Table 2.
Pooled sensitivity, pooled specificity, and area under the receiver operating characteristic curve (AUROC) of serological tests stratified by detection time, detection method and antigen protein.
| Category | Antibody | Sensitivity with 95% CI (%) | Specificity with 95% CI (%) | AUROC with 95% CI (%) |
|---|---|---|---|---|
| Days 0–7 | IgM+IgG− (25 studies, 3803 samples) | 6 (4–10) | 98 (96–99) | 0.52 (1.00–0.00) |
| IgG+IgM− (26 studies, 3904 samples) | 4 (2–8) | 99 (98–100) | 0.77 (1.00–0.00) | |
| IgM+IgG+ (25 studies, 3803 samples) | 17 (13–22) | 100 (99–100) | 0.56 (0.07–0.96) | |
| IgM+IgG+/− (38 studies, 5710 samples) | 34 (27–41) | 97 (96–98) | 0.81 (1.00–0.00) | |
| IgG+IgM+/− (38 studies, 5794 samples) | 25 (20–30) | 98 (98–99) | 0.82 (0.14–0.99) | |
| IgM+ or IgG+ (41 studies, 6708 samples) | 39 (33–45) | 97 (96–98) | 0.80 (0.13–0.99) | |
| Days 8–14 | IgM+IgG− (36 studies, 5705 samples) | 8 (5–11) | 98 (97–99) | 0.66 (1.00–0.00) |
| IgG+IgM− (37 studies, 5876 samples) | 7 (4–12) | 99 (99–100) | 0.91 (1.00–0.00) | |
| IgM+IgG+ (35 studies, 5630 samples) | 49 (42–55) | 100 (99–100) | 0.88 (0.07–0.96) | |
| IgM+IgG+/− (50 studies, 7759 samples) | 66 (60–72) | 98 (96–98) | 0.94 (1.00–0.00) | |
| IgG+IgM+/− (48 studies, 8014 samples) | 64 (59–68) | 99 (98–99) | 0.92 (0.17–1.00) | |
| IgM+ or IgG+ (52 studies, 8966 samples) | 76 (72–79) | 98 (97–98) | 0.93 (0.18–1.00) | |
| >14 days | IgM+IgG− (36 studies, 5140 samples) | 4 (3–7) | 98 (97–98) | 0.93 (0.18–1.00) |
| IgG+IgM− (38 studies, 5387 samples) | 12 (7–21) | 98 (97–99) | 0.61 (1.00–0.00) | |
| IgM+IgG+ (36 studies, 5139 samples) | 64 (54–72) | 99 (98–100) | 0.95 (1.00–0.00) | |
| IgM+IgG+/− (53 studies, 7855 samples) | 81 (74–87) | 100 (99–100) | 0.97 (0.19–1.00) | |
| IgG+IgM+/− (51 studies, 7634 samples) | 89 (85–92) | 98 (96–98) | 0.98 (1.00–0.00) | |
| IgM+ or IgG+ (54 studies, 8225 samples) | 93 (90–95) | 99 (98–99) | 0.99 (0.20–1.00) | |
| Methods | CLIA (10 studies, 3077 samples) | 86 (73–94) | 100 (97–100) | 0.99 (1.00–0.00) |
| ELISA (14 studies, 4217 samples) | 83 (76–88) | 99 (97–100) | 0.97 (1.00–0.00) | |
| LFIA (50 studies, 12621 samples) | 75 (71–79) | 97 (96–98) | 0.95 (0.19–1.00) | |
| Antigens | S protein (14 studies, 3617 samples) | 90 (84–94) | 99 (98–100) | 0.99 (0.98–1.00) |
| N protein (9 studies, 2829 samples) | 79 (65–88) | 97 (94–99) | 0.96 (0.94–0.98) | |
| S and N protein (9 studies, 5936 samples) | 88 (83–91) | 98 (96–99) | 0.96 (0.94–0.97) | |
| Suspected | IgM+IgG− (8 studies, 1447 samples) | 5 (2–14) | 99 (96–100) | 0.74 (0.70–0.77) |
| IgG+IgM− (8 studies, 1446 samples) | 19 (8–37) | 100 (94–100) | 0.78 (0.75–0.82) | |
| IgM+IgG+ (8 studies, 1426 samples) | 32 (11–64) | 100 (96–100) | 0.98 (0.96–0.99) | |
| IgM+IgG+/− (10 studies, 1858 samples) | 47 (29–66) | 100 (96–100) | 0.95 (0.93–0.97) | |
| IgG+IgM+/− (10 studies, 1858 samples) | 72 (47–89) | 99 (96–100) | 0.99 (0.97–0.99) | |
| IgM+ or IgG+ (16 studies, 2856 samples) | 81 (59–92) | 99 (97–99) | 0.98 (0.98–1.00) |
CI, confidence interval; CLIA, chemiluminescence immunoassay; ELISA, enzyme-linked immunosorbent assay; LFIA, lateral flow immunosorbent assay; Suspected, patients with clinical suspicion of coronavirus disease 2019 had typical epidemiological history, signs and symptoms but did not have a positive reverse transcription polymerase chain reaction result.