2015—2019年上海地区25-羟基维生素D室间质量评价结果分析

目的分析2015—2019年上海地区25-羟基维生素D25(OH)D]项目室间质量评价(EQA)结果,为提高25(OH)D检测质量提供依据。方法收集2015—2019年上海市临床检验中心(SCCL)25(OH)D项目的10次EQA结果,剔除离群值后计算各组均值(x)、标准差(s)和变异系数(CV)。结果参加SCCL 25(OH)D项目EQA的实验室数从2015年的41家增加至2019年的83家,5年内10次EQA的合格率分别为65.85%、74.70%、82.00%、83.67%、90.91%、87.50%、86.67%、91.89%、92.68%、92.77%。参评实验室的检测方法主要为电化学发光法和化学发光法,少数实验室使用酶联免疫吸附试验和液相色谱串联质谱法。在5年50个批号的EQA样本中,33个批次检测CV<20%,6个批次检测CV为20%~30%,其他批次检测CV均>30%。结论上海地区不同实验室25(OH)D检测结果仍存在较大差异,应加强实验室检测质量管理,推动25(OH)D检测的标准化,促进实验室间的结果互认。

Analysis on the external quality assessment results for 25-hydroxyvitamin D of Shanghai from 2015 to 2019

Objective To analyze the external quality assessment(EQA)results for 25-hydroxyvitamin D25(OH)D]in Shanghai from 2015 to 2019,and to provide experimental data for the improvement of 25(OH)D testing.Methods Ten rounds of EQA results for 25(OH)D in Shanghai Center for Clinical Laboratory(SCCL)from 2015 to 2019 were collected.The means(x),standard deviation(s)and coefficient of variation(CV)were calculated after eliminating outliers.Results The number of laboratories participating in EQA increased from 41 in 2015 to 83 in 2019.The percent of pass of the 10 EQA in the 5 years were 65.85%,74.70%,82.00%,83.67%,90.91%,87.50%,86.67%,91.89%,92.68%and 92.77%,respectively.The main detection methods were electrochemical luminescence and chemiluminescence,and enzyme-linked immunosorbent assay and liquid chromatography tandem-mass spectrometry were used in a few laboratories.A total of 50 batches were tested in 5 years,among which 33 batches showed a CV less than 20%,6 batches were between 20%and 30%,and the rest were more than 30%.Conclusion There is a large variation of 25(OH)D testing results among different laboratories in Shanghai.It is needed to strengthen the laboratory quality management,to impel the standardization of 25(OH)D testing and to promote the mutual recognition of laboratory test results.