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. 2021 Dec 22;9(3):e0100821.
doi: 10.1128/Spectrum.01008-21. Epub 2021 Dec 1.

Implementation and Accuracy of BinaxNOW Rapid Antigen COVID-19 Test in Asymptomatic and Symptomatic Populations in a High-Volume Self-Referred Testing Site

Zishan K Siddiqui  1 , Mihir Chaudhary  2 , Matthew L Robinson  1 , Anna B McCall  3 , Ria Peralta  3 , Rogette Esteve  3 , Charles W Callahan  4 , Yukari C Manabe  1 , James D Campbell  5 , J Kristie Johnson  6 , Maryam Elhabashy  7 , Melinda Kantsiper  8 ; CONQUER COVID Consortium; James R Ficke  9
Affiliations

Implementation and Accuracy of BinaxNOW Rapid Antigen COVID-19 Test in Asymptomatic and Symptomatic Populations in a High-Volume Self-Referred Testing Site

Zishan K Siddiqui et al. Microbiol Spectr. .

Abstract

Rapid antigen tests are simple to perform and provide results within 15 min. We describe our implementation and assess performance of the BinaxNOW COVID-19 Antigen Test (Abbott Laboratories) in 6,099 adults at a self-referred walk-up testing site. Participants were grouped by self-reported COVID-19 exposure and symptom status. Most (89%) were asymptomatic, of whom 17% reported potential exposure. Overall test sensitivity compared with reference laboratory reverse-transcription [RT] PCR testing was 81% (95% confidence interval [CI] 75%, 86%). It was higher in symptomatic (87%; 95% CI 80%, 91%) than asymptomatic (71%; 95% CI 61%, 80%) individuals. Sensitivity was 82% (95% CI 66%, 91%) for asymptomatic individuals with potential exposure and 64% (95% CI 51%, 76%) for those with no exposure. Specificity was greater than 99% for all groups. BinaxNOW has high accuracy among symptomatic individuals and is below the FDA threshold for emergency use authorization in asymptomatic individuals. Nonetheless, rapid antigen testing quickly identifies positive among those with symptoms and/or close contact exposure and could expedite isolation and treatment. IMPORTANCE The BinaxNOW rapid antigen COVID-19 test had a sensitivity of 87% in symptomatic and 71% asymptomatic individuals when performed by health care workers in a high-throughput setting. The performance may expedite isolation decisions or referrals for time-sensitive monoclonal antibody treatment in communities where timely COVID PCR tests are unavailable.

Keywords: COVID-19; SARS-CoV-2; field hospital; point-of-care testing; rapid antigen testing; reverse transcription PCR; sensitivity and specificity.

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Figures

FIG 1
FIG 1
Photographs showing BinaxNOW COVID-19 antigen test kit errors. (A) Normal strip alignment. (B) A misaligned strip. (C) A normal well to insert swab with sample. (D) A missing well.
FIG 2
FIG 2
Box plot showing RT-PCR cycle threshold values and COVID-19 rapid antigen test results for symptomatic and asymptomatic participants. Mean cycle threshold (CT) count (negative vs. positive, P value): asymptomatic (24.0 vs. 30.9, P < 0.0001); symptomatic (24.0 vs. 30.4, P < 0.0001).
FIG 3
FIG 3
Graph showing rapid antigen sensitivity for different RT-PCR cycle threshold cutoff values. CT, cycle threshold.
See this image and copyright information in PMC

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