Evaluation of analytical performance and comparison of clinical results of the new generation method AccuTnI+3 for the measurement of cardiac troponin I using both patients and quality control plasma samples

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.

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Evaluation and Comparison with Other High-Sensitivity Methods of Analytical Performance and Measured Values of a New Laboratory Test for Cardiac Troponin I Assay

The Journal of Applied Laboratory Medicine ◽

10.1093/jalm/jfab017 ◽

2021 ◽

Author(s):

Silvia Masotti ◽

Veronica Musetti ◽

Concetta Prontera ◽

Simona Storti ◽

Claudio Passino ◽

...

Keyword(s):

Cardiac Troponin ◽

Troponin I ◽

Limit Of Detection ◽

High Sensitivity ◽

Clinical Results ◽

Cardiac Troponin I ◽

Analytical Performance ◽

Multicenter Studies ◽

Automated Platform ◽

Chemiluminescent Method

Abstract Bakground The aim of this study was to evaluate both analytical characteristics and clinical results of a new chemiluminescent method for the measurement of cardiac troponin I (cTnI), named VITROS ® High Sensitivity Troponin I Assay, using the VITROS® 3600 automated platform. The results found with this new method were compared to those observed with hs-cTnI ARCHITECT and ECLIA hs-cTnT ELECSYS methods. Methods For evaluation of analytical performance and comparison of clinical results, plasma samples (lithium-heparin), were collected from apparently healthy subjects and patients with cardiovascular diseases. Results The hs-cTnI VITROS method showed values for limit of blank (LoB 0.33 ng/L), limit of detection (LoD, 0.91 ng/L), limit of quantifications at 20% (LoQ 20% CV, 1.82 ng/L), and 10% (LoQ 10% CV, 4,74 ng/L), which are comparable to those previously reported for other hs-cTnI methods. Moreover, the clinical results of the hs-cTnI VITROS method were found to be closely correlated to those of hs-cTnI ARCHITECT (R = 0,9883, N = 198) and ECLIA hs-cTnT Elecsys (R = 0,9704, N = 293) methods. Conclusions The hs-cTnI VITROS method shows analytical performance comparable to other cTnI and cTnT assay. The results of this study confirm that there are significant systematic differences among hs-cTnI methods. Further multicenter studies using larger reference populations are needed in order to obtain a better estimation, especially of the 99° percentile URL values categorized for sex and age of hs-cTnI and hs-cTnT methods.

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Evaluation of the analytical performance of a new ADVIA immunoassay using the Centaur XPT platform system for the measurement of cardiac troponin I

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2018-0054 ◽

2018 ◽

Vol 56 (9) ◽

pp. e229-e231 ◽

Cited By ~ 18

Author(s):

Veronica Musetti ◽

Silvia Masotti ◽

Concetta Prontera ◽

Simona Storti ◽

Rudina Ndreu ◽

...

Keyword(s):

Cardiac Troponin ◽

Troponin I ◽

Cardiac Troponin I ◽

Analytical Performance ◽

Platform System

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Long-term quality control testing on a high-sensitivity cardiac troponin I assay

Clinica Chimica Acta ◽

10.1016/j.cca.2019.08.006 ◽

2019 ◽

Vol 498 ◽

pp. 27-29 ◽

Cited By ~ 1

Author(s):

Peter A. Kavsak ◽

Kelsey MacEachern ◽

Eleonora Petryayeva ◽

Lorna Clark

Keyword(s):

Quality Control ◽

Cardiac Troponin ◽

Troponin I ◽

High Sensitivity ◽

Cardiac Troponin I ◽

Quality Control Testing

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Evaluation of analytical performance of the Pathfast® cardiac troponin I

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm.2009.182 ◽

2009 ◽

Vol 47 (7) ◽

Cited By ~ 8

Author(s):

Francesca Di Serio ◽

Marco Caputo ◽

Martina Zaninotto ◽

Cosimo Ottomano ◽

Mario Plebani

Keyword(s):

Cardiac Troponin ◽

Troponin I ◽

Cardiac Troponin I ◽

Analytical Performance

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Analytical performance of a sensitive assay for cardiac troponin I with loci™ technology

Clinical Biochemistry ◽

10.1016/j.clinbiochem.2010.04.073 ◽

2010 ◽

Vol 43 (12) ◽

pp. 998-1002 ◽

Cited By ~ 17

Author(s):

M.M. Arrebola ◽

J.A. Lillo ◽

M.J. Diez De Los Ríos ◽

M. Rodríguez ◽

A. Dayaldasani ◽

...

Keyword(s):

Cardiac Troponin ◽

Troponin I ◽

Cardiac Troponin I ◽

Analytical Performance ◽

Sensitive Assay

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Analytical performance of the i-STAT cardiac troponin I assay

Clinica Chimica Acta ◽

10.1016/j.cccn.2004.03.010 ◽

2004 ◽

Vol 345 (1-2) ◽

pp. 123-127 ◽

Cited By ~ 52

Author(s):

Fred S. Apple ◽

MaryAnn M. Murakami ◽

Robert H. Christenson ◽

John L. Campbell ◽

Cary J. Miller ◽

...

Keyword(s):

Cardiac Troponin ◽

Troponin I ◽

Cardiac Troponin I ◽

Analytical Performance

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Analytical evaluation of the new Beckman Coulter Access high sensitivity cardiac troponin I immunoassay

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2017-0350 ◽

2017 ◽

Vol 56 (1) ◽

Cited By ~ 15

Author(s):

Giuseppe Lippi ◽

Anna Ferrari ◽

Giorgio Gandini ◽

Matteo Gelati ◽

Claudia Lo Cascio ◽

...

Keyword(s):

Cardiac Troponin ◽

Troponin I ◽

Limit Of Detection ◽

High Sensitivity ◽

Cardiac Troponin I ◽

Analytical Performance ◽

The Novel ◽

Reference Limit ◽

Automated Immunoassay ◽

Upper Reference Limit

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.

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