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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]