National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines: Clinical Characteristics and Utilization of Biochemical Markers in Acute Coronary Syndromes

Morrow, David A.; Cannon, Christopher P.; Jesse, Robert L.; Newby, L. Kristin; Ravkilde, Jan; Storrow, Alan B.; Christenson, Robert H.; Apple, Fred S.; Francis, Gary S.; Tang, W.H. Wilson; Wu, Alan H.B.

doi:10.1373/clinchem.2006.084194

Cited by 429 publications

(354 citation statements)

References 200 publications

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“…Quality specifications for troponin assay require the presence of measurable cTnI and cTnT, also in the blood of healthy subjects [4][5][6]. However, measurement of the 99th URL of cTnI and cTnT levels is a challenging analytical issue due to low biomarker concentrations present in healthy subjects [7][8][9].…”

Section: Introductionmentioning

confidence: 99%

“…However, measurement of the 99th URL of cTnI and cTnT levels is a challenging analytical issue due to low biomarker concentrations present in healthy subjects [7][8][9]. Only after 2006 some manufacturers set-up the first new generation of cTnI and cTnT immunoassays with improved analytical sensitivity in accordance with the quality specifications indicated in international guidelines and consensus documents [4,[6][7][8][9][10][11][12][13][14][15][16]. Importantly, highly sensitive methods should also be able to measure troponin levels in the majority of healthy adults subjects (>50%), as suggested in some consensus documents [16][17][18].…”

Section: Introductionmentioning

confidence: 99%

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The 99th percentile of reference population for cTnI and cTnT assay: methodology, pathophysiology and clinical implications

Clerico

Zaninotto

Ripoli

et al. 2017

Clinical Chemistry and Laboratory Medicine (CCLM)

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According to recent international guidelines, including the 2012 Third Universal Definiton of Myocardial Infarction by the Joint ESC/ACCF/AHA/WHF Task Force, an increase in cardiac troponin (cTn) levels over the 99th percentile upper reference limit (99th URL) should be considered clinically relevant, this cut-off being measured with an imprecision ≤10 CV%. In theory 99th URL values strongly depend not only on demographic and physiological variables (i.e. criteria for considering the reference population "healthy"), but also on the analytical performance of cTn methods and mathematical algorithms used for the calculation. The aim of the present article was therefore to review the methodological and pathophysiological factors affecting the evaluation and calculation of the 99th URL for cTn assay. The critical analysis made showed that no uniform procedure is followed, and nor have experts or regulatory bodies provided uniform guidelines for researchers or cTn assays manufacturers as an aid in "their quest to define normality". In particular, little attention has been paid to the way in which a healthy reference population is to be selected, or the criteria for calculating the 99th URL value for cTn assays, thus highlighting the need for international recommendations not only for demographic and physiological variables criteria for defining a healthy reference population, but also for calculating mathematical algorithms for establishing/ calculating clinical decision values. An expert consensus group, comprising laboratory and clinical scientists, biomedical statisticians, industrial and regulatory representatives, should be responsible for drawing up these guidelines.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

The 99th percentile of reference population for cTnI and cTnT assay: methodology, pathophysiology and clinical implications

Clerico

Zaninotto

Ripoli

et al. 2017

Clinical Chemistry and Laboratory Medicine (CCLM)

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“…This guideline was consistent with the 2007 National Academy of Clinical Biochemistry laboratory medicine practice guideline. 5 The guideline suggests ordering troponin alone, without CK or CK-MB, in patients with suspected ACS. Furthermore, the guideline specifies that troponin should be assessed no more than three times, appropriately spaced over 18-24 hours, noting that there is no clinical utility to further testing or trending elevated troponin to peak or resolution in the absence of a diagnosis of ACS.…”

Section: Description Of Interventionmentioning

confidence: 99%

“…4 Guidelines developed in conjunction with the American Heart Association specify that troponin, evaluated no more than three times, is the preferred biomarker for diagnosis of ACS, and total CK and CK-MB should only be used if troponin is not available at the corresponding testing laboratory. 5 An analysis of more than 11,000 patients presenting to an ED found that there were zero instances where ACS was detected from a positive CK-MB when the troponin was negative. 6 Despite these guidelines, a recent survey of emergency medicine physicians at 98 US hospitals found that 85 % of institutions combine troponin with additional biomarkers such as CK-MB.…”

Section: Introductionmentioning

confidence: 99%

Reducing Excess Cardiac Biomarker Testing at an Academic Medical Center

et al. 2014

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“…Other indicators of activation of the coagulation system or inhibition of fibrinolytic activity are also elevated in patients with unstable angina (104) . However, the use of most of the biochemical markers of inflammation and activation of the coagulation cascade for the detection of unstable coronary artery disease is limited by their low specificity and lack of standardisation of the analytical procedures (105) .…”

Section: Markers Of Instability Of Coronary Artery Lesionsmentioning

confidence: 99%

New and emerging risk factors for CVD

Ferns

2008

Proc. Nutr. Soc.

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Morphological and immunocytochemical studies have elucidated the complex processes involved in atherogenesis. The notion of plaque instability has emerged from this work and underscored the importance of inflammation in determining clinical complications associated with atherosclerosis, such as acute coronary syndrome. Cells of the immune system have been detected within atherosclerotic lesions and auto-antibodies directed against modified LDL and heat-shock proteins have been identified in the blood of individuals with atherosclerosis. The use of risk 'engines', e.g. the Framingham coronary risk score, has facilitated the identification of individuals at high risk, but the constituent classical risk factors used in these algorithms do not adequately differentiate individuals at moderate risk. As age is a major component of the equations used in these algorithms they are not particularly useful in young adults, and their applicability to non-Caucasian populations has been questioned. Biomarkers of early disease and plaque instability have therefore both been sought. Although some of these markers have been shown individually to be associated with a significant hazard ratio, no substantial improvement in discrimination has been demonstrated when they are incorporated into a risk 'engine'. The latter has generally been assessed by receiver operator characteristic curve analysis, although this approach has been criticised. Other modalities, including imaging and functional assessments of vascular function, are now being developed for clinical use. CVD: Risk factors: Plaque instability: Biomarkers of early CVDThe UK prevalence of cardiovascular mortality remains amongst the highest in the world, accounting for approximately one-third of all deaths (1) . Atherosclerosis is now recognised as a chronic inflammatory condition, and remains as the major cause of CVD (2) . It is characterised by luminal narrowing of arteries and is associated with the deposition of lipid and matrix proteins in the blood-vessel wall (3) . A high risk of CVD is associated with abnormalities in lipid metabolism, hypertension and diabetes mellitus (4) , associations supported by landmark primary and secondary intervention trials (5,6) . These studies have contributed to the development of risk calculators and guidelines for the management of CVD (4,7) . The Framingham risk score (8) and Prospective Cardiovascular Münster (PROCAM) algorithm (9) are perhaps the best known of the risk 'engines', and are based on prospective cohort studies from well-characterised Caucasian populations living in the USA and Germany respectively. Deficiencies have been recognised in extending the data from these cohort studies to individual patients. For example, ethnicity, family history and adiposity are factors that were not originally considered, but for which corrections have been advocated in recent guidelines (4) . The risk 'engines' also underestimate the absolute risk of patients with preexisting CVD and diabetes, and it is therefore no longer recommen...

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National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines: Clinical Characteristics and Utilization of Biochemical Markers in Acute Coronary Syndromes

Cited by 429 publications

References 200 publications

The 99th percentile of reference population for cTnI and cTnT assay: methodology, pathophysiology and clinical implications

The 99th percentile of reference population for cTnI and cTnT assay: methodology, pathophysiology and clinical implications

Reducing Excess Cardiac Biomarker Testing at an Academic Medical Center

New and emerging risk factors for CVD

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