A comprehensive review of upper reference limits reported for (high-)sensitivity cardiac troponin assays: the challenges that lie ahead
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Eline P.M. Cardinaels
Abstract
Cardiac troponins (cTn) are the preferred markers for the diagnosis of acute myocardial infarction (AMI). The guidelines recommend the use of the 99th percentile upper reference concentration of a healthy population as the diagnostic cut-off for AMI. However, a broad range of upper reference limits is still employed, complicating the diagnosis of AMI. This overview is meant to assist laboratory specialists to define an appropriate cut-off value for the diagnosis of AMI. Therefore, we provide an overview of the analytical performance and upper reference limits of seven (high-)sensitivity cTn assays: Roche high-sensitivity cTnT and ADVIA Centaur, Stratus CS, Dimension Vista, Vitros ECi, Access and Architect cTnI assays. It is shown that none of the reference populations completely met the guidelines, including those in package inserts. Forty percent of the studies collected less than the advised minimum of 300 subjects. Many studies (50%) did not report their inclusion criteria, while lower 99th percentile limits were observed when more stringent selection criteria were applied. Higher troponin cut-offs were found in men and elderly subjects, suggesting sex- and age-specific cut-offs would be considered. Therefore, there is still need for a large, rigorously screened reference population to more accurately establish cTn upper reference limits.
©2012 by Walter de Gruyter Berlin Boston
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Artikel in diesem Heft
- Masthead
- Masthead
- Editorials
- Reference values and the journal: why the past is now present
- Other-than-annual variations in morning determinations of uric acid
- Reviews
- Blood biochemical markers of bone turnover: pre-analytical and technical aspects of sample collection and handling
- A comprehensive review of upper reference limits reported for (high-)sensitivity cardiac troponin assays: the challenges that lie ahead
- Mini Review
- Reference change values
- Opinion Papers
- Obtaining reference intervals traceable to reference measurement systems: is it possible, who is responsible, what is the strategy?
- Analytical performance, reference values and decision limits. A need to differentiate between reference intervals and decision limits and to define analytical quality specifications
- A pragmatic proposal for permissible limits in external quality assessment schemes with a compromise between biological variation and the state of the art
- Original Articles
- Age dependence of within-subject biological variation of nine common clinical chemistry analytes
- Population-based pediatric reference intervals for general clinical chemistry analytes on the Abbott Architect ci8200 instrument
- Uric acid biorhythm, a feature of long-term variation in a clinical laboratory database
- Age-related changes in serum amino acids concentrations in healthy individuals
- Characterisation of a highly sensitive troponin I assay and its application to a cardio-healthy population
- Are the currently used reference intervals for creatine kinase (CK) reflecting the general population? The Tromsø Study
- Age-specific thyroid hormone and thyrotropin reference intervals for a pediatric and adolescent population
- Serum thyroglobulin reference values according to NACB criteria in healthy subjects with normal thyroid ultrasound
- Thyroid volume influences serum calcitonin levels in a thyroid-healthy population: results of a 3-assay, 519 subjects study
- Impact of the reference values on the clinically-relevant cut-offs. The example of cortisol testing in children
- Trimester-specific reference intervals for haemoglobin A1c (HbA1c) in pregnancy
- The concentration of adiponectin in breast milk is related to maternal hormonal and inflammatory status during 6 months of lactation
- Age- and sex-specific reference limits for creatinine, cystatin C and the estimated glomerular filtration rate
- Determination of the biological variation of S100β and lactate dehydrogenase in disease-free patients with malignant melanoma
- Reference intervals and biological variation for kallikrein 6: influence of age and renal failure
- Faecal haemoglobin concentrations by gender and age: implications for population-based screening for colorectal cancer
- Reference intervals of extended erythrocyte and reticulocyte parameters
- Haematological and iron metabolism parameters in professional cyclists during the Giro d’Italia 3-weeks stage race
- Reference change values for lens culinaris agglutinin-reactive α-fetoprotein and des-γ-carboxy prothrombin in patients with chronic hepatitis C
- Letters to the Editor
- Disadvantages of using biological variation data for reference change values
- Reference change values may need some improvement but are invaluable tools in laboratory medicine
- Insulin-like growth factor 1 reference intervals for a chemiluminescent enzyme immunometric assay (Immulite 2000®) in an adult Mediterranean population
- Reference values for new red blood cell and platelet parameters on the Abbott Diagnostics Cell-Dyn Sapphire
- Congress Abstracts
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