Establishment of national reference for anti-Clonorchis sinensis IgG serum

Objective To establish a national reference for evaluation of detection reagent of antiClonorchis sinensis IgG.Methods A total of 26 serum samples of clonorchiasis patients confirmed by positive stool examination was collected in Guangzhou during 2010-2012,and 15 plasma samples of healthy blood donors were bought for each 200 ml.Samples were screened and evaluated with two domestic registered diagnostic kits for anti-Clonorchis sinensis.The composition of reference was determined,and sub-package accuracy and water content were detected.Three collaborative units were selected to calibrate and to detect the coincidence of positive reference and negative reference and the detection limit.Results The panel of Clonorchis sinensis IgG serum consisted of 9 positive and 10 negative samples,and one lowest detection sample,and one precision sample.Sub-package accuracy was 0.6％ and 0.7％.Water content was 2.8％.The coincidence of both positive reference and negative reference was100％,and the detection limit was no more than 1:32.Conclusion The national reference panel of Anti-Clonorchis sinensis IgG serum was established. Key words: Clonorchis sinensis;  Detection reagent;  National reference