[1]张 艳,王华丽,吴 风,等.运用外部质量评估数据和生物学变异数据估算甲状腺功能指标实验室间参考变化值[J].现代检验医学杂志,2022,37(05):186-189.[doi:10.3969/j.issn.1671-7414.2022.05.037]
　ZHANG Yan,WANG Hua-li,WU Feng,et al.Estimation of the Inter-Laboratory Reference Change of Thyroid Function Indicators between Laboratories with External Quality Assessment Data and Biological Variation Data[J].Journal of Modern Laboratory Medicine,2022,37(05):186-189.[doi:10.3969/j.issn.1671-7414.2022.05.037]
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运用外部质量评估数据和生物学变异数据估算甲状腺功能指标实验室间参考变化值()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第37卷
期数:
2022年05期
页码:
186-189
栏目:
质量控制·实验室管理
出版日期:
2022-09-15

文章信息/Info

Title:
Estimation of the Inter-Laboratory Reference Change of Thyroid Function Indicators between Laboratories with External Quality Assessment Data and Biological Variation Data
文章编号:
1671-7414（2022）05-186-04
作者:
张 艳; 王华丽; 吴 风; 徐晓华; 孔丽蕊
成都市郫都区中医医院检验科，成都 611730
Author(s):
ZHANG Yan;  WANG Hua-li;  WU Feng;  XU Xiao-hua;  KONG Li-rui
Department of Clinical Laboratory, Traditional Chinese Medicine Hospital of Pidu District, Chengdu 611730, China
关键词:
外部质量评估; 生物学变异; 甲状腺功能指标; 实验室间参考变化值
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2022.05.037
文献标志码:
A
摘要:
目的　通过外部质量评估(external quality assessment，EQA) 数据和生物变异数据估算甲状腺功能指标的实验室间参考变化值(inter-laboratory reference change value，IL-RCV)，探索实验室间结果互操作性的依据。方法　在国家卫生健康委临床检验中心2021 年开展的第1 次EQA 活动中，选取雅培全自动免疫系统i2000sr/i2000/i1000sr 分析的促甲状腺激素(TSH)、三碘甲状腺原氨酸(T3)、甲状腺素(T4)、游离三碘甲状腺原氨酸(FT3) 和游离甲状腺素(FT4) 数据，取五个质控材料所得变异系数的中位数作为各指标的实验室间分析变异（analytical variation，CVA），同时在欧洲生物学变异网站上查询各指标的个体内生物变异（within-subject variation，CVI）数据。在检测指标具有偏态分布的假设下，使用对数-正态方法计算RCV, 公式如下：RCVpos/neg=100%×{exp[±Zα×21/2(SD2A+SD2I )1/2-1]}，SD2A=ln(CV2A+1)，SD2I =ln(CV2I +1)，估算在95%（双侧）概率下各指标的IL-RCV，并评估其在实验室间的运用。结果　在95%（双侧）概率下，TSH，T3，T4，FT3 和FT4 的IL-RCVpos 依次为86.7%，40.0%，26.3%，26.9% 和141.5%；IL-RCVneg 依次为-46.4%，-28.6%，-20.8%，-21.2% 和-58.6%。各检测指标的RCVpos 与RCVneg 界限不对称，向上的界限大于向下的界限。不同指标间的结果差异大，RCVpos 变化范围较RCVneg 更宽。结论　在实验室间测量不确定度范围内，EQA 数据和生物学变异数据允许评估甲状腺功能指标的IL-RCV，可用于探索实验室医学互操作性的边界。
Abstract:
Objective　To explore the basis for inter-laboratory interoperability of results using external quality assessment (EQA) data and biological variation data to estimate the inter-laboratory reference changes (IL-RCV) of thyroid function indicators. Methods　Thyroid stimulating hormone (TSH), triiodothyronine (T3), thyroxine (T4), free triiodothyronine (FT3) and free thyroxine (FT4) data analyzed by Abbott automatic immune system i2 000sr/i2 000 / i1 000SR were selected in the first EQA activity in 2021 held by National Clinical Laboratory Center. The median coefficient of variation obtained from five quality control materials was taken as inter-laboratory analytical variation (CVA) of each indicator, and the within-Subject variation (CVI) data of each analytical indicator was searched on the European biological variation website. Under the assumption that the detection indexes had skewness distribution, the log-normal method was used to calculate RCV, and the formula was as follows: RCVpos/neg=100%×{exp[±Zα×21/2(SD2A +SD2 I )1/2-1]}, SD2A =ln(CV 2A +1), SD2 I =ln(CV2 I +1), estimate the IL-RCV of each indicator with 95% (bilateral) probability and evaluate the use between laboratories. Results　With 95% (bilateral) probability, IL-RCVpos of TSH, T3, T4, FT3 and FT4 were 86.7%，40.0%，26.3%，26.9% and 141.5%. IL-RCVneg were -46.4%， -28.6%，-20.8%，-21.2% and -58.6%, respectively. The bounds of RCVpos and RCVneg of each indicator were asymmetric, and the bounds of upward was larger than that of downward. The results varied greatly among different indicators, RCVpos had a wider range of variation than RCVneg. Conclusion　Within the uncertainty of inter-laboratory measurements, EQA data and biological variation data allowed the assessment of IL-RCV for indicators of thyroid function and can be used to explore the boundaries of medical interoperability between laboratories.

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备注/Memo

备注/Memo:
基金项目：成都市医学科研课题，编号：2021178。
作者简介：张艳（1982-），女，本科，学士，副主任技师，研究方向：临床检验与质量管理，E-mail:114612396@qq.com。
通讯作者：孔丽蕊（1972-），女，本科，主任技师，研究方向：临床检验与质量管理，E-mail:524392472@hotmail.com。
更新日期/Last Update: 2022-09-15