Critical literature review and pooled analysis of diagnostic accuracy of Ortho VITROS SARS-CoV-2 antigen test for diagnosing acute SARS-CoV-2 infections
Pooled analysis of VITROS SARS-CoV-2 antigen test
Abstract
Background: The present study is aimed at reviewing and meta-analyzing the currently published data on the diagnostic accuracy of Ortho VITROS SARS-CoV-2 antigen test for diagnosing acute SARS-CoV-2 infections.
Methods: An electronic search was conducted in Scopus and Medline with the keywords “VITROS” AND “antigen” AND “COVID-19” OR “SARS-CoV-2” AND “immunoassay” within the search fields “TITLE” AND “ABSTRACT” AND “KEYWORDS”, without no date (i.e., up to January 23, 2022) or language restrictions, aimed at detecting documents reporting the diagnostic accuracy of this SARS-CoV-2 immunoassay compared with reference molecular diagnostic methods.
Results: Overall, 5 studies (n=2734 samples) were finally included in our pooled analysis, four of which also provided diagnostic sensitivity in oro- and nasopharyngeal samples with high viral load. The pooled cumulative diagnostic sensitivity and specificity were 0.82 (95%CI, 0.78-0.86) and 1.00 (95%CI, 1.00-1.00), respectively, whilst the area under the curve was 0.995 (95%CI, 0.993-0.997), the cumulative agreement 97.2% (95%CI, 96.5-97.8%), with 0.89 (95%CI, 0.86-0.91) kappa statistics, thus reflecting an almost perfect concordance with reference molecular biology techniques. The pooled diagnostic sensitivity in samples with high viral load was as high as 0.98 (95%CI, 0.96-0.99).
Conclusions: These results confirm that the automated and high-throughput Ortho VITROS SARS-CoV-2 antigen test may represent a valuable surrogate of molecular testing for diagnosing acute SARS-CoV-2 infections, especially in subjects with high viral load.
References
2. Haldane V, De Foo C, Abdalla SM, et al. Health systems resilience in managing the COVID-19 pandemic: lessons from 28 countries. Nat Med 2021;27:964-80.
3. Lippi G, Mattiuzzi C, Henry BM. Updated picture of SARS-CoV-2 variants and mutations. Diagnosis (Berl). 2021 Dec 23. doi: 10.1515/dx-2021-0149. Epub ahead of print.
4. Lippi G, Mattiuzzi C, Henry BM. Neutralizing potency of COVID-19 vaccines against the SARS-CoV-2 Omicron (B.1.1.529) variant. J Med Virol. 2022 Jan 5. doi: 10.1002/jmv.27575. Epub ahead of print.
5. American Association of Clinical Chemistry. Coronavirus Testing Survey. Available at: https://www.aacc.org/science-and-research/covid-19-resources/aacc-covid-19-testing-survey: Last accessed: January 23, 2022.
6. Lippi G, Horvath AR, Adeli K. Editorial and Executive Summary: IFCC Interim Guidelines on Clinical Laboratory testing during the COVID-19 Pandemic. Clin Chem Lab Med 2020;58:1965-9.
7. Bohn MK, Mancini N, Loh TP, et al. IFCC Interim Guidelines on Molecular Testing of SARS-CoV-2 Infection. Clin Chem Lab Med 2020;58:1993-2000.
8. Bohn MK, Lippi G, Horvath AR, et al. IFCC interim guidelines on rapid point-of-care antigen testing for SARS-CoV-2 detection in asymptomatic and symptomatic individuals. Clin Chem Lab Med 2021;59:1507-15.
9. Lee J, Song JU, Shim SR. Comparing the diagnostic accuracy of rapid antigen detection tests to real time polymerase chain reaction in the diagnosis of SARS-CoV-2 infection: A systematic review and meta-analysis. J Clin Virol. 2021 Nov;144:104985. doi: 10.1016/j.jcv.2021.104985. Epub 2021 Sep 16.
10. Ortho-Clinical Diagnostics. VITROS SARS-CoV-2 Antigen Test – Package Insert. Available at: https://www.fda.gov/media/145073/download: Last accessed, January 23, 2022.
11. Zamora J, Abraira V, Muriel A, Khan KS, Coomarasamy A. Meta-DiSc: a software for meta-analysis of test accuracy data. BMC Med Res Methodol 2006;6:31.
12. Favresse J, Gillot C, Oliveira M, et al. Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection. J Clin Med 2021;10:265.
13. Fourati S, Soulier A, Gourgeon A, et al. Performance of a high-throughput, automated enzyme immunoassay for the detection of SARS-CoV-2 antigen, including in viral "variants of concern": Implications for clinical use. J Clin Virol 2022;146:105048.
14. Levett PN, Cheung B, Kustra J, et al. Evaluation of a high volume antigen test for detection of SARS-CoV-2. J Clin Virol 2021;142:104938.
15. Matsuzaki N, Orihara Y, Kodana M, et al. Evaluation of a chemiluminescent enzyme immunoassay-based high-throughput SARS-CoV-2 antigen assay for the diagnosis of COVID-19: The VITROS® SARS-CoV-2 Antigen Test. J Med Virol 2021;93:6778-81.
16. Paul D, Gupta A, Rooge S, et al. 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.
17. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics 1977;33:159-74.
18. Khan A, Waris H, Rafique M, et al. The Omicron (B.1.1.529) variant of SARS-CoV-2 binds to the hACE2 receptor more strongly and escapes the antibody response: Insights from structural and simulation data. Int J Biol Macromol 2022;200:438-48.
19. Lippi G, Henry BM, Sanchis-Gomar F, Mattiuzzi C. Updates on laboratory investigations in coronavirus disease 2019 (COVID-19). Acta Biomed 2020;91:e2020030.
20. Lippi G, Henry BM, Adeli K. Diagnostic performance of the fully automated Roche Elecsys SARS-CoV-2 antigen electrochemiluminescence immunoassay: a pooled analysis. Clin Chem Lab Med. 2022. doi: 10.1515/cclm-2022-0053. Online ahead of print.
21. Salvagno GL, Gianfilippi G, Fiorio G, Pighi L, De Nitto S, Henry BM, Lippi G. Clinical Assessment of the DiaSorin LIAISON SARS-CoV-2 Ag Chemiluminescence Immunoassay. EJIFCC 2021;32:216-23.
22. Caputo V, Bax C, Colantoni L, et al. Comparative analysis of antigen and molecular tests for the detection of Sars-CoV-2 and related variants: A study on 4266 samples. Int J Infect Dis 2021;108:187-9.
23. Frieden TR, Lee CT. Identifying and Interrupting Superspreading Events-Implications for Control of Severe Acute Respiratory Syndrome Coronavirus 2. Emerg Infect Dis 2020;26:1059-66.
24. Kumar S, Jha S, Rai SK. Significance of super spreader events in COVID-19. Indian J Public Health 2020;64:S139-41.
25. Lakdawala SS, Menachery VD. Catch Me if You Can: Superspreading of COVID-19. Trends Microbiol 2021;29:919-29.
26. Goyal A, Reeves DB, Cardozo-Ojeda EF, Schiffer JT, Mayer BT. Viral load and contact heterogeneity predict SARS-CoV-2 transmission and super-spreading events. Elife 2021;10:e63537.
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