Malliaros D P, Wong S S, Wu A H, Campbell J, Leonard H, Houser S, Berg M, Gornet T, Brown C, Feng Y J
Ciba Corning Diagnostics Corporation, East Walpole, Massachusetts 02032, USA.
Ther Drug Monit. 1997 Apr;19(2):224-9. doi: 10.1097/00007691-199704000-00019.
A chemiluminescent immunoassay for theophylline in serum or plasma was developed for the Ciba Corning ACS: 180 automated analyzer. The assay has a limit of quantitation of 0.2 microgram/ml, with a range up to 40 micrograms/ml. The cross-reactivity to metabolites 1,3-dimethyluric acid 3-methylxanthine was 3.4% and 2.5%, respectively. Overall means of 101.0% and 97.8% were determined from dilution linearity and addition studies, respectively. When compared to a high-performance liquid chromatography (HPLC) method, a linear regression of ACS Theophylline = 0.996 (HPLC) + 0.35, r = 0.991, n = 93, was obtained. Similar results were obtained when the ACS assay was compared to other immunoassays. Precision (within-run and total coefficient of variation or CV) was < 6% in the therapeutic range (10-20 micrograms/ml). The performance data demonstrate that the ACS Theophylline assay provides an additional choice for the clinical measurement of the drug.
针对汽巴康宁ACS: 180自动分析仪开发了一种用于检测血清或血浆中茶碱的化学发光免疫分析法。该分析方法的定量限为0.2微克/毫升，范围高达40微克/毫升。对代谢物1,3 - 二甲基尿酸和3 - 甲基黄嘌呤的交叉反应率分别为3.4%和2.5%。通过稀释线性和加样研究分别确定总体均值为101.0%和97.8%。与高效液相色谱（HPLC）法相比，得到的线性回归方程为：ACS茶碱 = 0.996（HPLC）+ 0.35，r = 0.991，n = 93。将ACS分析方法与其他免疫分析方法进行比较时，也得到了类似结果。在治疗范围内（10 - 20微克/毫升），精密度（批内和总变异系数或CV）< 6%。性能数据表明，ACS茶碱分析方法为该药物的临床检测提供了另一种选择。
