Table 2.
Diagnostic Accuracy of Lateral Flow Urine Lipoarabinomannan Assay and/or Smear Microscopy for Culture-Confirmed Tuberculosis
| Testing Method | Sensitivity | Specificity | PPV, % (95% CI) | NPV, % (95% CI) | ||
|---|---|---|---|---|---|---|
| No./Total | % (95% CI) | No./Total | % (95% CI) | |||
| LF-LAM assay | ||||||
| All patients | 54/72 | 75.0 (63.9–83.6) | 158/208 | 76.0 (69.7–81.3) | 51.9 (42.4–61.3) | 89.8 (84.4–93.4) |
| CD4 cell count | ||||||
| <50/μL | 38/42 | 90.5 (77.9–96.2) | 106/141 | 75.2 (67.4–81.6) | 52.1 (40.8–63.1) | 96.4 (91.0–98.6) |
| 50–100/μL | 9/15 | 60.0 (35.7–80.2) | 34/42 | 81.0 (66.7–90.0) | 52.9 (31.0–73.8) | 85.0 (70.9–92.9) |
| >100/μL to 200/μL | 7/15 | 46.7 (24.8–69.9) | 18/25 | 72.0 (52.4–85.7) | 50.0 (26.8–73.2) | 69.2 (50.0–83.5) |
| Smear microscopy | ||||||
| All patients | 44/72 | 61.1 (49.6–71.5) | 204/208 | 98.1 (95.2–99.2) | 91.7 (80.4–96.7) | 87.9 (83.1–91.5) |
| CD4 cell count | ||||||
| <50/μL | 30/42 | 71.4 (56.4–82.8) | 137/141 | 97.2 (92.9–98.9) | 88.2 (73.4–95.3) | 91.9 (86.5–95.3) |
| 50–100/μL | 5/15 | 33.3 (15.2–58.3) | 42/42 | 100 (91.6–100) | 100 (56.6–100) | 80.8 (68.1–89.2) |
| >100/μL to 200/μL | 9/15 | 60.0 (35.7–80.2) | 25/25 | 100 (86.7–100) | 100 (70.1–100) | 80.6 (63.7–90.8) |
| LF-LAM assay or smear | ||||||
| All patients | 62/72 | 86.1 (76.3–92.3) | 158/208 | 76.0 (69.7–81.3) | 55.4 (46.1–64.2) | 94.0 (89.4–96.7) |
| CD4 cell count | ||||||
| <50/μL | 40/42 | 95.2 (84.2–98.7) | 106/141 | 75.2 (67.4–81.6) | 53.3 (42.2–64.2) | 98.1 (93.5–99.5) |
| 50–100/μL | 10/15 | 66.7 (41.7–84.8) | 34/42 | 81.0 (66.7–90.0) | 55.6 (33.7–75.4) | 87.2 (73.3–94.4) |
| >100/μL to 200/μL | 12/15 | 80.0 (54.8–93.0) | 18/25 | 72.0 (52.4–85.7) | 63.2 (41.0–80.9) | 85.7 (65.4–95.0) |
Abbreviations: CI, confidence interval; LF-LAM, lateral flow urine lipoarabinomannan; NPV, negative predictive value; PPV, positive predictive value.