IHA和ELISA试剂盒在血吸虫病临床检验中特异性的评价

Assessment of specificity of IHA and ELISA reagent kits in clinical detection of schistosomiasis

目的评价间接血凝试验(IHA)和酶联免疫吸附试验(ELISA)两种试剂盒在血吸虫病临床诊断中价值。方法采集非血吸虫病流行区的肝吸虫病人、肺吸虫病人、姜片虫病人、正常人群和乙肝病人血清,按照单盲试验的原则进行IHA和ELISA检测,对比分析两法特异性。结果 IHA和ELISA两种试剂盒,检测567份健康人员(献血员和中小学生)的特异性分别为97.88%和98.41%,检测65份肺吸虫病人血清的交叉阳性率为21.54%和18.46%.检测52份肝吸虫病人血清的交叉阳性率为5.77%和3.85%,检测56份姜片虫病人血清的交叉阳性率为3.57%和5.36%,检测195份乙肝病人假阳性率分别为2.56%和6.67%;两种试剂盒在检测其它三种吸虫病人的交叉反应均无显著意义(χ~2=0.19～0.21,P=0.661 0～0.646 7),但两法与肺血吸虫交叉反应均较高(χ~2=8.76～11.87,P=0.000 6～0.0031),而与肝吸虫和姜片虫交叉略高于正常人群(χ~2=2.33～4.13,P=0.126 6～0.0420)。IHA试剂盒在检测乙肝病人和健康正常人群的阳性率无显著差异(χ~2=0.04,P=0.841 1),ELISA试剂盒在检测乙肝病人的阳性率显著高于健康正常人群(χ~2=7.90,P=0.0050),其阳性率是健康正常人群的4.20倍。结论在血吸虫病现场筛查和医院门诊检查血吸虫病时.IHA试剂盒优于ELISA试剂盒。

Objective To assess the value of the indirect hemagglutination assay(IHA) and enzyme-linked immunosorbent assay(ELISA) reagent kits in clinical diagnosis of schistosomiasis.Methods The sera were collected from the cases with clonorchiasis,paragonimiasis,fasciolopsiasis,hepatitis B and healthy people in areas where schistosomiasis was not endemic,the schistosome antibody was detected with IHA and ELISA using the single-blindness method,and the specificities of both methods were compared.Results The specificity was 97.88%and 98.41%for IHA and ELISA in detection of 567 healthy people(blood donors and primary and middle school students).The cross positive rate was 21.54%) and 18.46%for IHA and ELISA in detection of 65 sera of paragonimiasis cases,5.77%and 3.85%in detection of 52 sera clonorchiasis cases,and 3.57%and 5.36%in detection of 56 sera of fasciolopsiasis cases.The false positive rate of IHA and ELISA for detection of 195 patients with hepatitis 13 was 2.56%and 6.67%,respectively.There were no significant differences of cross-reaction in detection of paragonimiasis,clonorchiasis and fasciolopsiasis(x^2=0.19-0.21,P= 0.6610-0.646 7).However,both methods had higher cross-reaction with paragonimiasis(x^2=8.76-11.87,P= 0.000 6-0.003 1),while the cross-reaction with clonorchiasis and fasciolopsiasis were a bit higher than that with healthy people(x^2=2.33- 4.13,P=0.126 6-0.042 0).There was no significant difference of the positive rate in detection of cases with hepatitis B and the healthy people by IHA(x^2=0.04,P=0.841 1),while the positive rate of hepatitis B virus infection detected by ELISA was significantly higher than that in the healthy people (x^2=7.90,P=0.005 0),being about 4.20 times more than the latter.Conclusion IHA reagent kit is superior to ELISA kit in field screening of schistosomiasis and clinic examination of schistosomiasis in hospital.