Table 3. Sensitivity and specificity comparison between GenBody and in-house IA assays for study of Zika diagnosis, Singapore*.
| Late phase, 7–16 dpo | Sensitivity, % (95% CI) |
Specificity, % (95% CI) |
|||||
|---|---|---|---|---|---|---|---|
| GenBody | Lateral flow |
GenBody | Lateral flow |
||||
| F1 | F2 | F1 | F2 | ||||
| IgM | 28.6 (15.7–44.6) | 76.2 (60.5–87.9) | 73.8 (58.0–86.1) | 97.4 (86.5–99.9) | 100.0 (91.0–100.0) | 94.9 (82.7–99.4) | |
| IgG | 71.4 (55.4–84.3) | 85.7 (71.4–94.6) | 76.2 (60.5–87.9) | 61.5 (44.6–76.6) | 79.5 (63.5–90.7) | 89.7 (75.8–97.1) | |
| IgM/IgG | 78.6 (63.2–89.7) | 85.7 (71.4–94.6) | 85.7 (71.5–94.6) | 56.0 (42.1–74.4) | 79.5 (63.5–90.7) | 84.6 (69.5–94.1) | |
*All IA assays were evaluated with TTSH plasma for IgM and IgG test (ZIKV, n = 42; DENV, n = 39, 7–16 dpo, subset of blinded test samples). GenBody strips were tested in a nonblinded approach, and compared with F1 and F2 results that were obtained from the blinded test of the validation set. DENV, dengue virus; dpo, days post onset of symptoms; F1, capture format; F2, detector format; IA, immunochromatographic assay; TTSH, Tan Tock Seng Hospital; ZIKV, Zika virus.