Table 1.
Summary of studies included in the meta-analysis (Note: TP = No. of True Positive Cases; FP = No. of False Positive Cases; FN = No. of False Negative Cases; TN = No. of True Negative Cases; Se. = sensitivity; Sp. = specificity; PPV = predicted positive value; PNV = predicted negative value; Cohen’s Kappa values should be interpreted as follows: 0.0–0.20 no agreement, 0.21–0.39 minimal agreement, 0.40–0.59 weak agreement, 0.60–0.79 moderate agreement, 0.80–0.90 strong agreement, > 0.90 almost perfect agreement; POCT = Point-of-Care Test).
| Reference | Characteristics of the Samples | Commercial Test | No. of Samples | TP | FP | FN | TN | Se. | Sp. | PPV | PNV | Accuracy | Cohen’s Kappa |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Imai et al. 2020 [27] | 139 samples from 112 COVID-19 patients, 48 negative patients from Saitama Hospital | Artron laboratories | 187 | 60 | 1 | 79 | 47 | 42.2% | 97.9% | 98.4% | 37.3% | 57.2% | 0.268 |
| Lassaunière et al. 2020 [8] | 30 COVID-19 confirmed cases admitted to intensive care unit vs. 10 samples from healthy donors + patients with previous history of coronarivus infection (N = 5), non-coronavirus respiratory infection (N = 45), dengue (N = 9), CMV (N = 2), EBV (N = 10). | Artron Laboratories | 47 | 25 | 0 | 5 | 17 | 83.3% | 100% | 100% | 77.3% | 89.4% | 0.783 |
| Acro Biotech | 20 | 4 | 3 | 1 | 12 | 80.0% | 80.0% | 57.1% | 92.3% | 80.0% | 0.529 | ||
| AutoBio Diagnostics | 62 | 28 | 0 | 2 | 32 | 93.3% | 100% | 100% | 94.1% | 96.8% | 0.935 | ||
| Dynamiker | 62 | 27 | 0 | 3 | 32 | 90.0% | 100% | 100% | 91.4% | 95.2% | 0.903 | ||
| CTK Biotech | 62 | 27 | 0 | 3 | 32 | 90.0% | 100% | 100% | 91.4% | 95.2% | 0.903 | ||
| Cassaniti et al. 2020 [7] | 30 negative healthy controls vs. 30 COVID-19 cases tested with both POCT and RT-PCR | VivaDiag | 60 | 19 | 0 | 11 | 30 | 63.3% | 100% | 100% | 73.2% | 81.7% | 0.633 |
| 50 subjects with suspected COVID-19 sequentially tested with POCT and RT-PCR | VivaDiag | 50 | 7 | 1 | 31 | 11 | 18.4% | 91.7% | 87.5% | 26.2% | 36.0% | 0.054 | |
| Virgilio Paradiso et al. 2020 [10] | 191 cases with suspected COVID-19 sequentially tested with POCT and RT-PCR | VivaDiag | 191 | 21 | 13 | 49 | 107 | 30.0% | 89.2% | 61.8% | 68.6% | 67.4% | 0.215 |
| Perez-Garcia et al. 2020 [11] | 45 healthy controls vs. 55 SARS-CoV-2 cases | AllTest Biotech | 100 | 26 | 0 | 29 | 45 | 47.3% | 100% | 100% | 60.8% | 71.0% | 0.447 |
| Döhla et al. 2020 [22] | 39 cases randomly selected among subjects referring to a German COVID-19 screening center | Undisclosed manufacturer | 49 | 8 | 3 | 14 | 27 | 36.4% | 88.9% | 72.7% | 63.2% | 65.3% | 0.265 |
| Bendavid et al. 2020 [24] | 30 orthopedic patients, samples collected before COVID-19 pandemics; 37 PCR confirmed COVID-19 samples | Premier Biotech | 67 | 25 | 0 | 12 | 30 | 67.6% | 100% | 100% | 71.4% | 82.1% | 0.651 |
| Xiang et al. 2020 [25] | 35 healthy individuals; 91 RT-PCR confirmed plasma samples from COVID-19 patients | Zhuhai Livzon Diagnostics | 126 | 75 | 0 | 16 | 35 | 82.4% | 100% | 100% | 68.6% | 87.3% | 0.723 |
| Adams et al. 2020 [23] | Random samples from a pool of 40 SARS-CoV-2 positive blood samples, and 50 SARS-CoV-2 negative blood samples | Undisclosed manufacturers | 93 | 18 | 0 | 15 | 60 | 54.5% | 100% | 100% | 80.0% | 54.5% | 0.608 |
| 128 | 23 | 1 | 14 | 90 | 62.2% | 98.9% | 95.8% | 86.5% | 62.2% | 0.682 | |||
| 93 | 21 | 2 | 12 | 58 | 63.6% | 96.7% | 91.3% | 82.0% | 63.6% | 0.647 | |||
| 98 | 25 | 1 | 13 | 59 | 65.8% | 98.3% | 96.2% | 81.9% | 65.8% | 0.681 | |||
| 91 | 19 | 2 | 12 | 58 | 61.3% | 96.7% | 90.5% | 82.9% | 61.3% | 0.629 | |||
| 91 | 20 | 1 | 11 | 59 | 64.5% | 98.3% | 95.2% | 84.3% | 64.5% | 0.682 | |||
| 93 | 23 | 3 | 10 | 57 | 69.7% | 95.0% | 88.5% | 85.1% | 69.7% | 0.679 | |||
| 92 | 18 | 0 | 14 | 60 | 56.3% | 100% | 100% | 81.1% | 56.3% | 0.626 | |||
| 212 | 22 | 4 | 48 | 138 | 31.4% | 97.2% | 84.6% | 74.2% | 31.4% | 0.340 | |||
| Liu et al. 2020 [26] | 179 consecutive patients, grouped by results of RT-PCR in SARS-CoV-2 positive (No.90), and negative ones (No.89) | Undisclosed manufacturer | 179 | 77 | 13 | 8 | 81 | 90.6% | 86.2% | 85.6% | 91.0% | 88.3% | 0.765 |