Table 8. Specificity of the serology test based on the ELISA using the PGL-Tb1 or the ESAT-6/CFP10 antigens and their cumulative results in the different groups of individuals classified as low risk of TB infection.
Antigen | n/N | Blood donors | n/N | Healthy subjects | p value of blood donors versus Healthy subjects | n/N | Total |
Percentage (95% CI) | |||||||
PGL-Tb1* | 418/459 | 91.1 (88.0–93.4) | 90/100 | 90.0 (82.4–94.5) | p = 0.7038 | 508/559 | 90.9 (88.2–93.1) |
ESAT-6/CFP10** | 421/459 | 91.7 (88.8–94.0) | 90/100 | 90.0 (82.4–94.5) | p = 0.5573 | 511/559 | 91.4 (88.7–93.5) |
PGL-Tb1 versus ESAT-/CFP10 (p value) | p = 0.8141 | p = 1.000 | p = 0.8334 | ||||
Both antigens | 389/459 | 84.8 (81.1–87.9) | 80/100 | 80.0 (70.9–86.8) | p = 0.2336 | 469/559 | 83.9 (80.6–86.9) |
Footnotes: n/N = number of negative tests/number of tested sera in each group; * Cut-off value for PGL-Tb1: OD = 0.130; ** Cut-off value for ESAT-6/CFP10: OD = 0.100.