Authors: Ian W. Pray, PhD^1,2,3,*; Laura Ford, PhD^1,2,*; Devlin Cole, MD^3,4; Christine Lee, PhD^1,5; John Paul Bigouette, PhD^1,2; Glen R. Abedi, MPH¹; Dena Bushman, MSN, MPH^1,2; Miranda J. Delahoy, PhD^1,2; Dustin Currie, PhD^1,2; Blake Cherney, MS¹; Marie Kirby, PhD¹; Geroncio Fajardo, MD¹; Motria Caudill, PhD^1,6; Kimberly Langolf, MS⁷; Juliana Kahrs, MS⁷; Patrick Kelly, MD^4,8; Collin Pitts, MD^4,8; Ailam Lim, PhD⁹; Nicole Aulik, PhD⁹; Azaibi Tamin, PhD¹; Jennifer L. Harcourt, PhD¹; Krista Queen, PhD¹; Jing Zhang, PhD¹; Brett Whitaker, PhD¹; Hannah Browne¹; Magdalena Medrzycki, PhD¹; Patricia Shewmaker, PhD¹; Jennifer Folster, PhD¹; Bettina Bankamp, PhD¹; Michael D. Bowen, PhD¹; Natalie J. Thornburg, PhD¹; Kimberly Goffard, MBA¹⁰; Brandi Limbago, PhD¹; Allen Bateman, PhD^7,11; Jacqueline E. Tate, PhD¹; Douglas Gieryn¹⁰; Hannah L. Kirking, MD¹; Ryan Westergaard, MD, PhD^3,4; Marie Killerby, VetMB¹; CDC COVID-19 Surge Laboratory Group (View author affiliations)

Summary

What is already known about this topic?

Antigen tests for SARS-CoV-2 are inexpensive and can return results within 15 minutes, but test performance data in asymptomatic and symptomatic persons are limited.

What is added by this report?

Compared with real-time reverse transcription–polymerase chain reaction (RT-PCR) testing, the Sofia antigen test had a sensitivity of 80.0% and specificity of 98.9% among symptomatic persons; accuracy was lower (sensitivity 41.2% and specificity 98.4%) when used for screening of asymptomatic persons.

What are the implications for public health practice?

To account for reduced antigen test accuracy, confirmatory testing with a nucleic acid amplification test (e.g., RT-PCR) should be considered after negative antigen test results in symptomatic persons and positive antigen test results in asymptomatic persons.

For More Information: https://www.cdc.gov/mmwr/volumes/69/wr/mm695152a3.htm