Table 1.
Demographics and Baseline Results
| Characteristic | Overall (N = 992) | ≥1 Culture TB Positive (n = 219) | Results of First Xpert Assay (n = 970)a |
Results of 2 Xpert Assays (n = 990)b |
||||
|---|---|---|---|---|---|---|---|---|
| Positive (n = 187) | Negative (n = 783) | P Valuec | Positive (n = 210) | Negative (n = 780) | P Valuec | |||
| Age at entry, median (IQR) | 46 (35–54) | 40 (30–51) | 38 (28–51) | 47 (37–54) | <.001 | 39 (28–51) | 47 (38–55) | <.001 |
| Male sex | 617 (62.2) | 129 (58.9) | 116 (19.1) | 490 (80.9) | .889 | 130 (21.1) | 485 (78.9) | .942 |
| Site of enrollment | <.001 | <.001 | ||||||
| Brazil | 155 (15.6) | 37 (16.9) | 32 (20.6) | 123 (79.4) | 37 (23.9) | 118 (76.1) | ||
| South Africa | 199 (20.1) | 90 (41.1) | 76 (39.2) | 118 (60.8) | 84 (42.2) | 115 (57.8) | ||
| United States | 638 (64.3) | 92 (42.0) | 79 (12.7) | 542 (87.3) | 89 (14.0) | 547 (86.0) | ||
| HIV infection status | ||||||||
| HIV infected | 446 (45.0) | 89 (40.6) | 71 (16.2) | 367 (83.8) | .028 | 85 (19.1) | 361 (80.9) | .133 |
| On ART at enrollment (HIV infected only) | ||||||||
| Yes | 155 (34.8) | 12 (13.5) | 12 (8.1) | 137 (91.9) | <.001 | 15 (9.7) | 140 (90.3) | <.001 |
| No | 291 (65.2) | 77 (86.5) | 59 (20.4) | 230 (79.6) | 70 (24.1) | 221 (75.9) | ||
| Presenting symptomsd | ||||||||
| Cough | 923 (93.0) | 205 (93.6) | 177 (19.6) | 725 (80.4) | .322 | 199 (21.6) | 722 (78.4) | .267 |
| Fevere | 526 (53.0) | 122 (55.7) | 108 (21.0) | 406 (79.0) | .118 | 119 (22.7) | 406 (77.3) | .052 |
| Weight lossf | 608 (61.3) | 171 (78.1) | 150 (25.2) | 446 (74.8) | <.001 | 165 (27.2) | 442 (72.8) | <.001 |
| Night sweatsg | 545 (54.9) | 125 (57.1) | 106 (20.1) | 422 (79.9) | .644 | 123 (22.6) | 421 (77.4) | .354 |
| Any of the above | 982 (99.0) | 217 (99.1) | 186 (19.4) | 774 (80.6) | .455 | 208 (21.2) | 772 (78.8) | .925 |
| CXR result | <.001 | <.001 | ||||||
| Abnormal | 776 (78.2) | 197 (90.0) | 172 (22.6) | 588 (77.4) | 190 (24.5) | 585 (75.5) | ||
| CXR findingsh (abnormal only) | ||||||||
| Infiltrate | 380 (49.0) | 139 (70.6) | 124 (33.3) | 248 (66.7) | <.001 | 134 (35.4) | 245 (64.6) | <.001 |
| Cavitation | 125 (16.1) | 73 (37.1) | 74 (59.7) | 50 (40.3) | <.001 | 77 (62.1) | 47 (37.9) | <.001 |
| Pleural effusion | 115 (14.8) | 25 (12.7) | 20 (18.2) | 90 (81.8) | .228 | 21 (18.3) | 94 (81.7) | .091 |
| Other | 419 (54.0) | 79 (40.1) | 70 (16.9) | 343 (83.1) | <.001 | 76 (18.2) | 342 (81.8) | <.001 |
| Location of evaluation | ||||||||
| Inpatient | 572 (57.7) | 98 (44.7) | 84 (15.1) | 471 (84.9) | <.001 | 92 (16.1) | 478 (83.9) | <.001 |
| Outpatient | 420 (42.3) | 121 (55.3) | 103 (24.8) | 312 (75.2) | 118 (28.1) | 302 (71.9) | ||
| TB treatment historyi | <.001 | <.001 | ||||||
| Current TB treatment | 189 (19.1) | 111 (50.7) | 105 (57.4) | 78 (42.6) | 112 (59.6) | 76 (40.4) | ||
| Prior TB treatment | 129 (13.0) | 20 (9.1) | 19 (14.8) | 109 (85.2) | 21 (16.3) | 108 (83.7) | ||
| No history of TB treatment | 666 (67.1) | 88 (40.2) | 63 (9.7) | 588 (90.3) | 77 (11.6) | 588 (88.4) | ||
| AFB smear statusj | ||||||||
| ≥1 AFB+ | 152 (15.3) | 133 (60.7) | 131 (87.3) | 19 (12.7) | <.001 | 135 (88.8) | 17 (11.2) | <.001 |
| 2 AFB– | 838 (84.5) | 86 (39.3) | 56 (6.8) | 762 (93.2) | 75 (9.0) | 761 (91.0) | ||
| Final TB determination | <.001 | <.001 | ||||||
| AFB+/TB culture positive | 133 (13.4) | 133 (60.7) | 129 (98.5) | 2 (1.5) | 133 (100.0) | 0 (0.0) | ||
| AFB–/TB culture positive | 86 (8.7) | 86 (39.3) | 46 (54.8) | 38 (45.2) | 59 (69.4) | 26 (30.6) | ||
| Clinical TB | 57 (5.7) | 0 (0.0) | 2 (3.7) | 52 (96.3) | 4 (7.0) | 53 (93.0) | ||
| Extrapulmonary TB | 2 (0.2) | 0 (0.0) | 0 (0.0) | 2 (100.0) | 0 (0.0) | 2 (100.0) | ||
| No TB | 702 (70.8) | 0 (0.0) | 7 (1.0) | 680 (99.0) | 10 (1.4) | 691 (98.6) | ||
| Indeterminate | 12 (1.2) | 0 (0.0) | 3 (25.0) | 9 (75.0) | 4 (33.3) | 8 (66.7) | ||
Data are presented as No. (%) unless otherwise specified, with column percentages under the Overall and ≥1 Culture TB Positive results and row percentages under the Xpert results.
Abbreviations: AFB, acid-fast bacilli; AFB–, AFB smear negative; AFB+, AFB smear positive; ART, antiretroviral therapy; CXR, chest radiograph; HIV, human immunodeficiency virus; IQR, interquartile range; TB, tuberculosis; Xpert, Xpert MTB/RIF assay.
a Xpert results on sputum sample #1. Invalid results (n = 20) and missing results due to site or laboratory errors (n = 2) were excluded.
b Per-participant Xpert results based on 2 sputum samples (positive = 1 or 2 Xpert-positive results; negative = 2 Xpert-negative or 1 negative plus 1 invalid/missing result). Invalid results (n = 2) were excluded.
c χ2 test, except weight loss, night sweats, AFB status, and final TB determination (Fisher exact test), and age (Wilcoxon test).
d Participants may report >1 symptom.
e There were 21, 6, 6, 14, 8, and 13, respectively, participants whose presence of fever was unknown.
f There were 37, 4, 3, 33, 4, and 33, respectively, participants whose presence of weight loss was unknown.
g There were 25, 2, 3, 21, 3, and 22, respectively, participants whose presence of night sweats was unknown.
h Participants may have >1 abnormal CXR finding.
i There were 8, 0, 0, 8, 0, and 8, respectively, participants whose tuberculosis treatment history was unknown.
j There were 2, 2, 0, 2, 0, and 2, respectively, participants whose AFB status was unknown due to site/laboratory errors.