Analytic Sensitivity of the Abbott Binaxnow Lateral Flow Immunochromatographic Assay for the SARS-CoV-2 Omicron Variant
13 Pages Posted: 24 Feb 2022
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 represent a broad range of viral loads. 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.
Note: Funding: This study was funded by a grant from the Massachusetts Consortium for Pathogen Readiness.
Declaration of Interests: None to declare.
Ethics Approval Statement: This study was deemed non-human subjects research and approved by the Mass General Brigham Institutional Review Board (protocol 2021P003604).
Keywords: SARS-CoV-2, Omicron variant, rapid antigen tests, lateral flow immunoassays, analytic sensitivity
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