Editorial Board. She was not involved in the editorial process for this review.

Sian Taylor‐Phillips: ST‐P is Chair of the UK National Screening Committee Research Methodology Group and a Data Scientist Member of the UK National Screening Committee. ST‐P holds an NIHR Research Professorship (NIHR302434), looking at how to accurately bring together different sources of research evidence to support policy decisions, and an NIHR Career Development Fellowship (NIHR‐CDF‐2016‐018) for methods of evaluating screening tests (paid to University of Warwick, though ST‐P benefitted). ST‐P also declares funding from Birmingham University (originally from FIND diagnostics, a charity) to fund a staff member to work on this review (approximately six months part‐time); paid to Warwick University. ST‐P is a co‐author on the EDSAB‐HOME study, which was funded by Public Health England; however, neither she nor her institution received funds for participating in that study.

Ann Van den Bruel: no relevant interests.

Jonathan Deeks: JD has published or been quoted in opinion pieces in scientific publications, and in the mainstream and social media related to diagnostic testing. JD was the statistician on the Birmingham evaluation of the Innova test (Ferguson 2021). There was no funding for this evaluation of the Innova test. JD is a Member of the Royal Statistical Society (RSS) COVID‐19 Taskforce Working group, and Co‐Chair of the RSS Diagnostic Test Working Advisory Group (unpaid positions). JD is an Editor for the Cochrane DTA Editorial Team. He was not involved in the editorial process for this review.

Figures

2
Risk of bias and applicability concerns graph: review authors' judgements about each domain presented as percentages across included studies

3
Risk of bias and applicability concerns summary graph: review authors' judgements about each domain for each included study

4
Forest plot of data contributing to overall analysis, sorted by study setting (n = 147 evaluations; 142 in asymptomatic and 5 in mainly asymptomatic cohorts) **DE:** Germany; **ED:** emergency department; **HCW:** healthcare worker

5
Forest plot of data for antigen tests for asymptomatic populations by reported exposure to SARS‐CoV‐2  **DE:** Germany; **ED:** emergency department; **HCW:** healthcare worker

6
Forest plot of data for antigen tests for asymptomatic populations by reported exposure to SARS‐CoV‐2 (within‐study comparisons)

7
Forest plot of data for asymptomatic participants by week after contact with confirmed case

8
Forest plot of data in subgroups by Ct value **Ct:** cycle threshold; **DE:** Germany; **ED:** emergency department; **HCW:** healthcare worker

9
Forest plot of data for within‐study comparison of data for children and adults **AN:** anterior nasal; **nos:** not otherwise specified

10
Forest plot of data by sample site **AN:** anterior nasal; **DE:** Germany; **ED:** emergency department; **HCW**: healthcare worker; **NMT**: nasal mid‐turbinate; **nos**: not otherwise specified; NP: nasopharyngeal; OP: oropharyngeal; TA: throat aspirate; TS: throat swab; TW: throat wash

11
Forest plot of within‐study comparisons by sample site, collection or interpretation **AN:** anterior nasal; **HCW**: healthcare worker; **NMT**: nasal mid‐turbinate; **nos**: not otherwise specified; NP: nasopharyngeal; OP: oropharyngeal

12
Forest plot of individual study results in asymptomatic participants by assay **Ag:** antigen; **AN:** anterior nasal; **DE:** Germany; **ED:** emergency department; **HCW:** healthcare worker; **NMT:** nasal mid‐turbinate; **nos:** not otherwise specified; **NP:** nasopharyngeal; **OP:** oropharyngeal; **TA:** throat aspirate; **TS:** throat swab; **TW:** throat wash; **VTM:** viral transport medium

13
Forest plot of studies reporting within‐study comparisons by test brand **Ag:** antigen; **AN:** anterior nasal; **NP:** nasopharyngeal; **OP:** oropharyngeal; **TA:** throat aspirate; **TS:** throat swab; **TW:** throat wash; **VTM:** viral transport medium

14
Forest plot of within‐study comparisons by age in studies that included symptomatic participants **AN:** anterior nasal; **NP:** nasopharyngeal; y: year

15
Forest plot of data by vaccination status and prior SARS‐CoV‐2 infection in studies that included symptomatic participants

16
Forest plot of data by SARS‐CoV‐2 variant in studies that included symptomatic participants **nos:** not otherwise specified; **PCR:** polymerase chain reaction; **WGS:** whole genome sequencing

See this image and copyright information in PMC

Update of

Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection.
Dinnes J, Sharma P, Berhane S, van Wyk SS, Nyaaba N, Domen J, Taylor M, Cunningham J, Davenport C, Dittrich S, Emperador D, Hooft L, Leeflang MM, McInnes MD, Spijker R, Verbakel JY, Takwoingi Y, Taylor-Phillips S, Van den Bruel A, Deeks JJ; Cochrane COVID-19 Diagnostic Test Accuracy Group. Dinnes J, et al. Cochrane Database Syst Rev. 2022 Jul 22;7(7):CD013705. doi: 10.1002/14651858.CD013705.pub3. Cochrane Database Syst Rev. 2022. Update in: Cochrane Database Syst Rev. 2025 Nov 28;11:CD013705. doi: 10.1002/14651858.CD013705.pub4. PMID: 35866452 Free PMC article. Updated.

References

1. Struyf T, Deeks JJ, Dinnes J, Takwoingi Y, Davenport C, Leeflang MM, et al. Signs and symptoms to determine if a patient presenting in primary care or hospital outpatient settings has COVID-19. Cochrane Database of Systematic Reviews 2021, Issue 2. Art. No: CD013665. [DOI: 10.1002/14651858.CD013665.pub2] - DOI
1. Stegeman I, Ochodo EA, Guleid F, Holtman G, Yang B, Cunningham J, et al. Routine laboratory testing to determine if a patient has COVID-19. Cochrane Database of Systematic Reviews 2020, Issue 11. Art. No: CD013787. [DOI: 10.1002/14651858.CD013787] - DOI
1. Ebrahimzadeh S, Islam N, Dawit H, Salameh JP, Kazi S, Fabiano N, et al. Thoracic imaging tests for the diagnosis of COVID-19. Cochrane Database of Systematic Reviews 2022, Issue 5. Art. No: CD013639. [DOI: 10.1002/14651858.CD013639.pub5] - DOI
1. Dinnes J, Sharma P, Berhane S, Van Wyk SS, Nyaaba N, Domen J, et al. Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection. Cochrane Database of Systematic Reviews 2022, Issue 7. Art. No: CD013705. [DOI: 10.1002/14651858.CD013705.pub3] - DOI
1. Fox T, Geppert J, Dinnes J, Scandrett K, Bigio J, Sulis G, et al. Antibody tests for identification of current and past infection with SARS-CoV-2. Cochrane Database of Systematic Reviews 2022, Issue 11. Art. No: CD013652. [DOI: 10.1002/14651858.CD013652.pub2] - DOI

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Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection

Affiliations

Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

Update of

References

Publication types

MeSH terms

Substances

Grants and funding

LinkOut - more resources

Full Text Sources

Medical

Miscellaneous