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Analytic Performance of a Point-of-Care Instrument for Measurement of Cardiac Markers: An Evaluation Under Clinical Conditions
Department of Cardiology, Cardiothoracic Center, University Hospital, Uppsala, Sweden.
Department of Cardiology, Cardiothoracic Center, University Hospital, Uppsala, Sweden.
Orebro University Hospital. Department of Cardiology, Cardiothoracic Center, University Hospital, Uppsala, Sweden.
Department of Cardiology, Cardiothoracic Center, University Hospital, Uppsala, Sweden.
2003 (English)In: Point of Care, ISSN 1533-029X, E-ISSN 1533-0303, Vol. 2, no 4, 235-242 p.Article in journal (Refereed) Published
Abstract [en]

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.

A large number of patients are admitted to coronary care units (CCUs) with chest pain suggestive of an acute coronary syndrome (ie, unstable angina or acute myocardial infarction [AMI]). The diagnosis of AMI is immediately established only in case of ST elevation in the electrocardiogram (EKG). The large majority of chest pain patients, however, will have a nondiagnostic EKG for AMI. In those patients, confirmation of AMI is mainly dependent on serial testing of biochemical markers of myocardial damage, which currently is a time-consuming procedure.

Fast evaluation of patients with chest pain leads to several advantages. First, tests or procedures for establishing a definite or alternative diagnosis can be initiated earlier or avoided in appropriate circumstances. Second, rapid identification of patients suitable for treatment aimed at reducing morbidity and mortality (eg, percutaneous coronary intervention or Gp IIb/IIIa receptor antagonist treatment) may be possible. Furthermore, considerable economic gains might be achieved by early identification of patients who are at sufficiently low risk to be discharged or transferred from the CCU to a less resource-demanding unit. 1–3

To achieve fast assessment of chest pain patients, a short-assay turnaround time (TAT) is necessary. Normally, TAT includes the delay in the delivery of the sample to the laboratory, the preanalytic steps necessary to prepare the sample, the analysis time itself, and the effort it takes to deliver results to the ordering physician. To reach a TAT of less than 30 minutes, point-of-care (POC) instruments for analysis of cardiac markers have been developed, combining advantages such as near-patient assessment, a short sample-to-diagnosis time, and reasonable costs.

The aim of the current study was to examine and validate the feasibility of such a POC instrument—the Stratus CS STAT Fluorometric Analyzer (Dade Behring, Deerfield, IL)—in a routine setting of patients presenting with chest pain suggestive of an AMI but without confirming EKG changes. The analytic qualities and clinical performance of the assays of the commonly used cardiac markers troponin I (TnI), creatine kinase–MB (CK-MB), and myoglobin were studied and compared with results obtained from the central laboratory. Additionally, clinical characteristics such as user friendliness and TAT were evaluated.

Place, publisher, year, edition, pages
Lippincott Williams & Wilkins, 2003. Vol. 2, no 4, 235-242 p.
National Category
Cardiac and Cardiovascular Systems
Research subject
Cardiology
Identifiers
URN: urn:nbn:se:oru:diva-57688OAI: oai:DiVA.org:oru-57688DiVA: diva2:1096135
Available from: 2017-05-17 Created: 2017-05-17 Last updated: 2017-05-17Bibliographically approved

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