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

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

doi:10.1016/j.jcv.2021.105048

Cited by 9 publications

(5 citation statements)

References 7 publications

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“…Thus, the improved sensitivity of central laboratory antigen tests in patients with lower viral loads (higher Ct counts) would allow for the earlier detection of COVID-19. Other recent studies also support the improved sensitivity of high-throughput antigen tests [21], with a sensitivity of 93.8-100% in subjects with Ct counts between 26-30, even across different SARS-CoV-2 variants.…”

Section: Discussionmentioning

confidence: 69%

Evaluation and Validation of the Roche Elecsys SARS-CoV-2 Antigen Electro-Chemiluminescent Immunoassay in a Southeast Asian Region

et al. 2022

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Introduction: SARS-CoV-2 antigen tests can complement and substitute for RT-PCR tests. Centralized laboratory automated SARS-CoV-2 antigen tests that can be scaled to process a large number COVID-19 cases simultaneously are now available. We have evaluated the new Roche Elecsys SARS-CoV-2 antigen electro-chemiluminescent immunoassay. Methods: The Roche SARS-CoV-2 antigen assay is a double-antibody sandwich electro-chemiluminescent immunoassay, which reports a cut-off index (COI) (COI ≥ 1.0 considered positive). We assessed assay precision and linearity, and confirmed the reactivity limit. We determined the assay sensitivity and specificity with a verification group (289 controls and 61 RT-PCR positive COVID-19 cases). Assay performance was also validated against the consecutive samples we received (7657 controls and 17 cases) for SARS-CoV-2 antigen testing from June to October 2021. Result: The assay had a within-run precision CV of 3.0% at COI 0.68, and a CV of 1.5% at COI 3.49. Between-run precision was 3.0% at COI 0.68 and 1.8% at COI 3.49. The assay was linear from COI 0.65 to 7.84. All 35 C50 ± 20% test results performed over 7 days were positive/negative, respectively. In the verification group, overall sensitivity was 42.6% (26/61 positive, 95% CI 30.0–55.9), and specificity was 99.7% (1/289 positive, 95% CI 98.1–100). The agreement between the SARS-CoV-2 antigen and the RT-PCR cycle threshold (Ct) count was good (r = 0.90). In cases with Ct counts ≤ 30, the antigen assay sensitivity improved to 94.7% (18/19 positive, 95% CI 74.0–99.9). In our validation group, antigen sensitivity was 62.5% (5/8 antigen positive, 95% CI 24.5–91.5) within the first week of disease onset, but no cases were reactive after the first week of disease onset. Conclusion: The Elecsys SARS-CoV-2 antigen assay has good performance within manufacturer specifications. The sensitivity of the Roche antigen assay was greatest when used in patients with lower RT-PCR Ct values (≤30) and within the first week of disease onset.

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Section: Discussionmentioning

confidence: 69%

Evaluation and Validation of the Roche Elecsys SARS-CoV-2 Antigen Electro-Chemiluminescent Immunoassay in a Southeast Asian Region

et al. 2022

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“…All samples were stored at −80°C. Although LFT assays have not been designed for use with frozen samples, freeze-thaw procedures have been shown to minimally affect LFT assay sensitivity, particularly for C T values of ≤30 ( 2 , 3 ).…”

Section: Resultsmentioning

confidence: 99%

Performance of 22 Rapid Lateral Flow Tests for SARS-CoV-2 Antigen Detection and Influence of “Variants of Concern”: Implications for Clinical Use

et al. 2022

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“…Thirty four of such document were not included since they did not present information on Ortho VITROS SARS-CoV-2 antigen test for diagnosing acute SARS-CoV-2 infection (n=23), were review articles (n=7), did not correlate test accuracy with a reference SARS-CoV-2 molecular diagnostic technique (n=3), or were a case report (n=1). Overall, 5 studies (n=2734 samples) could finally be included in our pooled analysis (12)(13)(14)(15)(16).…”

Section: Resultsmentioning

confidence: 99%

Critical literature review and pooled analysis of diagnostic accuracy of Ortho VITROS SARS-CoV-2 antigen test for diagnosing acute SARS-CoV-2 infections

Lippi¹,

Nocini²,

Brandon³

2022

J Med Biochemistry

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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 SARSCoV-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.

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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

Cited by 9 publications

References 7 publications

Evaluation and Validation of the Roche Elecsys SARS-CoV-2 Antigen Electro-Chemiluminescent Immunoassay in a Southeast Asian Region

Evaluation and Validation of the Roche Elecsys SARS-CoV-2 Antigen Electro-Chemiluminescent Immunoassay in a Southeast Asian Region

Performance of 22 Rapid Lateral Flow Tests for SARS-CoV-2 Antigen Detection and Influence of “Variants of Concern”: Implications for Clinical Use

Critical literature review and pooled analysis of diagnostic accuracy of Ortho VITROS SARS-CoV-2 antigen test for diagnosing acute SARS-CoV-2 infections

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