Table 5.
Sensitivity and specificity of FujiLAM versus AlereLAM against MRS (A) and CRS (B) by CD4 strata
| Test | N | TP | FP | FN | TN | Sensitivity (95% CI) | Specificity (95% CI) | |
| 0–100 cells/µL | FujiLAM | 148 | 27 | 35 | 5 | 81 | 84.4% (67.2–94.7) | 69.8% (60.6–78.0) |
| AlereLAM | 148 | 21 | 14 | 11 | 102 | 65.6% (46.8–81.4) | 87.9% (80.6–93.2) | |
| △Sn and △Sn | 18.8% (6.0 to 35.3) | −18.1% (−27.6 to −9.0) | ||||||
| >100 cells/µL | FujiLAM | 288 | 20 | 3 | 12 | 253 | 62.5% (43.7–78.9) | 98.8% (96.6–99.8) |
| AlereLAM | 288 | 12 | 2 | 20 | 254 | 37.5% (21.1–56.3) | 99.2% (97.2–99.9) | |
| △Sn and △Sn | 25.0% (11.6 to 42.1) | −0.4% (−2.5 to 1.5) | ||||||
| 0–200 cells/µL | FujiLAM | 237 | 39 | 35 | 10 | 153 | 79.6% (65.7–89.8) | 81.4% (75.1–86.7) |
| AlereLAM | 237 | 29 | 15 | 20 | 173 | 59.2% (44.2–73.0) | 92.0% (87.2–95.5) | |
| △Sn and △Sn | 20.4% (11.5 to 33.6) | −10.6% (−17.0 to −4.8) | ||||||
| >200 cells/µL | FujiLAM | 199 | 8 | 3 | 7 | 181 | 53.3% (26.6–78.7) | 98.4% (95.3–99.7) |
| AlereLAM | 199 | 4 | 1 | 11 | 183 | 26.7% (7.8–55.1) | 99.5% (97.0–100.0) | |
| △Sn and △Sn | 26.6% (0.8 to 52.0) | −1.1% (−3.9 to 1.0) | ||||||
| 101–200 cells/µL | FujiLAM | 89 | 12 | 0 | 5 | 72 | 70.6% (44.0–89.7) | 100.0% (95.0–100.0) |
| AlereLAM | 89 | 8 | 1 | 9 | 71 | 47.1% (23.0–72.2) | 98.6% (92.5–100.0) | |
| △Sn and △Sn | 23.5% (−0.8 to 47.3) | 1.4% (−3.7 to 7.5) | ||||||
| CRS | Test | N | TP | FP | FN | TN | Sensitivity (95% CI) | Specificity (95% CI) |
| 0–100 cells/µL | FujiLAM | 148 | 38 | 24 | 13 | 73 | 74.5% (60.4–85.7) | 75.3% (65.5–83.5) |
| AlereLAM | 148 | 28 | 7 | 23 | 90 | 54.9% (40.3–68.9) | 92.8% (85.7–97.0) | |
| △Sn and △Sn | 19.6% (6.0 to 33.9) | −17.5% (−27.6 to −8.1) | ||||||
| >100 cells/µL | FujiLAM | 288 | 21 | 2 | 22 | 243 | 48.8% (33.3–64.5) | 99.2% (97.1–99.9) |
| AlereLAM | 288 | 12 | 2 | 31 | 243 | 27.9% (15.3–43.7) | 99.2% (97.1–99.9) | |
| △Sn and △Sn | 20.9% (11.0 to 35.2) | 0.0% (−1.9 to 1.9) | ||||||
| 0–200 cells/µL | FujiLAM | 237 | 50 | 24 | 22 | 141 | 69.4% (57.5–79.8) | 85.5% (79.1–90.5) |
| AlereLAM | 237 | 36 | 8 | 36 | 157 | 50.0% (38.0–62.0) | 95.2% (90.7–97.9) | |
| △Sn and △Sn | 19.4% (9.0 to 31.0) | −9.7% (−16.1 to −3.9) | ||||||
| >200 cells/µL | FujiLAM | 199 | 9 | 2 | 13 | 175 | 40.9% (20.7–63.6) | 98.9% (96.0–99.9) |
| AlereLAM | 199 | 4 | 1 | 18 | 176 | 18.2% (5.2–40.3) | 99.4% (96.9–100.0) | |
| △Sn and △Sn | 22.7% (0.4 to 43.4) | −0.6% (−3.1 to 1.6) | ||||||
| 101–200 cells/µL | FujiLAM | 89 | 12 | 0 | 9 | 68 | 57.1% (34.0–78.2) | 100.0% (94.7–100.0) |
| AlereLAM | 89 | 8 | 1 | 13 | 67 | 38.1% (18.1–61.6) | 98.5% (92.1–100.0) | |
| △Sn and △Sn | 19.0% (0.6 to 40.0) | 1.5% (−4.0 to 7.9) |
Abbreviations: AlereLAM, Alere Determine TB LAM Ag assay; CI, confidence interval; CRS, composite reference standard; FN, false negatives; FP, false positives; FujiLAM, Fujifilm SILVAMP TB LAM assay; LAM, lipoarabinomannan; MRS, microbiological reference standard; Sn, sensitivity; Sp, specificity; TN, true negatives; TP, true positive.
(A) Diagnostic accuracy using a MRS: Definite tuberculosis were considered reference standard positive. Not tuberculosis and Possible tuberculosis were considered reference standard negative. (B) Diagnostic accuracy using a CRS: Definite tuberculosis and Possible tuberculosis were considered reference standard positive. Not tuberculosis were considered reference standard negative.