FDA. In Vitro Diagnostics EUAs 2022 [updated 14.4.2022. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas.

Mina MJ, Parker R, Larremore DB. Rethinking Covid-19 test sensitivity - A strategy for Containment. N Engl J Med. 2020;383(22):e120.

Article  CAS  PubMed  Google Scholar 

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.

WHO. Antigen-detection in the diagnosis of SARS-CoV-2 infection 2021 [updated 6.10.2021. https://www.who.int/publications/i/item/antigen-detection-in-the-diagnosis-of-sars-cov-2infection-using-rapid-immunoassays.

Parvu V, Gary DS, Mann J, Lin Y-C, Mills D, Cooper L et al. Factors that influence the reported sensitivity of Rapid Antigen Testing for SARS-CoV-2. Front Microbiol. 2021;12.

He X, Lau EHY, Wu P, Deng X, Wang J, Hao X, et al. Temporal dynamics in viral shedding and transmissibility of COVID-19. Nat Med. 2020;26(5):672–5.

Article  CAS  PubMed  Google Scholar 

FINDDX. Test Directory 2022 [ https://www.finddx.org/covid-19/test-directory/.

Johns Hopkins CfHS. Antigen and Molecular Tests for COVID-19 2022 [ https://www.centerforhealthsecurity.org/covid-19TestingToolkit/molecular-based-tests/current-molecular-and-antigen-tests.html.

Brümmer LE, Katzenschlager S, McGrath S, Schmitz S, Gaeddert M, Erdmann C, et al. 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 Med. 2022;19(5):e1004011.

Article  PubMed  PubMed Central  Google Scholar 

Fragkou PC, Moschopoulos CD, Dimopoulou D, Ong DSY, Dimopoulou K, Nelson PP, et al. Performance of point-of care molecular and antigen-based tests for SARS-CoV-2: a living systematic review and meta-analysis. Clin Microbiol Infect. 2023;29(3):291–301.

Article  CAS  PubMed  Google Scholar 

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 Syst Reviews. 2022(7).

Ltd AIO. mariPOC tests [cited 2023 20.12.]. https://www.arcdia.com/maripoc/tests/.

Pollock Nira R, Savage Timothy J, Wardell H, Lee Rose A, Mathew A, Stengelin M, et al. Correlation of SARS-CoV-2 Nucleocapsid Antigen and RNA concentrations in nasopharyngeal samples from children and adults using an ultrasensitive and Quantitative Antigen Assay. J Clin Microbiol. 2021;59(4). https://doi.org/10.1128/jcm.03077-20.

Khalid MF, Selvam K, Jeffry AJN, Salmi MF, Najib MA, Norhayati MN, et al. Performance of Rapid Antigen tests for COVID-19 diagnosis: a systematic review and Meta-analysis. Diagnostics (Basel). 2022;12(1):110.

Article  CAS  PubMed  Google Scholar 

Khandker SS, Nik Hashim NHH, Deris ZZ, Shueb RH, Islam MA. Diagnostic accuracy of Rapid Antigen Test kits for detecting SARS-CoV-2: a systematic review and Meta-analysis of 17,171 suspected COVID-19 patients. J Clin Med. 2021;10(16):3493.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Fragkou PC, De Angelis G, Menchinelli G, Can F, Garcia F, Morfin-Sherpa F, et al. Update of European Society of Clinical Microbiology and Infectious diseases coronavirus disease 2019 guidelines: diagnostic testing for severe acute respiratory syndrome coronavirus 2. Clin Microbiol Infect. 2023;29(7):876–86.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Keskin AU, Ciragil P, Topkaya AE. Clinical accuracy of Instrument-Read SARS-CoV-2 Antigen Rapid Diagnostic tests (Ag-IRRDTs). Int J Microbiol. 2022;2022:9489067.

Article  PubMed  PubMed Central  Google Scholar 

Brümmer L, Katzenschlager S, Gaeddert M, Erdmann C, Schmitz S, Bota M, et al. The accuracy of novel antigen rapid diagnostics for SARS-CoV-2: a living systematic review and meta-analysis. PLoS Med. 2021;18(8):e1003735.

Article  PubMed  PubMed Central  Google Scholar 

Katzenschlager S, Brümmer LE, Schmitz S, Tolle H, Manten K, Gaeddert M, et al. 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. Sci Rep. 2023;13(1):21913.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. PLoS Med. 2021;18(3):e1003583.

Article  PubMed  PubMed Central  Google Scholar 

Katharina Manten SK, Lukas Brümmer, Claudia M, Denkinger. Feasibility and accuracy of novel instrument-based antigen testing against SARS-CoV-2: a systematic review and meta-analysis [Protocol]. NIHR, PROSPERO. International prospective register of systematic reviews2021 [updated 13 September 2021. https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=276232.

van Enst WA, Ochodo E, Scholten RJPM, Hooft L, Leeflang MM. Investigation of publication bias in meta-analyses of diagnostic test accuracy: a meta-epidemiological study. BMC Med Res Methodol. 2014;14(1):70.

Article  PubMed  PubMed Central  Google Scholar 

Deeks JJ, Macaskill P, Irwig L. The performance of tests of publication bias and other sample size effects in systematic reviews of diagnostic test accuracy was assessed. J Clin Epidemiol. 2005;58(9):882–93.

Article  PubMed  Google Scholar 

Neukam K, Lucero A, Gutierrez-Valencia A, Amaya L, Echegoyen N, Martelli A, et al. Point-of-care detection of SARS-CoV-2 antigen among symptomatic vs. asymptomatic persons: testing for COVID-19 vs. infectivity. Front Public Health. 2022;10:995249.

Article  PubMed  PubMed Central  Google Scholar 

Sitoe N, Sambo J, Mabunda N, Nguenha N, Chilaule J, Rafael J et al. Clinical performance of self-collected nasal swabs and Antigen Rapid tests for SARS-CoV-2 detection in resource-poor settings. Biomedicines. 2022;10(9).

FINDDx. FIND Evaluation of LumiraDx. SARS-CoV-2 Ag Test. External Report. [updated Version 2.0, 8 October 2021. https://www.finddx.org/wp-content/uploads/2023/01/20211008_lumiradx_lumiradx_FV_EN.pdf.

Paul D, Gupta A, Rooge S, Gupta E. Performance evaluation of automated chemiluminescence immunoassay based antigen detection - moving towards more reliable ways to predict SARS-CoV-2 infection. J Virol Methods. 2021;298:114299.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Montalvo Villalba MC, Sosa Glaria E, Rodriguez Lay LLA, Valdes Ramirez O, Vallina Garcia D, Arencibia Garcia A, et al. Performance evaluation of Elecsys SARS-CoV-2 Antigen immunoassay for diagnostic of COVID-19. J Med Virol. 2022;94(3):1001–8.

Article  CAS  PubMed  Google Scholar 

Iqbal B, Khan M, Shah N, Dawood MM, Jehanzeb V, Shafi M. Comparison of SARS-CoV-2 antigen electrochemiluminescence immunoassay to RT-PCR assay for laboratory diagnosis of COVID-19 in Peshawar. Diagnosis (Berl). 2022;9(3):364–8.

Article  CAS  PubMed  Google Scholar 

FINDDx FIND. Evaluation of SD Biosensor, Inc. STANDARDTM F COVID-19 Ag FIA. External Report Site Specific Report [updated Version 1.1 3 June 2022. https://www.finddx.org/wp-content/uploads/2023/01/20221004_sd_biosensor_standard_F_india_FV_EN.pdf.

Drain PK, Ampajwala M, Chappel C, Gvozden AB, Hoppers M, Wang M, et al. A Rapid, High-Sensitivity SARS-CoV-2 Nucleocapsid Immunoassay to Aid diagnosis of Acute COVID-19 at the point of care: a clinical performance study. Infect Dis Ther. 2021;10(2):753–61.

Article  PubMed  PubMed Central  Google Scholar 

Amrish M, Bri S, Ashok G, Pradeep K, Raúl AOG, Kate T et al. Performance of Gazelle COVID-19 point-of-care test for detection of nucleocapsid antigen from SARS-CoV-2. medRxiv. 2022:2022.03.23.22272094.

Pekosz A, Parvu V, Li M, Andrews JC, Manabe YC, Kodsi S, et al. Antigen-based testing but not real-time polymerase chain reaction correlates with severe Acute Respiratory Syndrome Coronavirus 2 viral culture. Clin Infect Dis. 2021;73(9):e2861–6.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Porte L, Legarraga P, Vollrath V, Aguilera X, Munita JM, Araos R, et al. Evaluation of a novel antigen-based rapid detection test for the diagnosis of SARS-CoV-2 in respiratory samples. Int J Infect Dis. 2020;99:328–33.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Porte L, Legarraga P, Iruretagoyena M, Vollrath V, Pizarro G, Munita J, et al. Evaluation of two fluorescence immunoassays for the rapid detection of SARS-CoV-2 antigen-new tool to detect infective COVID-19 patients. PeerJ. 2021;9:e10801.

Article  PubMed  PubMed Central  Google Scholar 

Weitzel T, Legarraga P, Iruretagoyena M, Pizarro G, Vollrath V, Araos R, et al. Comparative evaluation of four rapid SARS-CoV-2 antigen detection tests using universal transport medium. Travel Med Infect Dis. 2021;39:101942.

Article  CAS  PubMed  Google Scholar 

Jaaskelainen AE, Ahava MJ, Jokela P, Szirovicza L, Pohjala S, Vapalahti O, et al. Evaluation of three rapid lateral flow antigen detection tests for the diagnosis of SARS-CoV-2 infection. J Clin Virol. 2021;137:104785.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Gili A, Paggi R, Russo C, Cenci E, Pietrella D, Graziani A, et al. Evaluation of Lumipulse® G SARS-CoV-2 antigen assay automated test for detecting SARS-CoV-2 nucleocapsid protein (NP) in nasopharyngeal swabs for community and population screening. Int J Infect Dis. 2021;105:391–6.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Lefever S, Indevuyst C, Cuypers L, Dewaele K, Yin N, Cotton F, et al. Comparison of the quantitative DiaSorin Liaison Antigen Test to reverse Transcription-PCR for the diagnosis of COVID-19 in symptomatic and asymptomatic outpatients. J Clin Microbiol. 2021;59(7):e0037421.

Article  PubMed  Google Scholar 

Koeleman JGM, Brand H, de Man SJ, Ong DSY. Clinical evaluation of rapid point-of-care antigen tests for diagnosis of SARS-CoV-2 infection. Eur J Clin Microbiol Infect Dis. 2021;40(9):1975–81.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Blairon L, Cupaiolo R, Thomas I, Piteüs S, Wilmet A, Beukinga I, et al. Efficacy comparison of three rapid antigen tests for SARS-CoV-2 and how viral load impact their performance. J Med Virol. 2021;93(10):5783–8.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Frediani JK, Levy JM, Rao A, Bassit L, Figueroa J, Vos MB, et al. Multidisciplinary assessment of the Abbott BinaxNOW SARS-CoV-2 point-of-care antigen test in the context of emerging viral variants and self-administration. Sci Rep. 2021;11(1):14604.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Van der Moeren N, Zwart VF, Goderski G, Rijkers GT, van den Bijllaardt W, Veenemans J, et al. Performance of the Diasorin SARS-CoV-2 antigen detection assay on the LIAISON XL. J Clin Virol. 2021;141:104909.

Article  PubMed