Twenty-Four-Hour Biological Variation Profiles of Cardiac Troponin I in Individuals with or without Chronic Kidney Disease

Linden, Naomi van der; Hilderink, Judith M; Cornelis, T.; Kimenai, Dorien M; Klinkenberg, Lieke J.J.; Doorn, William P van; Litjens, Elisabeth J R; Suijlen, Jeroen D.E. van; Loon, Luc J. C. van; Bekers, Otto; Kooman, Jeroen P.; Meex, Steven J.R.

doi:10.1373/clinchem.2017.275107

Cited by 36 publications

(37 citation statements)

References 4 publications

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“…This enhances the need for relevant and robust estimates of BV also in a long-term setting in healthy individuals to aid in the interpretation of changes in cTn, as well as establishing reference change value (RCV) and analytical performance specifications (APS) for the use of cTn in such a manner [11]. Currently available BV data for cTnI BV have been summarized by Nordenskjöld et al [12] and are mostly based on [1] analysis with a non-commercial analytical system [13], [2] small cohorts of potentially unhealthy individuals [12,14,15] or [3] based on sampling with a short time interval (24 h) [16]. The scope of our study was to estimate the weekly BV of high-sensitive cTnI with two recently released commercial methods targeting different epitopes, Siemens Atellica and Singulex Clarity (Singulex is as of June 2019 no longer on the market), on the well-characterized population of the European Biological Variation Study (EuBIVAS) [17][18][19][20].…”

Section: Introductionmentioning

confidence: 99%

The European Biological Variation Study (EuBIVAS): weekly biological variation of cardiac troponin I estimated by the use of two different high-sensitivity cardiac troponin I assays

Ceriotti

Marco

Fernández–Calle

et al. 2020

Clinical Chemistry and Laboratory Medicine (CCLM)

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BackgroundCardiac troponins (cTn) are specific markers for cardiac damage and acute coronary syndromes. The availability of new high-sensitivity assays allows cTn detection in healthy people, thus permitting the estimation of biological variation (BV) of cTn. The knowledge of BV is important to define analytical performance specifications (APS) and reference change values (RCVs). The aim of this study was to estimate the within- and between-subject weekly BV (CVI, CVG) of cTnI applying two high-sensitivity cTnI assays, using European Biological Variation Study (EuBIVAS) specimens.MethodsThirty-eight men and 53 women underwent weekly fasting blood drawings for 10 consecutive weeks. Duplicate measurements were performed with Singulex Clarity (Singulex, USA) and Siemens Atellica (Siemens Healthineers, Germany).ResultscTnI was measurable in 99.4% and 74.3% of the samples with Singulex and Atellica assays, respectively. Concentrations were significantly higher in men than in women with both methods. The CVI estimates with 95% confidence interval (CI) were for Singulex 16.6% (15.6–17.7) and for Atellica 13.8% (12.7–15.0), with the observed difference likely being caused by the different number of measurable samples. No significant CVI differences were observed between men and women. The CVG estimates for women were 40.3% and 36.3%, and for men 65.3% and 36.5% for Singulex and Atellica, respectively. The resulting APS and RCVs were similar for the two methods.ConclusionsThis is the first study able to estimate cTnI BV for such a large cohort of well-characterized healthy individuals deriving objective APS and RCV values for detecting significant variations in cTnI serial measurements, even within the 99th percentile.

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Section: Introductionmentioning

confidence: 99%

The European Biological Variation Study (EuBIVAS): weekly biological variation of cardiac troponin I estimated by the use of two different high-sensitivity cardiac troponin I assays

Ceriotti

Marco

Fernández–Calle

et al. 2020

Clinical Chemistry and Laboratory Medicine (CCLM)

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“…These results show that observed changes in consecutively measured BNP and NT-proBNP samples must be relatively large to meet the threshold for a ‘true’ change, while smaller changes between serial measurements of hs-TnT and ST2 are indicative of a significant change. Studies examining biological variation have been performed in healthy populations, but a growing interest in variation components of biomarkers in populations with (cardiovascular) disease resulted in newer studies addressing biological variation in heart failure and chronic kidney disease 15 17–20 38. We found that indices of biological variation in stable AVS approximated indices found in studies investigating biological variation in healthy subjects and chronic and stable heart failure 17 20 38…”

Section: Discussionmentioning

confidence: 78%

“…Studies investigating biological variation of cardiac biomarkers have been performed in healthy subjects, but data obtained from specific patient populations are rare,15–20 limiting the generalisability of the findings from healthy subjects to patients. Biological variation of biomarkers in patients with AVS has never been reported.…”

Section: Introductionmentioning

confidence: 99%

Biological variation of cardiac markers in patients with aortic valve stenosis

et al. 2019

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ObjectiveCardiac biomarkers hold promise for follow-up and management of aortic valve stenosis (AVS). When interpreting serial biomarker measurements of patients with AVS, it can be challenging to distinguish ‘real changes’ from ‘random fluctuation’. Hence, robust estimation of the biological variation of these biomarkers is essential. In the present study we assessed biological variation of B-type natriuretic peptide (BNP), N-terminus pro-brain natriuretic peptide (NT-proBNP), high-sensitivity troponin-T and high-sensitivity troponin-I (hs-TnT and hs-TnI), and ST2 in subjects with stable AVS.MethodsSerial blood sampling was performed in 25 subjects with moderate AVS—confirmed by echocardiography—and all free from acute cardiovascular events in the past 6 months. Blood samples were taken on seven standardised occasions during 1 year. Analytical variation (CVA), within-subject biological variation (CVI), between-subject biological variation (CVG), index of individuality (II) and reference change values were calculated for all cardiac biomarkers.ResultsCVI was highest for BNP (62.0%, 95% CI 52.5 to 75.4) and lowest for hs-TnI (9.2%, 95% CI 2.8 to 13.8). CVG exceeded the CVI for all biomarkers except BNP, and ranged from 19.8% (95% CI 13.8 to 33.4) for ST2 to 57.2% (95% CI 40.4 to 97.3) for hs-TnT. NT-proBNP, hs-TnT and ST2 revealed CVA <5%, while BNP and hs-TnI showed a higher CVA (19.7 and 14.9, respectively). All biomarkers except BNP showed marked individuality, with II ranging from 0.21 to 0.67 (BNP 1.34).ConclusionThis study provides the first biological variation estimates of cardiac biomarkers in patients with stable AVS. These estimates allow a more evidence-based interpretation of biomarker changes in the follow-up and management of patients with AVS.Trial registration numberNCT02510482

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“…It is yet thought that cTnT as well as cTnI are cleared by the kidney, but in patients with renal failure, cTnT is increased more frequently than cTnI [35]. It might therefore be possible that a diurnal change in cTnT clearance could contribute to the circadian variability described [7,8,36] previously.…”

Section: Discussionmentioning

confidence: 96%

Circadian rhythm of cardiac troponin I and its clinical impact on the diagnostic accuracy for acute myocardial infarction

Wildi

Singeisen

Twerenbold

et al. 2018

International Journal of Cardiology

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Twenty-Four-Hour Biological Variation Profiles of Cardiac Troponin I in Individuals with or without Chronic Kidney Disease

Cited by 36 publications

References 4 publications

The European Biological Variation Study (EuBIVAS): weekly biological variation of cardiac troponin I estimated by the use of two different high-sensitivity cardiac troponin I assays

The European Biological Variation Study (EuBIVAS): weekly biological variation of cardiac troponin I estimated by the use of two different high-sensitivity cardiac troponin I assays

Biological variation of cardiac markers in patients with aortic valve stenosis

Circadian rhythm of cardiac troponin I and its clinical impact on the diagnostic accuracy for acute myocardial infarction

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