Table 2.
Measure of diagnostic performance of Bioline, NxTek and Biocredit RDTs
| Diagnostic Measure | N | Microscopy [95CI] (n/N) |
Bioline HRP2 [95CI] (n/N) |
NxTek HRP2 [95CI] (n/N) | Biocredit HRP2 [95CI] (n/N) |
Biocredit LDH [95CI] (n/N) | Biocredit HRP2/LDH [95CI] (n/N) |
|---|---|---|---|---|---|---|---|
| Sensitivity (all densities) | 205 | 28.3% [22.2, 34.9] (58/205) | 39.5% [32.8,46.6] (81/205) | 49.3% [42.2, 56.3] (101/205) | 50.7% [43.7, 57.8] (104/205) | 37.1% [30.5, 44.1] (76/205) |
52.2% [45.1, 59.2] (107/205) |
| Only samples with > 2000 parasites/µL | 37 | 70.3% [53.0, 84.1] (26/37) |
94.6 [81.8, 99.3] (35/37) |
100 [94.3, 100] (37/37) |
94.6 [81.8, 99.3] (35/37) |
94.6 [81.8, 99.3] (35/37) |
94.6 [81.8, 99.3] (35/37) |
| Only samples with > 200 parasites/µL | 63 | 76.2 [63.8, 86.0] (48/63) |
88.9 [78.4, 95.4] (56/63) |
95.2 [86.7, 99.0] (60/63) |
92.1 [82.4, 97.4] (58/63) |
90.5 [80.4, 96.4] (57/63) |
92.1 [82.4, 97.4] (58/63) |
| Only samples with > 20 parasites/µL | 89 | 62.9% [52.0, 72.9] (56/89) |
78.7 [68.7, 86.6] (70/89) |
88.8 [80.3, 94.5] (79/89) |
88.8 [80.3, 94.5] (79/89) |
74.2 [63.8, 82.9] (66/89) |
88.8 [80.3, 94.5] (79/89) |
| Specificity | 244 |
98.8% [96.5, 99.8] (241/244) |
98.8% [96.5, 99.8] (241/244) |
97.1% [94.2, 98.8] (237/244) |
97.1% [94.2, 98.8] (237/244) |
98.8% [96.5, 99.8] (241/244) |
96.3% [93.1, 98.3] (235/244) |
| Positive Predictive Value | 333 | 94.9% [85.7, 98.3] | 95.9% [88.3, 98.6] | 91.9% [84.4, 95.9] | 91.9% [84.4, 95.9] | 95.7% [87.8, 98.6] | 89.8% [82.2, 94.4] |
| Negative Predictive Value | 333 | 87.9% [84.8, 90.3] | 92.7% [89.5, 94.9] | 95.9% [92.9, 97.7] | 95.9% [92.9, 97.7] | 91.3% [88.1, 93.7] | 95.9% [92.9, 97.7] |
| Accuracy (AUC) | 449 | 0.892[0.85, 0.92] | 0.887 [0.84, 0.93] | 0.929 [0.89, 0.96] | 0.929 [0.89, 0.96] | 0.870 [0.82, 0.92] | 0.931 [0.90, 0.96] |
| 95% LOD (parasites/µL) | 205 | 4393 [2129, 9064] | 331 [148, 739] | 84 [40, 177] | 85 [43, 171] | 349 [142, 858] | 56 [28, 118] |
N: Sample size used for diagnostic measurement