Evaluation of clinical efficacy of a specific antibody detection kit for human echinococcosis / 中华地方病学杂志

ABSTRACT

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 489cases).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％,x2 =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.