TABLE 1.
Summary of previous studies on sensitivity and specificity of COVID-19 serological diagnosis.
| Methods and studies | Antigens | IgM | IgG | IgM or IgG | IgA | ||||
|---|---|---|---|---|---|---|---|---|---|
| Sensitivity (%) | Specificity (%) | Sensitivity (%) | Specificity (%) | Sensitivity (%) | Specificity (%) | Sensitivity (%) | Specificity (%) | ||
| ELISA | |||||||||
| Lassaunière et al. (2020) | S | 65.0 | 96.0 | 90.0 | 93.0 | ||||
| Guo et al. (2020) | N | 85.4 | 77.9 | 92.7 | |||||
| Dogan et al. (2020) | N | 99.1 | 94.9 | ||||||
| RBD | 100 | 90.9 | 100 | 99.3 | 94.3 | 87.9 | |||
| Snoeck et al. (2020) | SARS-CoV-2 | 97.8 | 85.7 | 89.2 | 92.9 | ||||
| Varadhachary et al. (2020) | N, S1 | 92.0 | 97.0 | ||||||
| Bailey et al. (2020) | |||||||||
| Kit 1 | N | 100 | 99.6 | ||||||
| Kit 2 | S1 | 99.4 | 99.6 | ||||||
| Kit 3 | S | 97.6 | 99.3 | ||||||
| Kit 4 | S1 | 94.4 | 99.6 | ||||||
| Kit 5 | S1 | 100 | 92.5 | ||||||
| Kit 6 | S | 85.7 | 100 | ||||||
| Bortz et al. (2020) | S | 91.0 | 99.0 | 70.0 | 99.0 | ||||
| Iyer et al. (2020) | S | 81.0 | 100 | 97.0 | 100 | 91.0 | 100 | ||
| GeurtsvanKessel et al. (2020) | |||||||||
| Kit 1 | RBD | 99.0 | 90.0 | 99.0 | 81.0 | 94.0 | 97.0 | ||
| Kit 2 | S1 | ||||||||
| Kit 3 | S1 | ||||||||
| Fujigaki et al. (2020) | |||||||||
| Kit 1 | RBD | 79.7 | 94.0 | 77.9 | 98.0 | 80.2 | 97.0 | ||
| Kit 2 | S1 | 76.8 | 99.0 | 72.1 | 97.0 | 79.1 | 94.0 | ||
| Kit 3 | N | 63.8 | 88.0 | 84.3 | 79.0 | 80.2 | 82.0 | ||
| La Rosa Fabian and Urquizo Briceno (2020) | S | 92.3 | 65.4 | ||||||
| Huynh et al. (2020) | S | 100 | 95.5 | 100 | 96.7 | 100 | 97.6 | ||
| RBD | 100 | 97.3 | 100 | 94.6 | 100 | 97.0 | |||
| Tre-Hardy et al. (2021) | N | 48.7 | 98.7 | 94.9 | 96.2 | 89.7 | 98.7 | ||
| Nuccetelli et al. (2020) | |||||||||
| Kit 1 | N | 80.0 | 100 | 94.0 | 93.0 | 82.0 | 93.0 | ||
| Kit 2 | N | 92.0 | 100 | 98.0 | 94.0 | 92.0 | 94.0 | ||
| Mazzini et al. (2021) | RBD | 85.7 | 98.1 | ||||||
| Van Elslande et al. (2020) | |||||||||
| Kit 1 | S | 39.2 | 91.3 | 62.1 | 98.1 | 65.4 | 90.3 | ||
| Kit 2 | S | 72.5 | 95.1 | 68.0 | 93.2 | 76.5 | 91.3 | ||
| Kit 3 | S | 65.4 | 100 | 62.8 | 99.0 | 65.4 | 99.0 | ||
| Kit 4 | S | 32.0 | 99.0 | 64.7 | 99.0 | 66.7 | 98.1 | ||
| Kit 5 | N | 69.3 | 95.1 | 61.4 | 99.0 | 69.3 | 95.2 | ||
| Kit 6 | N | 43.8 | 91.3 | 64.7 | 97.2 | 71.2 | 88.3 | ||
| Kit 7 | N | 56.2 | 93.2 | 71.2 | 90.3 | 79.1 | 85.4 | ||
| Jaaskelainen et al. (2020) | S1 | 33.3 | 91.9 | 61.5 | 73.0 | ||||
| Beavis et al. (2020) | S1 | 82.9 | 88.4 | 67.1 | 97.1 | ||||
| Sterlin et al. (2020) | S | 91.0 | 98.0 | ||||||
| Pieri et al. (2020) | |||||||||
| Kit 1 | N | 33.3–80.0 | 98.5 | 50.0–100 | 92.5 | ||||
| Kit 2 | N | 88.2 | 92.0 | 92.5 | 93.3 | ||||
| Liu, Liu, Kou et al. (2020) | N | 68.2 | 100 | 70.1 | 100 | 80.4 | 100 | ||
| S | 77.1 | 100 | 74.3 | 100 | 82.2 | 100 | |||
| Adams et al. (2020) | S | 70.0 | 100 | 85.0 | 100 | 85.0 | 100 | ||
| Whitman et al. (2020) | S | 56.9 | 96.9 | 73.8 | 88.8 | 75.4 | 87.5 | ||
| N | 72.3 | 95.0 | |||||||
| Liu, Liu, Zheng et al. (2020) | N | 83.0 | 96.6 | ||||||
| Freeman et al. (2020) | S | 96.0 | 99.3 | ||||||
| Zhao et al. (2020) | N, S | 82.7 | 98.6 | 64.7 | 99.0 | 99.3 | 99.1 | ||
| Lou et al. (2020) | S | 92.5 | 100 | 88.8 | 99.0 | 97.5 | 99.1 | ||
| Zhong et al. (2020) | S | 97.9 | 99.7 | 97.9 | 99.7 | ||||
| Xiang et al. (2020) | N | 77.3 | 100 | 83.3 | 95.0 | ||||
| Perera et al. (2020) | RBD | 78.7 | 100 | 72.3 | 98.6 | ||||
| Nguyen et al. (2020) | |||||||||
| Kit 1 | N | 92.2 | 99.6 | ||||||
| Kit 2 | S | 90.0 | 100 | ||||||
| Kit 3 | S | 92.5 | 100 | ||||||
| Zava and Zava (2021) | |||||||||
| Kit 1 | N | 90.0 | 100 | ||||||
| Kit 2 | N | 98.4 | 99.8 | ||||||
| Kohmer et al. (2020) | 70.6 | 83.3 | |||||||
| CLIA | |||||||||
| Ma et al. (2020) | RBD | 96.8 | 92.3 | 96.8 | 99.8 | 98.6 | 100 | 99.6 | 98.1 |
| Marklund et al. (2020) | RBD | 37.5 | 100 | 91.7 | 100 | 45.8 | 100 | ||
| GeurtsvanKessel et al. (2020) | S | 90.0 | 81.0 | ||||||
| Pieri et al. (2020) | |||||||||
| Kit 1 | N | 65.5–100 | 99.8 | ||||||
| Kit 2 | N, S | 78.6 | 97.5 | 91.2 | 97.3 | ||||
| Manalac et al. (2020) | N | 97.9 | 99.6 | ||||||
| Lou et al. (2020) | S | 86.3 | 99.3 | ||||||
| Zhong et al. (2020) | S | 97.9 | 95.3 | 95.7 | 96.7 | ||||
| Lin et al. (2020) | RBD | 81.2 | 82.3 | 97.5 | 82.3 | 80.0 | 91.1 | ||
| Cai et al. (2020) | S | 57.2 | 100 | 71.4 | 100 | 81.5 | 100 | ||
| Infantino et al. (2020) | N, S | 73.3 | 92.2 | 76.7 | 100 | ||||
| Jin et al. (2020) | N, S | 48.1 | 100 | 88.9 | 90.9 | ||||
| Xie et al. (2020) | N, E | 93.8 | 85.0 | 100 | 100 | ||||
| Yangchun (2020) | S | 70.2 | 96.2 | 96.1 | 92.4 | ||||
| Qian et al. (2020) | N, S | 85.9 | 98.1 | 96.6 | 98.1 | ||||
| Nguyen et al. (2020) | |||||||||
| Kit 1 | S | 90.0 | 100 | ||||||
| Kit 2 | S | 100 | 100 | ||||||
| Kit 3 | N | 100 | 99.8 | ||||||
| LFIA | |||||||||
| Lassaunière et al. (2020) | |||||||||
| Kit 1 | Unknown | 90.0 | 100 | ||||||
| Kit 2 | Unknown | 90.0 | 100 | ||||||
| Kit 3 | Unknown | 93.3 | 100 | ||||||
| Kit 4 | Unknown | 83.3 | 100 | ||||||
| Kit 5 | Unknown | 80.0 | 80.0 | ||||||
| GeurtsvanKessel et al. (2020) | |||||||||
| Kit 1 | S, N | 99.0 | 89.0 | ||||||
| Kit 2 | N | 85.0 | 90.0 | ||||||
| Kit 3 | S, N | 88.0 | 100.0 | ||||||
| La Rosa Fabian and Urquizo Briceno (2020) | S | 66.7 | 69.2 | ||||||
| Nuccetelli et al. (2020) | |||||||||
| Kit 1 | N | 71.0 | 94.0 | 80.0 | 96.0 | ||||
| Kit 2 | N | 84.0 | 94.0 | 71.0 | 96.0 | ||||
| Van Elslande et al. (2020) | N | 55.6 | 96.1 | 92.1 | 90.3 | 70.0 | 85.4 | ||
| Whitman et al. (2020) | |||||||||
| Kit 1 | N | 62.7 | 87.9 | 56.3 | 96.3 | 65.9 | 86.9 | ||
| Kit 2 | N | 72.2 | 97.1 | 63.5 | 98.1 | 75.4 | 95.2 | ||
| Kit 3 | N | 68.5 | 90.7 | 67.7 | 91.6 | 52.4 | 89.7 | ||
| Kit 4 | N | 73.4 | 84.3 | 53.9 | 99.1 | 74.2 | 84.3 | ||
| Kit 5 | S | 29.2 | 96.3 | 54.9 | 100 | 58.4 | 96.3 | ||
| Kit 6 | S | 70.1 | 98.1 | 54.3 | 99.1 | 71.7 | 97.2 | ||
| Kit 7 | S | 48.8 | 100 | 57.5 | 100 | 50.4 | 100 | ||
| Kit 8 | S | 57.8 | 98.1 | 57.0 | 98.1 | 46.9 | 98.1 | ||
| Kit 9 | S | 66.4 | 94.9 | 64.7 | 96.0 | 66.4 | 94.9 | ||
| Kit 10 | N | 70.2 | 99.1 | ||||||
| Lou et al. (2020) | S | 88.8 | 98.1 | 86.3 | 99.5 | 97.5 | 95.2 | ||
| Li et al. (2020) | S | 82.6 | 91.4 | 70.5 | 94.1 | 88.7 | 90.6 | ||
| Pérez-García et al. (2020) | N | 21.8 | 100 | 41.8 | 100 | 47.3 | 100 | ||
| Imai et al. (2020) | N | 43.2 | 97.9 | 14.4 | 100 | 43.2 | 97.9 | ||
| Ying et al. (2020) | S | 37.8 | 93.3 | 83.3 | 92.1 | 85.6 | 91.0 | ||
| Cassaniti et al. (2020) | S | 83.3 | 100 | 80.0 | 100 | 83.3 | 100 | ||
| Hoffman et al. (2020) | N, S | 69.0 | 100 | 93.1 | 99.2 | ||||
| Chen et al. (2020) | N, S | 100 | 91.7 | ||||||
| Zhang et al. (2020) | RBD | 86.9 | 99.4 | ||||||
| VirgilioParadiso et al. (2020a) | RBD | 30.7 | 89.2 | ||||||
| Nguyen et al. (2020) | |||||||||
| Kit 1 | S | 95.7 | 99.7 | 99.0 | 99.4 | 99.0 | 99.0 | ||
| Kit 2 | S | 93.8 | 96.0 | ||||||
| Kit 3 | N | 77.4 | 87.1 | 93.5 | 94.4 | ||||
| Kohmer et al. (2020) | 62.5 | 100 | |||||||
| IFA | |||||||||
| Jia (VirgilioParadiso et al., 2020b) | 72.0 | 39.0 | 71.0 | 52.0 | 87.5 | 72.7 | |||
| Kohmer et al. (2020) | 76.5 | 86.4 | |||||||
| Edouard et al. (2021) | 41.0 | 93.0 | |||||||