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Table 1 Overview of recommendations for field evaluation of quantitative G6PD assays

From: Methods for the field evaluation of quantitative G6PD diagnostics: a review

Task Recommendation Reference
Sample size for performance evaluation Two approaches, based on:
• Desired performance indicators
• Minimal difference in means measured by two methods
[51, 52]
Sample size WHO pre-qualification • 200 G6PD specimens
• 200 G6PD intermediate specimens
• 1000 G6PD normal specimens
[34]
Sample Venous or capillary blood [40, 41]
Max time to reference testing 4–7 days [35,36,37,38]
Sample storage temperature At 4–8 °C [35,36,37,38]
Reference testing Spectrophotometry [24, 42]
Statistical methods • Bland–Altman plot
• Scatter plot
• Histogram of G6PD activity distribution/test assay
• ROC analysis
• Adjusted male median
• Sensitivity, specificity, positive and negative predictive value
[24, 55, 56]