Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection
- PMID: 35866452
- PMCID: PMC9305720
- DOI: 10.1002/14651858.CD013705.pub3
Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection
Abstract
Background: Accurate rapid diagnostic tests for SARS-CoV-2 infection would be a useful tool to help manage the COVID-19 pandemic. Testing strategies that use rapid antigen tests to detect current infection have the potential to increase access to testing, speed detection of infection, and inform clinical and public health management decisions to reduce transmission. This is the second update of this review, which was first published in 2020.
Objectives: To assess the diagnostic accuracy of rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection. We consider accuracy separately in symptomatic and asymptomatic population groups. Sources of heterogeneity investigated included setting and indication for testing, assay format, sample site, viral load, age, timing of test, and study design.
Search methods: We searched the COVID-19 Open Access Project living evidence database from the University of Bern (which includes daily updates from PubMed and Embase and preprints from medRxiv and bioRxiv) on 08 March 2021. 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 studies of people with either suspected SARS-CoV-2 infection, known SARS-CoV-2 infection or known absence of infection, or those who were being screened for infection. We included test accuracy studies of any design that evaluated commercially produced, rapid antigen tests. We included evaluations of single applications of a test (one test result reported per person) and evaluations of serial testing (repeated antigen testing over time). Reference standards for presence or absence of infection were any laboratory-based molecular test (primarily reverse transcription polymerase chain reaction (RT-PCR)) or pre-pandemic respiratory sample.
Data collection and analysis: We used standard screening procedures with three people. Two people 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 155 study cohorts (described in 166 study reports, with 24 as preprints). The main results relate to 152 evaluations of single test applications including 100,462 unique samples (16,822 with confirmed SARS-CoV-2). Studies were mainly conducted in Europe (101/152, 66%), and evaluated 49 different commercial antigen assays. Only 23 studies compared two or more brands of test. Risk of bias was high because of participant selection (40, 26%); interpretation of the index test (6, 4%); weaknesses in the reference standard for absence of infection (119, 78%); and participant flow and timing 41 (27%). Characteristics of participants (45, 30%) and index test delivery (47, 31%) differed from the way in which and in whom the test was intended to be used. Nearly all studies (91%) used a single RT-PCR result to define presence or absence of infection. The 152 studies of single test applications reported 228 evaluations of antigen tests. Estimates of sensitivity varied considerably between studies, with consistently high specificities. Average sensitivity was higher in symptomatic (73.0%, 95% CI 69.3% to 76.4%; 109 evaluations; 50,574 samples, 11,662 cases) compared to asymptomatic participants (54.7%, 95% CI 47.7% to 61.6%; 50 evaluations; 40,956 samples, 2641 cases). Average sensitivity was higher in the first week after symptom onset (80.9%, 95% CI 76.9% to 84.4%; 30 evaluations, 2408 cases) than in the second week of symptoms (53.8%, 95% CI 48.0% to 59.6%; 40 evaluations, 1119 cases). For those who were asymptomatic at the time of testing, sensitivity was higher when an epidemiological exposure to SARS-CoV-2 was suspected (64.3%, 95% CI 54.6% to 73.0%; 16 evaluations; 7677 samples, 703 cases) compared to where COVID-19 testing was reported to be widely available to anyone on presentation for testing (49.6%, 95% CI 42.1% to 57.1%; 26 evaluations; 31,904 samples, 1758 cases). Average specificity was similarly high for symptomatic (99.1%) or asymptomatic (99.7%) participants. We observed a steady 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 34.3% to 91.3% in symptomatic participants (20 assays with eligible data) and from 28.6% to 77.8% for asymptomatic participants (12 assays). For symptomatic participants, summary sensitivities for seven assays were 80% or more (meeting acceptable criteria set by the World Health Organization (WHO)). The WHO acceptable performance criterion of 97% specificity was met by 17 of 20 assays when tests were used according to manufacturer instructions, 12 of which demonstrated specificities above 99%. For asymptomatic participants the sensitivities of only two assays approached but did not meet WHO acceptable performance standards in one study each; specificities for asymptomatic participants were in a similar range to those observed for symptomatic people. At 5% prevalence using summary data in symptomatic people during the first week after symptom onset, the positive predictive value (PPV) of 89% means that 1 in 10 positive results will be a false positive, and around 1 in 5 cases will be missed. 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 38% to 52%, meaning that between 2 in 5 and 1 in 2 positive results will be false positives, and between 1 in 2 and 1 in 3 cases will be missed.
Authors' conclusions: Antigen tests vary in sensitivity. In people with signs and symptoms of COVID-19, sensitivities are highest in the first week of illness when viral loads are higher. Assays that meet appropriate performance standards, such as those set by WHO, could replace laboratory-based RT-PCR when immediate decisions about patient care must be made, or where RT-PCR cannot be delivered in a timely manner. However, they are more suitable for use as triage to RT-PCR testing. The variable sensitivity of antigen tests means that people who test negative may still be infected. Many commercially available rapid antigen tests have not been evaluated in independent validation studies. Evidence for testing in asymptomatic cohorts has increased, however sensitivity is lower and there is a paucity of evidence for testing in different settings. Questions remain about the use of antigen test-based repeat testing strategies. 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.
Copyright © 2022 The Authors. Cochrane Database of Systematic Reviews published by John Wiley & Sons, Ltd. on behalf of The Cochrane Collaboration.
Conflict of interest statement
Jonathan J 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 which is mentioned in the discussion of the paper. There was no funding for this evaluation of the Innova test. JD is a member of the Royal Statistical Society (RSS) COVID‐19 taskforce steering group, and co‐chair of the RSS Diagnostic Test Advisory Group. He is a consultant adviser to the World Health Organization (WHO) Essential Diagnostic List. JD receives payment from the BMJ as their Chief Statistical advisor.
Jacqueline Dinnes: none known
Yemisi Takwoingi: none known
Clare Davenport: none known
Mariska MG Leeflang: none known
René Spijker: none known
Lotty Hooft: none known
Ann Van den Bruel: none known
Devy Emperador: is employed by FIND with funding from DFID and KFW. FIND is a global non‐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.
Sabine Dittrich: is employed by FIND with funding from DFID and Australian Aid. FIND is a global non‐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.
Sian Taylor‐Phillips: none known
Sarah Berhane: none known
Jane Cunningham: none known
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Update of
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Love 2021 {published data only}
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- Love NK, Ready D, Turner C, Yardley L, Rubin GJ, Hopkins S, et al. The acceptability of testing contacts of confirmed COVID-19 cases using serial, self-administered lateral flow devices as an alternative to self-isolation. medRxiv [Preprint] 2021. [DOI: ] - PubMed
Masia 2021 [A] {published data only}
-
- Masiá M, Fernández-González M, Sánchez M, Carvajal M, García JA, Gonzalo-Jiménez N, et al. Nasopharyngeal Panbio COVID-19 Antigen performed at point-of-care has a high sensitivity in symptomatic and asymptomatic patients with higher risk for transmission and older age. Open Forum Infectious Diseases 2021;8(3):ofab059. [DOI: ] - PMC - PubMed
-
- Masia M, Fernandez-Gonzalez M, Sanchez M, Carvajal M, Garcia JA, Gonzalo N, et al. Nasopharyngeal Panbio COVID-19 antigen performed at point-of-care has a high sensitivity in symptomatic and asymptomatic patients with higher risk for transmission and older age. medRxiv [Preprint] 2020. [DOI: ] - PMC - PubMed
Masia 2021 [B] {published data only}
-
- Masiá M, Fernández-González M, Sánchez M, Carvajal M, García JA, Gonzalo-Jiménez N, et al. Nasopharyngeal Panbio COVID-19 Antigen performed at point-of-care has a high sensitivity in symptomatic and asymptomatic patients with higher risk for transmission and older age. Open Forum Infectious Diseases 2021;8(3):ofab059. [DOI: ] - PMC - PubMed
Masia 2021 [C] {published data only}
-
- Masiá M, Fernández-González M, Sánchez M, Carvajal M, García JA, Gonzalo-Jiménez N, et al. Nasopharyngeal Panbio COVID-19 Antigen performed at point-of-care has a high sensitivity in symptomatic and asymptomatic patients with higher risk for transmission and older age. Open Forum Infectious Diseases 2021;8(3):ofab059. [DOI: ] - PMC - PubMed
Merino 2021 {published data only}
-
- Merino-Amador P, Guinea J, Muñoz-Gallego I, González-Donapetry P, Galán J-C, Antona N, et al. Multicenter evaluation of the Panbio™ COVID-19 Rapid Antigen-Detection Test for the diagnosis of SARS-CoV-2 infection. medRxiv [Preprint] 2020. [DOI: ]
Mertens 2020 {published data only}
Miyakawa 2021 [A] {published data only}
-
- Miyakawa K, Funabashi R, Yamaoka Y, Jeremiah SS, Katada J, Wada A, et al. SARS-CoV-2 antigen rapid diagnostic test enhanced with silver amplification technology. medRxiv [Preprint] 2021. [DOI: ]
Miyakawa 2021 [B] {published data only}
-
- Miyakawa K, Funabashi R, Yamaoka Y, Jeremiah SS, Katada J, Wada A, et al. SARS-CoV-2 antigen rapid diagnostic test enhanced with silver amplification technology. medRxiv [Preprint] 2021. [DOI: ]
Miyakawa 2021 [C] {published data only}
-
- Miyakawa K, Funabashi R, Yamaoka Y, Jeremiah SS, Katada J, Wada A, et al. SARS-CoV-2 antigen rapid diagnostic test enhanced with silver amplification technology. medRxiv [Preprint] 2021. [DOI: ]
Miyakawa 2021 [D] {published data only}
-
- Miyakawa K, Funabashi R, Yamaoka Y, Jeremiah SS, Katada J, Wada A, et al. SARS-CoV-2 antigen rapid diagnostic test enhanced with silver amplification technology. medRxiv [Preprint] 2021. [DOI: ]
Mockel 2021(a) {published data only}
Mockel 2021(b) {published data only}
Nagura‐Ikeda 2020 {published data only}
-
- Nagura-Ikeda M, Imai K, Tabata S, Miyoshi K, Murahara N, Mizuno T, et al. Clinical evaluation of self-collected saliva by quantitative reverse transcription-PCR (RT-qPCR), direct RT-qPCR, reverse transcription-loop-mediated isothermal amplification, and a rapid antigen test to diagnose COVID-19. Journal of Clinical Microbiology 2020;58(9):e01438-20. [DOI: ] - PMC - PubMed
Nalumansi 2020 {published data only}
Nash 2020 {published data only}
-
- Nash B, Badea A, Reddy A, Bosch M, Salcedo N, Gomez AR, et al. The impact of high frequency rapid viral antigen screening on COVID-19 spread and outcomes: a validation and modeling study. medRxiv [Preprint] 2020. [DOI: ]
Ngo Nsoga 2021 {published data only}
Nikolai 2021(a) [A] {published data only}
Nikolai 2021(a) [B] {published data only}
Nikolai 2021(b) [A] {published data only}
Nikolai 2021(b) [B] {published data only}
Okoye 2021 {published data only}
Olearo 2021 [A] {published data only}
Olearo 2021 [B] {published data only}
Olearo 2021 [C] {published data only}
Olearo 2021 [D] {published data only}
-
- Olearo F, Noerz D, Heinrich F, Sutter JP, Roedel K, Schultze A, et al. Handling and accuracy of four rapid antigen tests for the diagnosis of SARS-CoV-2 compared to RT-qPCR. medRxiv [Preprint] 2020. [https://doi.org/10.1101/2020.12.05.20244673] - PMC - PubMed
Osterman 2021(a) [A] {published data only}
Osterman 2021(a) [B] {published data only}
Osterman 2021(b) {published data only}
Parada‐Ricart 2020 {published data only}
Pena 2021 {published data only}
Pena‐Rodriguez 2021 {published data only}
Perez‐Garcia 2021 [A] {published data only}
Perez‐Garcia 2021 [B] {published data only}
Peto 2021(a) [A] {published data only}
-
- Peto T, Affron D, Afrough B, Agasu A, Ainsworth M, Allanson A, et al. COVID-19: Rapid antigen detection for SARS-CoV-2 by lateral flow assay: a national systematic evaluation of sensitivity and specificity for mass-testing. EClinicalMedicine 2021;36:10.1016/j.eclinm.2021.100924. [DOI: ] - PMC - PubMed
-
- Public Health England (PHE). Preliminary report from the Joint PHE Porton Down & University of Oxford SARS-CoV-2 test development and validation cell: rapid evaluation of lateral flow viral antigen detection devices (LFDs) for mass community testing. Public Health England, 2020.
Peto 2021(a) [B] {published data only}
-
- Peto T, Affron D, Afrough B, Agasu A, Ainsworth M, Allanson A, et al. COVID-19: Rapid antigen detection for SARS-CoV-2 by lateral flow assay: a national systematic evaluation of sensitivity and specificity for mass-testing. EClinicalMedicine 2021;36:10.1016/j.eclinm.2021.100924. [EMBASE: httpa://doi,org/10.1016/j.eclinm.2021.100924] - PMC - PubMed
Peto 2021(a) [C] {published data only}
-
- Peto T, Affron D, Afrough B, Agasu A, Ainsworth M, Allanson A, et al. COVID-19: Rapid antigen detection for SARS-CoV-2 by lateral flow assay: a national systematic evaluation of sensitivity and specificity for mass-testing. EClinicalMedicine 2021;36:10.1016/j.eclinm.2021.100924. [DOI: ] - PMC - PubMed
Peto 2021(a) [D] {published data only}
-
- Peto T, Affron D, Afrough B, Agasu A, Ainsworth M, Allanson A, et al. COVID-19: Rapid antigen detection for SARS-CoV-2 by lateral flow assay: a national systematic evaluation of sensitivity and specificity for mass-testing. EClinicalMedicine 2021;36:10.1016/j.eclinm.2021.100924. [DOI: ] - PMC - PubMed
Peto 2021(a) [E] {published data only}
-
- Peto T, Affron D, Afrough B, Agasu A, Ainsworth M, Allanson A, et al. COVID-19: Rapid antigen detection for SARS-CoV-2 by lateral flow assay: a national systematic evaluation of sensitivity and specificity for mass-testing. EClinicalMedicine 2021;36:10.1016/j.eclinm.2021.100924. [DOI: ] - PMC - PubMed
Peto 2021(a) [F] {published data only}
-
- Peto T, Affron D, Afrough B, Agasu A, Ainsworth M, Allanson A, et al. COVID-19: Rapid antigen detection for SARS-CoV-2 by lateral flow assay: a national systematic evaluation of sensitivity and specificity for mass-testing. EClinicalMedicine 2021;36:10.1016/j.eclinm.2021.100924. [DOI: ] - PMC - PubMed
Peto 2021(a) [G] {published data only}
Peto 2021(b) [non‐HCW tested] {published data only}
-
- Peto T, Affron D, Afrough B, Agasu A, Ainsworth M, Allanson A, et al. COVID-19: Rapid antigen detection for SARS-CoV-2 by lateral flow assay: a national systematic evaluation of sensitivity and specificity for mass-testing. EClinicalMedicine 2021;36:10.1016/j.eclinm.2021.100924. [DOI: ] - PMC - PubMed
-
- Public Health England (PHE). Preliminary report from the Joint PHE Porton Down & University of Oxford SARS-CoV-2 test development and validation cell: rapid evaluation of lateral flow viral antigen detection devices (LFDs) for mass community testing. Public Health England, 2020.
Peto 2021(c) [A ‐ HCW tested] {published data only}
-
- Public Health England (PHE). Preliminary report from the Joint PHE Porton Down & University of Oxford SARS-CoV-2 test development and validation cell: rapid evaluation of lateral flow viral antigen detection devices (LFDs) for mass community testing. Public Health England, 2020.
Peto 2021(c) [A ‐ Lab tested] {published data only}
-
- Peto T, Affron D, Afrough B, Agasu A, Ainsworth M, Allanson A, et al. COVID-19: Rapid antigen detection for SARS-CoV-2 by lateral flow assay: a national systematic evaluation of sensitivity and specificity for mass-testing. EClinicalMedicine 2021;36:10.1016/j.eclinm.2021.100924. [DOI: ] - PMC - PubMed
-
- Public Health England (PHE). Preliminary report from the Joint PHE Porton Down & University of Oxford SARS-CoV-2 test development and validation cell: rapid evaluation of lateral flow viral antigen detection devices (LFDs) for mass community testing. Public Health England, 2020.
Peto 2021(c) [B ‐ Lab tested] {published data only}
-
- Peto T, Affron D, Afrough B, Agasu A, Ainsworth M, Allanson A, et al. COVID-19: Rapid antigen detection for SARS-CoV-2 by lateral flow assay: a national systematic evaluation of sensitivity and specificity for mass-testing. EClinicalMedicine 2021;36:10.1016/j.eclinm.2021.100924. [DOI: ] - PMC - PubMed
Peto 2021(c) [C ‐ Lab tested] {published data only}
-
- Peto T, Affron D, Afrough B, Agasu A, Ainsworth M, Allanson A, et al. COVID-19: Rapid antigen detection for SARS-CoV-2 by lateral flow assay: a national systematic evaluation of sensitivity and specificity for mass-testing. EClinicalMedicine 2021;36:10.1016/j.eclinm.2021.100924. [DOI: ] - PMC - PubMed
Peto 2021(c) [D ‐ Lab tested] {published data only}
-
- Peto T, Affron D, Afrough B, Agasu A, Ainsworth M, Allanson A, et al. COVID-19: Rapid antigen detection for SARS-CoV-2 by lateral flow assay: a national systematic evaluation of sensitivity and specificity for mass-testing. EClinicalMedicine 2021;36:10.1016/j.eclinm.2021.100924. [DOI: ] - PMC - PubMed
Peto 2021(d) {published data only}
-
- Peto T, Affron D, Afrough B, Agasu A, Ainsworth M, Allanson A, et al. COVID-19: Rapid antigen detection for SARS-CoV-2 by lateral flow assay: A national systematic evaluation of sensitivity and specificity for mass-testing. EClinicalMedicine 2021;36:10.1016/j.eclinm.2021.100924. [DOI: ] - PMC - PubMed
-
- Public Health England (PHE). Preliminary report from the Joint PHE Porton Down & University of Oxford SARS-CoV-2 test development and validation cell: rapid evaluation of lateral flow viral antigen detection devices (LFDs) for mass community testing. Public Health England, 2020.
PHE 2020 {published data only}
-
- Public Health England (PHE). Preliminary report from the Joint PHE Porton Down & University of Oxford SARS-CoV-2 test development and validation cell: rapid evaluation of lateral flow viral antigen detection devices (LFDs) for mass community testing. Public Health England, 2020.
Pickering 2021(a) [A] {published data only}
Pickering 2021(a) [B] {published data only}
Pickering 2021(a) [C] {published data only}
Pickering 2021(a) [D] {published data only}
Pickering 2021(a) [E] {published data only}
Pickering 2021(a) [F] {published data only}
Pickering 2021(b) [A] {published data only}
Pickering 2021(b) [B] {published data only}
Pickering 2021(b) [C] {published data only}
Pickering 2021(c) [A] {published data only}
Pickering 2021(c) [B] {published data only}
-
- Pickering S, Batra R, Snell LB, Merrick B, Nebbia G, Douthwaite S, et al. Comparative performance of SARS-CoV-2 lateral flow antigen tests demonstrates their utility for high sensitivity detection of infectious virus in clinical specimens. medRxiv [Preprint] 2021:10.1101/2021.02.27.21252427. [DOI: ] - PMC - PubMed
Pilarowski 2020a {published data only}
Pilarowski 2021 {published data only}
-
- Pilarowski G, Lebel P, Sunshine S, Liu J, Crawford E, Marquez C, et al. Performance characteristics of a rapid SARS-CoV-2 antigen detection assay at a public plaza testing site in San Francisco. Journal of Infectious Diseases 2021;23(7):1139-44. [EMBASE: https://doi.org/10.1093/infdis/jiaa802] - PMC - PubMed
-
- Pilarowski G, Lebel P, Sunshine S, Liu J, Crawford E, Marquez C, et al. Performance characteristics of a rapid SARS-CoV-2 antigen detection assay at a public plaza testing site in San Francisco. medRxiv [Preprint] 2020. [EMBASE: https://doi.org/10.1101/2020.11.02.20223891] - PMC - PubMed
Pollock 2021a {published data only}
-
- Pollock NR, Jacobs JR, Tran K, Cranston AE, Smith S, O'Kane CY, et al. Performance and implementation evaluation of the Abbott BinaxNOW Rapid Antigen Test in a high-throughput drive-through community testing site in Massachusetts. Journal of Clinical Microbiology 2021;59(5):e00083-21. - PMC - PubMed
Pollock 2021b {published data only}
-
- Pollock NR, Tran K, Jacobs JR, Cranston AE, Smith S, O'Kane CY, et al. Performance and operational evaluation of the Access Bio CareStart Rapid Antigen Test in a high-throughput drive-through community testing site in Massachusetts. Open Forum Infectious Diseases 2021;8(7):ofab243. [DOI: ] - PMC - PubMed
Porte 2020 {published data only}
Porte 2021 [A] {published data only}
-
- Porte L, Legarraga P, Iruretagoyena M, Vollrath V, Pizarro G, Munita JM, et al. Rapid SARS-CoV-2 antigen detection by immunofluorescence – a new tool to detect infectivity. medRxiv [Preprint] 2020. [DOI: ]
Porte 2021 [B] {published data only}
-
- Porte L, Legarraga P, Iruretagoyena M, Vollrath V, Pizarro G, Munita JM, et al. Rapid SARS-CoV-2 antigen detection by immunofluorescence – a new tool to detect infectivity. medRxiv [Preprint] 2020. [DOI: ]
Pray 2021 {published data only}
Prince‐Guerra 2021 {published data only}
-
- Prince-Guerra JL, Almendares O, Nolen LD, Gunn JKL, Dale AP, Buono SA, et al. Evaluation of Abbott BinaxNOW Rapid Antigen Test for SARS-CoV-2 Infection at two community-based testing sites - Pima County, Arizona, November 3-17, 2020. MMWR: Morbidity and Mortality Weekly Report 2021;70(3):100-5. - PMC - PubMed
Ristic 2021 {published data only}
Rottenstreich 2021 {published data only}
Saeed 2021 [A] {published data only}
Saeed 2021 [B] {published data only}
Salvagno 2021 {published data only}
-
- Salvagno GL, Gianfilippi G, Bragantini D, Henry BM, Lippi G. Clinical assessment of the Roche SARS-CoV-2 rapid antigen test. Diagnosis (Berl) 2021;8(3):322-6. [DOI: ] - PubMed
Schildgen 2021 [A] {published data only}
Schildgen 2021 [B] {published data only}
Schildgen 2021 [C] {published data only}
Schuit 2021(a) {published data only}
Schuit 2021(b) {published data only}
Schwob 2020(a) {published data only}
Schwob 2020(b) {published data only}
Schwob 2020(c) {published data only}
-
- Schwob JM, Miauton A, Petrovic D, Perdrix J, Senn N, Jaton K, et al. Antigen rapid tests, nasopharyngeal PCR and saliva PCR to detect SARS-CoV-2: a prospective comparative clinical trial. medRxiv [Preprint] 2020. [EMBASE: https://doi.org/10.1101/2020.11.23.20237057] - PMC - PubMed
Scohy 2020 {published data only}
Shidlovskaya 2021 [A] {published data only}
Shidlovskaya 2021 [B] {published data only}
Shrestha 2020 {published data only}
-
- Shrestha B, Neupane AK, Pant S, Shrestha A, Bastola A. Sensitivity and specificity of lateral flow antigen test kits for COVID-19 in asymptomatic population of quarantine centre of Province 3. Kathmandu University Medical Journal 2020;18(70):36-9. - PubMed
Smith 2021 {published data only}
Stohr 2021 [A] {published data only}
-
- Stohr JJ, Zwart VF, Goderski G, Meijer A, Nagel-Imming CR, Kluytmans-van den Bergh MF, et al. Self-testing for the detection of SARS-CoV-2 infection with rapid antigen tests. medRxiv [Preprint] 2021;40(8):1721-6. [EMBASE: https://doi.org/10.1101/2021.02.21.21252153] - PMC - PubMed
Stohr 2021 [B] {published data only}
Stokes 2021(a) [A] {published data only}
-
- Stokes W, Berenger BM, Portnoy D, Scott B, Szelewicki J, Singh T, et al. Clinical performance of the Abbott Panbio with nasopharyngeal, throat, and saliva swabs among symptomatic individuals with COVID-19. European Journal of Clinical Microbiology and Infectious Diseases 2021;40(8):1721-6. [DOI: ] - PMC - PubMed
Stokes 2021(a) [B] {published data only}
-
- Stokes W, Berenger BM, Portnoy D, Scott B, Szelewicki J, Singh T, et al. Clinical performance of the Abbott Panbio with nasopharyngeal, throat, and saliva swabs among symptomatic individuals with COVID-19. European Journal of Clinical Microbiology & Infectious Disease 2021;40(8):1721-6. [DOI: ] - PMC - PubMed
Stokes 2021(a) [C] {published data only}
-
- Stokes W, Berenger BM, Portnoy D, Scott B, Szelewicki J, Singh T, et al. Clinical performance of the Abbott Panbio with nasopharyngeal, throat, and saliva swabs among symptomatic individuals with COVID-19. European Journal of Clinical Microbiology & Infectious Diseases 2021;40(8):1721-6. [DOI: ] - PMC - PubMed
Stokes 2021(b) {published data only}
-
- Stokes W, Berenger BM, Portnoy D, Scott B, Szelewicki J, Singh T, et al. Clinical performance of the Abbott Panbio with nasopharyngeal, throat, and saliva swabs among symptomatic individuals with COVID-19. European Journal of Clinical Microbiology & Infectious Diseases 2021;40(8):1721-6. [DOI: ] - PMC - PubMed
Stromer 2020 {published data only}
Takeda 2020 {published data only}
-
- Takeda Y, Mori M, Omi K. SARS-CoV-2 qRT-PCR Ct value distribution in Japan and possible utility of rapid antigen testing kit. medRxiv [Preprint] 2020. [DOI: ]
Takeuchi 2021a {published data only}
-
- Takeuchi Y, Akashi Y, Kato D, Kuwahara M, Muramatsu S, Ueda A, et al. The evaluation of a newly developed antigen test (QuickNaviTM-COVID19 Ag) for SARS-CoV-2: A prospective observational study in Japan. medRxiv [Preprint] 2021. [EMBASE: https://doi.org/10.1101/2020.12.27.20248876] - PMC - PubMed
Takeuchi 2021b {published data only}
Thommes 2021 [A] {published data only}
Thommes 2021 [B] {published data only}
Thommes 2021 [C] {published data only}
Thommes 2021 [D] {published data only}
Toptan 2021(a) {published data only}
Toptan 2021(b) {published data only}
Torres 2021a {published data only}
Torres 2021b {published data only}
Turcato 2021 {published data only}
-
- Turcato G, Zaboli A, Pfeifer N, Ciccariello L, Sibilio S, Tezza G, et al. Clinical application of a rapid antigen test for the detection of SARS-CoV-2 infection in symptomatic and asymptomatic patients evaluated in the emergency department: a preliminary report. Journal of Infection 2021;82(3):e14-6. - PMC - PubMed
Van der Moeren 2021(a) [A] {published data only}
-
- Van der Moeren N, Zwart VF, Lodder EB, Van den Bijllaardt W, Van Esch HR, Stohr JJ, et al. Performance evaluation of a SARS-CoV-2 rapid antigen test: test performance in the community in the Netherlands. medRxiv [Preprint] 2020. [DOI: ]
Van der Moeren 2021(a) [B] {published data only}
-
- Van der Moeren N, Zwart VF, Lodder EB, Van den Bijllaardt W, Van Esch HR, Stohr JJ, et al. Performance evaluation of a SARS-CoV-2 rapid antigen test: test performance in the community in the Netherlands. medRxiv [Preprint] 2020. [DOI: ]
Van der Moeren 2021(b) {published data only}
-
- Van der Moeren N, Zwart VF, Lodder EB, Van den Bijllaardt W, Van Esch HR, Stohr JJ, et al. Performance evaluation of a SARS-CoV-2 rapid antigen test: test performance in the community in the Netherlands. medRxiv [Preprint] 2020. [DOI: ]
Veyrenche 2021 {published data only}
Villaverde 2021 {published data only}
-
- Villaverde S, Dominguez-Rodriguez S, Sabrido G, Perez-Jorge C, Plata M, Romero MP, et al. Diagnostic accuracy of the Panbio severe acute respiratory syndrome coronavirus 2 antigen rapid test compared with reverse-transcriptase polymerase chain reaction testing of nasopharyngeal samples in the pediatric population. Journal of Pediatrics 2021;232:287-289 e4. - PMC - PubMed
Weitzel 2020 [A] {published data only}
Weitzel 2020 [B] {published data only}
Weitzel 2020 [C] {published data only}
Weitzel 2020 [D] {published data only}
Winkel 2020 {published data only}
-
- Winkel BM, Schram E, Gremmels H, Debast SB, Schuurman R, Wensing AM, et al. Screening for SARS-CoV-2 infection in asymptomatic individuals using the Panbio COVID-19 Antigen Rapid Test (Abbott) compared to RT-qPCR. medRxiv [Preprint] 2020. [https://doi.org/10.1101/2020.12.03.20243311] - PMC - PubMed
Yokota 2020(a) {published data only}
Yokota 2020(b) {published data only}
Young 2020 {published data only}
-
- Young S, Taylor SN, Cammarata CL, Varnado KG, Roger-Dalbert C, Montano A, et al. Clinical evaluation of BD Veritor SARS-CoV-2 point-of-care test performance compared to PCR-based testing and versus the Sofia 2 SARS Antigen point-of-care test. Journal of Clinical Microbiology 2020;59(1):e02338-20. [DOI: 10.1128/JCM.02338-20] - DOI - PMC - PubMed
References to studies excluded from this review
Ahava 2021 {published data only}
Aoki 2020 {published data only}
Bello‐Chavolla 2021 {published data only}
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- Bello-Chavolla OY, Antonio-Villa NE, Fernandez-Chirino L, Guerra C, Fermin-Martinez CA, Marquez-Salinas A, et al. Diagnostic performance and clinical implications of rapid SARS-CoV-2 antigen testing in Mexico using real-world nationwide COVID-19 registry data. medRxiv [Preprint] 2021. [DOI: ] - PMC - PubMed
Chen 2021 {published data only}
Corman 2020 {published data only}
Cubas‐Atienzar 2021 {published data only}
Dalal 2021 {published data only}
Diao 2020 {published data only}
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- Diao B, Wen K, Chen J, Liu Y, Yuan Z, Han C, et al. Diagnosis of acute respiratory syndrome coronavirus 2 infection by detection of nucleocapsid protein. medRxiv [Preprint] 2020. [DOI: ]
Dohla 2020 {published data only}
Downs 2021 {published data only}
Eshghifar 2021 {published data only}
Frnda 2021 {published data only}
Gili 2021 {published data only}
-
- Gili A, Paggi R, Russo C, Cenci E, Pietrella D, Graziani A, et al. Evaluation of automated test Lumipulse® G SARS-CoV-2 antigen assay for detection of SARS-CoV-2 nucleocapsid protein (NP) in nasopharyngeal swabs for community and population screening. International Journal of Infectious Diseases 2021;105:391-6. [DOI: ] - PMC - PubMed
Haage 2021a {published data only}
Haage 2021b {published data only}
Herrera 2020 {published data only}
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- Herrera V, Hsu V, Adewale A, Hendrix T, Johnson L, Kuhlman J, et al. Testing of healthcare workers exposed to COVID19 with rapid antigen detection. medRxiv [Preprint] 2020. [DOI: ]
Hingrat 2020 {published data only}
Hirotsu 2020 {published data only}
-
- Hirotsu Y, Maejima M, Shibusawa M, Nagakubo Y, Hosaka K, Amemiya K, et al. Comparison of automated SARS-CoV-2 antigen test for COVID-19 infection with quantitative RT-PCR using 313 nasopharyngeal swabs, including from seven serially followed patients. International Journal of Infectious Diseases 2020;99:397-402. - PMC - PubMed
Hirotsu 2021 {published data only}
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- Hirotsu Y, Maejima M, Shibusawa M, Amemiya K, Nagakubo Y, Hosaka K et al. Prospective study of 1,308 nasopharyngeal swabs from 1,033 patients using the LUMIPULSE SARS-CoV-2 antigen test: comparison with RT-qPCR. International Journal of Infectious Diseases 2021;105:7-14. [DOI: 10.1016/j.ijid.2021.02.005] - DOI - PMC - PubMed
Hledik 2020 {published data only}
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- Hledik M, Polechova J, Beiglboeck M, Herdina AN, Strassl R, Posch M. Analysis of the specificity of the SD Biosensor Standard Q Ag-Test based on Slovak mass testing data. medRxiv [Preprint] 2020. [DOI: ]
Hoehl 2020 {published data only}
-
- Hoehl S, Schenk B, Rudych O, Goettig S, Foppa I, Kohmer N, et al. At-home self-testing of teachers with a SARS-CoV-2 rapid antigen test to reduce potential transmissions in schools. medRxiv [Preprint] 2020. [DOI: ]
Kannian 2021 {published data only}
-
- Kannian P, Lavanya C, Ravichandran K, Jayaraman BG, Mahanathi P, Ashwini V, et al. Detection of SARS-CoV2 antigen in human saliva may be a reliable tool for large scale screening. medRxiv [Preprint] 2020. [DOI: ]
Kashiwagi 2020 {published data only}
Kobayashi 2021 {published data only}
Koskinen 2021 {published data only}
Kotsiou 2021 {published data only}
-
- Kotsiou OS, Pantazopoulos I, Papagiannis D, Fradelos EC, Kanellopoulos N, Siachpazidou D, et al. Repeated antigen-based rapid diagnostic testing for estimating the coronavirus disease 2019 prevalence from the perspective of the workers' vulnerability before and during the lockdown. International Journal of Environmental Research and Public Health 2021;18(4):1638. [DOI: ] - PMC - PubMed
Kurstjens 2020 {published data only}
-
- Kurstjens S, Van der Horst A, Herpers R, Geerits MW, Kluiters-de Hingh YC, Göttgens E-L, et al. Rapid identification of SARS-CoV-2-infected patients at the emergency department using routine testing. bioRxiv [Preprint] 2020:1-21. [DOI: ] - PubMed
Kyosei 2020 {published data only}
Lefever 2021 {published data only}
Le Hingrat 2020 {published data only}
-
- Le Hingrat Q, Visseaux B, Laouenan C, Tubiana S, Bouadma L, Yazdanpanah Y, et al. SARS-CoV-2 N-antigenemia: a new alternative to nucleic acid amplification techniques. medRxiv [Preprint] 2020. [DOI: ]
Li 2021 {published data only}
Liu 2021 {published data only}
Mahari 2020 {published data only}
-
- Mahari S, Roberts A, Shahdeo D, Gandhi S. eCovSens-Ultrasensitive novel in-house built printed circuit board based electrochemical device for rapid detection of nCOVID-19 antigen, a spike protein domain 1 of SARS-CoV-2. bioRxiv [Preprint] 2020. [DOI: ]
Mak 2020a {published data only}
Mak 2020b {published data only}
Marzinotto 2020 {published data only}
Mboumba 2021 {published data only}
-
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Mohamed 2021 {published data only}
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Peng 2020 {published data only}
Perchetti 2020 {published data only}
Pollock 2020a {published data only}
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Orsi 2021 {published data only}
Osmanodja 2021 {published data only}
Perez‐Garcia 2021 {published data only}
Qahtani 2021 {published data only}
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