Ultrasensitive quantification of cardiac troponin I by a Single Molecule Counting method: analytical validation and biological features

García-Osuna, Álvaro; Gaze, David; Grau-Agramunt, M.; Morris, Thomas; Telha, Catarina; Bartolome, Amelita; Bishop, Jeffrey J.; Monsalve, Luis; Livingston, Richard; Estis, Joel; Nolan, Niamh; Sandlund, Johanna; Ordóñez-Llanos, Jordi

doi:10.1016/j.cca.2018.08.015

Cited by 40 publications

(41 citation statements)

References 24 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Although the use of sex-specific cut-offs has been recommended when using most of the available hs-cTnI assays, these findings demonstrated that the sex-related differences of hs-cTnI concentrations are slight when measured by SMC technology. Our results are in accordance with previous studies performed using the same technology ( 7 ). Garcia-Osuna showed that the 99 th percentile of hs-cTnI measured by Singulex Clarity cTnI assay was 7.12 ng/L and 8.97 ng/L in females and males, respectively.…”

Section: Discussionsupporting

confidence: 93%

Establishing the 99th percentile for high sensitivity cardiac troponin I in healthy blood donors from Southern Italy

Agnello

Bellia

Scazzone

et al. 2019

Biochem. med. (Online)

View full text Add to dashboard Cite

Introduction: The knowledge of high sensitivity cardiac troponin I (hsTnI) distribution in a reference population is mandatory for its introduction in clinical practice. The aim of this study was to define the Upper Reference Limit (URL) of hsTnI measured by Single Molecule Counting technology (SMC) in an accurately selected reference population. Materials and methods: In the study 1140 blood donors were included and selected on the basis of medical history and biomarkers. High sensitivity cardiac troponin I was measured by SMC technology (Clarity, Singulex, Alamed, USA). The 99th percentile was calculated by the non-parametric method according to the Clinical and Laboratory Standard Institute - CLSI C28-A3. Results: The median age was 41 years (IQR: 28 - 50) and 69% were males. The overall 99th percentile was 5 ng/L (90% CI: 4.2 - 5.6). When considering sex-related differences, we found slight differences between the 99th percentile in males and females. Moreover, the 99th percentile trended with age, especially in females. Conclusions: We defined the 99th percentile of hs-cTnI measured by SMC technology in a highly selected healthy population, with only minor differences between males and females. Our findings provide the basic criteria for the reliable interpretation of hsTnI concentrations measured by the SMC technology in clinical settings.

show abstract

Section: Discussionsupporting

confidence: 93%

Establishing the 99th percentile for high sensitivity cardiac troponin I in healthy blood donors from Southern Italy

Agnello

Bellia

Scazzone

et al. 2019

Biochem. med. (Online)

View full text Add to dashboard Cite

show abstract

“…To examine if there was a general trend in the overall concentration over the study period, as described for other measurands in the EuBIVAS [19], and if individuals were at steady state, we calculated the regression of the mean of the 180 duplicate analysis from every blood drawing 1, 2 …. 10 (pooled mean group sample concentrations) versus the blood drawing number [1][2][3][4][5][6][7][8][9][10]. Subjects were considered in steady state if the 95% confidence intervals (CI) of the slope of the regression line included zero.…”

Section: Discussionmentioning

confidence: 99%

“…It is critical to understand if the observed variations in cTn concentration are really associated with a pathological condition or may just be attributable to analytical and biological variation (BV). The availability of new high-sensitive [7] or even "ultra-sensitive" [8,9] methods allows for measurement of cTnI in the majority of healthy subjects, allowing for the use of cTn as a risk indicator in the general population, for which there is increasing evidence [4,6,10]. 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].…”

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)

View full text Add to dashboard Cite

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.

show abstract

“…Молекулы СТ присутствуют как в сыворотке/ плазме крови, так и ряде других биологических жидкостей, образующихся в результате процессов фильтрации и секреции, в частности, в моче и ротовой жидкости [15][16][17][18]. Вместе с тем, молекулы СТ обладают относительно крупными размерами (и соответственно высокой молекулярной массой) по отношению к размеру пор почечного фильтра и обнаруживаются в моче далеко не у всех пациентов [19].…”

Section: понятие о циркадных ритмахunclassified

Circadian rhythms of cardiac troponins: mechanisms and clinical significance

2020

View full text Add to dashboard Cite

Modern laboratory methods for determining biomarkers of cardiovascular diseases are highly sensitive and can detect almost single molecules in human biological fluids, significantly speeding up and improving the diagnosis of cardiovascular diseases. However, in this case, there is a decrease in specificity and it is necessary to take into account a number of additional factors that may affect the result of the study. Recent studies have shown that circadian rhythms (CR) are among these factors. This review article is devoted to the discussion of recently discovered CR of cardiac troponins (CT). A number of articles reported that, both in healthy people and in patients with a number of chronic diseases, CT concentrations change during the day. Given that modern algorithms for diagnosing myocardial infarction (MI) are based on serial studies (0-1 h and 0-3 h) of blood serum, and the values of CT in the blood serum for the diagnosis of myocardial infarction (MI) for this period of time are only a few ng/l, the CT CR can to some extent affect the accuracy of MI diagnosis. Thus, natural physiological changes in the concentration of CT during the day can be mistakenly interpreted as diagnostically significant deviations and lead to an erroneous interpretation of laboratory test results.

show abstract

Ultrasensitive quantification of cardiac troponin I by a Single Molecule Counting method: analytical validation and biological features

Cited by 40 publications

References 24 publications

Establishing the 99th percentile for high sensitivity cardiac troponin I in healthy blood donors from Southern Italy

Establishing the 99th percentile for high sensitivity cardiac troponin I in healthy blood donors from Southern Italy

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

Circadian rhythms of cardiac troponins: mechanisms and clinical significance

Contact Info

Product

Resources

About