Multicentre Analytical Evaluation Of A New Point-Of-Care System For The Determination Of Cardiac And Thromboembolic Markers

Background: The cobas h 232 point-of-care analyzer by Roche is the instrument successor of the Cardiac reader allowing the quantitative determination of troponin T, creatine kinase MB, myoglobin, NT-proBNP and D-dimer.Methods: In this study 1329 patients with acute coronary syndromes, heart failure, thromboembolic or other diseases and 945 healthy donors were assessed. Comparisons versus central laboratory methods were carried out with 2379 samples from these individuals; out of these, 1591 samples gave quantitative results within the measuring range and were included in the evaluation.Results: The point-of-care assays for creatine kinase MB, myoglobin, NT-proBNP and D-dimer were within a relative bias range of -5.9 to +6.9 % A compared to the laboratory assay. The troponin T assay showed a bias of -11.0 % and after change of the calibration procedure of +1.9 %. None of the five point-of-care assays had a relative difference between the new system and the precursor device that was higher than +/- 5.0 %. Within-series coefficients of variation of patient samples were found in a range from 4.8 to 14.8 %. No significant interference was observed with lipemic, hemolytic and icteric blood or at different hematocrit values.Conclusions: Due to its good analytical agreement with the laboratory methods and with its precursor device, the cobas h 232 system can be reliably used to support on-site decision making for cardiovascular patients in acute and non-acute settings. (Clin. Lab. 2010;56:37-49)