Table 1.
Laboratory performance for the Abbott (Architect SARS-CoV-2 IgG), DiaSorin (Liaison SARS-CoV-2 S1/S2 IgG) and Roche (Cobas Elecsys Anti-SARS-CoV-2) SARS-CoV-2 serological assays in an Australian cohort
| Characteristic | Abbott | DiaSorin | Roche |
|---|---|---|---|
| Sensitivity by time interval in days from symptom onset (n) [95% CI] | |||
| 0–7 d (51) | 17.6% [9.6, 30.3] 23.5% [12.8, 37.5]a |
7.8% [3.1, 18.5] | 17.6% [9.6, 30.3] |
| 8–14 d (30) | 53.3% [36.1, 69.8] 70.0% [50.6, 85.3]a |
40.0% [24.6, 57.7]b | 53.3% [36.1, 69.8] |
| 15–30 d (42) | 95.2% [84.2, 99.2] 97.6% [87.4, 99.9]a |
88.1% [75.0, 94.8]b | 92.9% [81.0, 97.5] |
| 31–90 d (39) | 92.3% [79.7, 97.3] 97.4% [86.5, 99.9]a |
92.3% [79.7, 97.3]b | 100% [91.0, 100] |
| 121–150 d (11) | 100% [74.1, 100] 100% [74.1, 100]a |
100% [74.1, 100] | 100% [74.1, 100] |
| 151–210 d (44) | 68.2% [53.4, 80.0] 90.9% [78.3, 97.5]a |
88.6% [76.0, 95.4]b | 97.7% [88.2, 99.9] |
| Specificity (n) [95% CI] | |||
| Cross-reactive specimens (31) | 100% [88.8, 100] 100% [88.8, 100]a |
96.8 [83.3, 99.9] | 100% [88.8, 100] |
| Pre-pandemic controls (200) | 100% [98.2, 100] 99.5% [97.3, 99.99]a |
99.0% [96.4, 99.9] | 100% [98.2, 100] |
| Overall (231) | 100% [98.4, 100] 99.6% [97.6, 99.99]a |
98.7% [96.3, 99.7] | 100% [98.4, 100] |
CI, confidence interval (Clopper–Pearson).
a
Results when equivocal zone employed (0.49–<1.40) as per Abbott Diagnostics Product information Letter PI1060-20202, with equivocal results considered positive.
b
One sample in each time interval (different participants) with an equivocal result on the DiaSorin assay was considered positive.