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. 2022 Jan:146:105048.
doi: 10.1016/j.jcv.2021.105048. Epub 2021 Nov 29.

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

Slim Fourati  1 , Alexandre Soulier  2 , Aurélie Gourgeon  3 , Souraya Khouider  3 , Camille Langlois  3 , Arnaud Galbin  3 , Anne Le Bouter  3 , Christophe Rodriguez  2 , Marie Joanny  3 , Amélie Dublineau  3 , Dominique Challine  2 , Magali Bouvier-Alias  2 , Stéphane Chevaliez  2 , Étienne Audureau  4 , Jean-Michel Pawlotsky  2
Affiliations

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

Slim Fourati et al. J Clin Virol. 2022 Jan.

Abstract

Direct detection of SARS-CoV-2 viral antigens could replace RT-PCR, provided that its clinical performance is validated in different epidemiological settings. Here, we evaluated the performance of the VITROS Antigen test, an enzyme immunoassay detecting a SARS-CoV-2 antigen, in NPSs from 3 cohorts of patients.

Methods: Three cohorts including SARS-CoV-2 RNA-positive samples collected during the first and second wave of the French epidemic between March 2020 and February 2021 (including variant B.1.1.7/α and variant B.1.351/β).

Results: Among the 1763 prospectively tested subjects, 8.2% (145/1763) were SARS-CoV-2 RNA-positive by RT-PCR. Using Ct ≤ 30 and Ct ≤ 35 as thresholds, the sensitivities of the antigen assay were 98.8% (93.6-100%) and 93.5% (87.0-97.3%), respectively. The overall specificity of the assay was 100% (1614/1614; 99.8-100%). In a retrospective cohort of subjects infected with variants of concern, 90.4% (47/52) of NPSs containing B. B.1.1.7/α (Ct ≤ 35) and 100% (7/7) of those containing B.1.351/β were positive with the VITROS EIA SARS-CoV-2 Antigen test.

Conclusion: The excellent performance of the EIA Antigen test reported here, including in patients infected with viral "variants of concern", support the use of high-throughput, EIA-based SARS-CoV-2 antigen assays as an alternative or complement to nucleic acid testing in order to scale-up laboratory screening and diagnostic capacities.

Keywords: Antigen test; EIA; SARS CoV-2; Sensitivity; Specificity; Variants of concern.

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Conflict of interest statement

S.F. has served as a speaker for Abbvie and Abbott diagnostics. C.R. has served as an advisor, and/or speaker for Illumina, and Vela Diagnostics. SC has served as a speaker for Gilead, Abbvie and Abbott diagnostics. J.-M.P. has served as an advisor, and/or speaker for Abbvie, Gilead, Assembly Biosciences, Arbutus, Merck, Regulus, and Memo Therapeutics. The remaining authors have no conflict of interest to disclose.

Figures

Fig 1
Fig. 1
Sensitivity of the VITROS EIA SARS-CoV-2 Antigen test to detect two recently emerged SARS-CoV-2 “variants of concern”. The antigen test results are presented according to Ct values measured by TaqPath COVID19 RT-PCR kit. Among the 52 samples containing the B.1.1.7/α variant (with Ct ≤35), 47 tested positive with VITROS EIA SARS-CoV-2 Antigen (sensitivity: 90.4%). All of the 7 samples containing the B.1.351/β variant were positive with the antigen EIA (sensitivity: 100%; 95%CI: 57.1%−100% for Ct values ranging from 19 to 26).
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