日本血吸虫病间接血凝试验诊断试剂盒临床诊断效能

Diagnostic efficiency of Indirect Hemagglutination Assay Kit for antibody de-tection of schistosomiasis japonica

目的评价日本血吸虫病间接血凝试验(IHA)诊断试剂盒对血吸虫病的临床诊断效能。方法分别在江西省、安徽省和湖北省3个疫区现场进行血吸虫病调查,并采集371份病原学确诊的血吸虫病人血清(毛蚴孵化法或/和Kato-Katz法阳性,阳性金标准),761份无血吸虫感染史、无疫水接触史且病原学检测阴性者血清(阴性金标准)。采用日本血吸虫病IHA诊断试剂盒对上述血清进行血吸虫抗体检测,并计算阳性符合率(灵敏度)、阴性符合率(特异度)、阳性预测值和阴性预测值等诊断效能指标。结果日本血吸虫病IHA诊断试剂盒与阳性金标准的符合率为95.1%(95%可信区间:92.9%～97.3%),阴性金标准的符合率为97.8%(95%可信区间:96.8%～98.8%),阳性预测值和阴性预测值分别为95.4%和97.6%。试剂盒对不同感染度的阳性金标准血清(1～、41～、100～)检出的抗体阳性率之间差异无统计学意义;各年龄组间IHA灵敏度和特异度变化较小,差异均无统计学意义。结论日本血吸虫病IHA诊断试剂盒对血吸虫病具有较好的诊断效能,可用于血吸虫病的辅助诊断,适用于疫区大规模人群的血吸虫病现场筛查。

Objective To evaluate the clinical diagnostic efficiency of Indirect Hemagglutination Assay Kit（IHA kit） for anti-body detection of schistosomiasis japonica.Methods Schistosomiasis examinations by parasitological method were conducted in the schistosomiasis endemic areas in Jiangxi,Anhui and Hubei provinces,respectively.A total of 371 serum samples of schistoso-miasis patients and 761 serum samples of non patients without history of schistosome infection and infested water contact were col-lected.All the sera were detected by using IHA Kit.The diagnostic efficiency indicators of the kit,including sensitivity,specificity,positive predicted value,negative predicted value etc.were calculated.Results The sensitivity and specificity of the kit were 95.1%（95% confidence interval was between 92.9% and 97.3%） and 97.8%（95% confidence interval was between 96.8% and 98.8%）,respectively;the positive and negative predicted values were 95.4% and 97.6%,respectively.No statistically significant difference was found in the prevalence of IHA positive detecting by the kit among the groups with different EPG levels（≤40,41-100, 100）.Also,no significant difference was observed in sensitivity and specificity among the different age groups.Conclu-sions The IHA kit shows a relative high efficiency for diagnosis and can be used for mass screening of schistosomiasis in field sites.