包虫病特异性抗体检测试剂盒临床应用效果评价

Evaluation of clinical efficacy of a specific antibody detection kit for human echinococcosis

目的评价包虫病特异性抗体检测试剂盒(简称包虫病试剂盒)的临床应用效果,为试剂盒制作工艺进一步优化提供技术支持。方法通过回顾性调查方法,选择2012 - 2016年新疆医科大学第一附属医院经手术、病理学(金标准),以及包虫病试剂盒等方法检查确诊的包虫病患者1 481例和非包虫病患者1 055例作为调查对象,对临床病历资料进行分析,对包虫病试剂盒诊断效能进行评价,并应用逐步判别分析方法,构建判别分析函数式,建立包虫病诊断模型。同时分析包虫病试剂盒中4个抗原的检测效能。结果共调查2 536例患者[男1 275例,女1 261例,年龄(41.62±18.43)岁],30~59岁年龄组(1 489例)占比最高。包虫病患者患病器官主要为肝脏。包虫病试剂盒的敏感性为94.80%(1 404/1 481),特异性为71.00%(749/1 055),一致性为84.90%(2 153/2 536),约登指数为0.66,Kappa值为0.68。应用逐步判别分析方法,构建的判别分析函数式为Y=0.777X1 + 0.258X2 + 0.241X3 - 1.575,逐步判别分析模型诊断一致性与现行诊断标准比较,差异无统计学意义(85.73%比84.90%,χ^2=0.694,P > 0.05)。包虫病试剂盒对泡型和囊型包虫病的鉴别诊断一致性为76.07%(1 068/1 404)。包虫囊液抗原(EgCF)同包虫病试剂盒的检测效能比较,差异无统计学意义(P均> 0.05)。结论包虫病试剂盒诊断及鉴别诊断效能较高,适用于各级医院对包虫病的临床试验辅助诊断以及现场流行病学调查。EgCF可以作为包虫病单抗原试纸条的抗原,应用于包虫病流行病学调查等工作中。

Objective To evaluate the clinical application effect of a specific antibody detection kit for human echinococcosis (hydatidosis kit),and provide technical support for further optimization of the production process of hydatidosis kit.Methods Using the method of retrospective investigation,1 481 patients with hydatidosis and 1 055 no-hydatidosis patients who were diagnosed by operation,pathology (gold standard) and hydatidosis kit in First Affiliated Hospital of Xinjiang Medical University,from 2012 to 2016 were selected.The clinical data was analyzed.The diagnostic performance of the kit was evaluated.The stepwise discriminant analysis method was applied to construct discriminant analysis function and establish a diagnostic model for echinococcosis.The detection efficiency of four antigens in hydatidosis kit was analyzed.Results A total of 2 536 patients [1 275 males,1 261 females,aged (41.62 ± 18.43) years old] were investigated,with the highest proportion in the 30-59 age group (1 489 cases).Liver was the main organ affected by echinococcosis.The sensitivity,specificity and consistency of the hydatidosis kit were 94.80%(1 404/1 481),71.00%(749/1 055),and 84.90%(2 153/2 536),Yoden index was 0.66 and Kappa value was 0.68.The stepwise discriminant analysis function Y= 0.777X1 + 0.258X2 + 0.241X3-1.575 was constructed by the stepwise discriminant analysis method.There was no significant difference between the consistency of stepwise discriminant analysis model and the current diagnostic criteria (85.73% vs 84.90%,χ^2= 0.694,P > 0.05).The consistency of differential diagnosis between vesicular and cystic echinococcosis was 76.07%(1 068/1 404).There was no significant difference in the detection efficacy between Echinococcus granulosus cystic fluid antigen (EgCF) and hydatidosis kit (P > 0.05).Conclusions The diagnosis and differential diagnosis efficiency of hydatidosis kit is high.It is suitable for clinical diagnosis and field epidemiological investigation of echinococcosis in hospitals at all levels.EgCF can be used as the antigen of echinococcosis monoantigen strip,and can be applied in the epidemiological investigation of echinococcosis.