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Determination of sample size for validation of allergen-screening methods
Foster D McClure1, Qian F Graves
1U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Scientific Analysis and Support, Division of Mathematics, 5100 Paint Branch Pkwy, College Park, MD 20740-3835, USA. fmcclure@cfsan.fda.gov
Abstract:
For various levels of confidence (i.e., 80 and 90%) and ratios (K = sigmap2/sigmaN2, where sigmap2 and sigmaN2 are the analyte variances for the positive and negative distributions, respectively), sample sizes sufficient to test the requirements that a given method detects > or = 90% of the positives (> or = 5 ppm of a given analyte) while misclassifying < or = 10% of the negatives (implying a specificity rate, true negatives that will be correctly classified, of 90%) were estimated by using a rationale that minimizes the cost of sampling.