Table 2.
Performance measures of the ZIKV Detect™ 2.0 IgM Capture ELISA compared to the ZIKV Detect™ IgM Capture ELISA using serum panels 1 and 2 combined.
| ZIKV Detect™ 2.0 IgM Capture ELISA |
ZIKV Detect™ IgM Capture ELISA | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| ADB-DRLa |
MPIRb |
ADB-DRL+ MPIR | ADB-DRL + MPIR | ||||||
| Measure | N | POS | NEG | % (95% CI) | POS | NEG | % (95% CI) | Overall % (95% CI) | Overall % (95% CI) |
| Sensitivity | 114 | 105 | 9 | 92.1 (85.7, 95.8) | 106 | 8 | 93.0 (86.8, 96.4) | 92.5 (88.4, 95.3) | 90.4 (85.8, 93.5) |
| Specificityc | 78 | 2 | 76 | 97.4 (91.1, 99.3) | 2 | 76 | 97.4 (91.1, 99.3) | 97.4 (93.6, 99.0) | 79.5 (72.5, 85.1) |
| Specificityd | 205 | 11 | 194 | 94.6 (90.6, 97.0) | 10 | 195 | 95.1 (91.3, 97.3) | 94.9 (92.3, 96.6) | 56.6 (51.7, 61.3) |
| Accuracye | 89.0 (85.0, 92.0)) | 90.0 (86.1, 92.8) | 89.5 (86.8, 91.7) | 63.9 (60.1, 67.6) | |||||
| Controls | Coefficient of variation (95% CI) | ||||||||
| Positive | 15.0 (10.8, 24.6) | 16.5 (12.0, 26.4) | 15.7 (12.5, 21.4) | 34.3 (26.0, 51.1) | |||||
| Negative | 16.4 (11.8, 27.0) | 14.5 (10.6, 23.1) | 15.6 (12.4, 21.3) | 22.9 (17.5, 33.1) | |||||
| % agreement (Fleiss’ Kappa statistic: 95% CI) | |||||||||
| Agreement | 97.4 (0.96: 0.93, 0.99) | 79.5 (0.59: 0.51, 0.67) | |||||||
a
Arbovirus Diseases Branch-Diagnostic and Reference Laboratory.
b
Microbial Pathogenesis and Immune Response Laboratory.
c
Specificity denominator consists of true negatives only.
d
Specificity denominator consists of 10 YFV, 10 WNV, 10 CHIKV, 97 DENV and 78 NEG samples.
e
Accuracy based on proportion correctly identified within the following categories: ZIKV = “Presumptive Zika Positive,” DENV and WNV = “Presumptive Other Flavivirus,” and CHIKV and NEG = “Negative” (except for one CHIKV sample that was classified as “Presumptive Other Flavivirus” due to apparent dual infection).