摘要
目的了解福建省三级医院临床检验互认项目参考区间回报结果及来源,比较其常规化学与干化学各项目参考区间的差异,为建立全省范围健康人群临床检验互认项目参考区间提供帮助。方法收集福建省27家三级医院29个临床检验互认项目的 1 246个参考区间信息,剔除异常值和错误数据(下限高于上限、上下限相同等),分析常规化学与干化学各项目参考区间的差异。结果丙氨酸氨基转移酶、天门冬氨酸氨基转移酶、甘油三酯和总胆固醇参考区间下限以及甲胎蛋白、癌胚抗原参考区间上限的最大值和最小值之间差异很大;游离三碘甲状腺原氨酸和游离四碘甲状腺原氨酸报告结果单位不统一;参考区间来源中所占比例最高的3项依次是仪器及试剂厂家说明书、《全国临床检验操作规程》和国家卫生行业标准。在常规化学和干化学参考区间的比较中,丙氨酸氨基转移酶和乳酸脱氢酶差异有统计学意义(P<0.05)。结论目前,福建省三级医院部分临床检验互认项目参考区间差异明显,来源不统一;少数常规化学与干化学项目参考区间存在统计学上的差异。为了实现医疗机构检验结果的互认,必须在标准化的基础上,在一定区域内共享相同的参考区间。
Objective To investigate the results and sources of reference intervals in clinical laboratory interaccreditation items among Grade 3 hospitals in Fujian,compare the difference between routine and dry chemistry in these aspects,and provide a reference to establish reference intervals of clinical laboratory inter-accreditation items for healthy subjects in Fujian. Methods A total of 1 246 data of reference intervals were collected from 29 interaccreditation items of 27 Grade 3 hospitals in Fujian. All abnormal values and errors（lower limit was higher than upper one,or upper limit was as the same as lower one,etc.）were eliminated. The difference between routine and dry chemistry reference intervals were analyzed by SPSS 11.0.Results The differences between maximum and minimum values about the lower limits of alanine aminotransferase,aspartate aminotransferase,triglyceride and total cholesterol and the upper limits of alpha fetoprotein and carcinoembryonic antigen were big. The results of free triiodothyronine and free thyroxine were not unified. The 3 main sources of reference intervals were instructions of reagent manufacturers,the National Guide to Clinical Laboratory Procedures and the industry standards of the National Health and Family Planning Commission of the People＇s Republic of China. In comparison of routine and dry chemistry,the reference intervals of alanine aminotransferase and lactate dehydrogenase had signifi cant differences（P〈0.05）. Conclusions The reference intervals of a part of inter-accreditation items of Grade 3 hospitals in Fujian have differences,and the sources of them are various.A few assays have statistical signifi cance in routine and dry chemistry. In order to achieve inter-accreditation,all laboratories must share common reference intervals on the basis of standardization.
出处
《检验医学》
CAS
2016年第5期419-422,共4页
Laboratory Medicine
关键词
临床检验
参考区间
互认项目
常规化学
干化学
Clinical determination
Reference interval
Inter-accreditation items
Routine chemistry
Dry chemistry
