| 刘亚巍,尚进,洛佳坤,蒋知新,彭旭东,衣志勇.人心脏型脂肪酸结合蛋白检测试剂盒的方法学评价及在急性冠状动脉综合征患者诊断中的临床应用[J].中国临床保健杂志,2018,21(4):450-455. |
| 人心脏型脂肪酸结合蛋白检测试剂盒的方法学评价及在急性冠状动脉综合征患者诊断中的临床应用 |
| The clinical application of heart-type fatty acid-binding protein detection kit in the diagnosis of patients with acute coronary syndromes |
| 投稿时间：2018-02-10 |
| DOI：10.3969/J.issn.1672-6790.2018.04.005 |
| 中文关键词: 试剂盒,诊断 急性冠状动脉综合征 脂肪酸结合蛋白质类 方法学评价 |
| 英文关键词: Reagent kits,diagnostic Acute coronary syndrome Fatty acid-binding proteins Methodology evalution 〖FL |
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| 摘要点击次数: 6437 |
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| 中文摘要: |
| 目的 探讨中国自主研发成功具有完全自主知识产权的人心脏型脂肪酸结合蛋白(H-FABP)ELISA检测试剂盒与已上市的同类型试剂盒在临床诊断检测性能方面的等效性,并针对其性能的可接受性做全面的评估。方法 选取就诊于中国人民解放军总医院并被怀疑为急性冠状动脉综合征(ACS)收住院的患者,以及定期在中国人民解放军第三○五医院进行健康体检人员的血浆或血清。从中选出240例患者作为该临床研究的样本,按照平行分组和设置对照的实验原则,比较国产与荷兰两种H-FABP试剂盒的检测效果和相关性,同时针对国产H-FABP试剂盒检测实施了精密度试验、回收试验、抗干扰试验和稳定性试验,利用有关的智能软件来分析相关的试验数据,针对其临床检测的性能做完整的评估。结果 在全自动免疫分析测定仪的检测精度范围内,国产与荷兰试剂盒测定H-FABP值的相关系数R=0.96(P＜0.001)。对于国产试剂盒来说,其检测H-FABP的批内变异系数为5.7%~8.2%,批间变异系数为3.9%~4.1%,而回收率为91.1%~105.7%。并且,当总胆红素(TBIL)的浓度不相同时,对正常水平的H-FABP的影响度在-9.57%~2.39%；对异常水平的H-FABP的影响度在-20.71%~7.47%。当TG的浓度不相同时,对正常水平的H-FABP的影响度在-6.66%~10.13%；对异常水平的H-FABP的影响度在5.07%~10.91%。当溶血血红蛋白的浓度不相同时,其对正常水平的H-FABP的影响度在-9.18%~8.16%；对异常水平的H-FABP的影响度在-9.27%~9.83%。结论 国内自主研发的H-FABP检测试剂盒与荷兰生产的同类产品比较,具有良好的相关性和潜在临床应用价值。 |
| 英文摘要: |
| Objective To explore the clinical equivalence of the H-FABP ELISA detection kit in the of diagnosis field and assese the clinical diagnosis acceptability of kit. Methods The plasma or serum samples of suspected ACS patients in General Hospital of PLA and physical examination people from the 305th Hospital of PLA were collected.According to inclusion and exclusion criteria,240 samples were included in this study.The detection results of H-FABP reagent kit and Holland H-FABP kit were compared.The precision test,recovery test,interference test and stability test of H-FABP kit were assessedr. Results The correlation coefficient R of H-FABP and Holland kits was 0.96 (P<0.001).The coefficient variation of H-FABP was 5.7%-8.2%,and coefficient variation was 3.9%-4.1% between groups.The recovery rate of H-FABP was 91.1%-105.7%.The interference rate of different TBIL concentrations on normal H-FABP levels was -9.57%-2.39% and on abnormal H-FABP levels was -20.71%-7.47%.Similarly,the interference rate of different TG concentrations on normal H-FABP levels was -6.66%-10.13% and on abnormal H-FABP levels was 5.07%-10.91%.The interference rate of different concentrations of hemolysis hemoglobin on normal H-FABP levels was -9.18%-8.16% and on abnormal H-FABP levels was -9.27%-9.83%. Conclusion The domestic H-FABP ELISA detection kit has a significant correlation with Holland H-FABP detection kit with bright future in clinical application. |
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