Determination of sample size for validation of allergen-screening methods.
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.
McClure
Foster D
FD
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, USA. fmcclure@cfsan.fda.gov
Graves
Qian F
QF
D000485:Allergens / Q000032:analysis*; D005189:False Positive Reactions; D005504:Food Analysis / Q000379:methods* / Q000706:statistics & numerical data; D008433:Mathematics; D008832:Microchemistry; D018401:Sample Size; D012680:Sensitivity and Specificity
D000485:Allergens