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。
Objective To investigate the effect of measuring value transfer for human serum samples assigned by the reference laboratory network on improving the trueness of seven enzyme activities in clinical laboratories,such as ALT,AST,GGT,LDH,CK,AMY and ALP.Methods Depending on the medical institutions at all levels contacted by 5 reference laboratories in North China,South China,East China and Southwest China,the corresponding clinical laboratory measuring value transfer/traceability network was established. The frozen human serum samples with good interchangeability and standard material characteristics,including calibrator,sample 1 and sample 2,were provided by Beijing Aerospace General Hospital,and were assigned by 5 reference labotatories in four regions. These samples were sent to 48 clinical laboratories. These clinical laboratories measured sample 1 and sample 2 according to their standard operating procedures,and then measured the two samples again after adjusting their measurement system by using the supplied calibrator. The changes of trueness of detection results in these laboratories were evaluated according to the WS/T 403-2012 standard,and the changes of consistency for ALT and AST before and after measuring value transfer were investigated. Results The results of AMY,ALP,GGT,CK and LDH calibrator,sample 1 and sample 2assigned by the established network were 138. 7 U/L,278. 5 U/L and 68. 3 U/L,265. 3 U/L,94. 5 U/L and 134. 4 U/L,195. 8 U/L,89. 0U/L and 158. 9 U/L,393. 7 U/L,260. 0 U/L and 645. 3 U/L,and 302. 0 U/L,250. 0 U/L and 452. 7 U/L,respectively. The percentages of sample 1 and sample 2 which met the bias requirements of the WS/T 403-2012 standard before measuring value transfer for AMY,ALP and GGT were 65. 9% and 61. 0%,76. 6% and 78. 7%,and 66. 7% and 70. 8%,respectively,while after measuring value transfer,they were89. 2% and 83. 8%,86. 7% and 80. 0%,and 85. 4% and 91. 7%,respectively. The percentages of sample 2 which met the bias requirements of the WS/T 403-2012 standard before measuring value
出处
《临床检验杂志》
CAS
CSCD
2017年第2期138-141,148,共5页
Chinese Journal of Clinical Laboratory Science
基金
国家质检公益性行业科研指标(201210066)
北京市科技计划(Z141107006614010)
关键词
量值传递
溯源
参考实验室网络
正确度
measuring value transfer
traceability
reference laboratory network
trueness
