NISTの研究により、動物実験代替法の信頼性が高まる(NIST Study Gives Animal Testing Alternatives a Confidence Boost)


2022-05-17 アメリカ国立標準技術研究所(NIST)

動物実験を減らすための政府の取り組みの一環として、国立標準技術研究所(NIST)の研究者は、消費者製品安全委員会(CPSC)およびInotiv Inc.と協力して、皮膚アレルゲンをスクリーニングするための新しいプロトコルを作成しました。この方法は、動物実験よりも安価で迅速、かつ同等の性能を維持できる可能性があります。


計測科学的アプローチによる皮膚感作のための96ウェル親水性アレルゲンスクリーニングアッセイの開発 Development of a 96-Well Electrophilic Allergen Screening Assay for Skin Sensitization Using a Measurement Science Approach

Elijah J. Petersen,Richard Uhl,Blaza Toman,John T. Elliott,Judy Strickland,James Truax and John Gordon
Toxics  Published: 17 May 2022


The Electrophilic Allergen Screening Assay (EASA) has emerged as a promising in chemico method to detect the first key event in the adverse outcome pathway (AOP) for skin sensitization. This assay functions by assessing the depletion of one of two probe molecules (4-nitrobenzenethiol (NBT) and pyridoxylamine (PDA)) in the presence of a test compound (TC). The initial development of EASA utilized a cuvette format resulting in multiple measurement challenges such as low throughput and the inability to include adequate control measurements. In this study, we describe the redesign of EASA into a 96-well plate format that incorporates in-process control measurements to quantify key sources of variability each time the assay is run. The data from the analysis of 67 TCs using the 96-well format had 77% concordance with animal data from the local lymph node assay (LLNA), a result consistent with that for the direct peptide reactivity assay (DPRA), an OECD test guideline (442C) protein binding assay. Overall, the measurement science approach described here provides steps during assay development that can be taken to increase confidence of in chemico assays by attempting to fully characterize the sources of variability and potential biases and incorporate in-process control measurements into the assay.