Defining normality in a European multinational cohort: Critical factors influencing the 99th percentile upper reference limit for high sensitivity cardiac troponin I

AbstractBackground:This study was aimed to evaluate the analytical performance of the novel chemiluminescent and fully-automated Beckman Coulter Access hsTnI high-sensitivity immunoassay for measurement of cardiac troponin I (cTnI).Methods:The study, using lithium heparin samples, included assessment of limit of blank (LOB), limit of detection (LOD), functional sensitivity, linearity, imprecision (within run, between-run and total), calculation of 99th percentile upper reference limit (URL) in 175 healthy blood donors (mean age, 36±12 years; 47% women) and comparison with two other commercial cTnI immunoassays.Results:The LOB, LOD and functional sensitivity of Access hsTnI were 0.14, 0.34 and 1.35 ng/L, respectively. The within-run, between-run and total imprecision was 2.2%–2.9%, 4.6%–5.4%, and 5.4%–6.1%, respectively. The linearity was excellent in the range of cTnI values between 0.95 and 4195 ng/L (r=1.00). The 99th percentile URL was 15.8 ng/L. Measurable cTnI values were found in 173/175 healthy subjects (98.9%). Good agreement of cTnI values was found with AccuTnI+3 (r=0.97; mean bias, −9.3%), whereas less satisfactory agreement was found with Siemens Dimension Vista cTnI (r=0.95; mean bias, −55%).Conclusions:The results of our evaluation of the Beckman Coulter Access hsTnI indicate that the analytical performance of this fully-automated immunoassay is excellent.

Download Full-text

Impact of lipid markers and high-sensitivity C-reactive protein on the value of the 99th percentile upper reference limit for high-sensitivity cardiac troponin I

Clinica Chimica Acta ◽

10.1016/j.cca.2016.09.020 ◽

2016 ◽

Vol 462 ◽

pp. 193-200 ◽

Cited By ~ 4

Author(s):

Magdalena Krintus ◽

Marek Kozinski ◽

Tomasz Fabiszak ◽

Magdalena Kuligowska-Prusinska ◽

Ewa Laskowska ◽

...

Keyword(s):

Cardiac Troponin ◽

Troponin I ◽

High Sensitivity ◽

Cardiac Troponin I ◽

C Reactive Protein ◽

Reference Limit ◽

Reactive Protein ◽

Lipid Markers ◽

Upper Reference Limit

Download Full-text

Emergency department triage of patients with acute chest pain: definition of cardiac troponin I decisional value to manage patients without electrocardiographic evidence of ischemia

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm.2004.094 ◽

2004 ◽

Vol 42 (5) ◽

Cited By ~ 1

Author(s):

Pascale Beyne ◽

Erik Bouvier ◽

Patrick Werner ◽

Pierre Bourgoin ◽

Damien Logeart ◽

...

Keyword(s):

Chest Pain ◽

Cardiac Troponin ◽

Troponin I ◽

Acute Chest Pain ◽

Final Diagnosis ◽

Cardiac Troponin I ◽

Reference Limit ◽

Coronary Syndrome ◽

Definition Of ◽

Upper Reference Limit

AbstractThe aim of this study was to define the use of a new cardiac troponin I (cTnI) assay for emergency patients with chest pain and no specific electrocardiographic changes consistent with the presence of ischemia. Patients (n=106) admitted in Emergency/Cardiology Departments for chest pain and suspicion of acute coronary syndrome (ACS) were randomized into two diagnosis groups (ACS or non-ACS) by two independent cardiologists. cTnI measurements were performed at admission, and 6 hours and 12 hours later with a new generation assay (Access AccuTnI, Beckman Coulter). Using an upper reference limit of 0.04 μg/l, 27 patients had a cTnI elevation not related to the final diagnosis of ischemia; the positive predictive value (PPV) was 67% with specificity 48%. The decisional value was re-defined and set at 0.16 μg/l, a concentration corresponding to the 99th percentile of the non-ACS patient group. Precision (coefficient of variation) was 8% at this level, PPV 97% and specificity 98%. This new decisional value is now used in our institution and could be included in standard care guidelines to improve the management of patients presenting chest pain in emergency departments.

Download Full-text

Improved detection of minor ischemic myocardial injury with measurement of serum cardiac troponin I

Clinical Chemistry ◽

10.1093/clinchem/43.11.2047 ◽

1997 ◽

Vol 43 (11) ◽

pp. 2047-2051 ◽

Cited By ~ 111

Author(s):

Fred S Apple ◽

Alireza Falahati ◽

Pamela R Paulsen ◽

Elizabeth A Miller ◽

Scott W Sharkey

Keyword(s):

Cardiac Troponin ◽

Myocardial Injury ◽

Troponin I ◽

Cardiac Troponin I ◽

Clinical Sensitivity ◽

Reference Limit ◽

Normal Limits ◽

Serial Serum ◽

Upper Reference Limit ◽

Serum Cardiac Troponin

Abstract This study compared the diagnostic accuracy of the measurement of serum cardiac troponin I (cTnI) with creatine kinase (CK) MB mass in patients with minor myocardial injury whose measured total CK activity did not exceed twice the upper reference limit (300 U/L for men; 200 U/L for women). Forty-eight consecutive patients presenting with chest pain and with in-hospital documentation of myocardial injury were enrolled. Electrocardiogram, echocardiogram, and serial serum CK-MB mass, cTnI, and total CK were measured over 36 h after admission. Peak total CK activity was within normal limits in 28 patients (58%). The mean (±SD) peak CK-MB mass and cTnI concentrations were: 16.4 (11.8) μg/L and 132 (13.0) μg/L; respectively. The peak biochemical marker index (defined as CK-MB or cTnI divided by its respective upper reference limit) was significantly (P <0.05) higher for cTnI than for CK-MB from 7 to 36 h. The clinical sensitivity for detection of myocardial injury for cTnI was 100% [95% confidence interval (CI): 87.2% to 100%], compared with 81.8% (CI: 67.3% to 91.8%) for CK-MB. Thus, cTnI was more sensitive than CK-MB mass for detection of myocardial injury in patients with small increases of total CK.

Download Full-text

Temporal Evolution of Serum Concentrations of High‐Sensitivity Cardiac Troponin During 1 Year After Acute Coronary Syndrome Admission

Journal of the American Heart Association ◽

10.1161/jaha.120.017393 ◽

2021 ◽

Vol 10 (1) ◽

Author(s):

Victor J. van den Berg ◽

Rohit M. Oemrawsingh ◽

Victor A. W. M. Umans ◽

Isabella Kardys ◽

Folkert W. Asselbergs ◽

...

Keyword(s):

Acute Coronary Syndrome ◽

Cardiac Troponin ◽

Troponin I ◽

Temporal Evolution ◽

High Sensitivity ◽

Interindividual Variation ◽

Mixed Effect ◽

Reference Limit ◽

Coronary Syndrome ◽

Upper Reference Limit

Background Detailed insights in temporal evolution of high‐sensitivity cardiac troponin following acute coronary syndrome (ACS) are currently missing. We aimed to describe and compare the post‐ACS kinetics of high‐sensitivity cardiac troponin I (hs‐cTnI) and high‐sensitivity cardiac troponin T (hs‐cTnT), and to determine their intra‐ and interindividual variation in clinically stable patients. Methods and Results We determined hs‐cTnI (Abbott) and hs‐cTnT (Roche) in 1507 repeated blood samples, derived from 191 patients with ACS (median, 8/patient) who remained free from adverse cardiac events during 1‐year follow‐up. Post‐ACS kinetics were studied by linear mixed‐effect models. Using the samples collected in the 6‐ to 12‐month post‐ACS time frame, patients were then considered to have chronic coronary syndrome. We determined (differences between) the average hs‐cTnI and average hs‐cTnT concentration, and the intra‐ and interindividual variation for both biomarkers. Compared with hs‐cTnT, hs‐cTnI peaked higher (median 3506 ng/L versus 494 ng/L; P <0.001) and was quicker below the biomarker‐specific upper reference limit (16 versus 19 days; P <0.001). In the post–6‐month samples, hs‐cTnI and hs‐cTnT showed modest correlation ( r spearman =0.60), whereas the average hs‐cTnT concentration was 5 times more likely to be above the upper reference limit than hs‐cTnI. The intraindividual variations of hs‐cTnI and hs‐cTnT were 14.0% and 18.1%, while the interindividual variations were 94.1% and 75.9%. Conclusions Hs‐cTnI peaked higher after ACS and was quicker below the upper reference limit. In the post–6‐month samples, hs‐cTnI and hs‐cTnT were clearly not interchangeable, and average hs‐cTnT concentrations were much more often above the upper reference limit than hs‐cTnI. For both markers, the within‐patient variation fell largely below beween‐patient variation. Registration URL: https://www.trialregister.nl ; unique identifiers: NTR1698 and NTR1106.

Download Full-text

Potential impact of a novel pathway for suspected myocardial infarction utilising a new high-sensitivity cardiac troponin I assay

Emergency Medicine Journal ◽

10.1136/emermed-2020-210812 ◽

2021 ◽

pp. emermed-2020-210812

Author(s):

Rob Meek ◽

Louise Cullen ◽

Zhong Xian Lu ◽

Arthur Nasis ◽

Lisa Kuhn ◽

...

Keyword(s):

Myocardial Infarction ◽

Cardiac Troponin ◽

Troponin I ◽

Limit Of Detection ◽

High Sensitivity ◽

Routine Care ◽

Primary Objective ◽

Cardiac Troponin I ◽

Post Discharge ◽

Reference Limit

BackgroundHigh-sensitivity cardiac troponin I (hs-cTnI) assays promise high diagnostic accuracy for myocardial infarction (MI). In an ED where conventional cTnI was in use, we evaluated an assessment pathway using the new Access hsTnI assay.MethodsThis retrospective analysis recruited ED patients with suspected MI between June and September 2019. All patients received routine care with a conventional cTnI assay (AccuTnI +3: limit of detection (LoD) 10 ng/L, 99th centile upper reference limit (URL) 40 ng/L, abnormal elevation cut-point 80 ng/L). Arrival, then 90-minute or 360-minute cTnI levels for low and non-low risk patients, respectively (ED Assessment of Chest pain score) guided diagnosis and disposition which was at treating physician discretion. The same patients had arrival and 90-minute or 180-minute samples drawn for hs-cTnI levels (Access hsTnI: LoD 2 ng/L, 99th centile URL 10 ng/L (females) and 20 ng/L (males); abnormal elevation above the URL and delta >30%). Treating physicians were blinded to the hs-cTnI results. Using the hs-cTnI values, investigators retrospectively assigned likely diagnosis, disposition and likelihood of a 30-day major adverse cardiac event (MACE). Admission was recommended for significantly rising hs-cTnI elevations. The primary objective was to demonstrate an acceptable unexpected 30-day post-discharge MACE rate of <1%. cTnI elevation rates, diagnostic outcomes and ED disposition were also compared between pathways.ResultsFor the 935 patients, unexpected 30-day post-discharge MACE rates were 0/935 (0%, 95% CI 0% to 0.4%) with the conventional or novel pathway. For the high-sensitivity and conventional assays, respectively, abnormal elevation rates were 29% (95% CI 26% to 32%) and 19% (95% CI 17% to 22%), for MI were 9% (95% CI 8% to 11%) and 8% (95% CI 6% to 10%), and for hospital admission were 42% (95% CI 39% to 45%) and 43% (95% CI 40% to 47%).ConclusionThe novel pathway using the Access hsTnI assay has an acceptably low 30-day MACE rate.

Download Full-text

Cardiac troponin I release after a basketball match in elite, amateur and junior players

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2015-0304 ◽

2016 ◽

Vol 54 (2) ◽

Cited By ~ 9

Author(s):

Isaac López-Laval ◽

Alejandro Legaz-Arrese ◽

Keith George ◽

Olga Serveto-Galindo ◽

José María González-Rave ◽

...

Keyword(s):

Cardiac Troponin ◽

Troponin I ◽

Intermittent Exercise ◽

Individual Variability ◽

Scientific Data ◽

Cardiac Troponin I ◽

Post Exercise ◽

Reference Limit ◽

Upper Reference Limit ◽

The Individual

AbstractAvailable scientific data related to cardiac troponin I (cTnI) release after intermittent exercise is limited. It is also of interest to determine what personal or environmental factors mediate the exercise-induced release of cTnI. This study had two objectives: 1) to examine the individual release of cTnI to a basketball match; and 2) to establish the influence of athlete status as well as biological age on cTnI release.Thirty-six basketball players (12 adult elite [PBA]: 27.3±4.1 years, 12 adult amateur [ABA]: 29.6±2.9 years, and 12 junior elite [JBA]: 16.6±0.9 years) participated in a simulated basketball match with serial assessment of cTnI at rest, immediately post- and at 1, 3, 6, 12, and 24 h post-exercise.The basketball match increased cTnI levels (pre: median [range]; 0.006 [0.001–0.026]; peak post: 0.024 [0.004–0.244] μg/L; p=0.000), with substantial individual variability in peak values. PBA and JBA players showed higher baseline and post-exercise cTnI values than ABA (all p<0.05). Peak cTnI exceeded the upper reference limit (URL) in the 26% of players (3 PBA; 6 JBA).The current results suggest that intermittent exercise can promote the appearance of cTnI and that this is potentially mediated by athlete status.

Download Full-text