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Clinical Evaluation of the First Medical Whole Blood, Point-of-Care Testing Device for Detection of Myocardial Infarction

¹ Hennepin County Medical Center, Department of Laboratory Medicine and Pathology, Minneapolis, MN 55415.

² Medical College of Virginia, Departments of Pathology and Medicine, Richmond, VA 23225.

³ Mayday University Hospital, Surrey CR7 7YE, United Kingdom.

⁴ Alameda County Medical Center–Highland Campus, Department of Emergency Medicine, Oakland, CA 94602.
^a Address correspondence to this author at: Hennepin County Medical Center, Clinical Laboratories 812, 701 Park Ave., Minneapolis, MN 55415. Fax 612-904-4229; e-mail fred.apple{at}co.hennepin.mn.us

Background: Validation of whole blood, point-of-care testing devices for monitoring cardiac markers to aid clinicians in ruling in and ruling out myocardial infarction (MI) is necessary for both laboratory and clinical acceptance.

Methods: This study evaluated the clinical diagnostic sensitivity and specificity of the First Medical Cardiac Test device operated by nursing and laboratory personnel that simultaneously measures cardiac troponin I (cTnI), creatine kinase (CK) MB, myoglobin, and total CK on the Alpha Dx analyzer in whole blood for detection of MI. Over a 6-month period, 369 patients initially presenting to the emergency department with chest pain were evaluated for MI using modified WHO criteria. Eighty-nine patients (24%) were diagnosed with MI.

Results: In whole blood samples collected at admission and at 3- to 6-h intervals over 24 h, ROC curve-determined MI decision limits were as follows: cTnI, 0.4 µg/L; CKMB, 7.0 µg/L; myoglobin, 180 µg/L; total CK, 190 µg/L. Based on peak concentrations within 24 h after presentation, the following sensitivities (± 95% confidence intervals) were found: cTnI, 93% ± 5.5%; myoglobin, 81% ± 9.7%; CKMB, 90% ± 6.3%; total CK, 86% ± 7.5%. Sensitivities were maximal at >90% for both cTnI and CKMB at >12 h in MI patients, without differences between ST-segment elevation and non-ST-segment elevation MI patients.

Conclusions: The First Medical point-of-care device provides cardiac marker assays that can be used by laboratories and clinicians in a variety of hospital settings for ruling in and ruling out MI.

The following articles in journals at HighWire Press have cited this article:

				F. S. Apple, R. Ler, A. Y. Chung, M. J. Berger, and M. M. Murakami Point-of-Care i-STAT Cardiac Troponin I for Assessment of Patients with Symptoms Suggestive of Acute Coronary Syndrome, Clin. Chem., February 1, 2006; 52(2): 322 - 325. [Abstract] [Full Text] [PDF]

				M. Panteghini Acute Coronary Syndrome: Biochemical Strategies in the Troponin Era Chest, October 1, 2002; 122(4): 1428 - 1435. [Abstract] [Full Text] [PDF]

				F. S. Apple, M. M. Murakami, R. L. Jesse, M. A. Levitt, A. K. Berger, L. A. Pearce, and P. Collinson Near-Bedside Whole-Blood Cardiac Troponin I Assay for Risk Assessment of Patients with Acute Coronary Syndromes Clin. Chem., October 1, 2002; 48(10): 1784 - 1787. [Full Text] [PDF]