【Sensitivity and Specificity】
For IgG testing:
Method | RT-PCR | Total Results | ||
2019-nCOV IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) | Results | Positive | Negative | |
Positive | 233 | 2 | 235 | |
Negative | 25 | 287 | 312 | |
Total Results | 258 | 289 | 547 |
Relative Sensitivity:233/258=90.31%(95%CI*:86.04%-93.40%)
Relative Specificity:287/289=99.31% (95%CI*:97.34%-99.98%)
Accuracy:520/547=95.06% (95%CI*: 92.89%-96.61%)
*Confidence Interval
For IgM testing
Method | RT-PCR | Total Results | ||
2019-nCOV IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) | Results | Positive | Negative | |
Positive | 223 | 7 | 230 | |
Negative | 35 | 282 | 317 | |
Total Results | 258 | 289 | 547 |
Relative Sensitivity:223/258=86.43% (95%CI*:81.68%-90.11%)
Relative Specificity:282/289=97.58% (95%CI*: 94.99%-98.92%)
Accuracy:505/547=92.32% (95%CI*: 89.76%-94.29%)
*Confidence Interval
【DIRECTIONS FOR USE】
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