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Determination of Sample Size for Validation of Allergen-Screening Methods

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For various levels of confidence (i.e., 80 and 90%) and ratios (K = σP 2N 2 where σP 2 and σN 2 are the analyte variances for the positive and negative distributions, respectively), sample sizes sufficient to test the requirements that a given method detects ≥90% of the positives (≥5 ppm of a given analyte) while misclassifying ≤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.
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Document Type: Research Article

Affiliations: U.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

Publication date: 2003-09-01

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  • The Journal of AOAC INTERNATIONAL publishes refereed papers and reviews in the fields of chemical, biological and toxicological analytical chemistry for the purpose of showcasing the most precise, accurate and sensitive methods for analysis of foods, food additives, supplements and contaminants, cosmetics, drugs, toxins, hazardous substances, pesticides, feeds, fertilizers and the environment available at that point in time. The scope of the Journal includes unpublished original research describing new analytical methods, techniques and applications; improved approaches to sampling, both in the field and the laboratory; better methods of preparing samples for analysis; collaborative studies substantiating the performance of a given method; statistical techniques for evaluating data. The Journal will also publish other articles of general interest to its audience, e.g., technical communications; cautionary notes; comments on techniques, apparatus, and reagents.
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