雅培AxSYM地高辛II检测法的多中心研究及与6种针对地高辛样免疫反应因子敏感性检测方法的比较。

Multicenter study of Abbott AxSYM Digoxin II assay and comparison with 6 methods for susceptibility to digoxin-like immunoreactive factors.

作者信息

Azzazy H M, Duh S H, Maturen A, Schaller E, Shaw L, Grimaldi R, Shock G, Christenson R H

机构信息

Department of Pathology, University of Maryland School of Medicine, Baltimore 21201, USA.

出版信息

Clin Chem. 1997 Sep;43(9):1635-40.

PMID:9299945

Abstract

Performance characteristics of the Abbott nonpretreatment AxSYM Digoxin II assay were evaluated for quantification of digoxin at four independent sites. Correlation of digoxin measurements with the Abbott pretreatment AxSYM, Baxter Stratus II, Abbott TDx/ TDxFLx II, Abbott IMx, Emit 2000, and Beckman Synchron CX digoxin assays showed acceptable agreement, as indicated by: slope values > 0.84, r > 0.90, y-intercepts for all comparisons at or below the assay detection limit, and Sy/x ranging between 7.5% and 15.4% of the average digoxin value. Susceptibility to interference from digoxin-like immunoreactive factors (DLIFs) was examined in 233 samples from renal patients, liver disease patients, cord blood, and third-trimester pregnancies; the AxSYM Digoxin II assay demonstrated the least DLIFs interference. DLIF susceptibility for four of the methods was significantly greater (P < 0.05) than in the AxSYM Digoxin II assay; susceptibilities of the Stratus II and Emit 2000 methods were similar to the AxSYM Digoxin II assay.

摘要

在四个独立地点对雅培公司无需预处理的AxSYM地高辛II检测法进行性能特征评估，以对四个独立地点的地高辛进行定量分析。地高辛测量值与雅培公司需预处理的AxSYM检测法、百特Stratus II检测法、雅培TDx/TDxFLx II检测法、雅培IMx检测法、Emit 2000检测法以及贝克曼Synchron CX地高辛检测法之间的相关性显示出可接受的一致性，具体表现为：斜率值>0.84，r>0.90，所有比较的y轴截距在检测限或检测限以下，且Sy/x在平均地高辛值的7.5%至15.4%之间。对233份来自肾病患者、肝病患者、脐血和孕晚期孕妇的样本进行了地高辛样免疫反应因子（DLIFs）干扰敏感性检测；AxSYM地高辛II检测法显示出最小的DLIFs干扰。四种检测方法的DLIF敏感性显著高于AxSYM地高辛II检测法（P<0.05）；Stratus II和Emit 2000检测法的敏感性与AxSYM地高辛II检测法相似。