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用于底物标记荧光免疫分析的自动化系统(Optimate)的评估

Evaluation of an automated system (Optimate) for substrate-labeled fluorescent immunoassays.

作者信息

Sheehan M, Caron G

出版信息

Ther Drug Monit. 1985;7(1):108-14. doi: 10.1097/00007691-198503000-00019.

DOI:10.1097/00007691-198503000-00019
PMID:3887666
Abstract

Performance characteristics of substrate-labeled fluorescent immunoassays for the drugs phenytoin, phenobarbital, primidone, carbamazepine, theophylline, gentamicin, tobramycin, amikacin, and quinidine run on an Optimate automated fluorometric analyzer were compared with those of automated enzyme multiplied immunoassays (EMIT) for the same drugs performed on a Cobas centrifugal analyzer for patient samples and controls. For 100 patient samples assayed by both systems for each drug, excellent correlations were obtained, with correlation coefficients ranging from 0.96 to 0.99. Likewise, very good within-run (n = 10) and between-run (n = 30) precision was obtained by both methods. Values for controls and clinical specimens by the Optimate methods calculated using the same-day calibration curves were not significantly different from those calculated from calibration curves stored 14 days, indicating at least 14-day curve stability for all assays.

摘要

在Optimate自动荧光分析仪上运行的苯妥英、苯巴比妥、扑米酮、卡马西平、茶碱、庆大霉素、妥布霉素、阿米卡星和奎尼丁等药物的底物标记荧光免疫分析的性能特征,与在Cobas离心分析仪上对患者样本和对照进行的相同药物的自动酶放大免疫分析(EMIT)的性能特征进行了比较。对于由两个系统对每种药物检测的100份患者样本,获得了极佳的相关性,相关系数范围为0.96至0.99。同样,两种方法均获得了非常好的批内(n = 10)和批间(n = 30)精密度。使用当日校准曲线通过Optimate方法计算的对照和临床标本的值与根据存储14天的校准曲线计算的值无显著差异,表明所有检测至少有14天的曲线稳定性。

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