Table 4.
Sensitivity and specificity of kits tested at 3 laboratories compared to confirmed reference results.
| Overall CDC Diagnosis | Laboratory results |
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| ADB-DRL | PHAC | MPIR | Combined | ||||||||||||
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| Test | Measure | N | POS | EQ | NEG | % | POS | EQ | NEG | % | POS | EQ | NEG | % | % (95% CI) |
| InBiosa | Sensitivity | 64 | 54b | NA | 9 | 84.4 | 52b | NA | 11 | 81.3 | 53b | NA | 11 | 82.8 | 82.8 (77.0, 87.7) |
| Specificityc | 78 | 14b | NA | 57 | 73.1 | 6b | NA | 71 | 91.0 | 10b | NA | 67 | 87.2 | 83.3 (78.0, 87.6) | |
| Specificityd | 155 | 45b | NA | 110e | 71.0 | 40b | NA | 115d | 74.2 | 42b | NA | 113e | 72.9 | 72.7 (68.5,76.6) | |
| NovaTec | Sensitivityf | 64 | 40 | 3 | 21 | 67.2 | 40 | 5 | 19 | 70.3 | 45 | 1 | 18 | 71.9 | 69.8 (63.1, 76.0) |
| Specificityc | 78 | 2 | 0 | 76 | 97.4 | 1 | 0 | 77 | 98.7 | 2 | 0 | 76 | 97.4 | 97.9 (95.5, 99.2) | |
| Specificityd | 155 | 3 | 0 | 152 | 98.1 | 2 | 0 | 153 | 98.7 | 6 | 0 | 149 | 96.1 | 97.6 (96.0, 98.8) | |
| Euroimmun IgM | Sensitivitye | 64 | 28 | 4 | 32 | 50.0 | 30 | 3 | 31 | 51.6 | 33 | 4 | 27 | 57.8 | 53.1 (46.1, 60.1) |
| Specificityc | 78 | 0 | 1 | 77 | 98.7 | 1 | 1 | 76 | 97.4 | 3 | 1 | 74 | 96.2 | 97.0 (94.3, 98.7) | |
| Specificityd | 155 | 2 | 1 | 152 | 98.1 | 2 | 1 | 152 | 98.1 | 5 | 1 | 149 | 96.8 | 97.4 (95.7, 98.6) | |
| Euroimmun IgG | Sensitivityf | 64 | 20 | 1 | 43 | 32.8 | 20 | 0 | 44 | 31.3 | 22 | 3 | 39 | 39.1 | 34.4 (27.9, 41.3) |
| Specificityc | 78 | 1 | 0 | 77 | 98.7 | 0 | 1 | 77 | 98.7 | 2 | 0 | 76 | 97.4 | 98.3 (96.1, 99.5) | |
| Specificityd | 155 | 5 | 2 | 148 | 95.5 | 5 | 3 | 147 | 94.8 | 9 | 3 | 143 | 94.2 | 94.2 (91.8, 96.1) | |
| Euroimmun IgM + IgG | Sensitivityf | 64 | 39 | NA | 25 | 60.9 | 39 | NA | 25 | 60.9 | 42 | NA | 22 | 65.6 | 62.5 (55.5, 69.1) |
| Specificityc | 78 | 1 | NA | 77 | 98.7 | 1 | NA | 77 | 98.7 | 5 | NA | 73 | 93.6 | 97.0 (94.3, 98.7) | |
| Specificityd | 155 | 7 | NA | 148 | 95.5 | 7 | NA | 148 | 95.5 | 14 | NA | 141 | 91.0 | 94.0 (91.6, 95.9) | |
For InBios, positive plus negative numbers do not add up to N in some cases, because of the “Presumptive Other Flavivirus” category.
For the InBios kit, positive results are considered both “Presumptive Zika positive” and “Possible Zika positive”.
Specificity denominator consists of true negative samples only.
Specificity denominator consists of 10 YF, 10 WN, 10 CHIK, 47 DEN and 78 NEG samples.
Negative plus Presumptive Other Flavivirus results are classified as a negative result.
Sensitivity was calculated where equivocal results were classified as positive.