Table 3.
Clinical Performance of the Truvian Easy Check COVID-19 IgM/IgG Test Devicea
| Test | Prepandemic | PCR-Positive | |||||
|---|---|---|---|---|---|---|---|
| 0-6 d | 7-13 d | ≥14 d | |||||
| No Disease | Disease | Disease | Disease | ||||
| Truvian Ab positive | 1 | 17 | 16 | 57 | |||
| Truvian Ab negative | 55 | 5 | 2 | 2 | |||
| Total | 56 | 22 | 18 | 59 | |||
| Statistic | Value | (95% CI) | Value | (95% CI) | Value | (95% CI) | |
| Sensitivity (%) | 77.27 | (54.63-92.18) | 88.89 | (65.29-98.62) | 96.61 | (88.29-99.59) | |
| Specificity (%) | 98.21 | (90.45-99.95) | 98.21 | (90.45-99.95) | 98.21 | (90.45-99.95) | |
| Disease prevalence (%) | 5.0 | 5.0 | 5.0 | ||||
| Positive predictive value (%) | 69.49 | (24.37-94.15) | 72.37 | (27.17-94.85) | 74.01 | (28.98-95.21) | |
| Negative predictive value (%) | 98.80 | (97.43-99.44) | 99.41 | (97.85-99.84) | 99.82 | (99.30-99.95) | |
| Accuracy (%) | 97.17 | (90.64-99.60) | 97.75 | (91.26-99.80) | 98.13 | (93.67-99.75) |
Ab, antibody; CI, confidence interval; PCR, polymerase chain reaction.
aA total of 155 clinical samples consisting of 99 PCR-confirmed, SARS-CoV-2-positive patient sera samples from 2020 and 56 prepandemic patient sera samples from 2015 were used to evaluate the point-of-care testing performance of the Easy Check device.