CAJ | 학술논문

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。
목적：평개란주생물제품연구소연발적인심장형지방산결합단백（heart-type fatty acid-binding protein, H-FABP）ELISA검측시제합여이비준상시적동류시제합용우림상진단급성관맥종합증（acute coronary syndrome, ACS）적등효성급림상부합성。방법양본위중국인민해방군총의원주원적의진ACS환자적혈장혹혈청，근거입선표준화배제표준공입선160례양본，분별채용란주여하란H-FABP시제합진행평행、대조시험표준검측，량충시험산품결과적일치성채용Kappa검험화상관분석。결과란주시제합검측H-FABP진단ACS적령민도위91.8%，특이도위88.7%，정학솔위90.4%。하란시제합검측H-FABP진단ACS적령민도위90.3%，특이도위86.8%，정학솔위88.8%。량충산품측정결과재통계학상무차이（P=0.668，>0.05）。구유량호적일치성（Kappa=0.726，P<0.01）。결론란주생물연구소생산적H-FABP여하란HBT공사생산적H-FABP검측시제합용우진단ACS구유등효성차림상부합성량호，재림상상구유추엄응용개치。
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.