Abstract

A new reagent kit for serum primidone (PMD) assay by laser immunochemical system (i-PiT) was developed. This kit is different from the former kits in that it uses a drug-linked latex, which reacts with antibody to bring about agglutination and, according to the manual, blank test is unnecessary in the process of assay. First, we confirmed the ground for the omission of blank test in some experiments, and then studied the precision, accuracy and other features of i-PiT method using the reagent kit for serum PMD assay.The precision of i-PiT method without blank test applied to three-PMD-level specimens of patients, expressed as coefficient of variation, was not less than 8.0% of within-day and not more than 6.0% of between-run. Mean recovery of PMD was 101.2%. Moreover, to study the accuracy, PMD concentration in the sera of 20 patients was determined by i-PiT and EMIT methods. The correlation coefficient and the regression line were 0.978 and y= 0.983x+ 0.181 (y: i-PiT, x: EMIT), respectively.In consideration of the omission of blank test, precision and accuracy, the new reagent kit for serum PMD assay of i-PiT method is considered to be one of the useful reagent kits for determination of serum drug concentration in hospital laboratories.

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