摘要
目的探索测量不确定度评定在临床检验常规测量中的应用。方法以总胆固醇(TC)常规测量为例,按测量不确定度评定过程,分析不确定度分量的来源并分别按A类和B类进行评定;根据针对单一样本和针对受试者的方案合成标准不确定度,计算扩展不确定度。结果不确定度分量来源包括:不精密度、人体生理变异、校准品、偏倚。其中,不精密度分量按CLSIEP5A文件评定,分别为1.67%(TC=4.25mmol/L)和2.46%(TC=6.79mmol/L);参照文献,TC生理变异的不确定度分量为6.0%;根据厂家的溯源性报告,校准品的不确定度分量为0.4%;根据卫生部室间质评回报结果,偏倚所致的不确定度分量为2.03%(TC=3.52mmol/L)和0.45%(TC=6.74mmol/L)。经合成,针对单一样本的扩展不确定度为(4.25±0.22)mmol/L(κ=2)、(6.79±0.34)mmol/L(κ=2);针对受试者的扩展不确定度为(4.25±0.56)mmol/L(κ=2)、(6.79±0.88)mmol/L(κ=2)。结论临床检验常规测量中应根据具体情况分析不确定度分量的来源,用不同的方案合成标准不确定度。
Objective To explore the application of evaluation for measurement uncertainty in routine clinical laboratory.Methods The routine test of total cholesterol （TC） in serum was chosen as the example to evaluate the process of measurement uncertainty.The sources of uncertainty were identified,and the components of uncertainty were evaluated as type A and B respectively.According to the combining components for two different budgets the expand uncertainty in the direction for single sample or tested subjects was calculated respectively.Results The components of sources for uncertainty included imprecision,human physiological variation,calibrator and bias.The components of imprecision evaluated on the basis of CLIS EP5A document were 1.67% （TC = 4.25 mmol/L） and 2.46% （TC = 6.79 mmol/L） respectively.Refer to the literatures,the uncertainty from human physiological variation was 6% .The traceability report from manufacturers showed the uncertainty of calibrator was 0.4% .The bias was 2.03% （TC = 3.52 mmol/L） and 0.45% （TC = 6.74 mmol/L） respectively,according to the report of external quality assessment from State Health Ministry.Following the combination of all the components,the expand uncertainties were （4.25 ± 0.22） mmol/L （κ = 2）,（6.79 ± 0.34） mmol/L （κ = 2） for single sample,and （4.25 ± 0.56） mmol/L （κ = 2）,（6.79 ± 0.88） mmol/L （κ = 2） for tested subjects,respectively.Conclusions In routine clinical laboratory,the sources of uncertainty should be identified depended on specific circumstances,and the uncertainty from combined components with various budgets should be applied.
出处
《临床检验杂志》
CAS
CSCD
北大核心
2010年第5期372-374,共3页
Chinese Journal of Clinical Laboratory Science
关键词
测量不确定度
总胆固醇
质量控制
measurement uncertainty
total cholesterol
quality control
