h-CLATHuman Cell Line Activation Test
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According to this approach, 2 out of 3 concordant test results using the DPRA, ARE-NrF2 luciferase method, and the h-CLAT determine the prediction.
The BR around the classification threshold of the h-CLAT was calculated using test results from 13 substances tested during routine (in house) test applications, yielding 528 individual measurements covering different substances and concentrations (see Appendix 1, Tab.
In case of the h-CLAT, at least one of the test results of either the CD54 expression or the CD86 expression from at least one of the runs in an experiment has to fall into the BR for the experimental result to be borderline.
This was necessary because the testing protocols for LuSens and the h-CLAT require conducting two or more runs in order to classify a substance according to the results.
1 Quantification of the borderline range (BR) for the DPRA, LuSens, h-CLAT and LLNA
2 Identification of borderline substances in experimental sets tested with the DPRA, LuSens, h-CLAT and LLNA
Regarding the h-CLAT, the number of borderline substances varied between 8 and 10 (of 40), and in case of the LLNA, the number of substances considered borderline varied between 5 and 7 (of 22).
Within the BRs of the h-CLAT all substances considered borderline were positive and also sensitizers in the LLNA.
Based on the BRs considered and the experimental sets used in our analysis, the percentage of substances considered borderline in the DPRA, LuSens and h-CLAT was between 6% and 28% (Tab.