【摘要】 目的研制检测日本血吸虫抗体(IHA)的标准化间接血凝试剂盒。方法通过不同筛目尼龙绢和低频超声等方法制备、纯化日本血吸虫可溶性虫卵抗原,致敏人"O"型血红细胞;按医学决定水平确定免疫学质量控制标准及参考,优选原材料质量,规范生产工艺,研究制定反应体系的标准化,生产IHA试剂盒并进行鉴定。结果用生产的IHA试剂盒检测50例急性血吸虫病人血清全部阳性,检测201份慢性血吸虫病患者血清,193份阳性,敏感性96.0%;200份健康人血清均为阴性,特异性100%;肝吸虫、姜片虫、钩虫及乙肝患者血清均为阴性,肺吸虫病的交叉反应率为19.4%(6/31)。IHA试剂盒批内变异和批间变异小,有效诊断率为97.9%。同一批试剂盒在室温、4℃条件下保存3年未见效价明显改变。结论研制的IHA试剂盒具有较高的特异性和敏感性,可标准化生产。该试剂盒具有操作方便、快速、结果判断容易,不需要特殊的仪器设备,价格低廉等优点,可广泛用于现场查病。更多还原

【Abstract】 Objective To develop standardized indirect hemagglutination(IHA) assay kit for detection of Schistosoma japonicum antibody.Methods Human "O" type erythrocytes were sensitized with soluble egg antigen of schistosome,which was obtained and purified by using nylon mesh filter with different pore size and ultrasound treatment.Quality control standard and reference was made according to medical criterion.Raw and processed materials were optimized in quality;production technique was normalized,and reaction system was standardized.With all the above studies,the technique platform for the standard IHA kit has been developed.Results The sensitivity of the IHA kit was100% in 50 cases of acute schistosomiasis(50/50),96.0% in 201 cases of chronic schistosomiasis(193/201).The specificity of the assay was 100% in 200 healthy individuals(200/200).The cross-reaction was 19.4% in 31 cases of Paragonimiasis,and 0 in 30 cases of Clonorchiasis sinensis,43 cases of hookworm infection,50 cases of Fasciolopsiasis and 55 cases of Viral Hepatitis Type B infection.The rate of effective diagnosis was 97.9% and the coefficient of variations within one batch and between batches were excellent.The kit was stable at room temperature for at least 3 years.Conclusion IHA kit for possess higher specificity and sensitivity,and can be produced by standardized technique platform.The kit provided an economic,convenient,rapid,robust test for the detection of schistosome infection,suitable for a wide variety of field applications without any instrumentation.更多还原