南方医科大学学报

南方医科大学学报 ›› 2014, Vol. 34 ›› Issue (06): 901-.

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人心脏型脂肪酸结合蛋白检测试剂盒诊断急性冠状动脉综合征的价值

刘亚巍，田苗，蒋知新，洛佳坤，衣志勇   

  • 出版日期:2014-06-20 发布日期:2014-06-20

Evaluation of a heart-type fatty acid-binding protein detection kit for dignosis of acute
coronary syndrome

  • Online:2014-06-20 Published:2014-06-20

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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。

Abstract: 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.