Accuracy of 2 Rapid Antigen Tests During 3 Phases of SARS-CoV-2 Variants

Author:

Drain Paul K.123,Bemer Meagan123,Morton Jennifer F.123,Dalmat Ronit123,Abdille Hussein123,Thomas Katherine K.123,Uppal Timsy K.4,Hau Derrick4,Green Heather R.4,Gates-Hollingsworth Marcellene A.4,AuCoin David P.4,Verma Subhash C.4

Affiliation:

1. Department of Global Health, University of Washington, Seattle

2. Department of Medicine, University of Washington, Seattle

3. Department of Epidemiology, University of Washington, Seattle

4. Department of Microbiology and Immunology, School of Medicine, University of Nevada, Reno

Abstract

ImportanceVariants of SARS-CoV-2 have sequence variations in the viral genome that may alter the accuracy of rapid diagnostic tests.ObjectiveTo assess the analytical and clinical accuracy of 2 rapid diagnostic tests for detecting SARS-CoV-2 during 3 phases of variants.Design, Setting, and ParticipantsThis diagnostic study included participants aged 18 years or older who reported onset of COVID-19–like symptoms within the prior 5 days and were tested at multiple COVID-19 testing locations in King County, Washington, from February 17, 2021, to January 11, 2022, during 3 distinct phases of SARS-CoV-2 infection (pre-Delta, Delta, and Omicron).InterventionsTwo anterior nasal swab specimens were collected from each participant—1 for onsite testing by the SCoV-2 Ag Detect Rapid Self-Test and 1 for reverse transcriptase–polymerase chain reaction (RT-PCR) testing.Main Outcomes and MeasuresThe analytical limit of detection of the 2 rapid diagnostic tests (SCoV-2 Ag Detect Rapid Self-Test and BinaxNOW COVID-19 Ag Card) was assessed using Omicron (B.1.1.529/BA.1), Delta (B.1.617.2), and a wild-type (USA-WA1/2020) variant. Diagnostic sensitivity and specificity of clinical testing for the rapid antigen tests were compared with that of RT-PCR testing.ResultsA total of 802 participants were enrolled (mean [SD] age, 37.3 [13.3] years; 467 [58.2%] female), 424 (52.9%) of whom had not received COVID-19 vaccination and presented a median of 2 days (IQR, 1-3 days) from symptom onset. Overall, no significant differences were found in the analytical limit of detection or clinical diagnostic accuracy of rapid antigen testing across SARS-CoV-2 variants. The estimated limit of detection for both rapid nucleocapsid antigen tests was at or below a 50% tissue culture infectious dose of 62.5, and the positive percent agreement of the SCoV-2 Ag Detect Rapid Self-Test ranged from 81.2% (95% CI, 69.5%-89.9%) to 90.7% (95% CI, 77.9%-97.4%) across the 3 phases of variants. The diagnostic sensitivity increased for nasal swabs with a lower cycle threshold by RT-PCR, which correlates with a higher viral load.Conclusions and RelevanceIn this diagnostic study, analytical and clinical performance data demonstrated accuracy of 2 rapid antigen tests among adults with COVID-19 symptoms across 3 phases of SARS-CoV-2 variants. The findings suggest that home-based rapid antigen testing programs may be an important intervention to reduce global SARS-CoV-2 transmission.

Publisher

American Medical Association (AMA)

Subject

General Medicine

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