Biological variation of high sensitivity cardiac troponin-T in stable dialysis patients: implications for clinical practice
-
Magid A. Fahim
,
Andrew D. Hayen
Abstract
Background: Changes in high sensitivity cardiac troponin-T (hs-cTnT) concentrations may reflect either acute myocardial injury or biological variation. Distinguishing between these entities is essential to accurate diagnosis, however, the biological variation of hs-cTnT in dialysis population is currently unknown. We sought to estimate the within- and between-person coefficients of variation of hs-cTnT in stable dialysis patients, and derive the critical difference between measurements needed to exclude biological variation with 99% confidence.
Methods: Fifty-five prevalent haemo- and peritoneal-dialysis patients attending two metropolitan hospitals were assessed on 10 consecutive occasions; weekly for 5 weeks then monthly for 4 months. Assessments were conducted at the same dialysis cycle time-point and entailed hs-cTnT testing, clinical review, electrocardiography, and bioimpedance spectroscopy. Patients were excluded if they developed clinical or physiological instability.
Results: In total 137 weekly and 114 monthly hs-cTnT measurements from 42 stable patients were analysed. Respective between- and within-person coefficients of variation were 83% and 7.9% for weekly measurements, and 79% and 12.6% for monthly measurements. Within-person variation was unaffected by dialysis modality or cardiac co-morbidity. The bidirectional 99% reference change value was –25% and +33% for weekly measurements, and –37% and +58% for monthly measurements.
Conclusions: The between-person variation of hs-cTnT in the dialysis population is markedly greater than within-person variation indicating that hs-cTnT testing is best applied in this population using a relative change strategy. An increase of 33% or a reduction of 25% in serial hs-cTnT concentrations measured at weekly intervals excludes change due to analytical and biological variation alone with 99% confidence.
Acknowledgments
This study was presented at the ‘Young Investigator of The Year’ award session of The Australia and New Zealand Society of Nephrology (ANZSN) Annual Scientific Meeting 2013, Brisbane, Australia. We acknowledge the nephrologists, nurses, and dialysis patients at Princess Alexandra hospital, Brisbane, and Logan Hospital, Logan, Australia for their support throughout the study.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Financial support: The study funded in part by a research project grant from Kidney Health Australia (PG05 11) and an unrestricted equipment loan from Fresenius Medical Care, Asia-Pacific. Magid Fahim is a recipient of a National Health and Medical Research Council of Australia Postgraduate Research Scholarship and David Johnson is a current recipient of a Queensland Health Research Fellowship.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organisation(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
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©2015 by De Gruyter
Articles in the same Issue
- Frontmatter
- Editorial
- High-sensitivity assays for cardiac troponins
- Reviews
- High sensitivity cardiac troponin assays in the clinical laboratories
- Laboratory medicine as the science that underpins medicine: the “high-sensitivity” troponin paradigm
- Cardiac troponin assays: a review of quantitative point-of-care devices and their efficacy in the diagnosis of myocardial infarction
- Cardiovascular Diseases
- Evaluation of standardization capability of current cardiac troponin I assays by a correlation study: results of an IFCC pilot project
- Estimation of age- and comorbidities-adjusted percentiles of high-sensitivity cardiac troponin T levels in the elderly
- High-sensitivity cardiac troponin I in the general population – defining reference populations for the determination of the 99th percentile in the Gutenberg Health Study
- Kinetics of high-sensitivity cardiac troponin T or troponin I compared to creatine kinase in patients with revascularized acute myocardial infarction
- Biological variation of high sensitivity cardiac troponin-T in stable dialysis patients: implications for clinical practice
- Diagnosis of acute myocardial infarction in patients with renal insufficiency using high-sensitivity troponin T
- General Clinical Chemistry and Laboratory Medicine
- Active intervention in hospital test request panels pays
- An approach to establish the uncertainty budget of catalytic activity concentration measurements in a reference laboratory
- Uric acid: a potential biomarker of multiple sclerosis and of its disability
- Experience with the first fully automated chemiluminescence immunoassay for the quantification of 1α, 25-dihydroxy-vitamin D
- I-FABP and L-FABP are early markers for abdominal injury with limited prognostic value for secondary organ failures in the post-traumatic course
- Quantification of piperacillin, tazobactam, cefepime, meropenem, ciprofloxacin and linezolid in serum using an isotope dilution UHPLC-MS/MS method with semi-automated sample preparation
- Plasma visfatin/nicotinamide phosphoribosyltransferase (visfatin/NAMPT) concentration is not related to kidney function in elderly subjects
- Diagnostic performance study of an antigen microarray for the detection of antiphospholipid antibodies in human serum
- Dry ice exposure of plasma samples influences pH and lupus anticoagulant analysis
- Reference Values and Biological Variations
- A new robust statistical model for interpretation of differences in serial test results from an individual
- Cancer Diagnostics
- The value of red blood cell distribution width in endometrial cancer
- Letters to the Editors
- Serum high-sensitivity troponin concentrations in a multi-ethnic Asian population of stable chronic kidney disease patients
- Comparison between BNP values measured in capillary blood samples with a POCT method and those measured in plasma venous samples with an automated platform
- Reply to the article entitled “Impact of assay design on test performance: lessons learned from 25-hydroxyvitamin D” by Farrell et al., Clin Chem Lab Med 2014;52:1579–87
- Reply. Impact of assay design on test performance: lessons learned from 25-hydroxyvitamin D. Authors’ response to the Letter to the Editor by Donnelly et al.
- Therapeutic drug monitoring of voriconazole: validation of a novel ARK™ immunoassay and comparison with ultra-high performance liquid chromatography
- Interference of C-reactive protein with clotting times
Articles in the same Issue
- Frontmatter
- Editorial
- High-sensitivity assays for cardiac troponins
- Reviews
- High sensitivity cardiac troponin assays in the clinical laboratories
- Laboratory medicine as the science that underpins medicine: the “high-sensitivity” troponin paradigm
- Cardiac troponin assays: a review of quantitative point-of-care devices and their efficacy in the diagnosis of myocardial infarction
- Cardiovascular Diseases
- Evaluation of standardization capability of current cardiac troponin I assays by a correlation study: results of an IFCC pilot project
- Estimation of age- and comorbidities-adjusted percentiles of high-sensitivity cardiac troponin T levels in the elderly
- High-sensitivity cardiac troponin I in the general population – defining reference populations for the determination of the 99th percentile in the Gutenberg Health Study
- Kinetics of high-sensitivity cardiac troponin T or troponin I compared to creatine kinase in patients with revascularized acute myocardial infarction
- Biological variation of high sensitivity cardiac troponin-T in stable dialysis patients: implications for clinical practice
- Diagnosis of acute myocardial infarction in patients with renal insufficiency using high-sensitivity troponin T
- General Clinical Chemistry and Laboratory Medicine
- Active intervention in hospital test request panels pays
- An approach to establish the uncertainty budget of catalytic activity concentration measurements in a reference laboratory
- Uric acid: a potential biomarker of multiple sclerosis and of its disability
- Experience with the first fully automated chemiluminescence immunoassay for the quantification of 1α, 25-dihydroxy-vitamin D
- I-FABP and L-FABP are early markers for abdominal injury with limited prognostic value for secondary organ failures in the post-traumatic course
- Quantification of piperacillin, tazobactam, cefepime, meropenem, ciprofloxacin and linezolid in serum using an isotope dilution UHPLC-MS/MS method with semi-automated sample preparation
- Plasma visfatin/nicotinamide phosphoribosyltransferase (visfatin/NAMPT) concentration is not related to kidney function in elderly subjects
- Diagnostic performance study of an antigen microarray for the detection of antiphospholipid antibodies in human serum
- Dry ice exposure of plasma samples influences pH and lupus anticoagulant analysis
- Reference Values and Biological Variations
- A new robust statistical model for interpretation of differences in serial test results from an individual
- Cancer Diagnostics
- The value of red blood cell distribution width in endometrial cancer
- Letters to the Editors
- Serum high-sensitivity troponin concentrations in a multi-ethnic Asian population of stable chronic kidney disease patients
- Comparison between BNP values measured in capillary blood samples with a POCT method and those measured in plasma venous samples with an automated platform
- Reply to the article entitled “Impact of assay design on test performance: lessons learned from 25-hydroxyvitamin D” by Farrell et al., Clin Chem Lab Med 2014;52:1579–87
- Reply. Impact of assay design on test performance: lessons learned from 25-hydroxyvitamin D. Authors’ response to the Letter to the Editor by Donnelly et al.
- Therapeutic drug monitoring of voriconazole: validation of a novel ARK™ immunoassay and comparison with ultra-high performance liquid chromatography
- Interference of C-reactive protein with clotting times
