Table 5.
Extracted data from studies evaluating sensitivity and specificity of Leptospira biflexa serovar Patoc lateral flow IgM assays published prior to 4 July 2017
| Study first author (reference) |
Assay manufacturer |
True positive | False positive | True negative | False negative | Sensitivity (95% CI) |
Specificity (95% CI) |
||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| N | (%) | N | (%) | N | (%) | N | (%) | ||||
| Smits 1 (12) | KIT | 116 | (27.8) | 28 | (6.7) | 255 | (61.0) | 19 | (4.5) | 0.86 (0.79-091) | 0.90 (0.86-0.93) |
| Smits 2 (12) | KIT | 39 | (43.3) | 6 | (6.7) | 41 | (45.6) | 4 | (4.4) | 0.91 (0.78-0.97) | 0.87 (0.74-0.94) |
| Eapen (17) | Organon | 54 | (27.6) | 6 | (3.1) | 131 | (66.8) | 5 | (2.6) | 0.90 (0.80-0.95) | 0.96 (0.92-0.99) |
| Sehgal (13) | KIT | 37 | (31.6) | 3 | (2.6) | 44 | (37.6) | 33 | (28.2) | 0.53 (0.54-0.82) | 0.94 (0.82-0.98) |
| Kannan (10) | Zephyr | 28 | (36.8) | 11 | (14.5) | 25 | (32.9) | 12 | (15.8) | 0.70 (0.42-0.69) | 0.69 (0.53-0.82) |
| Limmathurotsakul (21) | KIT | 120 | (32.3) | 69 | (18.6) | 165 | (44.5) | 17 | (4.6) | 0.88 (0.81-0.92) | 0.71 (0.64-0.76) |
| Goris 1 (14) | BioMérieux | 74 | (5.3) | 57 | (4.1) | 1235 | (88.2) | 34 | (2.4) | 0.69 (0.59-0.77) | 0.96 (0.94-0.97) |
| Goris 2 (14) | Zephyr | 100 | (3.7) | 56 | (2.0) | 2495 | (91.3) | 83 | (3.0) | 0.55 (0.47-0.62) | 0.98 (0.97-0.98) |
| Eugene (18) | Zephyr | 34 | (40.5) | 12 | (14.3) | 32 | (38.1) | 6 | (7.1) | 0.85 (0.70-0.93) | 0.73 (0.58-0.84) |
| Niloofa (15) | Zephyr | 286 | (32.2) | 121 | (13.6) | 405 | (45.6) | 76 | (8.6) | 0.79 (0.75-0.83) | 0.77 (0.73-0.80) |
| Podgorsek (16) | Zephyr | 29 | (4.9) | 7 | (1.2) | 547 | (92.7) | 7 | (1.2) | 0.81 (0.65-0.90) | 0.99 (0.97-0.99) |
Footnote: Numbers refer to different datasets from within the same paper
Assay manufacturers: KIT: Royal Dutch Tropical Institute, Amsterdam, Netherlands; Organon, Oss, Netherlands; Zephyr Diagnostics, Goa, India; BioMérieux, Marcy-l'Étoile, France
Abbreviation: CI – confidence intervals