Clinical Chemistry
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Clinical Chemistry 55: 1303-1306, 2009. First published May 28, 2009; 10.1373/clinchem.2009.128363
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(Clinical Chemistry. 2009;55:1303-1306.)
© 2009 American Association for Clinical Chemistry, Inc.


Opinions

A New Season for Cardiac Troponin Assays: It’s Time to Keep a Scorecard

Fred S. Apple1,a

1 Hennepin County Medical Center and University of Minnesota School of Medicine, Department of Laboratory Medicine and Pathology Minneapolis, MN.

aAddress correspondence to the author at: Hennepin County Medical Center, Clinical Labs P4, 701 Park Ave., Minneapolis, MN 55415. Fax 612-904-4229; e-mail apple004@umn.edu.

The first 300 words of the full text of this article appear below.

Advancements in cardiac troponin (cTn)1 assay technology have created a conundrum for clinicians and laboratory scientists, who must determine which assays are best for optimal patient care. Unfortunately, few resources are available to guide the medical and scientific communities in this regard. International guidelines (1)(2)(3) have defined an increased cTn above the 99th percentile limit as an abnormal result; what is lacking, unfortunately, is an approach to define this limit across the heterogeneity of the assays. In spite of the evidence-based literature demonstrating that cTn concentrations tend to increase in individuals >60 years old (4), 99th percentile reference limits are often determined across wide age ranges using subjects as old as 70 years (convenience samples). Further frustrating the problem of selecting relevant reference subjects, in clinically defined "normal" individuals without known cardiovascular disease, increased cTn concentrations are indicative of a significantly higher risk of death (4)(5). The occurrence of such individuals in reference populations may reflect inadequate screening for comorbidities at the time of sample acquisition. Given such problems, a majority of laboratories either accept the manufacturer’s reference limit from the US Food and Drug Administration (FDA)-cleared package insert, perform an underpowered normal range study to establish a reference limit, or accept a reference limit published in the literature. To validate cTn assays, however—to level the playing field for all users—is necessary for the best patient care.

cTnI and cTnT are established as the standard biomarkers for the detection of myocardial injury and prognostic evaluation of patients with acute coronary syndrome (ACS) and without (1)(2)(3). The consensus guidelines from the Global Task Force for the Universal Definition of Myocardial Infarction (1) and the National Academy of Clinical Biochemistry (2. . . [Full Text of this Article]







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Copyright © 2009 by the American Association for Clinical Chemistry.