The clinical need for high-sensitivity cardiac troponin assays for acute coronary syndromes and the role for serial testing

Cardiac troponin is the biomarker of choice for the serologic diagnosis of acute coronary syndromes. International cardiology and laboratory medicine guidelines have suggested that the cutoff concentration be set at the 99th percentile of a healthy population, with an assay imprecision of 10% or les...

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Published inThe American heart journal Vol. 155; no. 2; pp. 208 - 214
Main Authors Wu, Alan H.B., Jaffe, Allan S.
Format Journal Article
LanguageEnglish
Published New York, NY Mosby, Inc 01.02.2008
Elsevier
Elsevier Limited
Subjects
Online AccessGet full text
ISSN0002-8703
1097-6744
1097-6744
DOI10.1016/j.ahj.2007.10.016

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Abstract Cardiac troponin is the biomarker of choice for the serologic diagnosis of acute coronary syndromes. International cardiology and laboratory medicine guidelines have suggested that the cutoff concentration be set at the 99th percentile of a healthy population, with an assay imprecision of 10% or less. Unfortunately, most commercial troponin assays do not have the sensitivity and precision to reliably detect troponin in sera of healthy subjects. Therefore, there is a need to develop troponin assays with higher sensitivity, which cannot be achieved while also improving the assay's precision. Novel prototype analytical testing devices have been developed that are 5- to 10-fold more sensitive than existing commercial troponin assays. These tests should enable an earlier detection of myocardial infarction relative to the time of presentation and detect a higher percentage of emergency department chest pain patients who are at risk for short-term major adverse cardiac events. However, use of a high-sensitivity troponin assay will also result in detection of more patients who have cardiac necrosis due to a nonischemic etiology. Serial troponin testing will be necessary to determine the clinical significance of low levels of troponin release with use of high-sensitivity assays. Guidelines will need to be established to determine a change in troponin results that is statistically and clinically significant, and new considerations for the time interval needed between blood collections. This will enable the use of future high-sensitivity troponin assays to be more valuable.
AbstractList Cardiac troponin is the biomarker of choice for the serologic diagnosis of acute coronary syndromes. International cardiology and laboratory medicine guidelines have suggested that the cutoff concentration be set at the 99th percentile of a healthy population, with an assay imprecision of 10% or less. Unfortunately, most commercial troponin assays do not have the sensitivity and precision to reliably detect troponin in sera of healthy subjects. Therefore, there is a need to develop troponin assays with higher sensitivity, which cannot be achieved while also improving the assay's precision. Novel prototype analytical testing devices have been developed that are 5- to 10-fold more sensitive than existing commercial troponin assays. These tests should enable an earlier detection of myocardial infarction relative to the time of presentation and detect a higher percentage of emergency department chest pain patients who are at risk for short-term major adverse cardiac events. However, use of a high-sensitivity troponin assay will also result in detection of more patients who have cardiac necrosis due to a nonischemic etiology. Serial troponin testing will be necessary to determine the clinical significance of low levels of troponin release with use of high-sensitivity assays. Guidelines will need to be established to determine a change in troponin results that is statistically and clinically significant, and new considerations for the time interval needed between blood collections. This will enable the use of future high-sensitivity troponin assays to be more valuable.
Background Cardiac troponin is the biomarker of choice for the serologic diagnosis of acute coronary syndromes. International cardiology and laboratory medicine guidelines have suggested that the cutoff concentration be set at the 99th percentile of a healthy population, with an assay imprecision of 10% or less. Unfortunately, most commercial troponin assays do not have the sensitivity and precision to reliably detect troponin in sera of healthy subjects. Therefore, there is a need to develop troponin assays with higher sensitivity, which cannot be achieved while also improving the assay's precision. Methods and Results Novel prototype analytical testing devices have been developed that are 5- to 10-fold more sensitive than existing commercial troponin assays. These tests should enable an earlier detection of myocardial infarction relative to the time of presentation and detect a higher percentage of emergency department chest pain patients who are at risk for short-term major adverse cardiac events. However, use of a high-sensitivity troponin assay will also result in detection of more patients who have cardiac necrosis due to a nonischemic etiology. Conclusions Serial troponin testing will be necessary to determine the clinical significance of low levels of troponin release with use of high-sensitivity assays. Guidelines will need to be established to determine a change in troponin results that is statistically and clinically significant, and new considerations for the time interval needed between blood collections. This will enable the use of future high-sensitivity troponin assays to be more valuable.
Cardiac troponin is the biomarker of choice for the serologic diagnosis of acute coronary syndromes. International cardiology and laboratory medicine guidelines have suggested that the cutoff concentration be set at the 99th percentile of a healthy population, with an assay imprecision of 10% or less. Unfortunately, most commercial troponin assays do not have the sensitivity and precision to reliably detect troponin in sera of healthy subjects. Therefore, there is a need to develop troponin assays with higher sensitivity, which cannot be achieved while also improving the assay's precision.BACKGROUNDCardiac troponin is the biomarker of choice for the serologic diagnosis of acute coronary syndromes. International cardiology and laboratory medicine guidelines have suggested that the cutoff concentration be set at the 99th percentile of a healthy population, with an assay imprecision of 10% or less. Unfortunately, most commercial troponin assays do not have the sensitivity and precision to reliably detect troponin in sera of healthy subjects. Therefore, there is a need to develop troponin assays with higher sensitivity, which cannot be achieved while also improving the assay's precision.Novel prototype analytical testing devices have been developed that are 5- to 10-fold more sensitive than existing commercial troponin assays. These tests should enable an earlier detection of myocardial infarction relative to the time of presentation and detect a higher percentage of emergency department chest pain patients who are at risk for short-term major adverse cardiac events. However, use of a high-sensitivity troponin assay will also result in detection of more patients who have cardiac necrosis due to a nonischemic etiology.METHODS AND RESULTSNovel prototype analytical testing devices have been developed that are 5- to 10-fold more sensitive than existing commercial troponin assays. These tests should enable an earlier detection of myocardial infarction relative to the time of presentation and detect a higher percentage of emergency department chest pain patients who are at risk for short-term major adverse cardiac events. However, use of a high-sensitivity troponin assay will also result in detection of more patients who have cardiac necrosis due to a nonischemic etiology.Serial troponin testing will be necessary to determine the clinical significance of low levels of troponin release with use of high-sensitivity assays. Guidelines will need to be established to determine a change in troponin results that is statistically and clinically significant, and new considerations for the time interval needed between blood collections. This will enable the use of future high-sensitivity troponin assays to be more valuable.CONCLUSIONSSerial troponin testing will be necessary to determine the clinical significance of low levels of troponin release with use of high-sensitivity assays. Guidelines will need to be established to determine a change in troponin results that is statistically and clinically significant, and new considerations for the time interval needed between blood collections. This will enable the use of future high-sensitivity troponin assays to be more valuable.
Author Wu, Alan H.B.
Jaffe, Allan S.
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  givenname: Allan S.
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  fullname: Jaffe, Allan S.
  organization: Cardiovascular Division and Division of Laboratory Medicine, Mayo Clinic, Rochester, MN
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Issue 2
Keywords Heart
High
Cardiovascular disease
Medical screening
Coronary heart disease
Myocardial disease
Phlebology
Assay
Need
Sensitivity
Troponin
Circulatory system
Cardiology
Acute coronary syndrome
Language English
License CC BY 4.0
LinkModel DirectLink
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SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 14
ObjectType-Review-3
content type line 23
PMID 18215588
PQID 1504606997
PQPubID 2031075
PageCount 7
ParticipantIDs proquest_miscellaneous_70236832
proquest_journals_1504606997
pubmed_primary_18215588
pascalfrancis_primary_20037293
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PublicationCentury 2000
PublicationDate 2008-02-01
PublicationDateYYYYMMDD 2008-02-01
PublicationDate_xml – month: 02
  year: 2008
  text: 2008-02-01
  day: 01
PublicationDecade 2000
PublicationPlace New York, NY
PublicationPlace_xml – name: New York, NY
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PublicationTitle The American heart journal
PublicationTitleAlternate Am Heart J
PublicationYear 2008
Publisher Mosby, Inc
Elsevier
Elsevier Limited
Publisher_xml – name: Mosby, Inc
– name: Elsevier
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Snippet Cardiac troponin is the biomarker of choice for the serologic diagnosis of acute coronary syndromes. International cardiology and laboratory medicine...
Background Cardiac troponin is the biomarker of choice for the serologic diagnosis of acute coronary syndromes. International cardiology and laboratory...
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SubjectTerms Acute Coronary Syndrome - blood
Acute Coronary Syndrome - diagnosis
Acute coronary syndromes
Biological and medical sciences
Biomarkers - blood
Cardiology
Cardiology. Vascular system
Cardiovascular
Coronary heart disease
False Positive Reactions
Heart
Heart attacks
Humans
Ischemia
Medical sciences
Myocarditis. Cardiomyopathies
Pain
Reference Values
Risk Assessment
Sensitivity and Specificity
Studies
Troponin - blood
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Title The clinical need for high-sensitivity cardiac troponin assays for acute coronary syndromes and the role for serial testing
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