Table 3. Mean difference and correlation of Biosensor and reference method by site in phase B.
Site | G6PD (U/gHb): Mean Difference (95% LoA, p) | G6PD (rs, p) | Hb (g/dL): Mean Difference (95% LoA, p) | Hb (rs, p) |
---|---|---|---|---|
1 | -0.1 (-1.8 to 1.7, 0.245) | 0.548, <0.001 | -1.9 (-4.0 to 0.1, <0.001) | 0.254, 0.005 * |
2 | -0.2 (-1.8 to 1.4, 0.004) | 0.564, <0.001 | -1.9 (-4.1 to 0.2, <0.001) | -0.023, 0.806 * |
3 | 0.2 (-1.7 to 2.0, 0.088) | 0.659, <0.001 | -3.0 (-4.9 to -1.2, <0.001) | 0.350, <0.001 |
4 | 0.1 (-2.0 to 2.2, 0.504) | 0.536, <0.001 | -2.5 (-4.7 to -0.3, <0.001) | 0.312, 0.001 |
5 | 1.1 (-1.9 to 4.2, <0.001) | 0.575, <0.001 | 0.6 (-0.8 to 2.0, <0.001) | 0.416, <0.001 |
6 | -0.3 (-3.2 to 2.7, 0.055) | 0.509, <0.001 | -2.6 (-5.9 to 0.6, <0.001) | 0.095, 0.303 * |
7 | -1.1 (-3.1 to 0.8, <0.001) | 0.514, <0.001 | -0.1 (-1.7 to 1.5, 0.133) | 0.239, 0.009 * |
8 | -0.9 (-2.8 to 1.0, <0.001) | 0.609, <0.001 | -1.5 (-3.4 to 0.4, <0.001) | 0.500, <0.001 |
9 | -2.6 (-7.6 to 2.3, <0.001) | 0.569, <0.001 | -0.6 (-3.0 to 4.3, 0.009) | 0.391, <0.001 |
10 | -1.0 (-3.1 to 1.1, <0.001) | 0.563, <0.001 | -0.9 (-3.0 to 1.1, <0.001) | 0.211, 0.021 ** |
95% LoA = 95% limit of agreement
* Correlation was non-significant across all control categories (all p>0.005)
**Only correlation for Intermediate controls was significant: rs = 0.580, p = 0.001