Assessment of the analytical performances of biochemistry automate (Indiko Plus®) at the Laboratory of Pediatric and Academic Hospital Charles De Gaulle

Abstract

In order to comply with one of the requirements of ISO 15189 relating to on-site performance verification, this study was carried out with the aim of evaluating the performance of the Indiko Plus® analyser within the biochemistry laboratory of the Pediatric and Academic Hospital Charles de Gaulle Pediatric. This was a descriptive and analytical study that was done on control samples and patient serum. The repeatability of the measures with the Indiko Plus® automate was satisfactory for all the parameters. For intermediate precision, creatinine had a high CV % compared to the limits of 15% set. The accuracy assessment showed

high relative biases for ALT at the normal control level and for creatinine on both control levels. The cor- relation and analytical concordance of the assays was acceptable for the two automates. This study shows that Indiko Plus® admits a good precision on the parameters tested. Repeatability, intermediate precision and accuracy were acceptable on most parameters except creatinine. Its comparison with Huma Star 600® showed an acceptable analytical and clinical agreement.