Table 4.
Specificity of Diagnostic Tests in Specimens Collected at Birth in Different Groups of Uninfected Infants
| Cohort | Testing at Birth | no./No. | % | (95% CI) |
|---|---|---|---|---|
| Training cohort: Uninfected infants of infected mothers (n = 348) |
qPCR | 294/296 | 99.3 | (97.6–99.9) |
| Microscopy | 338/338 | 92.6 | (98.9–100.0) | |
| IgM-TESA blot | 335/346 | 96.8 | (94.4–98.4) | |
| IgM-SAPA test | 344/348 | 98.9 | (97.1–99.7) | |
| Training cohort: Uninfected infants of seronegative mothers (n = 92) | qPCR | NP | NP | NP |
| Microscopy | NP | NP | NP | |
| IgM-TESA blot | NP | NP | NP | |
| IgM-SAPA test | 90/92 | 97.8 | (92.4–99.7) | |
| Validation cohort: Uninfected infants of infected mothers (n = 217) |
qPCR | 212/213 | 99.5 | (97.4–99.9) |
| Microscopy | 189/190 | 99.5 | (97.8–100.0) | |
| IgM-TESA blot | 144/149 | 96.6 | (92.3–98.9) | |
| IgM-SAPA test | 201/217 | 92.6 | (88.3–95.7) | |
| Uninfected infants from nonendemic area (n = 186) |
qPCR | NP | NP | NP |
| Microscopy | NP | NP | NP | |
| IgM-TESA blot | 186/186 | 100.0 | (98.0–100.0) | |
| IgM-SAPA test | 184/186 | 98.9 | (96.2–99.9) |
Abbreviations: CI, confidence interval; IgM-SAPA test, immunoglobulin M shed acute-phase antigen test; IgM-TESA blot, Western blot with trypomastigote excretory-secretory antigen for the detection of immunoglobulin M antibodies; NP, not performed; qPCR, quantitative polymerase chain reaction.