[1]黄 冰,迟 晨,蒋玉新,等.中国14 家实验室基于同位素稀释质谱法检测人血清同型半胱氨酸水平的能力验证[J].现代检验医学杂志,2023,38(05):195-198.[doi:10.3969/j.issn.1671-7414.2023.05.037]
　HUANG Bing,CHI Chen,JIANG Yuxin,et al.Proficiency Testing of Human Serum Homocysteine Levels by 14 Laboratories in China Based on Isotope Dilution Mass Spectrometry[J].Journal of Modern Laboratory Medicine,2023,38(05):195-198.[doi:10.3969/j.issn.1671-7414.2023.05.037]
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中国14 家实验室基于同位素稀释质谱法检测人血清同型半胱氨酸水平的能力验证()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第38卷
期数:
2023年05期
页码:
195-198
栏目:
质量控制·实验室管理
出版日期:
2023-09-15

文章信息/Info

Title:
Proficiency Testing of Human Serum Homocysteine Levels by 14 Laboratories in China Based on Isotope Dilution Mass Spectrometry
文章编号:
1671-7414（2023）05-195-04
作者:
黄 冰1; 迟 晨1; 蒋玉新1; 洪 沫1; 曹 冉1; 崔 丽1; 曹云峰2
（1. 大连博源医学检验实验室有限公司质量部，辽宁大连 116000；2. 上海市生物医药技术研究院国家卫生健康委员会计划生育药具重点实验室，上海 200032）
Author(s):
HUANG Bing1;  CHI Chen1;  JIANG Yuxin1;  HONG Mo1;  CAO Ran1;  CUI Li1;  CAO Yunfeng2
（1. Department of Quality, Dalian Boyuan Medical Laboratory Co. Ltd., Liaoning Dalian 116000, China； 2. NHC Key Lab of Reproduction Regulation, Shanghai Institute for Biomedical and Pharmaceutical Technologies, Shanghai 200032, China）
关键词:
同位素稀释质谱法; 同型半胱氨酸; 能力验证; 比分数法
分类号:
Q503；R446.112
DOI:
10.3969/j.issn.1671-7414.2023.05.037
文献标志码:
A
摘要:
目的 评价检测实验室基于同位素稀释液相色谱串联质谱法（isotope dilution-liquid chromatography/tandemmass spectrometry，ID-LC/MS/MS) 检测人血清中同型半胱氨酸（homocysteine, Hcy）的能力。方法 采用单因素方差分析法和t 检验法分别对能力验证样品进行均匀性和稳定性评价；由参加实验室公议值确定指定值，采用稳健算法A 对参加实验室的回报结果进行分析，Z’ 比分数法对实验室检测能力进行评定。参加实验室为分布在9 个省份10 个城市的14家质谱检测实验室。结果 二种浓度的能力验证样品均满足均匀性和稳定性要求。14 家实验室二种浓度的Z’ 比分数绝对值均在2 以内，满意率为100%。结论 14 家实验室使用ID-LC/MS/MS 法检测人血清中同型半胱氨酸的能力均为满意。
Abstract:
Objective To evaluate the ability of laboratory to detect homocysteine（Hcy）in human serum by isotope dilutionliquid chromatography/tandem mass spectrometry（ID-LC/MS/MS). Methods One-way ANOVA and t-test were used to analyze the homogeneity and stability of proficiency testing samples, respectively. The specified values were determined from the participants’ communal values. The robust algorithm A was used to analyze the results of the participating laboratories, and the Z’ ratio score method was used to evaluate the detection ability of the laboratories. The participating laboratories were 14 mass spectrometry laboratories distributed in 10 regions of 9 provinces. Results The proficiency testing samples of two concentration levels met the homogeneity and stability requirements all, and the absolute values of Z’ ratio fractions at both concentration levels were within 2 in all 14 laboratories, with a satisfaction rate of 100%. Conclusion The ability of the 14 laboratories using IDLC/ MS/MS method to detect homocysteine in human serum was satisfactory.

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备注/Memo

备注/Memo:
基金项目： 大连市重点研发计划(2022YF15SN063)：心脑血管疾病相关代谢物标准物质的研制及转化应用；西藏自治区自然科学基金（XZ2020ZR-ZY79(Z)）：质谱分析技术检测脑梗死患者血清同型半胱氨酸含量在高原地区的临床应用；上海市生物医药技术研究院省部级重点实验室创新能力专项资助(CX2023-04) ：基于质谱技术的同型半胱氨酸代谢通路检测试剂盒的研制。
作者简介：黄冰(1994-)，女，硕士，研究方向：室间质评与能力验证，标准物质研制，E-mail：huangb916@163.com。
通讯作者： 曹云峰(1980-)，男，博士，正高级工程师，研究方向：室间质评与能力验证，标准物质研制等，E-mail：caoyunfeng@sibpt.com。
更新日期/Last Update: 2023-09-15