Table 1.
Rapid Antigen Tests Performance Among Asymptomatic COVID-19 Infections (United States Only)
| Name of Test | Sensitivity % (95% CI) | Specificity % (95% CI) | Notes | Site | Source |
|---|---|---|---|---|---|
| Abbott BinaxNOW rapid antigen test | 57.7% (95% CI, 36.9%–76.6%) (15 of 26) | 100% (99.6%–100%) (845 of 845) | Not asymptomatic but based upon absence of PCR threshold | San Francisco | Pilarowski G (2021) |
| Abbott BinaxNOW rapid antigen test | 70.2% (95% CI, 56.6 to 81.6) | 99.6% (95% CI, 98.9 to 99.9) | Asymptomatic adults | Massachusetts | Pollock NR (2021) |
| 65.4% (95% CI, 55.6 to 74.4) | 99.0% (95% CI, 98.0 to 99.6) | Asymptomatic children | Massachusetts | ||
| Abbott BinaxNOW COVID-19 Ag card (BinaxNOW) | 35.8 (27.3–44.9) % (95% CI) | 99.8 (99.6–100.0) % (95% CI) | Asymptomatic persons aged ≥10 years | Pima County, Arizona | Prince-Guerra, JL (2021) |
| Abbot BinaxNOW™ rapid SARS-CoV-2 antigen assay | 51.1% (95% CI: 42.5% to 59.7%) (Positive concordance) | Positive concordance was 64.4% (95% CI: 53.4% to 74.4%) among symptomatic children and 51.1% (95% CI: 42.5% to 59.7%) among asymptomatic children. | Los Angeles County | Sood N (2021) | |
| Abbot BinaxNOW COVID-19 antigen card | 53.3% | 100% | University of Utah | Okoye NC (2021) | |
| Abbot BinaxNOW coronavirus disease 2019 (COVID-19) Ag card test (BinaxNOW) | 51.6% | The sensitivity of the BinaxNOW coronavirus disease 2019 (COVID-19) Ag Card test (BinaxNOW) was 51.6% among asymptomatic healthcare employees relative to real-time reverse transcriptase polymerase chain reaction (rRT-PCR). (n=159) | Little Rock, Arkansas | James AE (2021) | |
| Abbot BinaxNOW rapid antigen COVID-19 test | 71% (95% CI 61%, 80%) | Greater than 99% | Asymptomatic individuals with potential exposure 82% (95% CI 66%, 91%) Asymptomatic no exposure 64% (95% CI 51%, 76%) for those with no exposure |
Baltimore Convention Center Field Hospital | Siddiqui ZK (2021) |
| Abbot BinaxNOW COVID-19 rapid antigen test | Low number of patients testing positive by the molecular and/or antigen tests, which limits any conclusions that can be made about the sensitivity of antigen testing | 99.8% | Asymptomatic patients undergoing COVID-19 preprocedural/surgical screening | United States | Stokes NL (2021) |
| Access Bio CareStart COVID-19 antigen test | 50.0% (95% CI, 41.0–59.0) | 99.1% (95% CI, 98.3–99.6) | Asymptomatic adults | Massachusetts | Pollock NR (2021) |
| 51.4% (95% CI, 34.4–68.1) | 97.8% (95% CI, 94.5–99.4) | Asymptomatic children | Massachusetts | ||
| Quidel rapid antigen test | Unclear | 100% | In asymptomatic individuals the Ag test detected less than half of those who had been infected with SARS-CoV-2 but identified 86% of those who were contagious and likely to spread the virus. | University of Arizona | Harris DT (2021) |
| Sofia SARS Antigen Fluorescent Immunoassay (FIA) (Quidel Corporation) | 41.2% (seven of 17) | 98.4% (840 of 854) | Among 871 paired specimens from asymptomatic participants, 21 (2.4%) were antigen-positive and 17 (2.0%) were real-time RT-PCR-positive. Antigen testing sensitivity was 41.2% (7 of 17), specificity was 98.4% (840 of 854), PPV was 33.3% (7 of 21), and NPV was 98.8% (840 of 850). |
Wisconsin | Pray IW (2021) |
Abbreviations: PCR, Polymerase chain reaction; PPV, positive predictive value; NPV, negative predictive value.