Table 12. Sensitivity of the serology test based on the ELISA using the PGL-Tb1 and ESAT-6/CFP10 antigens and their cumulative results in active pulmonary TB patients stratified by SM grade and HIV status.
| HIV status | n/N | SM (-) | n/N | SM scanty | n/N | SM (+) | n/N | SM (++) | n/N | SM (+++) |
| % (95% CI) | % (95% CI) | % (95% CI) | % (95% CI) | % (95% CI) | ||||||
| HIV-infected | ||||||||||
| PGL-Tb1 | 31/40 | 77.5 (61.6–89.2) | 4/4 | 100 (39.8–100) | 5/7 | 71.4 (29.0–96.3) | 6/10 | 60.0 (26.2–87.8) | 4/7 | 57.1 (18.4–90.1) |
| p SM (-) versus others | 0.56 | 0.66 | 0.42 | 0.35 | ||||||
| ESAT6/CFP10 | 28/40 | 70.0 (53.5–83.4) | 2/4 | 50.0 (68.0–93.2) | 3/7 | 42.9 (10.0–81.6) | 6/10 | 60.0 (26.2–87.8) | 3/7 | 42.9 (10. –81.6) |
| p SM (-) versus others | 0.58 | 0.21 | 0.71 | 0.21 | ||||||
| Both antigens | 33/40 | 82.5 (67.2–92.7) | 4/4 | 100 (39.8–100) | 5/7 | 71.4 (29.0–96.3) | 6/10 | 60.0 (26.2–87.8) | 4/7 | 57.1 (18.4–90.1) |
| p SM (-) versus others | 1.00 | 0.61 | 0.20 | 0.16 | ||||||
| HIV-uninfected | ||||||||||
| PGL-Tb1 | 19/64 | 29.7 (18.9–42.4) | 9/24 | 37.5 (18.8–59.4) | 20/53 | 37.7 (24.8–52.1) | 20/50 | 40.0 (26.4–54.8) | 36/79 | 45.6 (34.3–57.2) |
| p SM (-) versus others | 0.60 | 0.43 | 0.32 | 0.06 | ||||||
| ESAT6/CFP10 | 21/64 | 32.8 (21.6–45.7) | 6/24 | 25.0 (9.8–46.7) | 18/53 | 34.0 (21.5–48.3) | 13/50 | 26.0 (14.6–40.3) | 25/79 | 31.7 (21.6–43.1) |
| p SM (-) versus others | 0.61 | 1.00 | 0.54 | 1.00 | ||||||
| Both antigens | 28/64 | 43.8 (31.4–56.7) | 12/24 | 50.0 (29.1–70.9) | 26/53 | 49.1 (35.1–63.2) | 23/50 | 46.0 (31.8–60.7) | 43/79 | 54.4 (42.8–65.7) |
| p SM (-) versus others | 0.64 | 0.58 | 0.85 | 0.24 | ||||||
| HIV-unknown | ||||||||||
| PGL-Tb1 | 49/113 | 43.4 (34.1–53.0) | 9/14 | 64.3 (35.1–87.2) | 30/52 | 57.7 (43.2–71.3) | 11/39 | 28.2 (15.0–44.9) | 37/75 | 49.3 (37.6–61.1) |
| p SM (-) versus others | 0.16 | 0.10 | 0.13 | 0.46 | ||||||
| ESAT6/CFP10 | 30/113 | 26.6 (18.7–35.7) | 6/14 | 42.9 (17.7–71.1) | 18/52 | 34.6 (22.0–49.1) | 12/39 | 30.8 (17.0–47.6) | 23/75 | 30.7 (20.5–42.4) |
| p SM (-) versus others | 0.22 | 0.36 | 0.68 | 0.62 | ||||||
| Both antigens | 56/113 | 49.6 (40.0–59.1) | 10/14 | 71.4 (41.9–91.6) | 36/52 | 69.2 (54.9–81.3) | 20/39 | 51.3 (34.8–67.8) | 45/75 | 60.0 (48.4–71.2) |
| p SM (-) versus others | 0.16 | 0.0196 | 1.00 | 0.18 |
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.