Table 2.
Clinical performance of common commercially available laboratory-based SARS-CoV-2 antibody assays.
| Manufacturer | Type | Target | Sens (95% CI)a N |
Spec (95% CI) N |
1% prevalence (95% CI) |
5% prevalence (95% CI) |
||
|---|---|---|---|---|---|---|---|---|
| PPV | NPV | PPV | NPV | |||||
| Abbott Architect and Alinity | IgG | N protein | 100% (95.89, 100.00) N = 88/88 |
99.63% (99.05, 99.90) N = 1066/1070 |
72.99% (50.40, 87.78) | 100% | 93.37% (84.11, 97.40) | 100% |
| Beckman | IgG | S1 RBD | 99.41% (96.77, 99.99) N = 169/170b |
99.64% (99.17, 99.88) N = 1395/1400 |
73.76% (53.96, 87.09) | 99.99% (99.96, 100.00) | 93.61% (85.93, 97.23) | 99.97% (99.78, 100.00) |
| Bio-Rad Platelia | Total | N protein | 97.50% (86.84, 99.94) N = 39/40c |
99.56% (98.73, 99.91) N = 684/687 |
69.28% (42.14, 87.47) | 99.97% (99.82, 100.00) | 92.16% (79.15, 97.33) | 99.87% (99.09, 99.98) |
| Diasorin Liaison | IgG | Spike, S1 and S2 | 97.56% (87.40, 99.47) N = 40/41 |
99.3% (98.6, 99.6) N = 1082/1090 |
57.31% (40.19, 72.85) | 99.98% (98.55, 99.67) | 87.49% (77.79, 93.32) | 99.87% (99.11, 99.98) |
| Euroimmun | IgG | Spike, S1 | 94.44% (86.38, 98.47) N = 68/72d |
99.63% (99.13, 99.88) N = 1339/1344 |
71.94% (51.62, 86.04) | 99.94% (99.85, 99.98) | 93.04% (84.76, 96.98) | 99.71% (99.25, 99.89) |
| Euroimmun | IgA | Spike, S1 | 100% (47.82, 100.00) N = 5/5d |
92.5% (87.93, 95.74) N = 185/200 |
11.87% (7.65, 17.97) | 100% | 41.24% (30.13, 53.31) | 100% |
| Ortho | Total | Spike | 100% (92.75, 100.00) N = 49/49e |
100% (99.08, 100.00) N = 400/400 |
100% | 100% | 100% | 100% |
| Ortho | IgG | Spike | 85.71% (69.71, 95.19) N = 30/35e |
100% (99.10, 100.00) N = 407/407 |
100% | 99.86% (99.68, 99.94) | 100% | 99.25% (98.34, 99.67) |
| Roche cobas | Total | N protein | 100% (88.06, 100.00) N = 29/29 |
99.81% (99.65,99.91) N = 5262/5272 |
84.19% (74.14, 90.82) | 100% | 96.52% (93.73, 98.10) | 100% |
| Siemens Atellica and Centaur | Total | S1 RBD | 100% (91.59, 100.00) N = 42/42 |
99.82% (99.34, 99.98) N = 1089/1091 |
84.64% (57.98, 95.65) | 100% | 96.63% (87.79, 99.14) | 100% |
Assay performance reflects manufacturer-generated validation data as of July 11, 2020. Refer to IFU for Manufacturer updates. EuroImmun and BioRad assays are Enzyme-Linked Immunosorbent Assays (ELISAs), and the others are Chemiluminescent Immunoassays (CLIAs).
Unless stated otherwise, ≥14 days post onset of symptoms or positive RT- PCR is presented. Assays demonstrate reduced clinical sensitivity prior to approximately 13 days.
>14 days post onset of symptoms or positive SARS-CoV-2 RT-PCR.
>8 days post onset of symptoms or positive SARS-CoV-2 RT-PCR.
>10 days post onset of symptoms or positive SARS-CoV-2 RT-PCR.
≥6 days post onset of symptoms or positive SARS-CoV-2 RT-PCR.