Multicentre evaluation of the Boehringer Mannheim / Hitachi 911 Analysis System

Abstract

The analytical performance and practicability of the Boehringer Mannheim (BM)/mtaci 91 analysis system have been assessed in a multicentre evaluation, which involved six laboratories from European countries. Analytes commonly used in classical clinical chemistry were tested in a core programme, which mainlyfollowed lhe ECCLS guidelines. In addition, a satellite programme covered other analytes, such as proteins, drugs and urine analytes. In total, the study comprised more than 100 000 data items collected over a three-month period. The evaluation was supported with 'Computer Aided Evaluation' (CAEv) and telecommunications. Acceptance criteria for the results were established at the beginning ofthe study. Nearly all ofthe analytes met the imprecision limits.' within-run imprecision (as CVs) was 2l/ofor enzyme and substrate assays, l%for ISE methods and 5l/o for immunoassays; between-day imprecision was 3l/ofor enzyme and substrate assays, 2o//o for ISE methods and 10% for immunoassays.