Objective To investigate the correlation between I405 single nucleotide polymorphism in CETP gene and the therapeutic effect of simvastatin in dyslipidemia patients.Methods Genotype information of I405V in CETP gene was detected by SNaPshot TM primer extension assay in 375 dyslipidemia patients.Blood lipid profiles before and 6 weeks after treatment with simvastatin were recorded to analyze the correlation between the therapeutic effect of simvastatin and I405 polymorphism genostype.Results The frequency of I405 V polymorphism was 38.9%in II genotype,48.5% in IV genotype and 12.5%in VV genotype.After being treated with simvastatin for 6 weeks,the serum levels of TC were significantly decreased by 1.21 mmol/L(P <0.01)and HDL-C level was significantly increased by 0.74 mmol/L(P <0.01).Compared with the IV and VV genotypes of I405V polymorphism,the decrease of TC in II genotype patients were 0.26 mmol/L and 0.16 mmol/L more respectively (P<0.01).Meanwhile,the increase of HDL-C was significantly different among three genotypes(P<0.01).HDL-C in II genotype was increased by 0.85 mmol/L,which was 0.19 mmol/L and 0.15 mmol/L more compared with IV genotype and VV genotype,respectively.Conclusion I405V polymorphism in CETP gene is similar with the lipid-regulating effect of simvastatin.The decrease of blood lipid is more significant in patients with II genotype compared with patients with V allele,suggesting that II genotype is the maker which may predict the therapeutic effect of simvastatin in dyslipidemia patients.However,this conclusion still needs further evaluation.

Objective To validate the analytical performance of three Cys C reagents with particle-enhanced turbidimetric immunoassay(PETIA) method used on the automatic biochemistry analyzer for preliminary clinical application.Methods The performance of three Cys C reagents (labeled as A, B, C) with PETIA method from Shanghai Jing Yuan Co., Beijing Leadman Co. and Beijing Jiuqiang Co. on OlympusAU2700 automatic biochemistry analyzer were assessed.According to the standard of CLSI EP6-A, EP15-A and EP7-P, the precision, linearity range, disturbance (bilirubin, hemoglobin, chyle) were assessed, and compared with those of Cys C reagent based on particle-enhanced nephelometric immunoassay(PENIA) from Dade Behring Co.. The reference ranges for Cys C in serum of 120 healthy individual were evaluated.Results The within-run CVs of the three reagents (A, B and C) were 3.08%-3.2%, 2.3%-4.15% and 1.38%-1.53% respectively.The total CV in A, B and C were 3.29%-3.44%, 2.65%-5.18% and 1.67%-1.69% respectively, lower than the stated.Limits of quantitative determination (LOQ) of the three reagents were 0.41, 0.23 and 0.07 mg/L, basically meeting the testing requirement.The linearity range was 0.22-7.26 mg/L(r=0.996), 0.20-7.72 mg/L(r=0.999)and 0.20-7.62 mg/L(r=0.997)in the three reagents, which demonstrated a sound linear correlation. For interference tests, no remarkable interference (<±10%) of reagent C was detected when bilirubin≤684 μmol/L, hemoglobin≤9.7 g/L and Chyle turbidity≤6 200 FTU; and no significant interference of reagent B was found when bilirubin≤684 μmol/L, hemoglobin≤6.79 g/L and Chyle turbidity≤6 200 FTU; when bilirubin≤684 μmol/L, hemoglobin≤4.85 g/L and Chyle turbidity≤1 240 FTU reagent A was not interfered significantly. The comparison afte and before the high-speed centrifugation reveals that the average percentage of bias for reagents A, B, C measured Cys C in chylous serum samples of patients was -8.31%, 1.52%, 1.32%, respectively.In method comparison tests, the regression equations of the three reagents compared with Dade Behring PENIA Cys C reagent were as follows:Y=0.787X+0.492 (R2=0.976), Y=1.098X+0.137 (R2=0.982) and Y=1.037X+0.249 (R2=0.996), respectively. Agreement rates of the high Cys C in reagent A, B, C and Dade Behring Cys C reagent were 80% (Kappa=0.615,P=0.000), 100% (Kappa=1.000,P=0.000), 91.2% (Kappa=0.824,P=0.000); While for reference range of preliminary clinical assessment, diagnosis coincidence rate of reagent A increased to 98.8% (Kappa=0.974,P=0.000). Conclusions When used in automatic biochemical analyzer, the three Cys C reagent with PETIA showed high precision,sensitivity, and sound correlation with Dade Behring PENIA reagents.The three reagents are all able to meet clinical test requirements, nevertheless, anti-interference capability were diffierent and the reference range should be further validated.