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Inter-laboratory evaluation studies for establishment of notified ELISA methods for allergic substances (peanuts)
Authors:Akiyama Hiroshi  Nakamura Kenjin  Harikai Naoki  Watanabe Hiroko  Iijima Ken  Yamakawa Hirohito  Mizuguchi Yamato  Yoshikawa Reiji  Yamamoto Miho  Sato Hidetaka  Watai Masatoshi  Arakawa Fumihiro  Ogasawara Takeshi  Nishihara Rikuka  Kato Hisashi  Yamauchi Atsushi  Takahata Yoshihisa  Morimatsu Fumiki  Mamegoshi Shinichi  Muraoka Shiroo  Honjoh Tsutomu  Watanabe Takahiro  Sakata Kozue  Imamura Tomoaki  Toyoda Masatake  Matsuda Rieko  Maitani Tamio
Affiliation:National Institute of Health Sciences, Tokyo, Japan.
Abstract:Inter-laboratory evaluation studies were conducted for ELISA methods for allergic substances (peanuts). Extracts of biscuit, sauce, chocolate and butter spiked with peanut standard protein at a level of 5-20 ng/mL as sample solutions were analyzed in replicate in 10 laboratories. Coefficients of variation (CVs) of the ELISA methods using a Peanut Protein ELISA Kit (Peanut kit) and a FASTKIT Peanut ELISA kit (Peanut ELISA kit) were mostly below 10%. Mean recoveries of the peanut standard protein from the food extracts were over 40% in the two ELISA methods. Repeatability relative standard deviations of peanut standard protein in four food extracts were in the ranges of 15.2-49.7% and 3.0-28.3% for the Peanut kit and the Peanut ELISA kit, respectively. Reproducibility relative standard deviations of peanut standard protein in four food extracts were 23.5-44.4%, 9.6-28.4% for the Peanut kit and the Peanut ELISA kit, respectively. The detection limits of both ELISA methods were 2-2.5 ng/mL in sample solutions. These results suggested that the notified ELISA methods are reliable and reproducible for the inspection of peanut protein levels in extracts of biscuit, sauce, chocolate and butter.
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