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

Masaharu Fujita, Yusuke Yamamoto, Shinichi Watanabe, Tsunetsugu Sugawara, Koji Wakabayashi, Yu Tahara, Nobuyuki Horie, Keiichi Fujimoto, Kei Kusakari, Yoshihiko Kurokawa, Tsuyoshi Kawakami, Kohichi Kojima, Takashi Sozu, Takuto Nakayama, Takeru Kusao, Jon Richmond, Kleinstreuer Nicole, Bae Hwa Kim, Hajime Kojima, Toshihiko KasaharaAtsushi Ono

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
JournalJournal of Applied Toxicology
DOIs
Publication statusPublished - Jan 1 2019

Fingerprint

Validation Studies
Assays
Derivatives
Amino Acids
Acids
Skin
Peptides
Protein Binding
Technology
Education
Sensitivity and Specificity
Testing

Keywords

  • accuracy
  • ADRA (amino acid derivative reactivity assay)
  • between-laboratory reproducibility (BLR)
  • predictive capacity
  • sensitivity
  • specificity
  • within-laboratory reproducibility (WLR)

ASJC Scopus subject areas

  • Toxicology

Cite this

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. / 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, Bae Hwa; Kojima, Hajime; Kasahara, Toshihiko; Ono, Atsushi.

In: Journal of Applied Toxicology, 01.01.2019.

Research output: Contribution to journalArticle

Fujita, M, Yamamoto, Y, Watanabe, S, Sugawara, T, Wakabayashi, K, Tahara, Y, Horie, N, Fujimoto, K, Kusakari, K, Kurokawa, Y, Kawakami, T, Kojima, K, Sozu, T, Nakayama, T, Kusao, T, Richmond, J, Nicole, K, Kim, BH, Kojima, H, Kasahara, T & Ono, A 2019, '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', Journal of Applied Toxicology. https://doi.org/10.1002/jat.3834
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, Bae Hwa ; Kojima, Hajime ; Kasahara, Toshihiko ; Ono, Atsushi. / 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. In: Journal of Applied Toxicology. 2019.
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abstract = "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.",
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AU - Sugawara, Tsunetsugu

AU - Wakabayashi, Koji

AU - Tahara, Yu

AU - Horie, Nobuyuki

AU - Fujimoto, Keiichi

AU - Kusakari, Kei

AU - Kurokawa, Yoshihiko

AU - Kawakami, Tsuyoshi

AU - Kojima, Kohichi

AU - Sozu, Takashi

AU - Nakayama, Takuto

AU - Kusao, Takeru

AU - Richmond, Jon

AU - Nicole, Kleinstreuer

AU - Kim, Bae Hwa

AU - Kojima, Hajime

AU - Kasahara, Toshihiko

AU - Ono, Atsushi

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