Analytical Sensitivity of Eight Different SARS-CoV-2 Antigen-Detecting Rapid Tests for Omicron-BA.1 Variant

Article Article scientifique Article Analytical Sensitivity of Eight Different SARS-CoV-2 Antigen-Detecting Rapid Tests for Omicron-BA.1 Variant eng 2022-08-08 2022-08-31 author Bekliz Meriem 0000-0003-3186-1877 952376 author Adea Kenneth 631795 author Puhach Olha 804660 author Perez Rodriguez Francisco Javier 0000-0003-0380-9625 868142 author Marques Melancia Stéfane 837267 author Baggio Stéphanie 0000-0002-5347-5937 706989 author Corvaglia Anna Rita 60955 author Jacquerioz Frédérique Aline 850244 author Alvarez Catia 778118 author Essaidi-Laziosi Manel 0000-0003-1643-4965 682799 author Escadafal Camille author Kaiser Laurent 28229 author Eckerle Isabella Anne 0000-0002-4850-7172 894639 e0085322 10.1128/spectrum.00853-22 35938792 2165-0497 PMC9430749 https://journals.asm.org/doi/10.1128/spectrum.00853-22 The emergence of each novel SARS-CoV-2 variant of concern (VOC) requires investigation of its potential impact on the performance of diagnostic tests in use, including antigen-detecting rapid diagnostic tests (Ag-RDTs). Although anecdotal reports have been circulating that the newly emerged Omicron-BA.1 variant is in principle detectable by Ag-RDTs, few data on sensitivity are available. We have performed (i) analytical sensitivity testing with cultured virus in eight Ag-RDTs and (ii) retrospective testing in duplicates with clinical samples from vaccinated individuals with Omicron-BA.1 (n = 59) or Delta (n = 54) breakthrough infection on seven Ag-RDTs. Overall, in our analytical study we have found heterogenicity between Ag-RDTs for detecting Omicron-BA.1. When using cultured virus, we observed a trend toward lower endpoint sensitivity for Omicron-BA.1 detection than for earlier circulating SARS-CoV-2 and the other VOCs. In our retrospective study, the detection of Delta and Omicron-BA.1 was assessed in a comparable set of stored clinical samples using seven Ag-RDTs. Four hundred ninety-seven of all 826 tests (60.17%) performed on Omicron-BA.1 samples were positive, compared to 489/756 (64.68%) for Delta samples. In the analytical study, the sensitivity for both Omicron-BA.1 and Delta between the Ag-RDTs was variable. All seven Ag-RDTs showed comparable sensitivities to detect Omicron-BA.1 and Delta in the retrospective study. IMPORTANCE: Sensitivity for detecting Omicron-BA.1 shows high heterogenicity between Ag-RDTs, necessitating a careful consideration when using these tests to guide infection prevention measures. Analytical and retrospective testing is a proxy and timely solution to generate rapid performance data, but it is not a replacement for clinical evaluations, which are urgently needed. Biological and technical reasons for detection failure by some Ag-RDTs need to be further investigated. COVID-19 Omicron variant Omicron-BA.1 variant SARS-CoV-2 Antigen-detecting rapid diagnostic tests Variants of concern COVID-19 / diagnosis Humans Retrospective Studies SARS-CoV-2 / genetics Sensitivity and Specificity Dewey 613 Dewey 616 FIND (the global alliance for diagnostics) Hôpitaux Universitaires de Genève (HUG) Swiss National Science Foundation Phenotypic characterization of a SARS-CoV-2 clinical strain bio-bank and risk assessment of evolving virus variants 196383 CH Programmes Swiss National Science Foundation Real-time pandemic functional characterization of SARS-CoV-2 196644 CH Programmes 56 Département de médecine 221 54 Département de microbiologie et médecine moléculaire 21B 64 Département de santé et médecine communautaires 22A false 1255 Virus émergents 993 400 Virologie clinique 668 Microbiology spectrum 10 4 9354e459-47ac-4cad-9d09-6a51484071b5 Article (Published version) Public Article-scientifique-from-europePmc.pdf 1415318 application/pdf CC BY-4.0 40356772-540d-4417-a444-b4ae25825dee Appendix Public spectrum.00853-22-s0001.pdf 138903 application/pdf openAccess Faculté de médecine / Section de médecine clinique / Département de médecine Faculté de médecine / Section de médecine fondamentale / Département de microbiologie et médecine moléculaire Faculté de médecine / Section de médecine clinique / Département de santé et médecine communautaires

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Analytical Sensitivity of Eight Different SARS-CoV-2 Antigen-Detecting Rapid Tests for Omicron-BA.1 Variant	Microbiology spectrum			2022	271	214

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