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
| Autor: | Aurélie Gourgeon, Dominique Challine, Arnaud Galbin, Alexandre Soulier, Amélie Dublineau, Anne Le Bouter, Camille Langlois, Souraya Khouider, Magali Bouvier-Alias, Slim Fourati, Marie Joanny, Stéphane Chevaliez, Jean-Michel Pawlotsky, Etienne Audureau, Christophe Rodriguez |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
SARS CoV-2 Antigen test Nucleic Acid Testing Sensitivity and Specificity Article EIA Immunoenzyme Techniques Sensitivity Antigen Virology Antigen assays Medicine Humans In patient Antigens Viral Retrospective Studies chemistry.chemical_classification Variants of concern Immunoassay medicine.diagnostic_test business.industry SARS-CoV-2 COVID-19 Retrospective cohort study Infectious Diseases Enzyme chemistry Specificity RNA Viral business |
| Zdroj: | Journal of Clinical Virology |
| ISSN: | 1873-5967 1386-6532 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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