Background: The study aim was to evaluate and compare the analytical performance of the new chemiluminescent immunoassay for cardiac troponin I (cTnI), called Access hs-TnI using DxI platform, with those of Access AccuTnI+3 method, and high-sensitivity (hs) cTnI method for ARCHITECT platform.
Methods: The limits of blank (LoB), detection (LoD) and quantitation (LoQ) at 10% and 20% CV were evaluated according to international standardized protocols. For the evaluation of analytical performance and comparison of cTnI results, both heparinized plasma samples, collected from healthy subjects and patients with cardiac diseases, and quality control samples distributed in external quality assessment programs were used.
Results: LoB, LoD and LoQ at 20% and 10% CV values of the Access hs-cTnI method were 0.6, 1.3, 2.1 and 5.3 ng/L, respectively. Access hs-cTnI method showed analytical performance significantly better than that of Access AccuTnI+3 method and similar results to those of hs ARCHITECT cTnI method. Moreover, the cTnI concentrations measured with Access hs-cTnI method showed close linear regressions with both Access AccuTnI+3 and ARCHITECT hs-cTnI methods, although there were systematic differences between these methods. There was no difference between cTnI values measured by Access hs-cTnI in heparinized plasma and serum samples, whereas there was a significant difference between cTnI values, respectively measured in EDTA and heparin plasma samples.
Conclusions: Access hs-cTnI has analytical sensitivity parameters significantly improved compared to Access AccuTnI+3 method and is similar to those of the high-sensitivity method using ARCHITECT platform.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1515/cclm-2017-0387 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Diagnostic accuracy of a machine learning algorithm using point-of-care high-sensitivity cardiac troponin I for rapid rule-out of myocardial infarction: a retrospective study.
Lancet Digit Health
October 2024
Department of Cardiology, University Heart and Vascular Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; University Center of Cardiovascular Science, University Heart and Vascular Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Population Health Innovation, University Heart and Vascular Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; German Center for Cardiovascular Research (DZHK), Partner Sites Hamburg/Kiel/Luebeck, Hamburg, Germany. Electronic address:
Background: Point-of-care (POC) high-sensitivity cardiac troponin (hs-cTn) assays have been shown to provide similar analytical precision despite substantially shorter turnaround times compared with laboratory-based hs-cTn assays. We applied the previously developed machine learning based personalised Artificial Intelligence in Suspected Myocardial Infarction Study (ARTEMIS) algorithm, which can predict the individual probability of myocardial infarction, with a single POC hs-cTn measurement, and compared its diagnostic performance with standard-of-care pathways for rapid rule-out of myocardial infarction.
Methods: We retrospectively analysed pooled data from consecutive patients of two prospective observational cohorts in geographically distinct regions (the Safe Emergency Department Discharge Rate cohort from the USA and the Suspected Acute Myocardial Infarction in Emergency cohort from Australia) who presented to the emergency department with suspected myocardial infarction.
A Comparison Study: Possible Bias in Troponin I Measurement Obtained with a Point of Care Testing and a Central Laboratory Analyzers Employing Different Biological Matrices and Anticoagulants.
Diagnostics (Basel)
July 2024
U.O. Clinical Pathology, Medical and Diagnostics Department P.O. Fidenza, Azienda AUSL of Parma, 43125 Parma, Italy.
Background: high-sensitive cardiac TroponinI (hs-cTnI) is widely used for diagnosis of acute coronary syndromes. The latest recommendation for hs-cTnI determination is the protocol 0-1 h finalized to improve the rule out accuracy of the test. A Point of Care Testing able to guarantee these performances could be very useful due to reducing the turnaround time and ruling out patients suspected of ACS, especially by using biological matrices that are not required for centrifuge.
View Article and Find Full Text PDFComparability of Beckman Coulter Cardiac Troponin I Assays.
Ann Clin Lab Sci
May 2024
Department of Pathology, The University of Alabama at Birmingham, Birmingham AL, USA
Objective: Cardiac troponin I (cTnI) is one of the most sensitive and specific biomarkers of myocardial injury. The rise and/or fall of cardiac troponins above the 99th percentile of the upper reference limit (URL) is required in the assessment of acute myocardial infarction.
Methods: We analyzed the variation between the Beckman Coulter contemporary cTnI AccuTnI+3 assay and high sensitivity cTnI (hs-cTnI) assay tested on DXI 800 using 424 patient specimens with troponin levels ranging from 0-16754 ng/L.
Fetal cardiac troponin I levels decline toward birth in sheep.
Am J Physiol Heart Circ Physiol
June 2024
Center for Developmental Health, Knight Cardiovascular Institute, Oregon Health and Science University, Portland, Oregon, United States.
Elevated cardiac troponin I (cTnI), a myocardial damage biomarker, has been reported in cord blood of neonates delivered vaginally or by cesarean section. Although the neonatal peak likely reflects the physiological adjustment to extrauterine life, a better understanding of serial prepartum changes is required to determine physiological causes of fetal cTnI release. We longitudinally sampled eight healthy lambs (20 days before spontaneous birth to 5 days postnatal), and from three fetuses receiving intravenous IGF-1.
View Article and Find Full Text PDFAnalytical evaluation of the novel Mindray high sensitivity cardiac troponin I immunoassay on CL-1200i.
Clin Chem Lab Med
June 2024
Section of Clinical Biochemistry, University Hospital of Verona, Verona, Italy.
Objectives: The current study was designed to evaluate the analytical performance of the new Mindray highly sensitive cardiac troponin I (hs-cTnI) chemiluminescent immunoassay on Mindray CL-1200i, as a thorough validation of novel hs-cTnI methods is required before introduction into clinical practice.
Methods: The evaluation of the analytical performance of this hs-cTnI immunoassay encompassed the calculation of the limit of blank (LOB), limit of detection (LOD), functional sensitivity, imprecision, linearity, 99th percentile upper reference limit (URL) and concordance with another previously validated hs-cTnI chemiluminescent immunoassay.
Results: The LOB and LOD were 0.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!