Abstract

SARS-CoV-2 RT-PCR, the gold standard for diagnostic testing, may not be readily available or logistically applicable for routine COVID-19 testing in many rural communities in the United States. In this validation study, we compared the BinaxNOW™ COVID-19 Test Ag Card with SARS-CoV-2 RT-PCR in 214 participants who sought COVID-19 testing from a local public health district in Idaho, USA. The median age of participants was 35 and 82.7% were symptomatic. Thirty-seven participants (17.3%) had positive RT-PCR results. Results between the two tests were 94.4% concordant. The sensitivity of the BinaxNOW™ COVID-19 Test Ag Card was 67.6% (95% CI: 50.2-81.9%), and the specificity was 100.0% (95% CI: 97.9-100.0%). The positive predictive value (PPV) for the BinaxNOW™ COVID-19 Test Ag Card was 100.0% (95% CI: 86.2-100.0%), and the negative predictive value (NPV) was 93.6% (95% CI: 89.1-96.6%). Although the sensitivity of BinaxNOW™ COVID-19 Test Ag Card was lower than RT-PCR, rapid results and high specificity support its use for early detection of COVID-19, especially in settings where SARS-CoV-2 RT-PCR testing is not readily available. Rapid antigen tests, such as the BinaxNOW™ COVID-19 Test Ag Card, may be a more convenient tool in quickly identifying and preventing COVID-19 transmission, especially in rural settings.

Highlights

  • Detection of SARS-CoV-2, the virus that causes COVID-19, is essential for slowing community transmission

  • Demographic data including age, gender, race, ethnicity, and contact information were collected and participants were asked about their symptoms and previous vaccinations, recent travel, and whether they had been exposed to a person diagnosed with COVID-19 in the previous 14 days

  • Between November 2020 and May 2021, 214 eligible participants were enrolled in the study and paired nasopharyngeal samples were collected and tested

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Summary

Introduction

Detection of SARS-CoV-2, the virus that causes COVID-19, is essential for slowing community transmission. Real-time reverse transcription-polymerase chain reaction (RT-PCR) assays for COVID-19 diagnosis have excellent sensitivity and specificity but require laboratory instrumentation and sending specimens to a laboratory for testing can culminate in delayed turnaround times for results [1].

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