Abstract

Apoenzyme reactivation immunoassay system with Seralyzer reflectance photometer for the determination of serum phenytoin (PHT) and phenobarbital (PB) concentration (Seralyzer method) was evaluated. Each coefficient of variation of within-run and between-run precision for 3 concentrations of PHT or PB in serum was less than 4.0%. The serum PHT (33 samples) or PB (31 samples) concentrations were determined by Seralyzer method and compared with those determined by high-performance liquid chromatography (HPLC) and fluorescence polarization immunoassay (FPIA method). There were good agreements between HPLC and Seralyzer method results and FPIA method and Seralyzer method results, where all correlation coefficients were more than 0.992. The cross-reactivities of p-hydroxyphenylphenylhydantoin in PHT reagent strips, and p-hydroxyphenobarbital and several barbiturates in PB reagent strips were found. However, these cross-reactivities are not serious problems in clinical condition. Therefore, the Seralyzer method may be useful for serum drug-level monitoring of patients under PHT or PB therapy.

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