Results of the multicenter evaluation of the CEDIA Theophylline assay.

G Klein, M J Castiñeiras, W Collinsworth, A Courbe, M Delavenne, E Hänseler, D Hannak, P Kaspar, R Kattermann, A Knoke
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Abstract

We report on the results of the multicenter evaluation of the CEDIA Theophylline assay on Boehringer Mannheim/Hitachi analyzers in 15 clinical laboratories in Europe and U.S.A. Main items of investigation were imprecision, recovery of control sera, interlaboratory survey and method comparisons using patient samples. Imprecision was found to be comparable to other routine methods. An advantage of the CEDIA assay can be seen in the good interlaboratory transferability of results. The new test has been shown to measure very accurately particularly by comparison with HPLC procedures revealing highly correspondent results. The reagent can be used up to one month using multiple recalibration. Due to its high practicability and reliability the CEDIA Theophylline assay can be recommended as a very suitable routine method for therapeutic drug monitoring on random access analyzers like Boehringer Mannheim/Hitachi analysis systems.

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CEDIA茶碱测定的多中心评价结果。
本文报道了欧洲和美国15个临床实验室在勃林格曼海姆/日立(Boehringer Mannheim/Hitachi)分析仪上对CEDIA茶碱测定法进行多中心评价的结果。主要调查项目为不精确性、对照血清的回收、实验室间调查和使用患者样本的方法比较。发现不精确性与其他常规方法相当。CEDIA分析的一个优点可以从结果的良好实验室间可转移性中看出。新的测试已被证明测量非常准确,特别是通过与HPLC程序的比较,显示出高度对应的结果。该试剂可使用长达一个月,使用多次重新校准。由于CEDIA茶碱测定具有很高的实用性和可靠性,因此可以推荐作为随机访问分析仪(如勃林格曼海姆/日立分析系统)上治疗药物监测的非常合适的常规方法。
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