Analytic Sensitivity of the Abbott Binaxnow Lateral Flow Immunochromatographic Assay for the SARS-CoV-2 Omicron Variant

13 Pages Posted: 24 Feb 2022

See all articles by Sanjat Kanjilal

Sanjat Kanjilal

Harvard University - Department of Population Medicine

Sujata Chalise

Harvard University - Department of Pathology

Adnan Shami Shah

Harvard University - Department of Pathology

Chi-An Cheng

Harvard University - Department of Pathology

Yasmeen Senussi

Harvard University - Department of Pathology

Michael Springer

Harvard University - Department of Systems Biology

David Walt

Harvard University - Department of Pathology

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

Suggested Citation

Kanjilal, Sanjat and Chalise, Sujata and Shami Shah, Adnan and Cheng, Chi-An and Senussi, Yasmeen and Springer, Michael and Walt, David, Analytic Sensitivity of the Abbott Binaxnow Lateral Flow Immunochromatographic Assay for the SARS-CoV-2 Omicron Variant. Available at SSRN: https://ssrn.com/abstract=4041587 or http://dx.doi.org/10.2139/ssrn.4041587

Sanjat Kanjilal (Contact Author)

Harvard University - Department of Population Medicine ( email )

Boston, MA
United States

Sujata Chalise

Harvard University - Department of Pathology ( email )

Boston, MA
United States

Adnan Shami Shah

Harvard University - Department of Pathology ( email )

Boston, MA
United States

Chi-An Cheng

Harvard University - Department of Pathology ( email )

Boston, MA
United States

Yasmeen Senussi

Harvard University - Department of Pathology ( email )

Boston, MA
United States

Michael Springer

Harvard University - Department of Systems Biology ( email )

Boston,, MA 02115
United States

David Walt

Harvard University - Department of Pathology ( email )

Boston, MA
United States

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