Definitions of the levels of evidence (I—III) and grades of the recommendation (A, B, C, I) are presented at the end of the "Major Recommendations" field.
Note from the National Academy of Clinical Biochemistry (NACB) and the National Guideline Clearinghouse (NGC): The Laboratory Medicine Practice Guidelines (LMPG) evidence-based practice for point-of-care testing sponsored by the NACB have been divided into individual summaries covering disease- and test-specific areas. In addition to the current summary, the following are available:
Who are the stakeholders who should be involved in developing an accelerated protocol for use of biomarkers for evaluation of patients with possible acute coronary syndrome (ACS)?
Guideline 12. Members of emergency departments (EDs), primary care physicians, divisions of cardiology, 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 ACS.
Strength/consensus of recommendation: A
Level of evidence: III
Where should accelerated protocols for diagnosis or the rule-out of acute myocardial infarction (AMI) be implemented?
Guideline 13. For simplicity, this protocol should apply to either the facilitated diagnosis or the rule-out of AMI in the ED or to routine diagnosis from other areas of the hospital, should a patient develop symptoms consistent with ACS while hospitalized.
Strength/consensus of recommendation: B
Level of evidence: III
How should the effectiveness of accelerated protocols for diagnosis or the rule-out of AMI be assessed and measured?
Guideline 14. Members of EDs, divisions of cardiology, primary care physicians, hospital administrations, and clinical laboratories should work collectively to use quality-assurance measures, evidence-based guidelines, and monitoring to reduce medical error and improve the treatment of patients with possible ACS.
Strength/consensus of recommendation: A
Level of evidence: III
What should be the reference point for reporting the temporal sequence of blood specimens for patients suspected of having ACS?
Guideline 15. For routine clinical practice, blood collections should be referenced relative to the time of presentation to the ED and (when available) the reported time of chest-pain onset.
Strength/consensus of recommendation: A
Level of evidence: III
In addition to members of EDs, primary care physicians, divisions of cardiology, hospital administrations, and clinical laboratories, are there others who need to be involved in accelerated pathways for ACS patients?
Guideline 16. The multidisciplinary team must include personnel knowledgeable about local reimbursement. Vendors should work with customers to help optimize cost-effective provision of biomarker testing.
Strength/consensus of recommendation: A
Level of evidence: II
How rapidly are results of cardiac biomarker testing needed by clinicians? What standard for measurement for turnaround time (TAT) should be used?
Guideline 17. The laboratory should perform cardiac marker testing with a TAT of 1 h, optimally 30 min, or less. The TAT is defined as the time from blood collection to the reporting of results.
Strength/consensus of recommendation: A
Level of evidence: II
Is there a recommended strategy for laboratories that are unable to deliver cardiac biomarker results in a time frame of 1 h from time of collection to result reporting?
Guideline 18. Institutions that cannot consistently deliver cardiac marker TATs of ~1 h should implement point-of-care (POC) testing devices.
Strength/consensus of recommendation: B
Level of evidence: II
What should be the performance specifications and characteristics of POC technology for measurement of cardiac biomarkers?
Guideline 19. Performance specifications and characteristics for central laboratory and POC platforms should not differ.
Strength/consensus of recommendation: A
Level of evidence: III
What stakeholder(s) should be involved in device and platform selection, training, operator competency assessment, maintenance of POC equipment, and compliance with regulatory requirements?
Guideline 20. Laboratory personnel must be involved in selection of devices, the training of individuals to perform the analysis, the maintenance of POC equipment, the verification of the proficiency of operators on a regular basis, and the compliance of documentation with requirements by regulatory agencies.
Strength/consensus of recommendation: A
Level of evidence: III
Are qualitative (positive/negative) devices appropriate for assessment of cardiac biomarker results?
Guideline 21. Although it is recognized that qualitative systems do provide useful information, it is recommended that POC systems provide quantitative results.
Strength/consensus of recommendation: B
Level of evidence: II
What is the process that should be used as new biomarkers are developed and introduced into clinical use?
Guideline 22. 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) and
International Federation of Clinical Chemistry (IFCC) to develop committees for standardizing and establishing performance specifications for new analytes. These organizations will determine the need for analyte standardization according to the potential clinical importance of the marker and gather the necessary scientific expertise for the formation of a standardization committee.
Strength/consensus of recommendation: A
Level of evidence: III
Definitions:
Levels of Evidence
- Evidence includes consistent results from well-designed, well-conducted studies in representative populations.
- Evidence is sufficient to determine effects, but the strength of the evidence is limited by the number, quality, or consistency of the individual studies; generalizability to routine practice; or indirect nature of the evidence.
- Evidence is insufficient to assess the effects on health outcomes because of limited number or power of studies, important flaws in their design or conduct, gaps in the chain of evidence, or lack of information.
Strength of Recommendations
A - The National Academy of Clinical Biochemistry (NACB) strongly recommends adoption; there is good evidence that it improves important health outcomes and concludes that benefits substantially outweigh harms.
B - The NACB recommends adoption; there is at least fair evidence that it improves important health outcomes and concludes that benefits outweigh harms.
C - The NACB recommends against adoption; there is evidence that it is ineffective or that harms outweigh benefits.
I - The NACB concludes that the evidence is insufficient to make recommendations; evidence that it is effective is lacking, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined.
