临床输血与检验2011，Vol.13Issue(3)：234-237,4.DOI:10.3969/j.issn.1671-2587.2011.03.013
化学发光法检测第3代促甲状腺素实验性能确认
Performance Verification of TSH-3 Chemiluminescence Immunoassay
李德发 1邓芳梅 1孙丽芳 1杨方华 1黄玉英 2马东礼1
作者信息
- 1. 518026,广东省深圳市儿童医院检验科
- 2. 蚌埠医学院
- 折叠
摘要
Abstract
Objective To verify the method performance of TSH-3 chemiluminescence immunoassay.Methods Referring to CLSI evaluation protocols and pertinent literature, combining our actual works, we designed verification procedure and experimental methods.The precision, accuracy, analytical sensitivity, analytical measurement range, clinical reportable range and biotic interval of TSH-3 were verified on the Centaur XP chemiluminescence immunoassay system.Results would be compared with the declaration of the manufacturer.Results The results showed the within,without and betweer-day inaccuracy were 2.17％,2.14％ and 7.98％,6.81％,6.69％ respectively.The relative bias were from -3.45％ to -1.55％.LLD was 0.005 4 tμIU/ml, BLD was between 0.010 2 tμIU/ml and 0.015 3 μIU/ml, FS was about 0.017 0 μIU/ml.AMR was (0.005 4'～140.613 0) μIU/ml.CRR was (0.015 3～703.065) μlU/ml.Except for 2 specimen's TSH-3 results were beyond manufacturer's claimed, 35 results were within.Conclusion The performances of the detection system are according with the declaration of the manufacturer and meet the requests of the physicians.关键词
质量管理/性能确认/促甲状腺素Key words
Quality management/ Performance verification/ TSH分类
医药卫生引用本文复制引用
李德发,邓芳梅,孙丽芳,杨方华,黄玉英,马东礼..化学发光法检测第3代促甲状腺素实验性能确认[J].临床输血与检验,2011,13(3):234-237,4.
