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. 2021 Mar 19;59(4):e03282-20.
doi: 10.1128/JCM.03282-20. Print 2021 Mar 19.

Performance Characteristics of BinaxNOW COVID-19 Antigen Card for Screening Asymptomatic Individuals in a University Setting

Nkemakonam C Okoye #  1 , Adam P Barker #  2   3 , Kenneth Curtis  4 , Richard R Orlandi  5 , Emily A Snavely  1 , Cameron Wright  6 , Kimberly E Hanson  2   3   7 , Lauren N Pearson  8   3
Affiliations

Performance Characteristics of BinaxNOW COVID-19 Antigen Card for Screening Asymptomatic Individuals in a University Setting

Nkemakonam C Okoye et al. J Clin Microbiol. .

Abstract

We compared the performance of the Abbott BinaxNOW COVID-19 antigen card to that of a standard reverse transcription-PCR (RT-PCR) assay (Thermo Fisher TaqPath COVID-19 Combo kit) for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 2,645 asymptomatic students presenting for screening at the University of Utah. SARS-CoV-2 RNA was detected in 1.7% of the study participants by RT-PCR. BinaxNOW identified 24 infections but missed 21 infections that were detected by RT-PCR. The analytical sensitivity (positive agreement) and analytical specificity (negative agreement) for the BinaxNOW were 53.3% and 100%, respectively, compared to the RT-PCR assay. The median cycle threshold (CT ) value in the specimens that had concordant positive BinaxNOW antigen results was significantly lower than that of specimens that were discordant (CT of 17.6 versus 29.6; P < 0.001). In individuals with presumably high viral loads (CT of <23.0), a 95.8% positive agreement was observed between the RT-PCR assay and BinaxNOW. Due to the possibility of false-negative results, caution must be taken when utilizing rapid antigen testing for screening asymptomatic individuals.

Keywords: BinaxNOW COVID-19 antigen card; SARS-CoV-2; asymptomatic screening; rapid antigen tests.

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Figures

FIG 1
FIG 1
Distribution of the RT-PCR cycle threshold (CT) values in specimens with positive and negative BinaxNOW results. The P value is based on the Mann-Whitney test. The lines signify medians and interquartile ranges.
FIG 2
FIG 2
Distribution of the RT-PCR cycle threshold (CT) values in specimens with concordant positive BinaxNOW results (A) and discordant negative BinaxNOW results (B) sorted by order of nasal swab collection. The P value is based on the Mann-Whitney test. The lines signify medians and interquartile ranges.
FIG 3
FIG 3
Frequency distribution of RT-PCR cycle threshold (CT) values in all specimens with detectable SARS-CoV-2 and specimens with discordant BinaxNOW results.
See this image and copyright information in PMC

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