人心脏型脂肪酸结合蛋白检测试剂盒的临床评价

目的评价人心脏型脂肪酸结合蛋白(H-FABP)检测试剂盒(胶体金法)在急性心肌梗死(AMI)诊断中的价值。方法采用平行、盲法、对照的对比试验设计,比较其试验产品和对比产品对诊断AMI的敏感性、特异性、准确性。结果共测定240份临床血液标本。试验产品和对比产品的阳性符合率为100%,阴性符合率为96.15%,总符合率为97.92%。对比产品和试验产品结果不一致的5例标本以临床诊断结果为标准进行验证后,试验产品与临床诊断结果的阳性符合率为100%,总符合率为100%。采用Kappa检验考核两种产品测定结果的一致性,Kappa指数为0.958。经McNamara's test分析,两产品之间无差异,χ2=3.20,P>0.05。结论试验产品显示出较好的诊断价值,可以作为AMI早期诊断标志物,试验产品与对比产品等效。

Clinical trials of diagnostic kit for heart-type fatty acid-binding protein

Objective To the value of evaluate heart-type fatty acid-binding protein（H-FABP） diagnostic kit（colloidal gold method）in diagnosis of acute myocardial infarction（AMI）.Methods A parallel,blind,controlled trial was designed and conducted to compare the sensitivity,specificity and accuracy between the target diagnostic kit and controlled kit in AMI diagnosis.Results Totally 240 clinical blood samples were tested.The positive match rate,negative match rate,and total match rate between the target kit and control kit was 100%,96.15%,and 97.92% respectively.The 5 samples showing different results in the two kits were further compared to clinical diagnosis results,and 100% positive match rate and 100% total match rate were obtained between the target kit and the clinical diagnosis.The consistency of the two diagnostic kits was evaluated by Kappa analysis,and the Kappa index was 0.958.Results of McNamara＇s Test showed that there was no difference between these two products,χ2=3.20,P0.05.Conclusion The target kit showed good values and can be used as a marker in early AMI diagnosis.There was no significant difference in effection between the target diagnostic kit and controlled kit.