This guideline updates a previous version: Wu AH, Apple FS, Gibler WB, Jesse RL, Warshaw MM, Valdes R Jr. National Academy of Clinical Biochemistry Standards of Laboratory Practice: recommendations for the use of cardiac markers in coronary artery diseases. Clin Chem 1999 Jul;45(7):1104-21. [119 references] PubMed

• Chapter 1: Clinical characteristics and utilization of biochemical markers in acute coronary syndromes
• Chapter 2: Analytical issues for biochemical markers of acute coronary syndromes
• Chapter 3: Clinical utilization of cardiac biomarker testing in heart failure
• Chapter 4: Analytical issues for biomarkers of heart failure
• Chapter 6: Use of cardiac troponin and B-type natriuretic peptide or N-terminal proB-type natriuretic peptide for etiologies other than acute coronary syndromes and heart failure

Organization of Cardiac Biomarker Services

Collaboration on Providing Cardiac Biomarker Measurements

Recommendations for Stakeholder Collaboration on Cardiac Biomarker Services

Class I

1. Members of emergency departments, divisions of cardiology, primary care physicians, hospital administrations, and clinical laboratories should work collectively to develop an accelerated protocol for the use of biochemical markers in the evaluation of patients with possible acute coronary syndrome (ACS). (Level of Evidence: C)
2. Members of emergency departments, divisions of cardiology, primary care physicians, hospital administrations, and clinical laboratories should work collaboratively to use quality-assurance measures, evidence-based guidelines, and monitoring to reduce medical error and improve the treatment of patients with possible ACS. (Level of Evidence: C)

Class IIa

1. For simplicity, protocols for cardiac biomarker testing should apply to either the facilitated diagnosis or the rule-out of acute myocardial infarction (AMI) in the Emergency Department (ED) or to routine diagnosis from other areas of the hospital, should a patient develop symptoms consistent with ACS while hospitalized. (Level of Evidence: C)

Responsibility for Providing and Monitoring Cardiac Biomarker Measurements

Class I

1. Laboratory personnel must be involved in selection of devices, the training of individuals to perform the analysis, the maintenance of point-of-care (POC) equipment, the verification of the proficiency of operators on a regular basis, and assuring compliance and documentation of all requirements by regulatory agencies. (Level of Evidence: C)
2. The multidisciplinary team involved in cardiac biomarker testing must include personnel knowledgeable about local reimbursement. Vendors should work with customers to help optimize cost-effective provision of biomarker testing. (Level of Evidence: B)

Logistics of Cardiac Biomarker Services

Cardiac Biomarker Testing: Preanalytical, Analytical, and Postanalytical Aspects

Recommendations for cardiac biomarker measurements

Class I

1. The specimen of choice for analysis of biochemical markers of cardiac injury is plasma or anticoagulated whole blood to facilitate a more rapid turnaround time for testing. (Level of Evidence: C)
2. For routine clinical practice, blood collections should be referenced relative to the time of presentation to the emergency department and (when available) the reported time of chest pain onset. (Level of Evidence: C)
3. The laboratory should perform cardiac marker testing with a turnaround time of 1 hour, optimally 30 minutes, or less. The turnaround time is defined as the time from blood collection to the reporting of results. (Level of Evidence: B)
4. Performance specifications and characteristics for central laboratory and POC platforms must not differ. (Level of Evidence: C)

Class IIa

1. Institutions that cannot consistently deliver cardiac marker turnaround times of approximately 1 hour should implement POC testing devices. (Level of Evidence B)

Class IIb

1. While it is recognized that qualitative systems do provide useful information, it is recommended that POC systems provide quantitative results. (Level of Evidence: C)

Evolving Technology in Cardiac Biomarkers

Process for Adapting Evolving Biomarker Technology

Recommendations for Adapting Evolving Technologies

Class I

1. Early in the process, manufacturers are encouraged to seek assistance and provide support to professional organizations such as the American Association for Clinical Chemistry (AACC) or International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) to develop committees for the standardization of new analytes. These organizations will determine the need for analyte standardization based on the potential clinical importance of the marker and gather the necessary scientific expertise for the formation of a standardization committee. (Level of Evidence: C)

Definitions:

Weight of Evidence

A - Data derived from multiple randomized or appropriately designed clinical trials that involved large numbers of patients

B - Data derived from a limited number of randomized or appropriately designed trials that involved small numbers of patients or from careful analyses of observational registries

C - Expert Consensus was the primary basis for the recommendation

Summary of Indications

Class I: Conditions for which there is evidence and/or general agreement that a given laboratory procedure or treatment is useful and effective.

Class II: Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a laboratory procedure or treatment.

Class IIa: Weight of evidence/opinion is in favor of usefulness/efficacy.

Class IIb: Usefulness/efficacy is less well established by evidence/opinion.

Class III: Conditions for which there is evidence and/or general agreement that the laboratory procedure/treatment is not useful/effective and in some cases may be harmful.

All potential conflicts of interest for the NACB guidelines committee and ad hoc members of the writing committees are listed at the following: http://www.aacc.org/AACC/members/nacb/LMPG/OnlineGuide/PublishedGuidelines/ACSHeart/heartpdf.htm.

This guideline updates a previous version: Wu AH, Apple FS, Gibler WB, Jesse RL, Warshaw MM, Valdes R Jr. National Academy of Clinical Biochemistry Standards of Laboratory Practice: recommendations for the use of cardiac markers in coronary artery diseases. Clin Chem 1999 Jul;45(7):1104-21. [119 references] PubMed

Electronic copies: Available from the National Academy of Clinical Biochemistry (NACB) Web site.

Print copies: National Academy of Clinical Biochemistry publications are available through American Association for Clinical Chemistry (AACC) Press. To make a purchase or request a catalog, contact AACC Customer Service at 202-857-0717 or custserv@aacc.org.

Electronic copies: Available from the National Academy of Clinical Biochemistry (NACB) Web site.

Print copies: National Academy of Clinical Biochemistry publications are available through American Association for Clinical Chemistry (AACC) Press. To make a purchase or request a catalog, contact AACC Customer Service at 202-857-0717 or custserv@aacc.org.

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