title: Validation of quantitative and qualitative methods for detecting allergenic ingredients in processed foods in Japan.
abstract: A labeling system for food allergenic ingredients was established in Japan in April 2002. To monitor the labeling, the Japanese government announced official methods for detecting allergens in processed foods in November 2002. The official methods consist of quantitative screening tests using enzyme-linked immunosorbent assays (ELISAs) and qualitative confirmation tests using Western blotting or polymerase chain reactions (PCR). In addition, the Japanese government designated 10 μg protein/g food (the corresponding allergenic ingredient soluble protein weight/food weight), determined by ELISA, as the labeling threshold. To standardize the official methods, the criteria for the validation protocol were described in the official guidelines. This paper, which was presented at the Advances in Food Allergen Detection Symposium, ACS National Meeting and Expo, San Diego, CA, Spring 2012, describes the validation protocol outlined in the official Japanese guidelines, the results of interlaboratory studies for the quantitative detection method (ELISA for crustacean proteins) and the qualitative detection method (PCR for shrimp and crab DNAs), and the reliability of the detection methods.
authors.affiliation: National Institute of Health Sciences , 1-18-1 Kamiyoga, Setagaya-ku, Tokyo 158-8501, Japan.
authors.forename: Shinobu
authors.initials: S
authors.lastname: Sakai
authors.forename: Reiko
authors.initials: R
authors.lastname: Adachi
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Akiyama
authors.forename: Reiko
authors.initials: R
authors.lastname: Teshima
mesh_terms: D000485:Allergens / Q000009:adverse effects / Q000032:analysis*; D000818:Animals; D060829:Arthropod Proteins / Q000009:adverse effects / Q000032:analysis* / Q000235:genetics; D003445:Crustacea / Q000737:chemistry; D004247:DNA / Q000032:analysis* / Q000378:metabolism; D004044:Dietary Proteins / Q000009:adverse effects / Q000032:analysis*; D004797:Enzyme-Linked Immunosorbent Assay; D057140:Fast Foods / Q000009:adverse effects / Q000032:analysis*; D005512:Food Hypersensitivity / Q000209:etiology / Q000517:prevention & control; D005513:Food Inspection / Q000331:legislation & jurisprudence / Q000379:methods* / Q000592:standards; D005515:Food Labeling / Q000331:legislation & jurisprudence; D057141:Food, Preserved / Q000009:adverse effects / Q000032:analysis*; D017408:Guidelines as Topic; D006801:Humans; D007564:Japan; D007881:Legislation, Food; D057230:Limit of Detection; D016133:Polymerase Chain Reaction; D015203:Reproducibility of Results; D012758:Shellfish / Q000009:adverse effects / Q000032:analysis
chemical_list: D000485:Allergens; D060829:Arthropod Proteins; D004044:Dietary Proteins; D004247:DNA