Troponin revisited 2008: assay performance
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Jillian R. Tate
Abstract
Troponin quality specifications describing the pre-analytical, analytical and post-analytical performance of cardiac troponin (cTn) assays are important for both manufacturers of cTn assays and laboratories that routinely test for cTn. Pre-analytical requirements refer not only to acceptable sample type for analysis and the stability of cTn but also to the proper handling of specimens prior to analysis to avoid pre-analytical false positive results. Analytical issues that may contribute to differences between cTn assays include analytical sensitivity and imprecision at low cTn concentration, antibody specificity and immunoreactivity of plasma cTn forms, assay specificity and the presence of falsely positive and negative interferences, and for cTnI the lack of standardised measurement, all which may impact on patient cTn results. Current second generation cTnI and fourth generation cTnT assays generally have an imprecision of around 20% coefficient of variation (CV) at the 99th percentile of the reference population, which is greater than the recommended imprecision of 10% CV. As the next generation of more analytically sensitive cTn assays are developed it can be anticipated that cTn upper reference limits will decrease by approximately 10-fold. Monitoring assay imprecision at ultra low cTn concentrations will require that the laboratory uses a quality control close to this level and a negative control to monitor baseline drift. Establishment of cTn reference ranges will require reference populations to be cardio-healthy to enable differentiation from community populations who are at increased cardiovascular risk. Close collaboration between the laboratory and local clinicians is required to ensure adequate clinical validation of more sensitive cTn assays.
Clin Chem Lab Med 2008;46:1489–500.
©2008 by Walter de Gruyter Berlin New York
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- Highlight: Cardiovascular Biomarkers
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- Letters to the Editor
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Articles in the same Issue
- Editorial
- Biochemical markers in clinical cardiology: perspectives from present to future. 1st IFCC-Ortho Clinical Diagnostics Conference on Clinical Diagnosis and the Clinical Laboratory
- Highlight: Cardiovascular Biomarkers
- Reviews
- The clinical impact of the universal diagnosis of myocardial infarction
- Troponin revisited 2008: assay performance
- Standardization of troponin I measurements: an update
- Biochemistry of B-type natriuretic peptide – where are we now?
- Clinical relevance of non-cardiac determinants of natriuretic peptide levels
- What is the value of B-type natriuretic peptide testing for diagnosis, prognosis or monitoring of critically ill adult patients in intensive care?
- Natriuretic peptide testing in primary care patients
- Natriuretic peptide testing in emergency settings
- Minireviews
- Oxidative stress, free radicals and bone remodeling
- Plasma homocysteine and vascular disease in elderly patients with mental illness
- Opinion Papers
- Fate of abstracts presented at the 2002 IFCC meeting
- Transition from congress abstract to full paper: the case of a national Argentinean congress in clinical laboratory
- Genetics and Molecular Diagnostics
- Association of endothelin-1 gene polymorphisms with variant angina in Korean patients
- Single nucleotide polymorphisms in ABCG5 and ABCG8 genes in Chilean subjects with polygenic hypercholesterolemia and controls
- Paternal exclusion: allele sharing in microsatellite testing
- General Clinical Chemistry
- Rapid sample preparation and simultaneous quantitation of prostaglandins and lipoxygenase derived fatty acid metabolites by liquid chromatography-mass spectrometry from small sample volumes
- Plasma bilirubin correlations in non-obstructive cholestasis after partial hepatectomy
- Aggregation of lipoprotein and inflammatory parameters in families with a history of premature myocardial infarction: the Tallinn Myocardial Infarction Study
- Significant elevation of a Th2 cytokine, interleukin-10, in pelvic inflammatory disease
- Hemoglobin A1c determination in the A1C-Derived Average Glucose (ADAG) study
- The effect of the mode of delivery on maternal-neonatal interleukin-6, biogenic amine and their precursor amino acid concentrations
- A rapid liquid chromatography-tandem mass spectrometry analysis of whole blood sirolimus using turbulent flow technology for online extraction
- Validation and Outcome Studies
- Benefits of the iQ200 automated urine microscopy analyser in routine urinalysis
- Electrochemical detection of blood alcohol concentration using a disposable biosensor based on screen-printed electrode modified with Nafion and gold nanoparticles
- About the z-multiplier in total error calculations
- Letters to the Editor
- A hypothyroid patient with increased free thyroid hormones
- Evaluation of blood collection tubes specific for homocysteine measurement
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- Frequency and type of preanalytical errors in a laboratory medicine department in India
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