临床常用线性评价方案的应用比较

目的熟悉美国临床实验室标准化委员会(NCCLS)EP6-A线性评价方案的应用;探讨美国临床病理学家协会设备委员会(CAP-IRC)法、EP6-P、EP6-A线性评价方案的区别及适用性。方法按照EP6-A对采用电化学发光法检测的甲胎蛋白(AFP)、速率法检测的尿素和丙氨酸转氨酶(ALT)、免疫比浊法检测的载脂蛋白B(apo B)和荧光定量聚合酶链反应(PCR)检测的乙型肝炎病毒脱氧核糖核酸(HBV DNA)进行线性评估;以尿素为例建立检测线性范围;比较CAP-IRC法、EP6-P、EP6-A方案评价apo B线性结果的异同。结果按照EP6-A,AFP、ALT和HBV DNA(对数)可直接判断呈线性;尿素的真实线性范围为5.305~46.975 mol/L。apo B目测法可判断呈线性;EP6-P判断呈非线性;CAP-IRC法判断呈非线性但在临床可接受范围;EP6-A判断呈非线性,但在一定范围内呈线性。结论推荐临床实验室使用EP6-A线性评价方案对各个检测项目进行线性评价保证检测结果的准确可靠。

The linearity evaluation guidelines in clinical practice

Objective To compare the differences between linearity evaluation guidelines National Committee for Clinical Laboratory Standards(NCCLS) EP6-A,EP6-P and College of American Pathologists-Instrumentation Resource Committee(CAP-IRC) in the clinical practice. Methods Using linearity evaluation guidelines of NCCLS EP6-A,EP6-P and CAP-IRC to observe the linearity of measurement of the alpha fetoprotein(AFP),alanine aminotransferase(ALT),apolipoprotein B(apo B),hepatitis B virus(HBV) DNA and urea,which use different methods respectively,and to compare the similarities and differences between these linearity evaluation guidelines. Results The results of ALT,AFP,HBV DNA(logarithmic) measurement could be evaluated as linear based on EP6-A,and the real linearity range of urea was 5.305-46.975 mol/L.Apo B could be evaluated as linear within certain range based on EP6-A,nonlinear based on EP6-P,and nonlinear but clinical acceptable based on IRC. Conclusions Using EP6-A to evaluate linearity is more practicable in clinical laboratory.