Assessment of the Analytical Sensitivity of 10 Lateral Flow Devices against the SARS-CoV-2 Omicron Variant

Deerain, Joshua M.; Druce, Julian; Tran, Thomas; Batty, Mitchell; Yoga, Yano; Fennell, Michael; Dwyer, Dominic E.; Kok, Jen; Williamson, Deborah A.

doi:10.1128/jcm.02479-21

Cited by 90 publications

(108 citation statements)

References 4 publications

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“…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. Our results are also in agreement with the study by Deerain et al, which utilized serial dilutions of Omicron and Delta samples derived from viral cultures 8 . In that study, there was no difference in the analytic sensitivity for the Abbott Panbio™ COVID-19 Ag Rapid Test Device, which utilizes the same epitopes as the Abbott BinaxNOW™ COVID-19 Ag Card test marketed in the United States.…”

Section: Discussionsupporting

confidence: 93%

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: 93%

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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“…Although the US Food and Drug Administration (FDA) recently issued a statement that antigen test may have reduced sensitivity for the detection of Omicron 19 , real-world data was lacking. Consistent with others 4,20 , the National Microbiology Laboratory (NML) in Canada recently assessed the performance of several Ag-RDTs for Omicron detection, and results for Panbio and BTNX were comparable to previous evaluations using other SARS-CoV-2 lineages (NML unpublished communication).…”

Section: Discussionsupporting

confidence: 79%

“…Among other Omicron mutations, four mutations are in the gene encoding nucleocapsid, the target of most antigen-based rapid diagnostic tests (Ag-RDTs). While some recent data have alleviated initial concerns over the possibility of decreased sensitivity of Ag-RDTs with Omicron, there are other noted differences from previous VOCs 4 . Omicron has increased transmission, reduced vaccine effectiveness 5,6 , and recent studies have suggested there could be differences in tissue tropism 3,7,8 .…”

Section: Introductionmentioning

confidence: 90%

Investigating sensitivity of nasal or throat (ISNOT): A combination of both swabs increases sensitivity of SARS-CoV-2 rapid antigen tests

Goodall

LeBlanc

Hatchette

et al. 2022

Preprint

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The COVID-19 pandemic has been hallmarked by several waves of variants of concern (VoCs), each with novel challenges. Currently, the highly transmissible Omicron VOC is predominant worldwide, and sore throat is common among other cold-like symptoms. Anecdotes on social media suggested sampling ones throat can increase sensitivity for Omicron detection by antigen-based rapid testing devices (Ag-RDTs). This work determines whether the sensitivity of Ag-RDTs designed for nasal sampling is altered with use of self-administered throat swabs in self-perceived asymptomatic individuals. This investigation compared results of a common Ag-RDT (i.e. Abbott Panbio COVID-19 Ag Rapid Test Device) using three sampling sites: nasal swab; throat swab and; combined nasal/throat. All Ag-RDT results were confirmed with molecular testing. Compared to RT-PCR, samples from nasal or throat swabs each detected 64.5% of SARS-CoV-2 cases; however, combining the contributions of each swab increased sensitivity to 88.7%. This trend was also evident with the Rapid Response Ag-RDT (BTNX), which uses a more flexible swabs than Panbio. When nasal swab collection was compared to paired sampling of the nasal/throat using a single swab with the Panbio Ag-RDT, the sensitivity of each was 68.4% and 81.6%, respectively. No false-positive results were observed with nasal, throat, or combined nasal/throat sampling. Self-administered throat and nasal/throat swabs both had >90% acceptability. These findings support the use of self-collected combined nasal/throat sampling for Ag-RDT based SARS-CoV-2 detection in self perceived asymptomatic individuals.

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“…Antigen-based tests are less sensitive than RT-PCR-based tests; however, when the viral load is high, they quickly detect the positive individuals and hence are of utility in clinical settings and are approved in many countries for self-testing. Deerain et al (2021) evaluated ten commercial kits for their diagnostic potential, and they found that all the ten kits were able to detect both the Delta and Omicron variants. The detection limit was 6.50 log10 copies per mL and 6.39 log10 copies per mL for Delta and Omicron, respectively ( Deerain et al, 2021 ).…”

Section: Diagnosis Of Omicronmentioning

confidence: 99%

“… Deerain et al (2021) evaluated ten commercial kits for their diagnostic potential, and they found that all the ten kits were able to detect both the Delta and Omicron variants. The detection limit was 6.50 log10 copies per mL and 6.39 log10 copies per mL for Delta and Omicron, respectively ( Deerain et al, 2021 ). SARS-CoV-2 has undergone a broad process of recombination and mutation since its detection and has generated wide varieties of both the VOIs and VOCs.…”

Section: Diagnosis Of Omicronmentioning

confidence: 99%

Emergence of SARS-CoV-2 Omicron (B.1.1.529) variant, salient features, high global health concerns and strategies to counter it amid ongoing COVID-19 pandemic

Khandia

Singhal

Alqahtani

et al. 2022

Environmental Research

248

196

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Since the appearance in the late of December 2019, SARS-CoV-2 is rapidly evolving and mutating continuously, giving rise to various variants with variable degrees of infectivity and lethality. The virus that initially appeared in China later mutated several times, wreaking havoc and claiming many lives worldwide amid the ongoing COVID-19 pandemic. After Alpha, Beta, Gamma, and Delta variants, the most recently emerged variant of concern (VOC) is the Omicron (B.1.1.529) that has evolved due to the accumulation of high numbers of mutations especially in the spike protein, raising concerns for its ability to evade from pre-existing immunity acquired through vaccination or natural infection as well as overpowering antibodies-based therapies. Several theories are on the surface to explain how the Omicron has gathered such a high number of mutations within less time. Few of them are higher mutation rates within a subgroup of population and then its introduction to a larger population, long term persistence and evolution of the virus in immune-compromised patients, and epizootic infection in animals from humans, where under different immune pressures the virus mutated and then got reintroduced to humans. Multifaceted approach including rapid diagnosis, genome analysis of emerging variants, ramping up of vaccination drives and receiving booster doses, efficacy testing of vaccines and immunotherapies against newly emerged variants, updating the available vaccines, designing of multivalent vaccines able to generate hybrid immunity, up-gradation of medical facilities and strict implementation of adequate prevention and control measures need to be given high priority to handle the on-going SARS-CoV-2 pandemic successfully.

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Assessment of the Analytical Sensitivity of 10 Lateral Flow Devices against the SARS-CoV-2 Omicron Variant

Cited by 90 publications

References 4 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

Investigating sensitivity of nasal or throat (ISNOT): A combination of both swabs increases sensitivity of SARS-CoV-2 rapid antigen tests

Emergence of SARS-CoV-2 Omicron (B.1.1.529) variant, salient features, high global health concerns and strategies to counter it amid ongoing COVID-19 pandemic

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