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目的 :探讨甲状腺激素T3 、T4、FT3 、FT4、TSH检测结果不稳定和各项目间的不匹配原因 ,以提高检测质量 ,为临床提供可信的报告。方法 :通过实验室内质控改进分离方法 ,对各类加样器及放免测定仪定期监测 ,放免指标采用零管结合率 (B0 )、非特异结合 (NSB)、有效剂量值 (ED2 0 、ED50 、ED80 )、平均批变异系数 (ABCV)、平均病人值和质控血清含量的Shewart质控图 ,免放法选用B0 、NSB、ED80 、ED50 、ED2 0 、标准点偏差、质控血清和平均病人值。结果 :通过随意选择 1 0批标本共 96 4例测定结果分析 ,有 1 5 4例项目之间不匹配占 1 6 % ,而方法和操作的误差仅占不匹配标本的 5 8% ,其中大多数为甲状腺激素的生化特性和临床表现。结论 :分离误差是造成随机误差最主要来源 ,应选择稳定性好的分离法 ,推进固相分离替代均相分离 ,平均病人值有补充质控血清的作用 ,它和内质控的各项参数组成实验结果偏移取舍指标 ,以去除因方法和操作引起的误差 ,余下的不匹配结果原因为临床甲状腺疾病特点。实验人员要从技术和临床角度来分析结果 ,沟通实验室与临床的联系 ,才能知己知彼地提供给临床可信的报告
OBJECTIVE: To investigate the unstable results of thyroid hormones T3, T4, FT3, FT4 and TSH and the reasons for the mismatch between the items in order to improve the quality of testing and provide credible reports for clinical practice. Methods: By means of improving the quality control method in laboratories, all kinds of sample changers and radioimmunoassay devices were regularly monitored. The indexes of radioimmunoassay (B0), nonspecific binding (NSB), effective dose (ED20, ED50, ED80), the average batch coefficient of variation (ABCV), the mean patient value and the quality control serum Shewart quality control chart, exempt from the law using B0, NSB, ED80, ED50, ED20, standard deviation, quality control serum and Average patient value. Results: Through randomly selecting 96 samples from 10 batches of samples, there were 154 mismatches between projects accounting for 16%, while the error of methods and operations accounted for only 58% of the mismatched samples. Among them, large The majority of thyroid hormone biochemical characteristics and clinical manifestations. Conclusion: The separation error is the most important source of random error. Separation should be selected with good stability. Solid phase separation should be used instead of homogeneous separation. The average patient value should be supplemented with quality control serum. The experiment results are composed of offset selection indexes to eliminate the errors caused by the methods and operations. The remaining unmatched results are due to the characteristics of clinical thyroid diseases. The experimenter should analyze the results both technically and clinically to communicate with the clinical laboratory to know the truth and provide the clinically credible report