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全自动免疫分析系统——酶免疫检测系统ES 300——的评估及与内部方法对8种分析物检测结果的比较

Evaluation of a fully mechanised immunoassay--Enzymun-Test System ES 300--and comparison with in-house methods for 8 analytes.

作者信息

Bauernfeind M, Wood W G

机构信息

Immunodiagnostic Evaluation Dept., Boehringer Mannheim, Germany.

出版信息

Eur J Clin Chem Clin Biochem. 1993 Mar;31(3):165-72. doi: 10.1515/cclm.1993.31.3.165.

DOI:10.1515/cclm.1993.31.3.165
PMID:8490063
Abstract

The following analytes were determined with the automated enzyme immunoassay unit, Enzymun-Test System ES 300, and by routine in-house tests, and the results were compared: thyrotropin, free thyroxine, cortisol, immunoglobulin E, digoxin, digitoxin, insulin and carcinoembryonic antigen. The methods used for comparison included two radioimmunoassays, one with enzyme labelling, two with fluorescence enhanced enzyme reactions and 3 luminescence immunoassays. In most cases, the precision of the ES 300 lay between 2 and 5% in all assays in the concentration ranges of clinical interest. The inter-assay variation was almost identical to the intra-assay precision, which reflects the constancy of reagent quality and machine performance. The correlation between in-house and Enzymun-Test was excellent, even though the slope of the regression line was sometimes far from unity, due to the calibration materials used. ES 300 can be used as a stand alone unit and connected to a host computer. As a "walk-away" machine, it is suitable for laboratories with medium length series. It is a multi-batch analyser capable of taking 12 analytes and a maximal series length of 136 tubes excluding standards and controls.

摘要

使用自动酶免疫分析单元Enzymun-Test System ES 300并通过常规内部检测对以下分析物进行了测定,并对结果进行了比较:促甲状腺激素、游离甲状腺素、皮质醇、免疫球蛋白E、地高辛、洋地黄毒苷、胰岛素和癌胚抗原。用于比较的方法包括两种放射免疫分析,一种是酶标记法,两种是荧光增强酶反应法,以及三种发光免疫分析。在大多数情况下,在临床关注的浓度范围内,ES 300在所有检测中的精密度在2%至5%之间。批间变异几乎与批内精密度相同,这反映了试剂质量和仪器性能的稳定性。尽管由于所使用的校准材料,回归线的斜率有时远非1,但内部检测与Enzymun-Test之间的相关性非常好。ES 300可以作为独立单元使用,并连接到主机。作为一台“无需值守”的仪器,它适用于进行中等批量检测的实验室。它是一台多批次分析仪,能够检测12种分析物,最大样本系列长度为136管,不包括标准品和对照品。

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