摘要
目的调查北京市三级医院临床化学常规检测项目的室间变异,比较不同质评材料对室间质量评价的影响及不同分析方法间结果的差异,为临床实验室间检验结果互认提供实验数据。方法被调查的北京市三级医院临床生化实验室在常规条件下完成调查样本(5份混合人血清及2份质控血清)的检测,结果由调查人员当场取回。结果同批质控品用于现场调查及日常室间质量评价(EQA)的统计结果显示:除肌酸激酶(CK)两者变异系数(CV)接近外,其他所有调查项目,前者的均大于后者;不同检测系统检测人血清与质控品各调查项目的统计结果表明:碱性磷酸酶(ALP)项目,人血清的 CV 小于质控品的 CV;其他项目的 CV 均接近;方法分组统计结果显示:同一项目同方法相近浓度水平质控品的 CV 无明显大于人血清的 CV。同一项目不同方法组均值比较,多数项目组均相近,肌酐低浓度时,Jaffe's 动力学法与酶法组均有差异;血糖项目的葡萄糖氧化酶法(氧电极法)、尿素项目的二乙酰一肟法较其他方法组组均偏低。结论现场调查的结果更能反映临床实验室间的结果变异。两种质评材料比较,调查质控品 ALP 的测定有较人血清明显的基质效应;而对于其他项目,未见有明显于人血清的基质效应;同一项目不同分析方法检测结果可能存在差异,EQA 应视方法不同分组评价;为了保证基于统计学评价结果的意义以及更多的实验室结果能够互认,分析方法的相对集中是必要的。
Objective To investigate the variations of biochemistry tests among clinical laboratories in Beijing. Methods Seven serum samples were used for the survey. Five of the samples were pooled patient samples and two were lyophilized control materials that were the same as used in the last event of the regular External Quality Assessment （EQA） program. The samples were sent to and analyzed by the participating laboratories. Test results were collected on-site by designated surveyors and analyzed for interlaboratory variations. Results On the two control materials, the interlaboratory coefficients of variation （CVs） of the on-site survey results were significantly higher than that obtained in the last regular EQA event for all the tested analytes except creatine kinase that showed similar interlaboratory CVs in the two surveys. Interlaboratory CVs on the control materials were similar to that on the patient samples for most of the analytes. Alkaline phosphatase showed a lower CV on the patient samples. The peer method means varied but their variations were similar on the control materials and on the patient samples. Conclusions The interlaboratory comparability of clinical biochemistry test results may be better evaluated by on-site surveys. The control materials used in the currently EQA programs have very similar properties to patient samples. Result discrepancies between methods for some biochemistry tests still exist.
出处
《中华检验医学杂志》
CAS
CSCD
北大核心
2007年第7期757-761,共5页
Chinese Journal of Laboratory Medicine
关键词
室间质量评价
数据收集
生物化学
External quality assessment
Data collection
Biochemistry
