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. 2022 Feb:147:105023.
doi: 10.1016/j.jcv.2021.105023. Epub 2021 Oct 28.

Diagnostic accuracy of a rapid diagnostic test for the early detection of COVID-19

Ginette A Okoye  1 , Haja I Kamara  2 , Michelle Strobeck  3 , Thomas Alan Mellman  4 , John Kwagyan  3 , Ava Sullivan  5 , Angel S Byrd  1 , Babak Shokrani  5 , Hugh E Mighty  3
Affiliations

Diagnostic accuracy of a rapid diagnostic test for the early detection of COVID-19

Ginette A Okoye et al. J Clin Virol. 2022 Feb.

Abstract

Objectives: This study was undertaken to evaluate the diagnostic performance of the BinaxNOW COVID-19 Ag Card rapid antigen assay (Abbott; Chicago, IL, USA) in the detection of COVID-19 infection compared to the reference standard of PCR testing.

Methods: We evaluated the BinaxNOW COVID-19 Ag Card rapid antigen assay relative to a standard reference PCR test. We tested 3810 nasal swabs from symptomatic and asymptomatic adults undergoing surveillance COVID-19 testing at Howard University using one swab for each nostril. One swab was tested using the rapid antigen assay and the other using the PCR test.

Results: The sensitivity of the BinaxNOW COVID-19 Ag Card rapid antigen assay was 91.84% (95% confidence interval (CI): 80.40-97.73%) and the specificity was 99.95% (95% CI: 99.81-99.99%). The range of Ct values for the N gene was 10.74-34.90 (M = 26.88, SD=4.86). Fourteen (28.6%) samples had an N gene Ct value > 30. The average N gene Ct value for rapid test negative (i.e. false negative) samples was 31.92.

Conclusions: The sensitivity of the test in our symptomatic and asymptomatic cohort was lower than the manufacturer's reported sensitivity in a symptomatic cohort (97.1%). Despite their relatively lower sensitivity (especially in asymptomatic individuals), rapid tests have undeniable benefits (i.e., ease of use and rapid results) that make them a helpful tool in the control of the SARS-CoV-2 pandemic. Given the diagnostic accuracy of these tests as evidenced by this study, rapid tests can be thoughtfully employed in situations where swift results are critical.

Keywords: COVID-19; COVID-19 testing; Coronavirus; Diagnostic accuracy; RT-PCR; Rapid testing.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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