湖北地区健康人群缺血修饰白蛋白血清水平参考区间的建立及临床应用

The Establishment and Application of the Reference Interval of Ischemia Modified Albumin in Healthy Population of Hubei Area

目的:应用美国临床实验室标准化委员会颁布的CLSIC28-A3文件建立湖北地区健康人群缺血修饰白蛋白(IMA)的参考区间,并采用急性冠状动脉综合征(ACS)心肌缺血患者和健康人群验证此参考区间的可靠性。方法:按要求选择健康人群血清标本,采用白蛋白钴结合试验测定血清IMA,经统计分析后确定IMA参考区间。选择ACS心肌缺血患者和一批健康人群,同法测定其血清IMA,并与肌钙蛋白I(cTnI)平行检测比较,验证新建立参考区间的可靠性。结果:IMA的参考值为>65.20U/ml。ACS心肌缺血患者的IMA水平为46.00U/ml(95%CI:45.10～47.10),阳性率为98.90%;cTnI的血清水平为3.31ng/ml(95%CI:2.53～4.51),阳性率为93.40%。健康人群的IMA水平为70.20U/ml(95%CI:67.20～73.10);cTnI的血清水平为0.23ng/ml(95%CI:0.21～0.54)。结论:利用CLSIC28-A3文件建立IMA参考区间简便可行,能较客观反映临床症状,有助于缺血性心肌损伤的诊断。

Objective：To establish ischemia modified albumin（IMA）＇s reference interval in healthy people of Hubei area and verify the new reference interval in ACS patients and healthy people with the guide of CLSI C28-A3 file.Method：Follow the guide of CLSI C28-A3 file and select reference individual,obtain the blood sample and measure the serum IMA level with the principle of albumin cobalt binding test.The reference interval of IMA was calculated by statistical method.ACS patients and healthy people were selected to verify the new reference interval by measuring IMA and cTnI.Results：The reference interval of IMA in healthy population is above 65.20U/ml.Among ACS patients,the serum level of IMA and cTnI were 46.00U/ml（95%CI：45.10~47.10）,3.31ng/ml（95%CI：2.53~4.51）,respectively.IMA and cTnI levels were 70.20U/ml（95%CI：67.20~73.10）,0.23ng/ml（95%CI：0.21~0.54）in healthy people,respectively.Conclusion：The file of CLSI C28-A3 played a good guiding role in the establishment of reference interval,and the new reference interval of IMA in Hubei area was in accordance with clinical symptoms.