RESUMO
Objective To establish the test way of latex enhanced immune turbidimetric method for the concentration detection of urine free hemoglobin on the automatic biochemical analyzer,and evaluated the detection performance.Methods Prepared the detection reagents of latex enhanced immune turbidimetry method for detection of urine free hemoglobin with materials such as hemoglobin HBA0 antibody (8.5 mg/ml),80 nm carboxylic olystyrene latex microspheres (estapor,nanometer microspheres) and so on.Then,seted the project parameters on TBA120 automatic biochemical analyzer and proceeded the calibrations.Evaluated the detection performance by accuracy,precision,linear range,sensitivity,specificity and other indicators.Lastly,established the biological reference interval for urine free hemoglobin of healthy people in the region and verified it.Results To seted the project parameters on TBA120 automatic biochemical analyzer and passed the calibration.The calibration fitting curve had a smooth trend and no obvious deviation with each measuring point.In the recovery tests,added standard liquid with different concentrations of 100 mg/L and 500 mg/L to the samples with low values,the recovery rate was 95.3％ and 102.7％ respectively.Same to the samples with high values,the recovery rate was 104.2％ and 103.5％ respectively.In the precision test,samples with low and high value had a precision CV of 6.52％ and 4.18％ respectively.The linear range was 0 ～ 1 100 mg/L,analysis sensitivity was 2.8 mg/L.In the interference test,found that,samples had no obvious disturbance to the test with lower concentrations of free bilirubin,combined with bilirubin,vitamin C,animal hemoglobin lower than 342 μmol/L,342 μmol/L,0.03 g/L,500 mg/L respectively,while had significant interference when the concentration of chyle was higher than 870 FTU.Their study had established the biological reference interval of healthy people,male was 0～ 13.3 mg/L and female 0 ～ 17.1 mg/L,there was no significant difference between them by a t test (P＞0.05).Conclusion The latex enhanced immune turbidimetric method for the detection of urine free hemoglobin has the performance of testing clinical urine specimen,which not only solved the lackage problem of specificity for occult blood in the urine dry chemistry test and realized batch automation quantitative detection.The experimental data of this study provides a theoretical basis for the application of the method in other types of clinical samples.
RESUMO
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 range:7-720 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 .