Determination of sample size for validation of allergen-screening methods
McClure, F.D.; Graves, Q.F.
Journal - Association of Official Analytical Chemists 86(5): 1059-1062
2003
ISSN/ISBN: 0004-5756 PMID: 14632410 Document Number: 565863
For various levels of confidence (i.e., 80 and 90%) and ratios (K = sp2 / sN2, where s2p and s2N are the analyte variances for the positive and negative distributions, respectively), sample sizes sufficient to test the requirements that a given method detects 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. Reprinted by permission of the publisher.