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促肾上腺皮质激素新免疫放射分析方法的比较评估

Comparative evaluation of a new immunoradiometric assay for corticotropin.

作者信息

Wilkinson Charles W, Raff Hershel

机构信息

Department of Psychiatry and Behavioral Sciences, University of Washington and Geriatric Research Education and Clinical Center, VA Puget Sound Health Care System, 1660 S. Columbian Way, Seattle, WA 98108, USA.

出版信息

Clin Chem Lab Med. 2006;44(5):669-71. doi: 10.1515/CCLM.2006.113.

Abstract

We have characterized the performance of a commercial two-site immunoradiometric assay for manual in vitro diagnostic measurement of plasma corticotropin from Scantibodies Laboratory. We compared the results with those of a similar commonly used assay from Nichols Institute Diagnostics that has recently been withdrawn from production. The lower detection limit, range of the standard curve, cross-reactivity, and intra-assay and inter-assay imprecision of the two assays are very similar. Measurement of clinical samples and a series of samples from an experimental subject demonstrate high correlations between the two assays. These factors, together with recent clearance by the United States Food and Drug Administration for manual in vitro diagnostic measurement, make the Scantibodies corticotropin immunoradiometric assay an appropriate replacement for the Nichols assay.

摘要

我们已对Scantibodies实验室生产的用于血浆促肾上腺皮质激素体外诊断手工测量的商用双位点免疫放射分析方法的性能进行了表征。我们将结果与Nichols Institute Diagnostics公司一种近期已停产的类似常用分析方法的结果进行了比较。两种分析方法的检测下限、标准曲线范围、交叉反应性以及批内和批间不精密度非常相似。对临床样本和一名实验对象的一系列样本进行测量表明,两种分析方法之间具有高度相关性。这些因素,再加上最近美国食品药品监督管理局批准其用于体外诊断手工测量,使得Scantibodies促肾上腺皮质激素免疫放射分析方法成为Nichols分析方法的合适替代品。

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