title: Performance Tested Method multiple laboratory validation study of ELISA-based assays for the detection of peanuts in food.
abstract: Performance Tested Method multiple laboratory validations for the detection of peanut protein in 4 different food matrixes were conducted under the auspices of the AOAC Research Institute. In this blind study, 3 commercially available ELISA test kits were validated: Neogen Veratox for Peanut, R-Biopharm RIDASCREEN FAST Peanut, and Tepnel BioKits for Peanut Assay. The food matrixes used were breakfast cereal, cookies, ice cream, and milk chocolate spiked at 0 and 5 ppm peanut. Analyses of the samples were conducted by laboratories representing industry and international and U.S governmental agencies. All 3 commercial test kits successfully identified spiked and peanut-free samples. The validation study required 60 analyses on test samples at the target level 5 microg peanut/g food and 60 analyses at a peanut-free level, which was designed to ensure that the lower 95% confidence limit for the sensitivity and specificity would not be <90%. The probability that a test sample contains an allergen given a prevalence rate of 5% and a positive test result using a single test kit analysis with 95% sensitivity and 95% specificity, which was demonstrated for these test kits, would be 50%. When 2 test kits are run simultaneously on all samples, the probability becomes 95%. It is therefore recommended that all field samples be analyzed with at least 2 of the validated kits.
authors.affiliation: U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Division of Natural Products, 5100 Paint Branch Pkwy, College Park, MD 20740, USA. dpark@cfsan.fda.gov
authors.forename: Douglas L
authors.initials: DL
authors.lastname: Park
authors.forename: Scott
authors.initials: S
authors.lastname: Coates
authors.forename: Vickery A
authors.initials: VA
authors.lastname: Brewer
authors.forename: Eric A E
authors.initials: EA
authors.lastname: Garber
authors.forename: Mohamed
authors.initials: M
authors.lastname: Abouzied
authors.forename: Kurt
authors.initials: K
authors.lastname: Johnson
authors.forename: Bruce
authors.initials: B
authors.lastname: Ritter
authors.forename: Deborah
authors.initials: D
authors.lastname: McKenzie
mesh_terms: D000485:Allergens / Q000032:analysis; D010367:Arachis; D002099:Cacao; D002623:Chemistry Techniques, Analytical / Q000379:methods*; D002523:Edible Grain; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005069:Evaluation Studies as Topic; D005504:Food Analysis / Q000379:methods*; D007054:Ice Cream; D007753:Laboratories; D021183:Peanut Hypersensitivity; D015203:Reproducibility of Results; D012107:Research Design; D012680:Sensitivity and Specificity
chemical_list: D000485:Allergens