摘要
目的评价自建生化检测系统的分析性能,证实自建检测系统的试验结果的可靠性。方法用自建系统对不同水平质控品及新鲜人血清标本进行精密度和线性可测量范围的测定;用新鲜血清标本比较自建与比对系统的精密度并进行回归与相关分析。结果自建系统ALT,Urea,Crea,TC,ApoA1,ApoB,HDL-C等项目检测不精密度CV值满足美国CLIA'88能力比对检验的质量分析要求、线性测量范围特别是线性高值满足临床要求,与Roche可溯源参考检测系统试验结果相关系数>0.975;LDL-C存在方法学的差异,相关系数<0.975。结论方法学比对试验LDL-C相关系数<0.975,按SE%>1/2CLIA'88标准,LDL-C和HDL-C低值标本结果不被接受(另有文章报道),反应曲线满足Y=bX+a时,可利用回归方程对HDL-C试验结果的偏倚进行纠偏;其余项目相关系数>0.975,相关性满足统计学要求。
Objective To estimate on the capability of a self-developed biochemical testing system,and to prove the result reliability of the self-developed testing system. Methods Using a self-developed system and contrastive system to test on precision of quality managements and fresh serum sample ,and to survey on the scope of linear;also with returning and relative estimation on precision. Results Items as ALT,Urea,Crea,TC,ApoAl ,ApoB and HDL-C in self-developed system, whose assay imprecision CV conforms to the quality analytical request of American CLIA＇88 contractive test on ability,and the survey sphere of linear,especially the linear tip conforms to clinical request. Roche traceability reference assay system test result＇s relative coefficient was〉0, 975,and that of LDL-C was〈0. 975,with method difference. Conclusion Relative coefficient of LDL-C was〈0.975. Other items,according to SE% 1/2CLIA＇88,HDL-C and LDL-C its low-part sample result not to be acceptable （Recorded in other articles）. As reaction curve conforms to Y=bX＋a,bias of test result can be corrected by return-equation. The relativity of other items,with relative coefficientS0. 975,conforms to statistics theory.
出处
《现代检验医学杂志》
CAS
2008年第1期26-28,共3页
Journal of Modern Laboratory Medicine
基金
江苏省徐州市科技局社会发展项目(XZ2006238)
关键词
可比性
溯源性
检测系统
capability
traceability
assay system
