González Buitrago J M, Ruiz J, García Bastos J L, Navajo J A, Borque L, Maside C, Rodriguez A, Balas D, Palet A
Servicio de Bioquímica, Hospital Universitario de Salamanca, Spain.
Eur J Clin Chem Clin Biochem. 1994 Jun;32(6):489-93.
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 protocol follows ECCLS, IFCC and NCCLS guidelines. Using patient samples and commercial controls, within run and between run coefficients of variation were less than 3% in most cases, but as high as 9.7% for some CEDIA and latex assays. All the assays were linear, either in the reference or the therapeutic range of the analytes. No interference by haemolysis, lipaemia or icterus was observed. The methods were compared with other commercial methods. Coefficients of correlation were higher than 0.94 for all the methods. However, there were differences of slope and intercept for rheumatoid factor, apolipoprotein A-I and apolipoprotein B. On the Hitachi 911, all of the eight methods give precise and accurate results, and compare well with other established methods on immunoassay dedicated analysers. The discrepancies observed could be ascribed to current problems of immunoassay standardization.
本文报道了对新型分析仪日立911针对三类不同的均相免疫测定法（乳胶测定法、免疫沉淀测定法和CEDIA测定法）进行的多中心评估。评估方案遵循欧洲临床化学和实验室医学学会（ECCLS）、国际临床化学和检验医学联合会（IFCC）以及美国国家临床实验室标准委员会（NCCLS）的指南。使用患者样本和商业对照品，大多数情况下批内和批间变异系数小于3%，但某些CEDIA和乳胶测定法高达9.7%。所有测定法在分析物的参考范围或治疗范围内均呈线性。未观察到溶血、脂血或黄疸的干扰。将这些方法与其他商业方法进行了比较。所有方法的相关系数均高于0.94。然而，类风湿因子、载脂蛋白A-I和载脂蛋白B的斜率和截距存在差异。在日立911分析仪上，所有这八种方法都能给出精确和准确的结果，并且与免疫测定专用分析仪上的其他既定方法相比表现良好。观察到的差异可能归因于当前免疫测定标准化存在的问题。
