摘要
目的评价中山地区23家临床实验室糖化血红蛋白(HbA1c)检测系统的分析性能,为全市医疗机构间该项目检测结果的互认奠定基础。方法收集参加2018年中山地区HbA1c检测结果一致性调查的23家代表性医疗机构的检测结果、近6个月两个水平室内质控累积变异系数(CV)、检测方法及检测系统品牌。剔除超出±3s的数据,然后取均值作为靶值,并将每家实验室的CV、偏倚(Bias)绘制在IFCC模型图上。结果65%(15/23)的实验室两个水平均达到了IFCC所提出的总允许误差(TEa)<5 mmol/mol且>2σ的质量目标要求;高效液相色谱(HPLC)法性能达到了IFCC最低可接受标准,而免疫比浊法性能欠佳;伯乐、东曹、普门达到了IFCC标准,创艺性能欠佳;三甲和二甲医院均达到了IFCC标准,一甲医院未达到IFCC标准。结论不同检测方法、不同检测系统甚至不同级别医院HbA1c检测结果的一致性有待进一步提高。
Objective To evaluate the performance of HbA1c analyzers in 23 clinical laboratories in Zhongshan area and provide a basis for mutual recognition of the test results among medical institutions in the city.Methods The test results of 23 medical institutions,the cumulative variation coefficient(CV),the method and the brand of analyzers were recorded in the last six months.The data exceeding±3s were removed,and the mean value was taken as the target value.The CV%and bias%of each laboratory were plotted on the IFCC model.Results According to criterion of IFCC model,65%(15/23)clinical laboratories in the Zhongshan area met the quality target requirements which proposed by the IFCC,TEa<5 mmol/mol and>2σ.HPLC met the IFCC criterion,while immunoturbidimetric did not;Bio-Rad,Tosoh,and Pumen met the IFCC criterion,the performance of Creative Arts performance were poor;the gradeⅢA and gradeⅡA hospitals met the IFCC criterion,while the gradeⅠA hospitals did not.Conclusion The HbA1c-test consistency among different detection methods,different detection systems and different levels of hospital needs to be further improved.
作者
王霞
胡婷
索明环
卢兰芬
胡耀宗
王伟佳
WANG Xia;HU Ting;SUO Minghuan;LU Lanfen;HU Yaozong;WANG Weijia(Clinical Laboratory Center,Zhongshan Hospital of Sun Yat-Sun University,Zhongshan,Guangdong 528403,China)
出处
《检验医学与临床》
CAS
2020年第14期2039-2041,共3页
Laboratory Medicine and Clinic
基金
中山市科技计划项目(2015B1002)。
