Multicentre evaluation of the Boehringer Mannheim/Hitachi 917 analysis system

The new selective access analysis system BM/Hitachi 917 was evaluated in an international multicentre study, mainly according to the ECCLS protocol fo r the evaluation of analysers in clinical chemistry. Forty-three different analytes, covering 56 different methods-enzymes, substrates, electrolytes, specific proteins, drugs and urine applications-were tested in seven Europe an clinical chemistry laboratories. Additionally, the practicability of the BMI Hitachi 917 was tested according to a standardized questionnaire. With in-run CVs (median of 3 days) for enzymes, substrates and electrolytes were <2% except for creatine-kinase MB isoform and lipase at low concentration. For proteins, drugs and urine analytes the within-run CVs were <4% except for digoxin and albumin in urine. Between-day median CV's were generally <3 % for enzymes, substrates and electrolytes, and <6% for proteins, drugs and urine analytes except for lipase, creatine kinase and IMB isoform, D-dimer , glycosylated haemoglobin, rheumatoid factors, digoxin, digitoxin, theophy lline and albumin in urine in some materials. Linearity was found according to the test specifications or better and there were no relevant effects se en in drift and carryover. testing. The interference results clearly show t hat also for the BM/Hitachi 917 interference exists sometimes, as could be expected because of the chemistries applied. It is a situation that can be Sound in equivalent analysers as well. The accuracy is acceptable, regardin g a 95-105% recovery in standard reference material, with the exception of the creatinine Jaffe' method. Most of the 160 method comparisons showed acc eptable agreement according to our criteria: enzymes substrates, urine anal ytes deviation of slope +/-5%, electrolytes +/-3%; and proteins and drugs /-10%. The assessment of practicability for 14 groups of attributes resulte d in a grading of one-three scores better for the BM/Hitachi 917 than the p resent laboratory situation. In conclusion, the results of the study showed good analytical performance and confirmed the usefulness of the system as a consolidated workstation in medium-sized to large clinical chemistry labo ratories.