A new generation of lipoprotein(a)in clinical application and performance evaluation method for the detection of particles per unit / 国际检验医学杂志

ABSTRACT

Objective To evaluate the clinical significance of the International Federation of Clinical Chemistry and Laboratory Medicine international(IFCC) reference reagent(SRM2B) standardized ,particles unit method in detecting the lipoprotein(a)[Lp (a)] .Methods Precision ,linearity ,clinical reportable range ,reference interval index of total number of particles in the kit express-ing Lp(a) by nmol/L were evaluated ,and compared with the kit expressed Lp(a) by mg/L .At the same time serum alanine amin-otransferase(ALT) ,aspartate aminotransferase(AST) ,total bilirubin(TBIL) ,UREA ,creatinine(CREA) ,triglycerides(TG) ,total cholesterol(CHOL) ,high-density lipoprotein cholesterol(HDL-C) ,low density lipoprotein cholesterol(LDL-C) of all the subjects were detected and the correlations of them between LP(a) were analyzed .Results The method with-run coefficient of variation (CV)<1 .5% ,between-run CV< 2 .0 .Within the scope of 0 .6 -236 .0 nmol/L the linear was good(r2 = 0 .996 2) .Reportable range7-720 nmol/L ,normal reference range <75 nmol/L .With a total mass(mg/L) said good correlation between content Lp(a) kit .The correlation of Lp (a) and ALT ,AST ,TBIL ,UREA ,CERA ,TG ,CHOL ,HDL-C ,LDL-C of were -0 .120 ,-0 .091 ,-0 .372 ,-0 .096 ,-0 .087 ,0 .056 ,0 .263 ,0 .226 ,0 .159 .Conclusion This methods shows good performance ,and without interfer-ence from serum ALT ,AST ,UREA ,CERA ,TG ,HDL-C ,LDL-C levels ,but affected by the levels of serum TBIL and CHOL .It could be traced to the IFCC international reference methods and reference materials(SRM2B) ,which isn′t influenced by Lp(a) poly-morphisms ,detects Lp(a) particle number really ,expressed Lp(a) protein with nmol/L accurately ,helps evaluating clinical cardio-vascular disease risk ,and increases the comparability among different clinical research data .