Analytic sensitivity of the Abbott BinaxNOW? lateral flow immunochromatographic assay for the SARS-CoV-2 Omicron variant
Analytic sensitivity of the Abbott BinaxNOW? lateral flow immunochromatographic assay for the SARS-CoV-2 Omicron variant
Abstract The emergence of the SARS-CoV-2 Omicron variant has motivated a re-evaluation of the test characteristics for lateral flow immunochromatographic assays (LFIAs), commonly referred to as rapid antigen tests. To address this need, we evaluated the analytic sensitivity of one of the most widely used LFIAs in the US market, the Abbott BinaxNOW? COVID-19 Ag At-Home Card using 32 samples of Omicron and 30 samples of the Delta variant. Samples were chosen to intentionally over-represent the range of viral loads where differences are most likely to appear. We found no changes in the analytic sensitivity of the BinaxNOW? assay by variant even after controlling for variation in cycle threshold values in the two populations. Similar to prior studies, the sensitivity of the assay is highly dependent on the amount of virus present in the sample. While the analytic sensitivity of the BinaxNOW? LFIA remains intact versus the Omicron variant, its clinical sensitivity is influenced by the interaction between viral replication, the dynamics of tissue tropism and the timing of sampling. Further research is necessary to optimally adapt current testing strategies to robustly detect early infection by the Omicron variant to prevent transmission.
Kanjilal Sanjat、Chalise Sujata、Shah Adnan Shami、Walt David R.、Cheng Chi-An、Springer Michael、Senussi Yasmeen
Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Healthcare Institute||Department of Pathology, Brigham & Women?ˉs Hospital and Harvard Medical SchoolDepartment of Pathology, Brigham & Women?ˉs Hospital and Harvard Medical School||Wyss Institute for Biologically Inspired Engineering, Harvard UniversityDepartment of Pathology, Brigham & Women?ˉs Hospital and Harvard Medical School||Wyss Institute for Biologically Inspired Engineering, Harvard UniversityDepartment of Pathology, Brigham & Women?ˉs Hospital and Harvard Medical School||Wyss Institute for Biologically Inspired Engineering, Harvard UniversityDepartment of Pathology, Brigham & Women?ˉs Hospital and Harvard Medical School||Wyss Institute for Biologically Inspired Engineering, Harvard UniversityDepartment of Systems Biology, Harvard Medical SchoolDepartment of Pathology, Brigham & Women?ˉs Hospital and Harvard Medical School||Wyss Institute for Biologically Inspired Engineering, Harvard University
医学研究方法医药卫生理论基础医学
Kanjilal Sanjat,Chalise Sujata,Shah Adnan Shami,Walt David R.,Cheng Chi-An,Springer Michael,Senussi Yasmeen.Analytic sensitivity of the Abbott BinaxNOW? lateral flow immunochromatographic assay for the SARS-CoV-2 Omicron variant[EB/OL].(2025-03-28)[2025-04-29].https://www.medrxiv.org/content/10.1101/2022.01.10.22269033.点此复制
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