血清酶测定标准化的实验研究

Studies on standardization of serum enzyme determination

目的 通过酶校 (标 )准品在临床实验室中的应用 ,探讨血清酶测定标准化的新途径。方法 向参加实验室 (15 0家 )发放酶校准品 1支和血清样本 3支 ,各实验室用现行方法分别测定校准品和血清样本 ,记录检验结果 ;用校准品定标后再测定血清样本 1次 ,记录检验结果 ;计算校准品测定结果总体均值与标示值间的偏倚和校准前后血清样本测定结果精密度的变化。结果 丙氨酸氨基转移酶 (ALT)、天门冬氨酸氨基转移酶 (AST)、淀粉酶 (AMY)和乳酸脱氢酶 (LD)的测定结果均值与标准品标示值的相对偏倚≤± 6 % ,分别为 3 8% ,- 1 8% ,2 3%和 - 5 2 % ;碱性磷酸酶 (ALP)、γ 谷氨酰基转移酶 (GGT)和肌酶激酶 (CK)的实验室检测结果与标准品标示值间的相对偏倚小于 2 0 % ;分别为13 7% ,- 13 9%和 - 19 2 %。在应用校准品后 ,多数项目测定结果的变异系数 (CV % )得到不同程度的改善 ,ALT由 10 %～ 4 4 %下降至 8%～ 4 2 % ,LD由 16 %～ 39%下降至 8%～ 11%。结论 我国临床实验室对血清ALT、AST、AMY和LD的测定结果有较好的向国际标准溯源性 ;使用酶校准品可改善不同分析系统间测定结果的一致性。

Objective Investigating for the standardization of serum enzyme determination by using enzyme calibrator in lab tests Methods 150 laboratories were involved in this program. One enzyme calibrator and three patient samples were send to each participate lab The calibrator was tested using routine method and record the results The patient samples were analyzed before and after calibration Record the results All lab data was processed with computer Results Compare with the target values, the bias of alanine aminotransferase (ALT), aspartate aminotransferase (AST), amylase (AMY) and lactate dehydrogenase (LD) assays were 3 8%, -1 8%, 2 3% and -5 2% respectively, the bias of alkaline phosphatase (ALP), gamma glutamyltransferase (GGT) and creatine kinase (CK) assays were 13 7%, -13 9 and -19 2% respectively The precision of the enzyme assays were improved by using calibrators Conclusions The traceability of ALT, AST, AMY and LD assays were reasonable Calibrating by using enzyme calibrator can improve the assay precision among laboratories