摘要
目的评价兰州生物制品研究所研发的人心脏型脂肪酸结合蛋白(heart-type fatty acid-binding protein,H-FABP)ELISA检测试剂盒与已批准上市的同类试剂盒用于临床诊断急性冠脉综合症(acute coronary syndrome,ACS)的等效性及临床符合性。方法样本为中国人民解放军总医院住院的疑诊ACS患者的血浆或血清,根据入选标准和排除标准共入选160例样本,分别采用兰州与荷兰H-FABP试剂盒进行平行、对照试验标准检测,两种试验产品结果的一致性采用Kappa检验和相关分析。结果兰州试剂盒检测H-FABP诊断ACS的灵敏度为91.8%,特异度为88.7%,正确率为90.4%。荷兰试剂盒检测H-FABP诊断ACS的灵敏度为90.3%,特异度为86.8%,正确率为88.8%。两种产品测定结果在统计学上无差异(P=0.668,>0.05)。具有良好的一致性(Kappa=0.726,P<0.01)。结论兰州生物研究所生产的H-FABP与荷兰HBT公司生产的H-FABP检测试剂盒用于诊断ACS具有等效性且临床符合性良好,在临床上具有推广应用价值。
Objective To evaluation the performance of a heart-type fatty acid-binding protein （H-FABP） ELISA detection kit in the clinical diagnosis of acute coronary syndrome （ACS）. Methods Plasma or serum samples from 160 suspected ACS patients hospitalized in General Hospital of PLA were examined using Lanzhou H-FABP reagent kit and Holland H-FABP kit. Correlation of the two kits was evaluated and Kappa test was used to examine the consistency of the results of the two products. Results The sensitivity of H-FABP diagnosis of ACS detection Lanzhou kit was 91.8%, the specificity was 88.7%, and the total diagnostic rate was 90.42%. The sensitivity of H-FABP diagnosis of ACS detection Holland kit was 90.3%, the specificity was 86.8%, and the total diagnostic rate was 88.75%. The test results showed that two products yielded comparable results （P=0.668,〉0.05） with a good consistency （Kappa=0.726, P〈0.01）. Conclusions H-FABP ELISA detection kit produccted by LanZhou biological research institute has a good correlation with H-FABP detection kit produced by HBT company of Holland and has the potential for clinical application.
出处
《南方医科大学学报》
CAS
CSCD
北大核心
2014年第6期901-903,共3页
Journal of Southern Medical University
关键词
心脏型脂肪酸结合蛋白
诊断
急性冠脉综合征
heart type fatty acid binding protein
diganosis
acute coronary syndrome
