检验医学 ›› 2014, Vol. 29 ›› Issue (12): 1238-1242.

• 实验室管理·论著 • 上一篇    下一篇

甲状腺激素检测项目的性能评估

肖亚玲, 张传宝, 赵海建, 王薇, 王治国   

  1. 北京医院卫生部临床检验中心,北京 100730
  • 收稿日期:2014-03-03 出版日期:2014-12-30 发布日期:2015-01-14
  • 通讯作者: 王治国,联系电话:010-58115054。
  • 作者简介:肖亚玲,女,1990年生,硕士,主要从事临床检验诊断学实验室质量管理研究。
  • 基金资助:

    北京市自然科学基金资助项目(7143182)

The performance evaluation of thyroid hormone testing

XIAO Yaling, ZHANG Chuanbao, ZHAO Haijian, WANG Wei, WANG Zhiguo   

  1. National Center for Clinical Laboratory,Beijing Hospital,Beijing 100730,China
  • Received:2014-03-03 Online:2014-12-30 Published:2015-01-14

摘要:

目的 评估全国甲状腺激素项目的检测性能。方法 用室间质量评价(EQA)数据估计各实验室结果与靶值的差值百分数,室内质量控制(IQC)数据[变异系数(CV]评估不精密度。使用我国EQA评价标准和基于生物学变异的标准计算各项目差值百分数和不精密度的合格率,根据公式西格玛(σ=[允许总误差(TEa-偏倚(bias]/CV计算各检测项目的σ水平,绘制散点图,分析σ水平的分布。结果 促甲状腺素(TSH)项目CV均值和差值百分数中位数最低,而三碘甲腺原氨酸(T3)项目最高。无论使用何种标准计算CV和差值百分数的合格率,TSH项目的合格率都比其它项目高,而甲状腺素(T4)项目合格率最低。T4项目σ水平散点图的散点位置整体比其它项目低,分别有63.0%98.2% σ3;TSH项目整体比其它项目高,分别有75.6%72.9% σ≥3结论 σ水平分析是一种简便直观的评价分析性能的方法,甲状腺功能检测项目中TSH项目检测性能优于其它项目,而T4项目检测性能低于其它项目。

关键词: 甲状腺激素, 西格玛水平, 不精密度, 差值百分数

Abstract:

Objective To evaluate the performance of thyroid hormone testing all over the country. Methods The difference percentage between resultsand target values was estimated according to external quality assessmentEQA data and the imprecision was obtained according to internal quality controlIQC data [coefficient of variationCV]. The EQA evaluation criterion in our country and biological variation quality specification were used to analyze the acceptabilities of difference percentage and imprecision in each group. The sigmaσ value was calculated with the formula of σ=[total allowable errorTEa- bias]/CV. The scatter diagram was drawn and the distribution of σ value was analyzed. Results The mean of CV and the median of difference percentage for thyroid stimulating hormoneTSH were the lowest of all while those for triiodothyronineT3 were the highest. Regardless of quality specifications the acceptabilities of imprecision and difference
percentage for TSH were the highest
and those for thyroxineT4 were the lowest. The scatter of T4 in the scatter diagram of σ value was entirely low 63.0% and 98.2% σ3. However that of TSH was entirely high 75.6% and 72.9% σ≥3. Conclusions σ value is a simple and visible method to evaluate the testing performance. The performance of TSH is better than the others but T4 is worst of all.

Key words: Thyroid hormone, Sigma value, Imprecision, Difference percentage

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