Abstract
Abstract: Point-of-care testing of cardiac markers has been widely introduced into clinical practice. In this study, the authors examined the analytic qualities and the feasibility of a point-of-care device—the Stratus CS STAT Fluorometric Analyzer—under clinical conditions. Measurements of myoglobin, creatine kinase–MB (CK-MB), and troponin I (TnI) were performed in 197 consecutive patients admitted to the coronary care unit because of chest pain suggestive of a myocardial infarction. Additionally, all cardiac markers were determined on the AxSYM analyzer used as a comparative device. The Stratus CS demonstrated an average analytic imprecision (or coefficient of variation [CV]) of 4.0 to 5.1% for the TnI assay, 2.9 to 5.5% for CK-MB, and 3.7 to 4.7% for myoglobin. This was superior to CVs of AxSYM measurements, in particular concerning the lower range of TnI concentrations. The method comparison showed 17 to 22% lower Stratus CS myoglobin results and 24 to 29% lower Stratus CS CK-MB results. For TnI, Stratus CS results were factor 5 or factor 10 lower compared with AxSYM measurements and showed a great dispersion of values as a result of the higher CV of the AxSYM TnI assay. The diagnostic sensitivities and specificities of all 3 markers correlated well on both test systems. In conclusion, the Stratus CS showed an overall good performance, with analytic qualities and clinical performance as least as good as those of the AxSYM analyzer.
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