Study | N of samples tested | Age | EIA threshold | PRNT threshold | EIA equivocal grouped as | TP | FP | FN | TN | Sensitivity % (95% CI) | Specificity % (95% CI) | PPV % (95% CI) | NPV % (95% CI) | Kappa statistic | R |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cohen 2006 [25] | 100 | NR | < 0.1 O.D | Batch specific cut offa | Positive | 69 | 0 | 8 | 23 | 89.6 (80.6–95.4) | 100.0 (85.2–100.0) | 100.0(94.8–100.0)c | 74.2 (55.4–88.1)c | NR | 83.0% |
Cohen 2008 [21]e | 210 | 9 m | < 0.1 O.D (Automatic) | ≥ 120 mIU/mL | Positive | 118 | 2 | 60 | 30 | 66.3 (58.8–73.2)d | 93.8 (79.2–99.2)d | 98.3 (94.1–99.8)d | 33.3 (23.7–44.1)d | NR | 0.67e |
< 0.1 O.D (Automatic) | ≥ 120 mIU/mL | Negative | 57 | 0 | 121 | 32 | 32.0 (25.0–39.0)d | 100.0 (89.0–100.0)d | 100.0 (93.7–100.0)d | 20.9 (14.8–28.2)d | NR | 0.67e | |||
< 0.1 O.D (Manual) | ≥ 120 mIU/mL | Positive | 156 | 10 | 22 | 22 | 87.6 (81.9–92.1)d | 68.8(50.0–83.9)d | 94.0 (89.2–97.1)d | 50.0 (34.6–65.4)d | NR | NR | |||
< 0.1 O.D (Manual) | ≥ 120 mIU/mL | Negative | 110 | 1 | 68 | 31 | 62.0 (54.0–69.0)d | 97.0 (84.0–100.0)d | 99.1 (95.1–100.0)d | 31.3 (22.4–41.4)d | NR | NR | |||
Dorigo-Zetsma 2015 [45] | 154 | ≥ 18yrs | < 0.1 O.D | ≥ 120 mIU/mL | Positive | 139 | 0 | 14 | 1 | 90.8 (85.1–94.9) | 100.0 (2.5–100.0)c | 100.0 (97.4–100.0)c | 6.7 (0.2–31.9)c | NR | NR |
Ratnam 1995 [63] | 1287 | 12-15 m | < 0.1 O.D | ≥ 120 mIU/mL | Excluded | 160 | 4 | 0 | 39 | 100.0 (97.7–100.0) | 90.7 (77.9–97.4) | 97.6 (93.9–99.3) | 100.0 (91.0–100.0) | NR | NR |
≥ 8 mIU/mL | Excluded | 623 | 6 | 100 | 538 | 86.2 (83.4–88.6) | 98.9 (97.6–99.6) | 99.0 (97.9–99.6) | 84.3 (81.3–87.1) | NR | NR | ||||
Ratnam 1995 [63] | 229 | 1-16yrs | < 0.1 O.D | ≥ 120 mIU/mL | Excluded | 588 | 41 | 7 | 631 | 98.8 (97.6–99.5) | 93.9 (91.8–95.6) | 93.5 (91.3–95.3) | 98.9 (97.8–99.6) | NR | NR |
≥ 8 mIU/mL | Excluded | 164 | 0 | 22 | 17 | 88.2 (82.6–92.4) | 100.0 (80.5–100.0) | 100.0 (97.8–100.0) | 43.6 (27.8–60.4) | NR | NR | ||||
Tischer 2007 [27] | 151 | NR | < 0.1 O.D | ≥ 40 ± 20 mIU/mLb | Positive | 122 | 0 | 6 | 23 | 95.3 (90.1–98.3) | 100.0 (85.2–100.0) | 100.0 (97.0–100.0)c | 79.3 (60.3–92.0)c | NR | NR |
Warrener 2018 [67] | 316 | 4-15 m & 12-75 m | NR | ≥ 120 mIU/mL | Positive | 183 | 4 | 13 | 116 | 93.4 (88.9–96.4) | 96.7 (91.7–99.1) | 97.9 (94.6–99.4) | 89.9(83.4–94.5) | NR | 0.83 |
113 | 4-15 m | NR | ≥ 120 mIU/mL | Positive | 122 | 1 | 5 | 95 | 96.1 (91.1–98.7) | 99.0 (94.3–100.0) | 99 .2 (95.6–100.0)c | 95.0 (88.7–98.4)c | NR | NR | |
203 | 12-75 m | NR | ≥ 120 mIU/mL | Positive | 171 | 3 | 8 | 21 | 95.5 (91.4–98.1) | 87.5 (67.6–97.3) | 98.3 (95.0–99.6)c | 72.4 (52.8–87.3)c | NR | NR |