Abstract
The new selective access analysis system BM/Hitachi 917 was evaluated in an international multicentre study, mainly according to the ECCLS protocol for 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 European clinical chemistry laboratories. Additionally, the practicability of the BM/ Hitachi 917 was tested according to a standardized questionnaire. Within-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 CVs were generally < 3% for enzymes, substrates and electrolytes, and < 6% for proteins, drugs and urine analytes, except for lipase, creatine kinase and MB isoform, D-dimer, glycosylated haemoglobin, rheumatoid factors, digoxin, digitoxin, theophylline and albumin in urine in some materials. Linearity was found according to the test specifications or better and there were no relevant effects seen in drift and carry-over testing. The interference results clearly show that 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 found in equivalent analysers as well. The accuracy is acceptable regarding a 95–105% recovery in standard reference material, with the exception of the creatinine Jaffé method. Most of the 160 method comparisons showed acceptable agreement according to our criteria: enzymes, substrates, urine analytes deviation of slope ± 5%, electrolytes ± 3%, and proteins and drugs ± 10%. The assessment of practicability for 14 groups of attributes resulted in a grading of one–three scores better for the BM/Hitachi 917 than the present 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 laboratories.
Highlights
The Boehringer Mannheim/Hitachi 917 analysis system (BM/Hitachi 917) is the most recent medium to largesized analysis system which was introduced to the market by Boehringer Mannheim GmbH in December 1994.Description of the instrumentBM/Hitachi 917 is a selective access analyser with a capacity of at least 48 di erent tests onboard out of 86 stored applications including three ISE methods
43 di erent analytes covering 56 di erent methodsÐ enzymes, substrates, electrolytes, speci® c proteins, drugs and urine applicationsÐ were tested in a core programme mainly following the ECCLS guidelines [3]
The ® xed factor is the median from the median factor of the three calibration runs per day, provided that the coe cient of variation (CV ) calculated from the nine results is less than 3%
Summary
The Boehringer Mannheim/Hitachi 917 analysis system (BM/Hitachi 917) is the most recent medium to largesized analysis system which was introduced to the market by Boehringer Mannheim GmbH in December 1994.Description of the instrumentBM/Hitachi 917 is a selective access analyser with a capacity of at least 48 di erent tests onboard out of 86 stored applications including three ISE methods. E.g. predilution, high sample volume pipetting, mixing of short-long-ter m applications, STAT requests or additional wash steps for the pipettors or the cuvettes needed to eliminate reagent carry-over in certain cases lead to a reduction of the throughput. The software has integrated an algorithm for throughput optimization. It recognizes pipetting conictsÐ e.g. R2/R3 pipettingÐ and reschedules the steps so that the additional time needed for the conict situation is a minimum. The bar-coded system reagents consisting of one± three vials per test are set in any free position of the reagent disk. Application settings are loaded from applicationoppy disk or from application bar code sheet, both are delivered by Roche Diagnostics GmbH.
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