Fig 1.
The device consolidates a hemoglobin measurement device (on the left) with a G6PD activity measurement device (on the right). Two disposables and samples are therefore required, one of each analyte measurement. The device then calculates the G6PD activity normalized for hemoglobin concentration based on the two measurements.
Table 1.
Hematologic characteristics of study population by gender.
Fig 2.
Distribution of G6PD activity by gender and diagnostic device.
The left pane shows the results of the gold standard spectrophotometric assay, the right pane shows the results of the CareStart biosensor.
Fig 3.
Bland-Altman plot for G6PD activity with regression line.
Table 2.
Area under the curve for ROC analysis at different activity thresholds for the reference test and CareStart biosensor.
Table 3.
Threshold normalized G6PD activity values on the CareStart biosensor optimized to maximize sensitivity and specificity using Youden’s Index.