OBJECTIVE To evaluate whether three assays,respectively,for the measurement of human C-reactive protein(CRP),haptoglobin(Hp) and total bile acid(TBA) were suitable for the applications in cynomolgus monkeys.METHODS CRP was measured by an immune agglutination method and Hp was measured with an immunotubidimetric method.Reagent kits for both methods were provided by Roche Diagnostics.TBA was measured with an enzymatic cycling method supplied by Shanghai Zhengkang Biotechnology Co.Ltd.,China.All the reagent kits were operated on Cobas C501 chemistry analyzer.RESULTS The accuracy values of control materials analyzed during the validation were within the quoted ranges specified by the suppliers.Inter-assay CV values were all below 10%.Intra-assay CV values for CRP and TBA were below 5%.However,intra-assay CV for Hp at 0.32 g.L-1 was 7.82%.The performance of the Hp method close to the lowest level of detection was suboptimal and cannot be expected to give CV% better than 7.8%.The consequence of the suboptimal method performance at low concentration of Hp must not be over-interpreted.Besides,a good agreement was observed between the results of CRP and TBA obtained from CDSER and those from validated assays outside CDSER.Of note,plasma samples were stable for CRP and TBA at all tested conditions,ie 4 h at RT,1 day at 2-8℃,1 week or 4 weeks at-80℃.Minor deviations were seen for Hp which became unstable while stored at-80℃ for 4 weeks.However,the stability data was inconclusive due to relatively high intra-assay variation(CV%).The stability re-test needs to be done on samples with medium or high concentrations of Hp.CONCLUSION The assays for three biomarkers fulfilled the criteria of acceptance regardless of two minor exceptions(stability data and intra-assay data) associated with Hp. OBJECTIVE To evaluate whether three assays, respectively, for the measurement of human C-reactive protein (CRP), haptoglobin (Hp) and total bile acid (TBA) were suitable for the applications in cynomolgus monkeys. METHODS CRP was measured by an immune agglutination method and Hp was measured with an immunotubidimetric method. Reagent kits for both methods were provided by Roche Diagnostics. TBA was measured with an enzymatic cycling method supplied by Shanghai Zhengkang Biotechnology Co. Ltd., China. All the reagent kits were operated on Cobas C501 chemistry analyzer.RESULTS The accuracy values ​​of control materials olved analysis of the validation were within the quoted ranges specified by the suppliers. Inter-assay CV values ​​were all below 10%. Intra-assay CV values ​​for CRP and TBA were below 5% .However , the performance of the Hp method close to the lowest level of detection was suboptimal and can not be expected to give CV% better than 7.8%. The consequence of intra-assay CV for Hp at 0.32 gL-1 was 7.82%. of the suboptimal method performance at low concentration of Hp must not be over-interpreted .esides, a good agreement was observed between the results of CRP and TBA obtained from CDSER and those from validated assays outside CDSER.Of note, plasma samples were stable for CRP and TBA at all tested conditions, ie 4 h at RT, 1 day at 2-8 ° C., 1 week or 4 weeks at -80 ° C. Minor deviations were seen for Hp which became unstable while stored at -80 ° C. for 4 weeks . The stability of the assay data to be done on samples with medium or high concentrations of Hp. CONCLUSION The assays for three biomarkers fulfilled the criteria of acceptance regardless of two minor exceptions (stability data and intra-assay data) associated with Hp.