Evaluation of the ID NOW Among Symptomatic Individuals During the Omicron Wave

Author:

Stokes William,Venner Allison A.,Buss Emily,Tipples Graham,Berenger Byron M.

Abstract

ABSTRACTBACKGROUNDPoint of Care SARS-CoV-2 devices, such as the Abbott ID NOW have great potential, to help combat the COVID-19 pandemic. Starting in December, 2020, the ID NOW was implemented throughout the province of Alberta, Canada (population 4.4 million) in various settings. We aimed to assess the ID NOW performance during the BA.1 Omicron wave and compare it to previous waves.METHODSThe ID NOW was assessed in two distinct locations among symptomatic individuals: acute care (emergency room, urgent care, and hospitalized patients) and community assessment centres (AC) during the period January 5 – 18, 2022. Starting January 5, Omicron represented >95% of variants detected in our population. For every individual tested, two swabs were collected: one for ID NOW testing and the other for either reverse-transcriptase polymerase chain reaction (RT-PCR) confirmation of negative ID NOW results or for variant testing of positive ID NOW results.RESULTSA total of 3,041 paired samples were analyzed (1,139 RT-PCR positive). 1,873 samples were from 42 COVID-19 AC and 1,168 from 69 rural hospitals. ID NOW sensitivity for symptomatic individuals presenting to community AC and patients in hospital was 96.0% [95% confidence interval (CI) 94.5-97.3%, n=830 RT-PCR positive], and 91.6% (95% CI 87.9-94.4%, n=309 RT-PCR positive), respectively. SARS-CoV 2 positivity rate was very high for both populations (44.3% at AC, 26.5% in hospital).CONCLUSIONSSensitivity of ID NOW SARS-CoV-2, compared to RT-PCR, is very high during the BA.1 Omicron wave, and is significantly higher when compared to previous SARS-CoV-2 variant waves.

Publisher

Cold Spring Harbor Laboratory

Reference13 articles.

1. United States Food and Drug Administration. ID NOW COVID-19 – instructions for use. 2020. [Accessed Feb 10, 2022]. Available from: https://www.fda.gov/media/136525/download

2. Stokes W , Venner AA , Buss E , Tipples G , Berenger BM . Then and NOW: a prospective population-level validation of the Abbott ID NOW SARS-CoV-2 device implemented in multiple settings for testing asymptomatic and symptomatic individuals. MedRxiv 2022.04.30.22274189; doi:https://doi.org/10.1101/2022.04.30.22274189

3. Abbott. Evaluating Omicron and other COVID variants to ensure test effectiveness. [Accessed Feb 27, 2022]. Available from: https://www.abbott.com/corpnewsroom/diagnostics-testing/monitoring-covid-variants-to-ensure-test-effectiveness.html

4. Government of Alberta. 2022. [Accessed Feb 27, 2022]. Available from: https://www.alberta.ca/stats/covid-19-alberta-statistics.htm

5. SARS-CoV-2 Omicron variant shows less efficient replication and fusion activity when compared with Delta variant in TMPRSS2-expressed cells;Emerg Microbes Infect,2022

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