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参考方法在丙氨酸氨基转移酶测定标准化中的应用 被引量:2

Application of reference method in the standardization for the determination of alanine aminotransferase
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摘要 目的调查不同检测系统使用经参考方法赋值的冰冻人血清样本作为校准品进行校准后,不同来源样本丙氨酸氨基转移酶(ALT)测定结果的可比性与准确性的改变程度。方法 5份经4家候选参考实验室应用不含磷酸吡哆醛的ALT参考方法定值的冰冻人混合血清样本用于评价广州地区10个不同检测系统ALT催化活性结果的可比性与准确性。其中一个样本用作校准品校准各系统。比较校准前后各系统间新鲜血清样本与商品制备物测定结果的变异与偏倚。结果校准后,各检测系统间新鲜血清测定结果的变异由11.90%~8.60%下降到6.78%~2.30%,偏倚则从-12.52%~-8.44%下降到-3.36%~-0.08%。校准后,常规系统测定新鲜血清结果与参考方法的回归曲线的斜率和截距比校准前更接近1和0;而商品制备物测定结果校准后的斜率和截距则无明显改善。结论采用定值冰冻人血清样本作为校准品可以改善不同检测系统测定结果的准确性和可比性,但由于基质效应的存在不能改善商品制备物测定结果的可比性。 Objective To investigate the accuracy and comparability of alanine aminotransferase(ALT) measurement results in human serum samples and commercial materials before and after calibration with frozen human serum calibrator assigned by reference method.Methods Five frozen human-pooled serum samples were assigned values by the reference method without pyridoxal 5-phosphate for ALT in four candidate reference laboratories,which were used to evaluate the results of ALT catalytic activity detected by ten testing systems in Guangzhou.One of the serum sample was used as the common calibrator.The results of serum samples and commercial materials from different systems before and after calibration were analyzed for biases and intersystem variations.Results After calibration,the variance of the systems for the results of serum samples decreased from between 11.90% and 8.60% to between 6.78% and 2.30%,and the bias decreased dramatically from between-12.52% and-8.44% to between-3.36% and-0.08%.Slopes of the regression lines of ALT results of serum samples between reference systems and routine systems after calibration were closer to 1 and intercepts closer to 0 than those obtained before calibration.Conclusion Accuracy and comparability of ALT measurements could be improved by using a common human serum calibrator.But commercial materials might not be commutable for human serum in ALT measurements.
出处 《国际检验医学杂志》 CAS 2012年第14期1668-1670,共3页 International Journal of Laboratory Medicine
基金 国家"十一五"计划科技重大专项(2008ZX09312-021) 广东省科技计划项目(2010B031600128) 广东省医学科研基金课题(A2010216)
关键词 丙氨酸转氨酶 标准化 检测系统 alanine aminotransferase; standardization; detection system
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  • 1周华文,倪星忠,居漪,王美娟,张瑞镐.血清丙氨酸氨基转移酶测定标准化的探讨[J].中华检验医学杂志,2004,27(6):391-392. 被引量:4
  • 2张秀明,庄俊华,徐宁,黄宪章,陈茶,尹一兵,梁伟雄.不同检测系统血清酶测定结果的偏倚评估与可比性研究[J].中华检验医学杂志,2006,29(4):346-349. 被引量:137
  • 3张秀明,郑松柏,孙蕾,柯培锋,马骥,张文,林莲英.应用Westgard方法评价决定图判断生化检测系统性能的可接受性[J].中华检验医学杂志,2007,30(1):86-90. 被引量:73
  • 4李淑葵,何振坤,徐国宾,李海霞,王涛,但万春.血清γ-谷氨酰转移酶测定参考方法的建立及在酶校准品定值中的临床应用[J].中华检验医学杂志,2007,30(6):679-682. 被引量:4
  • 5International Organization for Standardization ISO18153. In vitro diagnostic medical device-Measurement of quantities in samples of biological origin-Metrological traceability of values for catalytic concentration of enzyme assigned to calibtators and control materials. 2003.
  • 6Schumann G, Bonora R, Cefiotti F, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37℃. Part 2. Reference procedure for the measurement of catalytic activity concentration of creatine kinase. Clin Chem Lab Med, 2002,40: 635-642.
  • 7Schumann G, Bonora R, Cefiotti F, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37℃. Part 3. Reference procedure for the measurement of catalytic activity concentration of lactate dehydrogenase. Clin Chem Lab Med,2002,40: 642-648.
  • 8Schumann G, Bonora R, Ceriotti F, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37℃. Part 4. Reference procedure for the measurement of catalytic activity concentration of alanine aminotransferase. Clin Chem Lab Med, 2002,40. 718-724.
  • 9Schumann G, Bonora R, Ceriotti F, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37℃. Part 5. Reference procedure for the measurement of catalytic activity concentration of aspartateaminotransferase. Clin Chem Lab Med,2002,40: 725-733.
  • 10Schumann G, Bonora R, Ceriotti F, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37℃. Part 6. Reference procedure for the measurement of catalytic activity concentration of γ- glutamyltransferase. Clin Chem Lab Med,2002,40: 734-738.

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