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目的探讨TM5．28单克隆抗体-生物素-亲和素系统检测日本血吸虫循环抗原及其诊断效果。方法制备TM5．28抗日本血吸虫肠相关抗原单克隆抗体,建立单抗-生物素-链霉亲和素检测系统,对各类血清(50份急性血吸虫病人、224份慢性血吸虫病人、49份晚期血吸虫病人;46份血吸虫病治疗前、治疗后6个月和治疗后1年的连续追踪病人;19份华支睾吸虫病人;31份肺吸虫病人; 23份乙型肝炎病人;100份正常人)进行检测。结果检测系统对慢性血吸虫病人和正常人检测的敏感性和特异性分别为83．1％和94．0％,Youden指数为0．771;对急性血吸虫病人的检出率94．0％;对肺吸虫、华支睾吸虫和肝炎病人的交叉反应为12．9、15．8和13．0％。血吸虫病人治疗后6个月和1年的阴转率分别为43．9％和62．1％,其OD值几何均数从治疗前的0．172下降到治疗后6个月的0．081和1年的0．068,下降了60．30％。轻、中感染度慢性血吸虫病人的检出率相近,分别为83．9％和82．1％,重感染度病人的检出率最高达90．00%。结论该系统对血吸虫病人检测显示了较高的诊断效能和化疗后阴转率,对人群感染状况的判定和个体诊断有一定的应用价值,为日本血吸虫病的免疫诊断和疗效考核提供了一种可行方法。
Objective To investigate the detection of circulating antigen of Schistosoma japonicum by TM5.28 monoclonal antibody-biotin-avidin system and its diagnostic value. Methods Monoclonal antibody against TM5.28 against Schistosoma japonicum gut associated antigen was prepared and the detection system of monoclonal antibody to biotin and streptavidin was established. Serum samples of 50 patients with acute schistosomiasis, 224 patients with chronic schistosomiasis, 49 patients with advanced schistosomiasis, Schistosomiasis patients; 46 consecutive patients with schistosomiasis before treatment, 6 months after treatment and 1 year after treatment; 19 clonorchiasis patients; 31 paragonimiasis patients; 23 hepatitis B patients; 100 normal subjects ) For testing. Results The sensitivity and specificity of the detection system for detecting schistosomiasis patients and normal controls were 83.1% and 94.0%, respectively, and the Youden index was 0.771. The detection rate of schistosomiasis patients was 94.0% Paragonimus, Clonorchiasis and Hepatitis patients had cross-reactions of 12.9, 15.8 and 13.0%. The negative conversion rates of schistosomiasis patients at 6 months and 1 year after treatment were 43.9% and 62.1%, respectively, and their geometric mean OD values decreased from 0.172 before treatment to 0.081 at 6 months after treatment And 0.068 in 1 year, a decrease of 60.30%. The detection rates of patients with mild and moderate chronic schistosomiasis were 83.9% and 82.1%, respectively, and the detection rate of patients with severe infections was up to 90.00%. Conclusion The system showed high diagnostic efficacy and post-chemotherapy negative conversion rate for schistosomiasis patients. It has certain value in judging the status of human infection and in individual diagnosis, and provides a method for immunodiagnosis and efficacy evaluation of schistosomiasis japonica Feasible method.