基于参考实验室网络定值的人血清样本量值传递效果评价

发布时间：2018-05-13 08:05

  本文选题：量值传递 + 溯源　； 参考：《临床检验杂志》2017年02期

【摘要】：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。
[Abstract]:Objective to study the effects of human serum samples based on reference laboratory network on alanine aminotransferase (alt), aspartate aminotransferase (AST), 纬 -glutamyl transferase (GGTT), lactate dehydrogenase (LDH), creatine kinase (CK), 伪 -starch. The transmission effect of seven enzyme indexes including amylase, alkaline phosphatase (ALP) and so on. Methods based on the medical institutions at all levels in the radiation areas of four reference laboratories in North, South, East and Southwest of China, the corresponding network of quantity transfer / traceability of conventional laboratories was established, and the interchangeability of Beijing Aerospace General Hospital was good. Frozen human serum samples with standard substance properties (calibrator, assessment sample 1, assessment sample 2), jointly assigned by 5 reference laboratories in 4 regions; samples sent to 48 laboratories throughout the country, Each laboratory measured two evaluation samples according to their respective standard operating procedures, and then measured two evaluation samples using frozen human serum samples provided as calibration products for calibration manufacturer's system. According to WS/T 403-2012 health industry standard, the change of accuracy of measurement results in each laboratory was judged. Results the calibration products of Amylla ALP GGTCK and LDH were analyzed. 鏍峰搧1鍙婃牱鍝，

本文编号：1882347