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The within‐ and between‐laboratory reproducibility and predictive capacity of the in chemico amino acid derivative reactivity assay: Results of validation study implemented in four participating laboratories
Author(s) -
Fujita Masaharu,
Yamamoto Yusuke,
Watanabe Shinichi,
Sugawara Tsunetsugu,
Wakabayashi Koji,
Tahara Yu,
Horie Nobuyuki,
Fujimoto Keiichi,
Kusakari Kei,
Kurokawa Yoshihiko,
Kawakami Tsuyoshi,
Kojima Kohichi,
Sozu Takashi,
Nakayama Takuto,
Kusao Takeru,
Richmond Jon,
Nicole Kleinstreuer,
Kim BaeHwa,
Kojima Hajime,
Kasahara Toshihiko,
Ono Atsushi
Publication year - 2019
Publication title -
journal of applied toxicology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.784
H-Index - 87
eISSN - 1099-1263
pISSN - 0260-437X
DOI - 10.1002/jat.3834
Subject(s) - reproducibility , transferability , reactivity (psychology) , cross reactivity , skin sensitization , chemistry , chromatography , computer science , sensitization , medicine , pathology , machine learning , cross reactions , immunology , alternative medicine , logit , antibody
The amino acid derivative reactivity assay (ADRA) is an in chemico alternative method that focuses on protein binding as the molecular initiating event for skin sensitization. It is a simple and versatile method that has successfully solved some of the problems of the direct peptide reactivity assay (DPRA). The transferability and within‐ and between‐laboratory reproducibility of ADRA were evaluated and confirmed as part of a validation study conducted at four participating laboratories. The transfer of ADRA technology from the lead laboratory to the four participating laboratories was completed successfully during a two‐step training program, after which the skin sensitization potentials of 40 coded chemicals were predicted based on the results of ADRA testing. Within‐laboratories reproducibility was 100% (10 of 10), 100% (10 of 10), 100% (7 of 7) and 90% (9 of 10), or an average of 97.3% (36 of 37); between‐laboratory reproducibility as calculated on the results of three laboratories at the time was 91.9%. The overall predictive capacity comprised an accuracy of 86.9%, sensitivity of 81.5% and specificity of 98.1%. These results satisfied the targets set by the validation management team for demonstrating transferability, within‐ and between‐laboratory reproducibility, and predictive capacity as well as gave a clear indication that ADRA is easily transferable and sufficiently robust to be used in place of DPRA.