Conner D P, Robinson J D, Lopez L M
Am J Hosp Pharm. 1984 Mar;41(3):500-2.
A modified method for the enzyme immunoassay (EMIT, Syva Company) of phenytoin is presented and compared with the standard method. Serum samples from 14 patients were analyzed for phenytoin content using both methods. All assays were performed by the same individual. Within-day and between-day variations of the modified method were determined. A carry-over study was done to determine if a sample with a high phenytoin concentration might contaminate subsequent samples with lower concentrations or whether samples with low concentrations could dilute subsequent samples with higher concentrations. Within-day and between-day variations of the modified method were 7.5% and 9.9%, respectively. These values are less than the 10% coefficient of variation limit claimed by the manufacturer of the standard method. The carry-over study revealed no significant carry-over with the modified method. An excellent correlation was observed between the values obtained from the two methods. The modified method can reduce assay costs by up to 40%. The modified method was found to provide accuracy and precision equivalent to the standard EMIT method at a substantial cost savings.
本文介绍了一种改良的苯妥英酶免疫测定法(EMIT,Syva公司),并将其与标准方法进行了比较。使用这两种方法对14名患者的血清样本进行了苯妥英含量分析。所有检测均由同一人进行。测定了改良方法的日内和日间变异。进行了残留研究,以确定高苯妥英浓度的样本是否会污染随后低浓度的样本,或者低浓度的样本是否会稀释随后高浓度的样本。改良方法的日内和日间变异分别为7.5%和9.9%。这些值低于标准方法制造商声称的10%变异系数限值。残留研究表明改良方法无明显残留。两种方法所得值之间观察到极好的相关性。改良方法可将检测成本降低多达40%。结果发现,改良方法在大幅节省成本的情况下,提供了与标准EMIT方法相当的准确性和精密度。