Table 3.
Sensitivity and Specificity of Rapid Diagnostic Tests, All Regions
| Product | Manufacturer | East Africa |
Brazil |
Indian Subcontinent |
|||
|---|---|---|---|---|---|---|---|
| Sensitivity (95% CI)(n = 250) | Specificity (95% CI)(n = 250) | Sensitivity (95% CI) | Specificity (95% CI) | Sensitivity (95% CI)(n = 250) | Specificity (95% CI)(n = 249) | ||
| CrystalKA | Span Diagnostics | 36.8% (31.1%–42.9%) | 98.0% (95.4%–99.1%) | 61.5% (55.2%–67.4%)a | 98.4% (95.9%–99.4%)b | 92.8% (88.9%–95.4%) | 99.2% (97.1%–99.8%) |
| DiaMed-IT LEISH | Bio-Rad Laboratories | 87.2% (82.5%–90.8%) | 96.4% (93.3%–98.1%) | 92.0% (87.8%–94.8%)c | 95.6% (92.2%–97.5%)d | 98.8% (96.5%–99.6%) | 97.6% (94.8%–98.9%) |
| Kalazar Detect | InBios International, | 67.6% (61.6%–73.1%) | 90.8% (86.6%–93.8%) | 84.7% (79.7%–88.7%)e | 96.8% (93.9%–98.4%)f | 99.6% (97.8%–99.9%) | 96.0% (92.8%–97.8%) |
| Signal–KA | Span Diagnostics | 73.2% (67.4%–78.3%) | 96.4% (93.3%–98.1%) | 79.2% (73.7%–83.8%)g | 98.8% (96.6%–99.6%)h | 100% (97.9%–100%)i | 100% (97.8%–100%)j |
| OnSite Leishmania Ab Rapid | CTK Biotech | NA | NA | NA | NA | 99.6% (97.8%–99.9%) | 96.8% (93.8%–98.4%) |
Abbreviations: CI, confidence interval; NA, not applicable.
a n = 244.
b n = 249.
c n = 237.
d n = 248.
e n = 249.
f n = 252.
g n = 250.
h n = 254.
i n = 175.
j n = 170.