Performance Tested Method multiple laboratory validation study of ELISA-based assays for the detection of peanuts in food.
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.
Park
Douglas L
DL
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
Coates
Scott
S
Brewer
Vickery A
VA
Garber
Eric A E
EA
Abouzied
Mohamed
M
Johnson
Kurt
K
Ritter
Bruce
B
McKenzie
Deborah
D
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
D000485:Allergens