Table 10. Sensitivity of the serology test based on the ELISA using the PGL-Tb1 and ESAT-6/CFP10 antigens and their cumulative results in active TB patients stratified by Smear Microscopy (SM), TB localization and HIV status.
Antigen | HIV status | Pulmonary | p value SM(−) versus SM(+) | Extrapulmonary | p valueSM(−) versus SM(+) | ||||||
n/N | SM-negative | n/N | SM-positive | n/N | SM-negative | n/N | SM-positive | ||||
% (95% CI) | % (95% CI) | % (95% CI) | % (95% CI) | ||||||||
PGLTb1* | Infected | 31/40 | 77.5 (61.6–89.2) | 19/28 | 67.9 (47.7–84.1) | 0.4130 | 22/30 | 73.3 (54.1–87.7) | 2/4 | 50.0 (9.6–93.2) | 0.5636 |
Uninfected | 19/64 | 29.7 (18.9–42.4) | 85/206 | 41.3 (34.5–48.3) | 0.1072 | 11/37 | 29.0 (15.4–45.9) | 2/9 | 22.2 (2.8–60.0) | 1.0000 | |
Unknown | 49/113 | 43.4 (34.1–53.0) | 87/180 | 48.3 (40.855.9) | 0.4704 | 19/55 | 34.6 (22.2–48.6) | 3/12 | 25.0 (5.5–57.2) | 0.7371 | |
Uninfected +unknown | 68/177 | 38.4 (31.2–46.0) | 172/386 | 44.6 (39.5–49.7) | 0.1989 | 30/92 | 32.3 (22.9–42.8) | 5/21 | 23.8 (8.2–47.2) | 0.6022 | |
Total | 99/217 | 45.6 (38.9–52.5) | 191/414 | 46.1 (41.3–51.1) | 0.9331 | 52/122 | 42.3 (33.4–51.5) | 7/25 | 28.0 (12.1–49.4) | 0.2626 | |
ESAT6/CFP10** | Infected | 28/40 | 70.0 (53.5–83.4) | 14/28 | 50.9 (30.7–69.4) | 0.1294 | 20/30 | 66.7 (47.2–82.7) | 3/4 | 75.0 (19.4–99.4) | 1.0000 |
Uninfected | 21/64 | 32.8 (21.6–45.7) | 62/206 | 30.1 (23.9–36.9) | 0.7567 | 9/37 | 24.3 (11.8–41.2) | 2/9 | 22.2 (2.8–60.0) | 1.0000 | |
Unknown | 30/113 | 26.6 (18.7–35.7) | 59/180 | 32.8 (26.0–40.2) | 0.2972 | 9/55 | 16.4 (7.7–28.8) | 2/12 | 16.7 (2.1–48.4) | 1.0000 | |
Uninfected +unknown | 51/177 | 28.8 (22.3–36.1) | 121/386 | 31.4 (26.8–36.2) | 0.5563 | 18/92 | 19.6 (12.0–29.2) | 4/21 | 19.1 (5.5–41.9) | 1.0000 | |
Total | 79/217 | 36.4 (30.0–43.2) | 135/414 | 32.6 (28.1–37.4) | 0.3761 | 38/122 | 31.2 (23.1–40.2) | 7/25 | 28.0 (12.1–49.4) | 0.8166 | |
Both antigens | Infected | 33/40 | 82.5 (67.2–92.7) | 19/28 | 67.9 (47.7–84.4) | 0.2451 | 23/30 | 73.3 (54.1–87.7) | 3/4 | 75.0 (19.4–99.4) | 1.0000 |
Uninfected | 28/64 | 43.8 (31.4–56.7) | 104/102 | 50.5 (43.5–57.5) | 0.3914 | 16/37 | 43.2 (27.1–60.5) | 4/9 | 44.4 (13.7–78.8) | 1.0000 | |
Unknown | 56/113 | 49.6 (40.0–59.1) | 111/180 | 61.7 (54.1–68.8) | 0.0523 | 22/55 | 40.0 (27.0–54.1) | 3/12 | 25.0 (5.5–57.2) | 0.5120 | |
Uninfected +unknown | 84/177 | 47.5 (39.9–55.1) | 215/386 | 55.7 (50.6–61.7) | 0.0699 | 38/92 | 46.3 (35.3–57.7) | 7/21 | 33.3 (14.6–57.0) | 0.3313 | |
Total | 117/217 | 53.9 (47.0–60.7) | 234/414 | 56.6 (51.6–61.4) | 0.5554 | 61/122 | 50.0 (40.8–59.2) | 10/25 | 40.0 (23.1–61.3 | 0.3884 |
Footnotes: TB: tuberculosis; HIV: human immunodeficiency virus; n/N = number of positive tests/number of tested sera in each group; SM: smear microscopy; * Cut-off value for PGL-Tb1: OD = 0.130; ** Cut-off value for ESAT-6/CFP10: OD = 0.100; CI: confidence interval.