[Elecsys 2010电化学发光免疫分析系统性能评估]

[Evaluation of the performance of the electrochemiluminescent immunoassay system of Elecsys 2010].

作者信息

Qin Weishi

机构信息

Department of Nuclear Medicine, West China Hospital, Sichuan University, Chengdu 610041.

出版信息

Sheng Wu Yi Xue Gong Cheng Xue Za Zhi. 2002 Dec;19(4):673-5.

PMID:12561376

Abstract

Performance of the electrochemiluminescent immunoassay system of Elecsys 2010 was evaluated by quantitative assay. The functional sensitivity of the TSH assay was 0.004 microU/ml. The extra-assay imprecision was RSD = 1.45%-4.65% in the range of TSH concentrations of 0.43-88.15 microU/ml. The intra-assay imprecision was RSD = 1.38%-3.14% in the range of TSH concentrations of 0.41-87.28 microU/ml. The recovery of TSH was in the range of 98.6%-104.4%. The correlation between theoretical values and obtained values of TSH was adequate(r = 0.999). We conclude that the Elecsys 2010 is provably satisfactory in sensitivity, precision, accuracy, reliability, practicability and rapidity.

摘要

通过定量测定对Elecsys 2010电化学发光免疫分析系统的性能进行了评估。促甲状腺激素（TSH）测定的功能灵敏度为0.004微国际单位/毫升。在TSH浓度为0.43 - 88.15微国际单位/毫升范围内，批间不精密度为相对标准偏差（RSD）= 1.45% - 4.65%。在TSH浓度为0.41 - 87.28微国际单位/毫升范围内，批内不精密度为RSD = 1.38% - 3.14%。TSH的回收率在98.6% - 104.4%范围内。TSH理论值与实测值之间的相关性良好（r = 0.999）。我们得出结论，Elecsys 2010在灵敏度、精密度、准确性、可靠性、实用性和快速性方面经证实令人满意。