Figure 1.
Schematic of study design.
Figure 2.
Scatter plots of method comparison for POC testing from multiple fingersticks compared to routine laboratory methodology (Phase I).
The vertical axis in each plot is either percentage similarity (A) or difference (B-D) between POC and predicate and the horizontal axis is the absolute value of predicate tests: A) Percentage similarity for CD4. Red dashed line indicates misclassification point of 350 cells/ul and circle highlights outliers. B-D) Bland Altman difference scatter plots for POC versus predicate methodology for Hb (B), ALT (C) and Cr (D). Grey areas indicate normal ranges for analytes based on predicate method and circles highlight outliers mostly based on RCPA guidelines.
Figure 3.
Scatter plots of method comparison of POC testing from a single fingerstick compared to routine laboratory methodology (phase II).
A) Percentage similarity for CD4. Red dashed line indicates misclassification point of 350 cells/ul and circle highlights outliers. B-D) Bland Altman difference scatter plots for POC versus predicate methodology for Hb (B), ALT (C) and Cr (D). Grey areas indicate normal ranges for analytes based on predicate method and circles highlight outliers mostly based on RCPA guidelines.
Figure 4.
Scatter plots showing sequence of POC testing from a single fingerstick (phase II) compared to routine laboratory methodology.
A) Percentage similarity for CD4. B-D) Bland Altman difference scatter plots for sequence of POC testing versus predicate methodology for Hb (B), ALT (C) and Cr (D). Blue indicates sequence 1: Reflotron followed by HemoCue and PIMA; Red indicates Sequence 2: HemoCue, Reflotron, PIMA; and green indicates Sequence 3: PIMA, Reflotron then HemoCue.