Inter-laboratory Evaluation Studies for Establishment of Notified ELISA Methods for Allergic Substances (Peanuts)

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  • 特定原材料（落花生）測定の厚生労働省通知ＥＬＩＳＡ法確立のための複数機関による評価研究
  • トクテイ ゲンザイリョウ ラッカセイ ソクテイ ノ コウセイ ロウドウショウ ツウチ ELISAホウ カクリツ ノ タメ ノ フクスウ キカン ニ ヨル ヒョウカ ケンキュウ

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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 FASTKITTM 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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