EVALUATION OF THE COBAS-CORE-II IMMUNOCHEMISTRY ANALYZER

A continuous random access immunoassay analyser, the COBAS Core II, wa s evaluated in the central laboratory of the Tumor Biology Center in F reiburg, Germany for three months. The performance of six COBAS Core i mmunoassays (AFP, CA 15-3, CEA, PSA, ISH and FT4) were investigated. I ntra-assay imprecision (CVs ranging from 1.8 to 4.9%) and inter-assay imprecision (CVs ranging from 2% to 8.5%) was good. Accuracy was verif ied with three commercially available quality control sera. In particu lar, the automatic dilution of the COBAS Core II proved useful and gav e superior reproducibility compared to manual dilution. A method compa rison with the Abbott AxSYM(TM) was also performed-using more than 600 routine patient samples. Goad correlation was found for all assays (s lopes ranging from 0.92-1.28, correlation r(s)=0.93-0.98), except for PSA because human specimens were used The COBAS Core II was evaluated for ease of use and efficiency compared to the Abbott AxSYM. The perfo rmance of the COBAS Core II immunoassay analyser was similar to the la boratory's routine analyser; the COBAS Core II required much less oper ator time. The COBAS Core II was found to be well suited to an oncolog y laboratory.