我国血脂7项检测指标参考区间来源调查

National Survey on reference intervals of 7 indicators of blood lipids and lipoproteins in China

目的调查我国血脂7项检测指标参考区间来源及上、下限分布现状。方法向参加2014年血脂室间质量评价的1045家临床实验室发放调查表,通过网络在线填报的方式收集总胆固醇（TC）、三酰甘油（TG）、高密度脂蛋白胆固醇（HDL-C）、低密度脂蛋白胆固醇（LDL-C）、载脂蛋白AⅠ（apo AⅠ）、载脂蛋白B（apo B）和脂蛋白a[Lp（a）]7个指标参考区间上、下限值,临床决定限,参考区间来源等并统计分析。结果共549家实验室参与回报,回报率为52.5%（549/1 045）。参考区间来源中所占比例最高的是试剂厂家说明书（54.5%～68.3%）,其次是《全国临床检验操作规程》（24.0%～34.9%）,实验室自己确定参考区间占3.3%～4.4%。部分指标参考区间上、下限出现交叉,上、下限及临床决定限的范围较宽。HDL-C、apo AⅠ和apo B分别有26、25、27家实验室的参考区间按性别分组,其他指标均为未分组。分别有152、140、156和144家实验室回报了TC、TG、HDL-C和LDL-C临床决定限,中位数分别为5.70、1.70、0.91和3.37 mmol/L。有14家实验室对LDL-C＂心血管病高危人群＂和＂极高危人群＂进行了危险分层。结论我国大多数实验室制定血脂的参考区间时未考虑性别、年龄等因素,仅少数实验室按性别分组,进行危险分层的实验室很少。

Objective To investigate the current status of reference intervals（ RI） applied in the testing of blood lipids and lipoproteins,including the sources of origin and the distribution of upper and lower limits. Methods Online questionnaires were issued towards 1 045 clinical laboratories participated in the 2014 external quality assessment（ EQA） program of blood lipids and lipoproteins.The informations regarding the upper / lower limits,sources of RIs and clinical decision levels of total cholesterol（ TC）,triglyceride（ TG）,high density lipoprotein cholesterol（ HDL-C）,low density lipoprotein cholesterol（ LDL-C）,lipoprotein（ a）,apolipoprotein A1（ Apo A1） and apolipoprotein B（ Apo B） were collected and statistically analyzed. Results A total of 549 laboratories submitted the data on-line,rendering a return rate of 52. 5%（ 549 /1 045）. The top proportion of RIs sources（ 54. 5% to 68. 3%） came from the instructions of reagent manufacturers,followed by recommendations from National Guide to Clinical Laboratory Procedures（ 24. 0%to 34. 9%）. The RIs determined independently by laboratories accounts for 3. 3% to 4. 4%. The upper and lower limits of RIs in certain indicators were overlapped,so considerably wide ranges of clinical decision levels were shown. The RIs of HDL-C,apo AⅠ and apo B were distinguished as gender subgroups in 26,25 and 27 participants respectively. The clinical decision levels of TC,TG,HDL-C and LDL-C were reported by 152,140,156 and 144 laboratories,of which the medians were 5. 70,1. 70,0. 91 and 3. 37 mmol / L,respectively. The risk-stratification system for LDL-C was employed in 14 laboratories to divide the RIs into ＂ high risk population＂ and ＂ very high risk population＂ in terms of cardiovascular diseases. Conclusion The majority of laboratories did not take gender,age and other influence factors into consideration for establishing RIs of blood lipids and lipoproteins. The gender subgroups for RIs were adopted in merely a handful of laboratories,and risk stratification of cardiovascular diseases was implemented in even fewer laboratories.