MULTICENTER EVALUATION OF THE BOEHRINGER-MANNHEIM-HITACHI-911 SYSTEM FOR HOMOGENEOUS IMMUNOASSAYS

A multicentre evaluation of the new analyser, Hitachi 911, is reported for three different classes of homogeneous immunoassays (latex assays , immunoprecipitation assays, and CEDIA assays). The evaluation protoc ol follows ECCLS, IFCC and NCCLS guidelines. Using patient samples and commercial controls, within run and between run coefficients of varia tion were less than 3% in most cases, but as high as 9.7% for some CED IA and latex assays. All the assays were linear, either in the referen ce or the therapeutic range of the analytes. No interference by haemol ysis, lipaemia or icterus was observed. The methods were compared with other commercial methods. Coefficients of correlation were higher tha n 0.94 for all the methods. However, there were differences of slope a nd intercept for rheumatoid factor, apolipoprotein A-I and apolipoprot ein B. On the Hitachi 911, all of the eight methods give precise and a ccurate results, and compare well with other established methods on im munoassay dedicated analysers. The discrepancies observed could be asc ribed to current problems of immunoassay standardization.