Table 2. Phase A results: coefficient of variation and median value measured for all Biosensors combined, spectrophotometry and Hemocue.
G6PD activity (in U/gHb) | Hb (in g/dL) | |||||
Assay | Low | Intermediate | High | Low | Intermediate | High |
Biosensors (n = 600) | ||||||
CV | 0.260 | 0.172 | 0.111 | 0.061 | 0.068 | 0.069 |
Median | 0.7 | 1.7 | 7.6 | 14.8 | 14.9 | 14.1 |
IQR | 0.6–0.8 | 1.5–1.8 | 7.2–8.2 | 14.3–15.6 | 14.2–15.5 | 13.5–15.0 |
SD | 0.17 | 0.28 | 0.85 | 0.91 | 1.01 | 0.98 |
Range | 0.1–1.0 | 0.6–2. 4 | 5.7–10.5 | 12.9–17.5 | 12.3–17.5 | 12.0–17.7 |
Reference (n = 60) | ||||||
CV | 0.141 | 0.165 | 0.124 | 0.009 | 0.007 | 0.022 |
Median | 0.9 | 2.7 | 7.6 | 18.4 | 16.5 | 14.9 |
IQR | 0.8–1.0 | 2.5–2.9 | 7.0–8.1 | 18.2–18.5 | 16.4–16.6 | 14.7–15.0 |
SD | 0.12 | 0.47 | 0.96 | 0.01 | 0.01 | 0.02 |
Range | 0.7–1.0 | 2.4–4.6 | 6.4–11.0 | 18.0–18.6 | 16.3–16.7 | 13.9–15.1 |
Recommended range G6PD (U/gHb) | Recommended value Hb (g/dL) | |||||
Manufacturer recommendation | 0.8–3.8 | 3.7–6.8 | 10.3–19.1 | 13.0 | 13.2 | 13.1 |
CV = coefficient of variation, IQR = interquartile range, SD = standard deviation