Table 3. Comparison of urinary LAM ELISA and strip tests with clinical diagnostics for diagnosing TBP (definite-TB for sensitivity and non-TB for specificity calculations).
| Diagnostic Test | Sensitivity (95% CI) (n/N) | Specificity (95% CI% CI) (n/N) | Positive Likelihood ratio, LR+ (95% CI) | Negative Likelihood ratio, LR− (95% CI) | Positive predictive value, PPV (95% CI) | Negative predictive value, NPV (95% CI) |
|---|---|---|---|---|---|---|
| Urine LAM ELISA | 17.4%* (9.1–30.7) 8/46 | 93.8% (71.7–98.9) 15/16 | 2.8 (0.1–63.3) | 0.9 (0.8–0.9) | 88.9% (56.5–98.0) | 28.3% (17.9–41.6) |
| Urine LAM strip test (grade 2 cut-point) | 26.7%* (15.9–41.0) 12/45 | 90.9% (62.2–98.4) 10/11 | 2.9 (0.3–32.6) | 0.8 (0.7–0.9) | 92.3% (66.7–98.6) | 23.3% (13.2–37.7) |
| Tygerberg score ≥6 | 85.3%* (75.9–81) 58/68 | 77.3% (56.6–89.9) 17/22 | 3.75 (2.52–5.59) | 0.19 (0.15–0.24) | 61.7% (56.9–66.2) | 92.5% (90.0–94.3) |
| IMPI Clinical predictors (rule-in cut-point >6.1) | 60.8%* (49.4–71.1) 45/74 | 96.3% (81.7–99.3) 26/27 | 16.4 (2.25–119.9) | 0.41 (0.38–0.44) | 87.6% (82.4–91.4) | 85.1% (82.5–87.5) |
| IMPI Clinical predictors (Youden’s and rule-out cut-point >3.5) | 91.9%* (83.4–96.2) 68/74 | 81.5% (63.3–91.8) 22/27 | 4.96 (3.34–7.36) | 0.1 (0.07–0.14) | 68.0% (63.3–72.4) | 95.9% (94.0–97.2) |
*Tygerberg score ≥6 and IMPI Clinical predictors (rule-in cut-point >6.1 and rule-out cut-point >3.5) had a significantly greater sensitivity (p < 0.001).