Table 3.
Sensitivity and specificity of InBios ZIKV Detect™ 2.0 IgM Capture ELISA using samples from probable primary and secondary infections and comparison to results from InBios ZIKV Detect™ IgM Capture ELISA.
| A. Sensitivity using confirmed ZIKV positive samples | ADB-DRL | MPIR | InBios ZIKV Detect™ 2.0 IgM Capture ELISA | InBios ZIKV Detect™ IgM Capture ELISAa | ||||||
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| Probable status | Reference tests | N | POSb | NEGc | % Sensitivity (95% CI) | POS | NEG | % Sensitivity (95% CI) | Mean sensitivity (95% CI) | Mean sensitivity (95% CI) |
| Primary | RT-PCR, PRNT90 | 7 | 7 | 0 | 100.0 (64.6, 100.0) | 7 | 0 | 100.0 (64.6, 100.0) | 100.0 (78.5, 100.0) | 100.0 (78.5, 100.0) |
| Primary | PRNT90 only | 64 | 57 | 7 | 89.1 (79.1, 94.6) | 59 | 5 | 92.2 (83.0, 96.6) | 90.6 (84.3, 94.6) | 83.6 (76.2, 89.0) |
| Overall 1° sensitivity | 71 | 64 | 7 | 90.1 (81.0, 95.1) | 66 | 5 | 93.0 (85.6, 97.0) | 91.5 (85.8, 95.1) | 85.2 (78.4, 90.1) | |
| Secondary | RT-PCR, PRNT90 | 43 | 41 | 2 | 95.3 (84.5, 98.7) | 40 | 3 | 93.0 (81.4, 97.6) | 94.2 (87.1, 97.5) | 98.8 (93.7, 99.9) |
| Secondary | PRNT90 only | 0 | 0 | 0 | 0 | 0 | ||||
| Overall 2° sensitivity | 43 | 41 | 2 | 95.3 (84.5, 98.7) | 40 | 3 | 93.0 (81.4, 97.6) | 94.2 (87.1, 97.5) | 98.8 (93.7, 99.9) | |
| Overall 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) | |
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| B. Specificity using confirmed DENV positive samples | ADB-DRLa | MPIRb | InBios ZIKV Detect™ 2.0 IgM Capture ELISA | InBios ZIKV Detect™ IgM Capture ELISAc | ||||||
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| Probable status | Reference tests | N | POSd | NEGe | % Specificity (95% CI) | POS | NEG | % Specificity (95% CI) | Mean specificity (95% CI) | Mean specificity (95% CI) |
| Primary | RT-PCRf, PRNT90g | 13 | 0 | 13 | 100.0 (77.2, 100.0) | 0 | 13 | 100.0 (77.2, 100.0) | 100.0 (87.1, 100.0) | 23.1 (11.0, 42.1) |
| Primary | PRNT90 only | 17h | 1 | 16 | 94.1 (73.0, 99.7) | 1 | 16 | 94.1 (73.0, 99.7) | 94.1 (80.9, 9834) | 44.1 (28.9, 60.5) |
| Overall 1° specificity | 30 | 1 | 29 | 96.7 (83.3, 99.8) | 1 | 29 | 96.7 (83.3, 99.8) | 96.7 (88.6, 99.1) | 35.0 (24.2, 47.6) | |
| Secondary | RT-PCR, PRNT90 | 37 | 8 | 29 | 78.4 (62.8, 88.6) | 7 | 30 | 81.1 (65.8, 90.5) | 79.7 (69.2, 87.3) | 4.1 (1.4, 11.3) |
| Secondary | PRNT90 only | 6 | 0 | 6 | 100.0 (61.0, 100.0) | 0 | 6 | 100.0 (61.0, 100.0) | 100.0 (75.8, 100.0) | 41.7 (19.3, 68.0) |
| Overall 2° specificity | 43 | 8 | 35 | 81.4 (67.4, 90.3) | 7 | 36 | 83.7 (70.0, 91.9) | 82.6 (73.2, 89.1) | 9.3 (4.8, 17.3) | |
| Overall specificity | 73 | 9 | 64 | 87.7 (78.2, 93.4) | 8 | 65 | 89.0 (79.8, 94.3) | 88.4 (82.1, 92.6) | 19.9 (14.2, 27.1) | |
Arbovirus Diseases Branch-Diagnostic and Reference Laboratory.
Microbial Pathogenesis and Immune Response Laboratory.
Numbers reported here include data from both ADB-DRL and MPIR and thus differ somewhat from the data reported in Table 5 of Basile et al. (2018).
Presumptive Zika Positive classified as POS. Note that in Table 5 of Basile et al. (2018), both Presumptive Zika Positive and Possible Zika positive were classified as POS.
Presumptive Other Flavivirus Positive and Negative classified as NEG.
Reverse transcriptase polymerase chain reaction.
90% Plaque-reduction neutralization test.
One sample was excluded from this analysis compared to the previously-published analysis.