Lower Limits for Reporting High-Sensitivity Cardiac Troponin Assays and Impact of Analytical Performance on Patient Misclassification
© Association for Diagnostics & Laboratory Medicine 2023..
BACKGROUND: Cardiac troponin measurements are indispensable for the diagnosis of myocardial infarction and provide useful information for long-term risk prediction of cardiovascular disease. Accelerated diagnostic pathways prevent unnecessary hospital admission, but require reporting cardiac troponin concentrations at low concentrations that are sometimes below the limit of quantification. Whether analytical imprecision at these concentrations contributes to misclassification of patients is debated.
CONTENT: The International Federation of Clinical Chemistry Committee on Clinical Application of Cardiac Bio-Markers (IFCC C-CB) provides evidence-based educational statements on analytical and clinical aspects of cardiac biomarkers. This mini-review discusses how the reporting of low concentrations of cardiac troponins impacts on whether or not assays are classified as high-sensitivity and how analytical performance at low concentrations influences the utility of troponins in accelerated diagnostic pathways. Practical suggestions are made for laboratories regarding analytical quality assessment of cardiac troponin results at low cutoffs, with a particular focus on accelerated diagnostic pathways. The review also discusses how future use of cardiac troponins for long-term prediction or management of cardiovascular disease may require improvements in analytical quality.
SUMMARY: Clinical guidelines recommend using cardiac troponin concentrations as low as the limit of detection of the assay to guide patient care. Laboratories, manufacturers, researchers, and external quality assessment providers should extend analytical performance monitoring of cardiac troponin assays to include the concentration ranges applicable in these pathways.
| Errataetall: | |
|---|---|
| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:70 |
|---|---|
| Enthalten in: |
Clinical chemistry - 70(2024), 3 vom: 02. März, Seite 497-505 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Aakre, Kristin M [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
|---|
| Anmerkungen: |
Date Completed 04.03.2024 Date Revised 04.04.2024 published: Print ErratumIn: Clin Chem. 2024 Mar 15;:. - PMID 38489534 Citation Status MEDLINE |
|---|
| doi: |
10.1093/clinchem/hvad185 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM365927597 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM365927597 | ||
| 003 | DE-627 | ||
| 005 | 20240405233307.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231227s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1093/clinchem/hvad185 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1366.xml |
| 035 | |a (DE-627)NLM365927597 | ||
| 035 | |a (NLM)38102065 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Aakre, Kristin M |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Lower Limits for Reporting High-Sensitivity Cardiac Troponin Assays and Impact of Analytical Performance on Patient Misclassification |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 04.03.2024 | ||
| 500 | |a Date Revised 04.04.2024 | ||
| 500 | |a published: Print | ||
| 500 | |a ErratumIn: Clin Chem. 2024 Mar 15;:. - PMID 38489534 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © Association for Diagnostics & Laboratory Medicine 2023. | ||
| 520 | |a BACKGROUND: Cardiac troponin measurements are indispensable for the diagnosis of myocardial infarction and provide useful information for long-term risk prediction of cardiovascular disease. Accelerated diagnostic pathways prevent unnecessary hospital admission, but require reporting cardiac troponin concentrations at low concentrations that are sometimes below the limit of quantification. Whether analytical imprecision at these concentrations contributes to misclassification of patients is debated | ||
| 520 | |a CONTENT: The International Federation of Clinical Chemistry Committee on Clinical Application of Cardiac Bio-Markers (IFCC C-CB) provides evidence-based educational statements on analytical and clinical aspects of cardiac biomarkers. This mini-review discusses how the reporting of low concentrations of cardiac troponins impacts on whether or not assays are classified as high-sensitivity and how analytical performance at low concentrations influences the utility of troponins in accelerated diagnostic pathways. Practical suggestions are made for laboratories regarding analytical quality assessment of cardiac troponin results at low cutoffs, with a particular focus on accelerated diagnostic pathways. The review also discusses how future use of cardiac troponins for long-term prediction or management of cardiovascular disease may require improvements in analytical quality | ||
| 520 | |a SUMMARY: Clinical guidelines recommend using cardiac troponin concentrations as low as the limit of detection of the assay to guide patient care. Laboratories, manufacturers, researchers, and external quality assessment providers should extend analytical performance monitoring of cardiac troponin assays to include the concentration ranges applicable in these pathways | ||
| 650 | 4 | |a Review | |
| 650 | 4 | |a Journal Article | |
| 650 | 7 | |a Troponin |2 NLM | |
| 700 | 1 | |a Apple, Fred S |e verfasserin |4 aut | |
| 700 | 1 | |a Mills, Nicolas L |e verfasserin |4 aut | |
| 700 | 1 | |a Meex, Steven J R |e verfasserin |4 aut | |
| 700 | 1 | |a Collinson, Paul O |e verfasserin |4 aut | |
| 700 | 0 | |a International Federation of Clinical Chemistry Committee on Clinical Applications of Cardiac Biomarkers (IFCC C-CB) |e verfasserin |4 aut | |
| 700 | 1 | |a Aakre, Kristin M |e investigator |4 oth | |
| 700 | 1 | |a Apple, Fred S |e investigator |4 oth | |
| 700 | 1 | |a Collinson, Paul O |e investigator |4 oth | |
| 700 | 1 | |a Hammarsten, Ola |e investigator |4 oth | |
| 700 | 1 | |a Jaffe, Allan S |e investigator |4 oth | |
| 700 | 1 | |a Meex, Steven J R |e investigator |4 oth | |
| 700 | 1 | |a Mills, Nicholas L |e investigator |4 oth | |
| 700 | 1 | |a Omland, Torbjørn |e investigator |4 oth | |
| 700 | 1 | |a Sandoval, Yader |e investigator |4 oth | |
| 700 | 1 | |a Cullen, Louise |e investigator |4 oth | |
| 773 | 0 | 8 | |i Enthalten in |t Clinical chemistry |d 1955 |g 70(2024), 3 vom: 02. März, Seite 497-505 |w (DE-627)NLM000002003 |x 1530-8561 |7 nnns |
| 773 | 1 | 8 | |g volume:70 |g year:2024 |g number:3 |g day:02 |g month:03 |g pages:497-505 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1093/clinchem/hvad185 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 70 |j 2024 |e 3 |b 02 |c 03 |h 497-505 | ||