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National Academy of Clinical Biochemistry and IFCC Committee for Standardization of Markers of Cardiac Damage Laboratory Medicine Practice Guidelines: Analytical Issues for Biochemical Markers of Acute Coronary Syndromes

¹ Hennepin County Medical Center, Minneapolis, MN.
² Medical College of Virginia, Richmond, VA.
³ Duke University Medical Center, Durham, NC.
⁴ University of California at San Francisco, San Francisco, CA.
⁵ University of Maryland School of Medicine, Baltimore, MD.

NACB COMMITTEE MEMBERS, Robert H. Christenson, Chair

Baltimore, MD

Fred S. Apple

Minneapolis, MN

Christopher P. Cannon

Boston, MA

Gary Francis

Cleveland, OH

Robert Jesse

Richmond, VA

David A. Morrow

Boston, MA

L. Kristin Newby

Durham, NC

Jan Ravkilde

Aarhus, Denmark

Alan B. Storrow

Nashville, TN

Wilson Tang

Cleveland, OH

Alan H.B. Wu

San Francisco, CA

IFCC COMMITTEE ON STANDARDIZATION OF MARKERS OF CARDIAC DAMAGE (C-SMCD) MEMBERS, Fred S. Apple, Chair

Minneapolis, MN

Robert H. Christenson

Baltimore, MD

Allan S. Jaffe

Rochester, MN

Johannes Mair

Innsbruck, Austria

Jordi Ordonez-Llanos

Barcelona, Spain

Franca Pagani

Brecia, Italy

Mauro Panteghini

Milan, Italy

Jillian Tate

Brisbane, Australia

Alan H.B. Wu

San Francisco, CA

^aAddress correspondence to this author at: Director, Rapid Response Laboratories, University of Maryland School of Medicine, 22 S. Greene St., Baltimore, MD 21201. Fax 410-328-5880; e-mail rchristenson@umm.edu.

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

	Introduction

 

• I. OVERVIEW OF ANALYTICAL ISSUES FOR ACUTE CORONARY SYNDROME (ACS) BIOMARKERS...548
  
• • A. Analytical Issues: Background...548
    
  
  
• II. ANALYTICAL BIOMARKER ISSUES...548
  
• • A. Cardiac Troponin Specifications...548
    
  • B. Cardiac Biomarker Turnaround...549
    
  • C. Biomarkers No Longer Recommended for Use in the Context of ACS...549
    
  • D. Determining Biomarker Decision Cutoff Characteristics for ACS...549
    
  • E. European Society of Cardiology (ESC)/American College of Cardiology (ACC) Recommendations...550
    
  
  
• III. REFERENCES...550
  

	I. Overview of Analytical Issues for Acute Coronary Syndrome (ACS) Biomarkers

 
a. Background
In 1999, the National Academy of Clinical Biochemistry (NACB)¹ published the first standards of laboratory practice addressing analytical and clinical recommendations for use of cardiac markers in coronary artery diseases (1). The objectives were to recommend the appropriate implementation and utilization of cardiac biomarkers, specifically for cardiac troponin (cTn), which had just gained US Food and Drug Administration (FDA) clearance as a cardiac biomarker to aid in the diagnosis of acute myocardial infarction (AMI). In 2001, the IFCC Committee on Standardization of Markers of Cardiac Damage (C-SMCD) recommended quality specifications for analytical and preanalytical factors for cTn assays (2). The objectives were intended for use by the manufacturers of commercial assays and by clinical laboratories that use cTn assays. The overall goal was to establish uniform criteria so that all cTn assays could objectively be evaluated for their analytical qualities and clinical performance. These general principles can also be applied to creatine kinase MB (CK-MB) mass and myoglobin assays by use of the analytical recommendations in this document. In this report, we provide the background for establishing updated practice guidelines with recommendations addressing analytical issues for cardiac biomarkers based on 8 years of evidence-based medical and scientific observations since the publication of the initial recommendations (1).

	II. Analytical Biomarker Issues

 
recommendations: analytical aspects of acs biomarkers
ALL CLASS I

1. Reference decision-limits should be established for each cardiac biomarker based on a population of normal, healthy individuals without a known history of heart disease (reference . . . [Full Text of this Article]

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