Multicentre evaluation of the Boehringer Mannheim/Hitachi 911 Analysis System

Abstract

The analytical performance and practicability of the Boehringer Mannheim (BM)/Hitachi 911 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 mainly followed the 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 of the study. Nearly all of the analytes met the imprecision limits: within-run imprecision (as CVs) was 2% for enzyme and substrate assays, 1% for ISE methods and 5% for immunoassays; between-day imprecision was 3l% for enzyme and substrate assays, 2% for ISE methods and 10% for immunoassays. No relevant drift effects (systematic deviation ≥ 3%) were observed over eight hours. The methods were linear over a wide range. Sample-related and reagent-dependent carry-over can be reduced to a negligible amount by integration of a softwarecontrolled wash-step. Endogenous interferences were found for creatinine (Jaffé method) and uric acid assays (caused by bilirubin), for creatine kinase, creatine kinase MB isoform and γ-glutamyltransferase (caused by haemoglobin), and for immunoglobulin A (caused by lipaemia) Accuracy was checked by an interlaboratory survey, recovery studies in control materials and method comparison studies. The survey showed that, with the exception of cholesterol and iron in two laboratories, the recovery of analytes did not deviate by more than 5%. Sixty-six of the 77 method comparisons performed met the acceptance criteria. The deviations of the remaining 11 results could be explained by differences in either calibration, application or by the use of different methods. Practicability was assessed using a questionnaire which covered all of the important aspects of an analysis system in the clinical laboratory. Twelve groups of attributes out of 14 were rater higher for the BM/Hitachi 911 than for the present situation in the laboratories concerned. Especially high scores were given for the versatility group. The acceptance criteria for the analytical performance of the BM/Hitachi 911 analysis system were fulfilled in all laboratory segments with few exceptions. The practicability exceeded the requirements in most of the attributes. The results of the study confirmed the usefulness of the system as a consolidated workstation in small- to medium-sized clinical laboratories and in STAT laboratories, or as an instrument for special analytes like proteins and drugs, or for urinalysis in large laboratories.

Pre-Altitude Serum Ferritin Levels and Daily Oral Iron Supplement Dose Mediate Iron Parameter and Hemoglobin Mass Responses to Altitude Exposure

“…Blood samples were collected at rest from a forearm antecubital vein by a trained phlebotomist. Pre- and post-altitude iron parameters (serum ferritin and TSAT) were measured at the AIS using either a Hitachi 911 (Boehringer, GmbH, Mannaheim, Ingelheim, Germany) or a COBAS Integra 400 (Roche Diagnostics, Switzerland) via immunoturbidimetry [ 23 ], with the same analyser always used for each pre versus post comparison.…”

Hämatologische und klinisch-chemische Referenzwerte für Hunde

“…Anschließend wird die Messzelle durch die interne Referenzlösung gewaschen. Je nach Anforderung werden die Analysedaten einzeln oder hintereinander vom Hitachi 911 gesendet und dann über die Kontrolleinheit zum Drucken gegeben(HOLCAK & RIEHS, 2003;ZAMAN et al 1993). Die Objektträger wurden nach Angaben des Herstellers mit demBlutausstrichfärbeautomat vonHema-Tek (Bayer, Leverkusen, Germany) vorgenommen.…”

Multicentre evaluation of the Boehringer Mannheim/Hitachi 917 analysis system

“…The interference results are given in table 8, clearly showing 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 [2].…”