TABLE 5.
Sensitivity and specificity of two-test algorithms using pairs of commercial SARS-CoV-2 serologic assaysh
| Cohort (no. of patients) | Abbott + DiaSorin |
Abbott + Roche |
DiaSorin + Roche |
P values | |||
|---|---|---|---|---|---|---|---|
| Sens (95% CI) | Spec (95% CI) | Sens (95% CI) | Spec (95% CI) | Sens (95% CI) | Spec (95% CI) | ||
| COVID-19 patients | |||||||
| <7 days after symptom onset (20) | 0 (0–14) | 15 (5–42) | 0 (0–14) | 0.13,a 0.50,b 1.00,c 1.00,d 0.50,e 0.13f | |||
| 7–14 days after symptom onset (53) | 36 (24–49) | 57 (43–69) | 38 (26–51) | 0.001,a 0.25,b 0.25,c 0.13,d 0.50,e 0.001f | |||
| Samples collected >14 days after symptom onset (55) | 89 (78–95) | 93 (82–98) | 87 (78–95) | 0.13,a 1.0,b 0.48,c 1.0,d 1.0,e 0.25f | |||
| Total (128) | 53 (45–62) | 66 (57–73) | 53 (45–62) | <0.0001,a 0.06,b 0.03,c 0.06,d 0.06,e 0.008f | |||
| Control cohort | |||||||
| Pre-COVID-19-era control serum set (1,204) | 100 (100) | 100 (100) | 100 (100) | 0.01,a <0.0001,b 0.01,c 0.50,d <0.0001,e 0.50f | |||
| Symptomatic control serum set (64) | 98 (91–100) | 98 (91–100) | 98 (91–100) | 1.0,a 0.25,b 1.0,c 1.0,d 0.25,e 1.0f | |||
| Total (1,268) | 99.9g (100) | 99.9g (100) | 99.9g (100) | 0.01,a <0.0001,b 0.01,c 0.25,d <0.0001,e 0.25f | |||
P values reflect the comparison between the Abbott assay and a 2-test algorithm pairing the Abbott and DiaSorin assays.
P values reflect the comparison between the DiaSorin assay and a 2-test algorithm pairing the Abbott and DiaSorin assays.
P values reflect the comparison between the Abbott assay and a 2-test algorithm pairing the Abbott and Roche assays.
P values reflect the comparison between the Roche assay and a 2-test algorithm pairing the Abbott and Roche assays.
P values reflect the comparison between the DiaSorin assay and a 2-test algorithm pairing the DiaSorin and Roche assays.
P values reflect the comparison between the Roche assay and a 2-test algorithm pairing the DiaSorin and Roche assays.
One sample from the symptomatic control serum set was positive using all 3 assays. The sample was from a healthy male his 30s who presented in April 2020 with fever, anosmia, shortness of breath, myalgias, and acute cardiomyopathy. Multiple respiratory SARS-CoV-2 RNA tests were negative. For the purposes of this study, the subject remained categorized as COVID-19 negative, but clinical suspicion remained high.
Abbreviations: Sens, sensitivity; Spec, specificity. P values that indicate significant differences are shown in boldface type.