Detection of the omicron variant virus with the Abbott BinaxNow SARS-CoV-2 Rapid Antigen Assay

Regan, James; Flynn, James P.; Choudhary, Manish; Uddin, Rockib; Lemieux, Jacob E.; Boucau, Julie; Bhattacharyya, Roby P.; Barczak, Amy K.; Li, Jonathan Z. K.; Siedner, Mark J.

doi:10.1101/2021.12.22.21268219

Cited by 13 publications

(13 citation statements)

References 10 publications

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“…Our results reinforce the findings of a smaller study that also examined the analytic sensitivity of the BinaxNOW™ versus Omicron with respect to its ability to detect both variants and in the estimated amount of nucleocapsid protein necessary to visualize a signal 7 . Our findings extend that work by including a larger number of independently collected clinical specimens and widening the range of viral loads in the sample set.…”

Section: Discussionsupporting

confidence: 85%

Analytic sensitivity of the Abbott BinaxNOW™ lateral flow immunochromatographic assay for the SARS-CoV-2 Omicron variant

Kanjilal

Chalise

Shah

et al. 2022

Preprint

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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.

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Section: Discussionsupporting

confidence: 85%

Analytic sensitivity of the Abbott BinaxNOW™ lateral flow immunochromatographic assay for the SARS-CoV-2 Omicron variant

Kanjilal

Chalise

Shah

et al. 2022

Preprint

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“…Our use of live virus, analyte volume, and swab type may explain the slight discrepancy with the manufacturers' LoDs. Our findings are consistent with similar investigations, but these studies fell short of the FDA's EUA requirement of 20 LoD replicates or included tests unavailable in the United States (15)(16)(17). In all, we demonstrate that the rapid antigen tests evaluated detect Omicron effectively, allaying concerns on the impact of the nucleocapsid mutations.…”

Section: Introductionsupporting

confidence: 91%

Limit of Detection for Rapid Antigen Testing of the SARS-CoV-2 Omicron Variant

Stanley

Hamel

Wolf

et al. 2022

Preprint

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There has been debate in the literature about the ability of antigen tests to detect the SARS-CoV-2 Omicron variant including indication on the US Food and Drug administration website that antigen tests may have lower sensitivity for the Omicron variant without provision of data or the potential scale of the issue (see https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutations-impact-covid-19-tests - omicronvariantimpact, accessed 1/27/2022). Here we determined the limit of detection (LoD) for the Omicron variant compared with the WA1 strain used for LoD studies described in the Instructions for Use for all Emergency Use Authorization (EUA)-approved antigen tests. Using live virus (to avoid artifactual findings potentially obtained with gamma-irradiated or heat-killed virus) quantified by plaque forming units (PFU), we examined the analytical sensitivity of three antigen tests widely used in the United States: the Abbott Binax Now, the AccessBio CareStart , and LumiraDx antigen tests. We found that the 95% detection threshold (LoD) for antigen tests was at least as good for Omicron as for the WA1 strain. Furthermore, the relationship of genome copies to plaque forming units for Omicron and WA1 overlap. Therefore, the LoD equivalency also applies if the quantitative comparator is genome copies determined from live virus preparations. Taken together, our data support the continued ability of the antigen tests examined to detect the Omicron variant.

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“…Using an FDA Emergency Use Authorized antigen test, a recent study showed detection of Omicron and Delta specimens with concentrations of 100,000 copies per swab or greater. 18 In this study, we determined the analytical sensitivity of a rapid antigen test with SARS-CoV-2 variants, including Omicron, Delta, Alpha, and Gamma. Our data show that the rapid antigen test has the lowest limit of detection with Alpha and Gamma (10 PFU/mL), followed by Omicron (100 PFU/mL) and Delta (1,000 PFU/mL) (Fig.…”

Section: Discussionmentioning

confidence: 99%

Detection of SARS-CoV-2 Omicron, Delta, Alpha and Gamma variants using a rapid antigen test

Salcedo¹,

Nandu²,

Boucau

et al. 2022

Preprint

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Throughout the coronavirus disease 2019 (COVID-19) pandemic, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants have emerged with different infection and disease dynamics. Testing strategies, including clinical diagnosis, surveillance, and screening, have been deployed to help limit the spread of SARS-CoV-2 variants. Rapid antigen tests, in particular, have been approved for self-testing in many countries and governments are supporting their manufacturing and distribution. However, studies demonstrating the accuracy of rapid antigen tests in detecting SARS-CoV-2 variants, especially the new Omicron variant, are limited. We determined the analytical sensitivity of a CE-marked rapid antigen test against the Omicron, Delta, Alpha and Gamma variants. The rapid antigen test had the most sensitive limit of detection (10 plaque forming units [PFU]/mL) when tested with the Alpha and Gamma variants, followed by the Omicron (100 PFU/mL) and Delta (1,000 PFU/mL) variants. Given the increasing numbers of breakthrough infections and the need to surveil infectiousness, rapid antigen tests are effective public health tools to detect SARS-CoV-2 variants.

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Detection of the omicron variant virus with the Abbott BinaxNow SARS-CoV-2 Rapid Antigen Assay

Cited by 13 publications

References 10 publications

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

Limit of Detection for Rapid Antigen Testing of the SARS-CoV-2 Omicron Variant

Detection of SARS-CoV-2 Omicron, Delta, Alpha and Gamma variants using a rapid antigen test

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