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 language | English |
|---|---|
| Journal | Journal of Applied Toxicology |
| DOIs | |
| Publication status | Published - Jan 1 2019 |
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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 journal › Article
}
TY - JOUR
T1 - The within- and between-laboratory reproducibility and predictive capacity of the in chemico amino acid derivative reactivity assay
T2 - Results of validation study implemented in four participating laboratories
AU - Fujita, Masaharu
AU - Yamamoto, Yusuke
AU - Watanabe, Shinichi
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
PY - 2019/1/1
Y1 - 2019/1/1
N2 - 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.
AB - 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.
KW - accuracy
KW - ADRA (amino acid derivative reactivity assay)
KW - between-laboratory reproducibility (BLR)
KW - predictive capacity
KW - sensitivity
KW - specificity
KW - within-laboratory reproducibility (WLR)
UR - http://www.scopus.com/inward/record.url?scp=85069851142&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85069851142&partnerID=8YFLogxK
U2 - 10.1002/jat.3834
DO - 10.1002/jat.3834
M3 - Article
C2 - 31313332
AN - SCOPUS:85069851142
JO - Journal of Applied Toxicology
JF - Journal of Applied Toxicology
SN - 0260-437X
ER -