Pilot study on harmonization of cardiac troponin I immunoassays using patients and quality control plasma samples. On behalf of the Italian Section of the European Ligand Assay Society (ELAS) and of the Study Group on Cardiovascular Biomarkers of the Società Italiana di Biochimica Clinica (SIBioC)

2016 ◽  
Vol 456 ◽  
pp. 42-48 ◽  
Author(s):  
Aldo Clerico ◽  
Andrea Ripoli ◽  
Silvia Masotti ◽  
Concetta Prontera ◽  
Simona Storti ◽  
...  
2019 ◽  
Vol 498 ◽  
pp. 27-29 ◽  
Author(s):  
Peter A. Kavsak ◽  
Kelsey MacEachern ◽  
Eleonora Petryayeva ◽  
Lorna Clark

2006 ◽  
Vol 8 (1) ◽  
pp. 19-23 ◽  
Author(s):  
Annika Linde ◽  
Nuala J. Summerfield ◽  
Margaret M. Sleeper ◽  
Fe B. Wright ◽  
Craig A. Clifford ◽  
...  

2018 ◽  
Vol 56 (3) ◽  
pp. 492-501 ◽  
Author(s):  
Silvia Masotti ◽  
Concetta Prontera ◽  
Veronica Musetti ◽  
Simona Storti ◽  
Rudina Ndreu ◽  
...  

AbstractBackground: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.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Sherif Bayoumy ◽  
Iida Martiskainen ◽  
Taina Heikkilä ◽  
Carita Rautanen ◽  
Pirjo Hedberg ◽  
...  

AbstractMeasurement of cardiac troponin I (cTnI) should be feasible for point-of-care testing (POCT) to diagnose acute myocardial infarction (AMI). Lateral flow immunoassays (LFIAs) have been long implemented in POCT and clinical settings. However, sensitivity, matrix effect and quantitation in lateral flow immunoassays (LFIAs) have been major limiting factors. The performance of LFIAs can be improved with upconverting nanoparticle (UCNP) reporters. Here we report a new methodological approach to quantify cTnI using UCNP-LFIA technology with minimized plasma interference. The performance of the developed UCNP-LFIA was evaluated using clinical plasma samples (n = 262). The developed UCNP-LFIA was compared to two reference assays, the Siemens Advia Centaur assay and an in-house well-based cTnI assay. By introducing an anti-IgM scrub line and dried EDTA in the LFIA strip, the detection of cTnI in plasma samples was fully recovered. The UCNP-LFIA was able to quantify cTnI concentrations in patient samples within the range of 30–10,000 ng/L. The LoB and LoD of the UCNP-LFIA were 8.4 ng/L and 30 ng/L. The method comparisons showed good correlation (Spearman’s correlation 0.956 and 0.949, p < 0.0001). The developed UCNP-LFIA had LoD suitable for ruling in AMI in patients with elevated cTnI levels and was able to quantify cTnI concentrations in patient samples. The technology has potential to provide simple and rapid assay for POCT in ED setting


2020 ◽  
Vol 25 (12) ◽  
pp. 3814
Author(s):  
A. M. Chaulin ◽  
P. D. Duplyakova ◽  
G. R. Bikbaeva ◽  
A. A. Tukhbatova ◽  
E. V. Grigorieva ◽  
...  

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