Abstract
Seralyzer system applying apoenzyme reactivation immunoassay system for determination of serum theophylline concentration (SERALYZER method) was evaluated. The coefficients of variation of within-run and between-run precisions for 3 concentrations of theophylline in serum were less than 4%. The serum theophylline concentrations determined by SERALYZER method for 40 samples were compared with those determined by high-performance liquid chromatography (HPLC), substrate-labeled fluorescent immunoassay method-fluorostat (SLFIA method-A), SLFIA method-OPTIMATE (SLFIA method-B) and fluorescence polarization immunoassay method (FPIA method). There were good agreements between HPLC and SERALYZER method results, SLFIA method-A and SERALYZER method results, SLFIA method-B and SERALYZER method results, and FPIA method and SERALYZER method results, where all correlation coefficients were 0.996. The cross-reactivities of caffeine, 8-chlorotheophylline, 1, 3-dimethyluric acid, 1, 7-dimethylxanthine, 3-methylxanthine, theobromine, and 1, 3, 7-trimethyluric acid in SERALYZER method were found. However, these cross-reactivities are not serious problems in clinical condition. Therefore, the SERALYZER method may be useful for the drug-level monitoring of patients under theophylline therapy.
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