Performance Evaluation of the Autokit Total Ketone Bodies

ABSTRACT

In this study, the Autokit Total Ketone Bodies kit (Wako Pure Chemical, Japan), a total ketone measurement assay using an enzymatic method, was evaluated using a Roche Cobas e702 instrument (Roche Diagnostics, Germany). Precision, linearity, carryover, and reference range verification were evaluated with reference to Clinical Laboratory Standards Institute guidelines. Standard materials provided by the manufacturer and patient samples were used for the evaluation. The precision and carryover of the evaluation result satisfied the acceptance criteria. Linearity was also acceptable at more than 0.99. The quantitative Autokit Total Ketone Bodies kit is precise, and can be widely used in clinical laboratories.