郑州地区表观健康人群sdLDL-C生物参考区间的建立与验证OACSTPCD

Objective To detect serum small dense low density lipoprotein cholesterol(sdLDL-C)by per-oxidase method among the apparently healthy people in Zhengzhou area to establish its activity value reference interval,and to conduct the verification.Methods A total of 785 healthy adults by physical examination in the Special Needs Center of this hospital from June 2019 to June 2020 were selected as the study subjects and grouped according to sex and age(18-＜30 years old,30-＜40 years old,40-＜50 years old,50-＜60 years old and ≥60 years old).The activity value of serum sdLDL-C was detected by the peroxidase method.The Kolmogorov-Smirnov(K-S)test was used to conduct the normality test of the data in each group,and the up-per and lower limits of sdLDL-C activity value reference intervals were set with bilateral 95％confidence in-tervals(CI).The other 100 serum samples from healthy physical examination subjects were collected to con-duct the reference interval verification.When the ratio value(R)≥ 90％,the verification was judged to be passed.Results The serum sdLDL-C activity values among the apparently healthy people in Zhengzhou area showed the normal distribution,which was(0.700±0.151)mmol/L for males and(0.670±0.137)mmol/L for females,and the difference between the males and females was statistically significant(P＜0.01).There was no statistical difference of sdLDL-C activity values in females among the varied age groups(P＞0.05),while which in males had statistical differences among the varied age groups(P＜0.05).Further analysis showed that there was no statistically significant difference among the age groups of 18-＜30 years old,30-＜40 years old and 40-＜50 years old(P＞0.05),and between the age groups of 50-＜60 years old and ≥60 years old(P＞0.05),therefore,the males were combined into the 18-＜50 years old group and ≥50 years old group.The reference interval of serum sdLDL-C activity value in apparently healthy people in Zhengzhou area were 0.400-0.938 mmol/L for females(18-80 years old),0.440-1.004 mmol/L for males(18-＜50 years old),0.368-0.976 mmol/L for males(≥50 years old).The R value of 100 healthy adults in physical examination was 0.98 and the newly established reference interval of serum sdLDL-C passed the veri-fication.Conclusion The reference intervals of serum sdLDL-C activity values among the apparently healthy adults in Zhengzhou area are preliminarily established and verified,which provides the reference basis for the risk assessment,diagnosis and treatment of cardiovascular diseases onset.