Ann Clin Microbiol 2021;24:67-73. Clinical Usefulness of SARS-CoV-2 Antibody Test
| Country | Sensitivity | Specificity |
|---|---|---|
| US FDA | 90% overall, 70% IgM, 90% IgG | 95% (overall – total) |
| UK MHRA (the Medicines and Healthcare products Regulatory Agency) | > 98% (95% CI 96%-100%) on specimens collected 20 days or more after the first appearance of symptoms | > 98% (95% CI 96% – 100%) |
| Health Canada | 95% for IgG or total antibodies in samples collected 2 weeks or more after symptom onset. | 98% |
Abbreviations: FDA, Food and Drug Administration; CI, confidence interval.