Table 2. Comparison of clinical performance of singleplex loop-mediated isothermal amplification for detection of Treponema pallidum and Haemophilus ducreyi against singleplex TaqMan quantitative PCR*.
| Characteristics | Sample size | Treponema pallidum | Haemophilus ducreyi |
|---|---|---|---|
| Total samples, no. | 293 | ||
| No. positive | 51 | 175 | |
| Sensitivity, % (95% CI) | 78.0 (64.9–87.3) | 91.0 (85.0–94.8) | |
| Specificity, % (95% CI) |
|
97.9 (94.8–99.2) |
75.3 (67.2–82.1) |
| Lesions containing a single pathogen† | 195 | ||
| No. positive | 34 | 158 | |
| Sensitivity, % (95% CI) | 82.5 (66.6–92.1) | 92.6 (86.5–96.2) | |
| Specificity, % (95% CI) |
|
97.9 (94.8–99.2) |
75.4 (67.2–82.1) |
| Lesions containing both pathogens† | 19 | ||
| No. positive samples | 17 | 17 | |
| Sensitivity, % (95% CI) | 68.4 (43.5–86.4) | 78.9 (53.9–93.0) | |
| Specificity, % (95% CI) | NA | NA |
*NA, not applicable. †Determined by quantitative PCR.