摘要
目的分别对自建生化检测系统(简称自建系统)和配套生化检测系统(简称配套系统)进行初步性能评价。方法依照美国临床实验室标准化委员会(NCCLS)EP10-A2文件,使用自建系统(OLYMPUS AU400生化分析仪、罗氏cfas校准品及国产试剂)和配套系统(OLYMPUS AU 400生化分析仪、OLYMPUS校准品及OLYMPUS原装试剂)测定天门冬氨酸氨基转移酶(AST)、葡萄糖(Glu)、γ-谷氨酰基转移酶(GGT)、丙氨酸氨基转移酶(ALT)4个项目,计算其偏差、总不精密度及其截距、斜率、非线性、互染率、漂移性,并与各项目对应设定值作比较。结果自建系统:ALT的低值偏差和Glu的中、高值偏差超出允许范围,ALT的低值总不精密度超出允许范围,其余项目的偏差和总不精密度均在允许范围之内。GGT、ALT的非线性、截距和斜率以及Glu的斜率差异有统计学意义,其余项目的截距、斜率、非线性、互染率、漂移性差异均无统计学意义。配套系统:ALT的低值总不精密度超出允许范围,其余项目的偏差和总不精密度均在允许范围之内。GGT的截距和斜率差异有统计学意义,其余项目的截距、斜率、非线性、互染率、漂移性差异均无统计学意义。结论无论是使用自建系统测定AST、GGT、ALT,还是使用配套系统检测AST、Glu、GGT、ALT,偏差都在允许范围内,总不精密度小于美国临床实验室改进法案修正案(CLIA′88)能力验证计划中分析质量要求规定的总允许误差的1/3,互染率较低,稳定性较好。自建系统检测Glu的准确度有待加强改善。
Objective To evaluate the preliminary function on self-built and matching biochemistry detection systems respectively.Methods The self-built detection system（OLYMPUS AU 400 biochemistry analyzer,Roche cfas calibrator and homemade reagents） and the matching detection system（OLYMPUS AU 400 biochemistry analyzer,OLYMPUS calibrator and OLYMPUS reagents） were applied into the determination of aspartate aminotransferase（AST）,glucose（Glu）,gamma-glutamyltransferase（GGT） and alanine aminotransferase（ALT） according to the Protocol EP10-A2 provided by National Committee for Clinical Laboratory Standards（NCCLS）.The deviations,total imprecision,intercepts,slope rates,nonlinearities,carryovers and drifts were calculated and compared with the range of set value.Results For the data of self-built system,the low value of ALT,middle and high values of Glu in deviations and low value of ALT in total imprecision exceeded permissive ranges,and the other deviations and total imprecision were all in the permissive ranges,among which the nonlinearities,intercepts and slope rates of GGT and ALT showed significant difference,as well as the slope rate of Glu.No significant difference was showed in other intercepts,slope rates,nonlinearities,carryovers and drifts.For the data of matching system,the low value of ALT in total imprecision was out of the permissive range with the other deviations and total imprecision were all in the permissive ranges.The intercept and slope rate of GGT had significant difference with the other intercepts,slope rates,nonlinearities,carryovers and drifts showing no significant difference.Conclusions The self-built system,which is applied to detect AST,GGT and ALT,and matching biochemistry system,which is applied to detect AST,Glu,GGT and ALT,have shown the deviations in permissive ranges.The total imprecisions are all less than 1/3 the Clinical Laboratory Imptovement Amendments 88（CLIA′88） with low carryovers and good stabilities.Furthermore,the accuracy of self-built system use
出处
《检验医学》
CAS
北大核心
2010年第5期345-348,共4页
Laboratory Medicine
基金
广州番禺区科技局基金资助项目(2007-Z-74-1)
