![]() ![]() The goal of the current study was to determine the analytical characteristics of the i-STAT cTnI assay (i-STAT, Princeton, NJ), a 10-min POC assay, designed to be performed at the bedside. ![]() Quality specifications that apply to cardiac troponin monitoring using central laboratory instrumentation, including both analytical (antibody selection, calibration to appropriate standards, calculation of limits of detection, interferent studies) and pre-analytical (sample storage effects, specimen types) factors, must also be applied in the assessment of POC cTn assays. In chest pain centers, patient triage and therapy management are often reliant upon cardiac troponin findings over the initial 6 to 9 h after presentation in the emergency department. In addition Emergency Medicine has endorsed the need for rapid turn around of cardiac biomarker testing, specifically cardiac troponin. Point-of-care (POC)/near bedside testing systems have been developed to reduce delays in specimen transportation and processing that often occur when cardiac markers are measured in a central laboratory. When the central laboratory is used to monitor biomarkers the American College of Cardiology, American Heart Association, and the National Academy of Clinical Biochemistry have designated that cTn results be available in <60 min from the time a patient's blood is drawn to reporting of results to the clinician. Differentiating patients with acute coronary syndromes is predicated on an increased cTn (non-ST-elevation MI) and normal cTn (unstable angina). In addition, prognosis and risk of death and cardiac events are related in part to the extent of increases of cTn in patients with an ischemic mechanism of injury. In the clinical setting of ischemia, the designation of myocardial infarction (MI) is predicated on an increased cTn above the 99th percentile reference cutoff. Conclusions: The i-STAT cTnI assay is a sensitive and precise monitor of cTnI, poised for point-of-care/near bedside clinical utilization for triage, diagnostics and risk management of acute coronary syndrome patients.Ĭardiac troponin (cTn) has been designated as the preferred biomarker for the diagnosis of myocardial injury. Regression analysis for the i-STAT cTnI between whole blood and plasma specimens and for whole blood between the i-STAT and Stratus CS cTnI assays demonstrated slopes of 1.06 and 0.89, respectively. An equimolar response within 5% was found for reduced and phosphorylated forms of TIC and IC complexes. ![]() The assay was not affected by common interferents. The 99th percentile reference limit was 0.08 μg/l. Results: Total imprecision (CV) of 10% and 20% were seen at 0.09 and 0.07 μg/l, respectively. Factors studied included antibody specificity, detection limit, imprecision, linearity, assay specificity, sample type stability, interferences, reference limit determination and comparison vs. A total of 186 whole blood specimens (lithium heparin) were collected from patients presenting with symptoms suggestive of acute coronary syndromes (ACS) for correlation studies as well as from 162 healthy subjects for reference interval determination. Methods: Three different hospitals participated in a patient specimen and analytical validation study ( n =186) for the i-STAT cTnI assay carried out in real time. Background : This study determines the analytical characteristics of the i-STAT cardiac troponin I assay (cTnI i-STAT, Princeton, NJ), a 10-min POC assay, designed to be performed at the bedside. ![]()
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