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目的研究基于参考实验室网络定值的人血清样本对改进临床实验室丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、γ-谷氨酰基转移酶(GGT)、乳酸脱氢酶(LDH)、肌酸激酶(CK)、α-淀粉酶(Amy)、碱性磷酸酶(ALP)等7个酶学指标量值传递的效果。方法依托华北、华南、华东、西南4个区域的5家参考实验室辐射区域内的各级医疗机构,建立相应的常规实验室量值传递/溯源网络;北京航天总医院提供互换性良好、具有标准物质特性的冰冻人血清样品(校准品、评估样品1、评估样品2),由4个区域5家参考实验室联合赋值;将样品发送至全国48家实验室,各实验室按各自的标准操作规程先测量2个评价样品,再用提供的冰冻人血清样品作为校准品校准厂家系统后再次测量2个评价样品,依据WS/T 403-2012卫生行业标准判断各实验室测量结果正确度的变化,ALT、AST观察结果一致性的变化。结果 Amy、ALP、GGT、CK、LDH的校准品、样品1及样品2网络定值结果分别为138.7 U/L、278.5 U/L、68.3 U/L,265.3 U/L、94.5 U/L、134.4 U/L,195.8 U/L、89.0 U/L、158.9 U/L,393.7U/L、260.0 U/L、645.3 U/L,302.0 U/L、250.0 U/L、452.7 U/L;常规测量系统Amy、ALP、GGT量值传递前样品1及样品2满足WS/T 403-2012偏移要求的百分率分别为65.9%、61.0%,76.6%、78.7%,66.7%、70.8%,量值传递后分别为89.2%、83.8%,86.7%、80.0%,85.4%、91.7%,CK、LDH量值传递前样品2满足行标要求的百分率为64.6%、58.3%,量值传递后为93.5%、84.8%;ALT、AST实验室常规测量系统量值传递前后一致性:量值传递前样品1及样品2为12.9%、11.3%,10.2%、8.9%,量值传递后为9.3%、8.2%,5.6%、5.9%。结论基于参考实验室网络定值人血清样本建立的校准常规系统量值传递路径明显提高了我国各级医疗机构临床实验室Amy等7个酶学项目检验结果的可比性,值得进一步推广。
OBJECTIVE: To study the effect of human serum samples based on reference laboratory network settings in improving clinical laboratory alanine aminotransferase (ALT), aspartate aminotransferase (AST), γ-glutamyl transferase (GGT) LDH, CK, Amy, ALP and so on. Methods Relying on the medical institutions at all levels in five reference laboratories in four regions of North China, South China, East China and Southwest China, a corresponding routine laboratory value delivery / tracing network was established. Beijing Aerospace General Hospital provided patients with good interchangeability, Frozen human serum samples (calibrator, assessment sample 1, assessment sample 2) with reference material properties were jointly assigned by 5 reference laboratories in 4 regions; samples were sent to 48 laboratories in the country, Standard Operating Procedures First, two evaluation samples were measured. Two frozen samples of frozen human serum were used as calibrators to calibrate the manufacturer’s system. Two evaluation samples were again measured to determine the accuracy of each laboratory measurement according to WS / T 403-2012 Health Industry Standards Changes in the ALT, AST observed changes in the consistency. Results The calibrations of Amy, ALP, GGT, CK, and LDH were 138.7 U / L, 278.5 U / L, 68.3 U / L, 265.3 U / L and 94.5 U / L for network 1 and 2 respectively. 134.4 U / L 195.8 U / L 89.0 U / L 158.9 U / L 393.7 U / L 260.0 U / L 645.3 U / L 302.0 U / L 250.0 U / L 452.7 U / The percentage of pre-delivery value of Amy, ALP and GGT in sample 1 and sample 2 satisfying the WS / T 403-2012 offset requirements were 65.9%, 61.0%, 76.6%, 78.7%, 66.7% and 70.8% The percentage of samples satisfying the criteria for the samples before delivery of CK and LDH was 64.6% and 58.3% after the values were passed, respectively, 89.2%, 83.8%, 86.7%, 80.0%, 85.4% and 91.7% 93.5%, 84.8%; ALT, AST laboratory measurement system before and after the consistency of the value transfer: before the value of the sample 1 and sample 2 is 12.9%, 11.3%, 10.2%, 8.9%, 9.3% , 8.2%, 5.6%, 5.9%. Conclusion The calibrated conventional system based on the reference laboratory network set-value serum sample transfer path significantly improves the comparability of the test results of seven enzymatic projects such as Amy in clinical laboratories of various medical institutions in our country and is worthy of further promotion.