Table 2.
Diagnostic accuracy of MTB-HR at a cutoff of 1·5 against the strict reference standard using culture for different subgroups
|
Samples, n |
Sensitivity, % (95% CI) | Specificity, % (95% CI) | ||||||
|---|---|---|---|---|---|---|---|---|
| All | True positive | False positive | False negative | True negative | ||||
| Overall | 334 | 76 | 20 | 51 | 187 | 59·8% (50·8–68·4) | 90·3% (85·5–94·0) | |
| Age, years | ||||||||
| <1 | 37 | 8 | 1 | 11 | 17 | 42·1% (20·3–66·5) | 94·4% (72·7–99·9) | |
| 1–4 | 99 | 19 | 6 | 9 | 65 | 67·9% (47·6–84·1) | 91·5% (82·5–96·8) | |
| 5–9 | 116 | 14 | 9 | 16 | 77 | 46·7% (28·3–65·7) | 89·5% (81·1–95·1) | |
| 10–14 | 82 | 35 | 4 | 15 | 28 | 70·0% (55·4–82·1) | 87·5% (71·0–96·5) | |
| HIV status | ||||||||
| Negative* | 302 | 72 | 17 | 46 | 167 | 61·0% (51·6–69·9) | 90·8% (85·6–94·5) | |
| Positive | 26 | 4 | 2 | 4 | 16 | 50·0% (15·7–84·3) | 88·9% (65·3–98·6) | |
| Malnutrition† | ||||||||
| None | 265 | 51 | 18 | 41 | 155 | 55·4% (44·7–65·8) | 89·6% (84·1–93·7) | |
| Mild or moderate | 34 | 13 | 1 | 4 | 16 | 76·5% (50·1–93·2) | 94·1% (71·3–99·9) | |
| Severe | 35 | 12 | 1 | 6 | 16 | 66·7% (41·0–86·7) | 94·1% (71·3–99·9) | |
| Site | ||||||||
| South Africa | 77 | 35 | 3 | 13 | 26 | 72·9% (58·2–84·7) | 89·7% (72·6–97·8) | |
| Tanzania | 109 | 15 | 6 | 16 | 72 | 48·4% (30·2–66·9) | 92·3% (84·0–97·1) | |
| Mozambique | 69 | 7 | 5 | 3 | 54 | 70·0% (34·8–93·3) | 91·5% (81·3–97·2) | |
| Malawi | 34 | 1 | 4 | 5 | 24 | 16·7% (0·4–64·1) | 85·7% (67·3–96·0) | |
| India | 45 | 18 | 2 | 14 | 11 | 56·3% (37·7–73·6) | 84·6% (54·6–98·1) | |
| Tuberculosis severity‡ | ||||||||
| Non severe§ | 21 | 9 | .. | 12 | .. | 42·9% (21·8–66·0) | .. | |
| Severe¶ | 102 | 66 | .. | 36 | .. | 64·7% (54·6–73·9) | .. | |
| Tuberculosis location‡ | ||||||||
| Pulmonary tuberculosis | 69 | 39 | .. | 30 | .. | 56·5% (44·0–68·4) | .. | |
| Extrapulmonary tuberculosis | 18 | 9 | .. | 9 | .. | 50·0% (26·0–74·0) | .. | |
| Pulmonary and extrapulmonary tuberculosis | 36 | 27 | .. | 9 | .. | 75·0% (57·8–87·9) | .. | |
| Lymph node tuberculosis | 20 | 14 | .. | 6 | .. | 70·0% (45·7–88·1) | .. | |
| Tuberculosis meningitis | 12 | 8 | .. | 4 | .. | 66·7% (34·9–90·1) | .. | |
Totals might differ due to missing data. MTB-HR=Cepheid Mycobacterium tuberculosis Host Response prototype cartridge.
*
Includes children who are HIV-exposed but not positive.
†
According to WHO child growth standards.19
‡
Tuberculosis disease severity and location imply that the child already has tuberculosis; therefore, calculating a specificity was not possible.
§
According to WHO definition,18 outlined in the appendix (p 3).
¶
Children not meeting non-severe tuberculosis disease definition.