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
| Autor: | Yoshihiko Kurokawa, Takeru Kusao, Atsushi Ono, Jon Richmond, Tsunetsugu Sugawara, Bae Hwa Kim, Hajime Kojima, Keiichi Fujimoto, Tsuyoshi Kawakami, Yusuke Yamamoto, Shinichi Watanabe, Koji Wakabayashi, Takashi Sozu, Kei Kusakari, Kleinstreuer Nicole, Toshihiko Kasahara, Nobuyuki Horie, Masaharu Fujita, Takuto Nakayama, Yu Tahara, Kohichi Kojima |
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| Rok vydání: | 2019 |
| Předmět: |
Validation study
Laboratory Proficiency Testing Transferability 010501 environmental sciences In Vitro Techniques Toxicology Animal Testing Alternatives 01 natural sciences 03 medical and health sciences Predictive Value of Tests Medicine Humans Amino Acids 030304 developmental biology 0105 earth and related environmental sciences Skin Alternative methods 0303 health sciences Reproducibility Chromatography business.industry Skin sensitization Reproducibility of Results Allergens Amino acid derivative Solvents Biological Assay Indicators and Reagents business Training program Laboratories |
| Zdroj: | Journal of applied toxicology : JATREFERENCES. 39(11) |
| ISSN: | 1099-1263 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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