scholarly journals Clinical and Analytical Performance of the Liaison Cardiac Troponin I Assay in Unstable Coronary Artery Disease, and the Impact of Age on the Definition of Reference Limits. A FRISC-II Substudy

2003 ◽  
Vol 49 (6) ◽  
pp. 880-886 ◽  
Author(s):  
Per Venge ◽  
Nina Johnston ◽  
Bo Lagerqvist ◽  
Lars Wallentin ◽  
Bertil Lindahl ◽  
...  

Abstract Background: Measurements of cardiac troponins are currently used as the standard for the detection of myocardial injury. None of the current assays complies with the new requirements on assay imprecision as proposed by the European Society of Cardiology/American College of Cardiology. Our aim was to evaluate the clinical and analytical performance of the Liaison cardiac troponin I (cTnI) assay. Methods:EDTA-plasma was used, and cardiac troponins were assayed with the first-generation AxSYM assay, the second-generation AccuTnI assay, the third-generation Elecsys assay, and the first-generation Liaison assay. Results: In a 6-day imprecision study, the Liaison cTnI assay had mean CV ≤10% at 0.027 μg/L and ≤20% at 0.015 μg/L. The 99th percentile of the upper reference limit (URL) of a reference population was 0.041 μg/L (age range, 41–76 years). Individuals <60 years had a significantly (P = 0.001) lower 99th percentile, 0.022 μg/L. The FRISC-II study participants with cTnI ≥0.041 μg/L had a poorer outcome relating to death/acute myocardial infarction than those with cTnI <0.041 μg/L (P <0.001). Treatment with low-molecular-weight heparin (dalteparin) or an invasive strategy reduced cardiac events only in patients with concentrations >0.041 μg/L (P = 0.002 and 0.02, respectively). Comparison with the AccuTnI assay showed that a large cohort of the patients with poor prognosis was identified by the AccuTnI assay but not by the Liaison cTnI assay. Conclusion: The Liaison cTnI assay is a sensitive assay with a CV ≤10% at the 99th percentile URL. The ability to detect age-related differences among apparently healthy individuals is unique among today’s commercial assays. The results indicate that different assays seem to identify different patient cohorts for cardiac risk in the lower range of cTnI concentrations.

Author(s):  
P. Hedberg ◽  
J. Valkama ◽  
E. Suvanto ◽  
S. Pikkujämsä ◽  
K. Ylitalo ◽  
...  

The availability of a simple, sensitive, and rapid test using whole blood to facilitate processing and to reduce the turnaround time could improve the management of patients presenting with chest pain. The aim of this study was an evaluation of the Innotrac Aio! second-generation cardiac troponin I (cTnI) assay. The Innotrac Aio! second-generation cTnI assay was compared with the Abbott AxSYM first-generation cTnI, Beckman Access AccuTnI, and Innotrac Aio! first-generation cTnI assays. We studied serum samples from 15 patients with positive rheumatoid factor but with no indication of myocardial infarction (MI). Additionally, the stability of the sample with different matrices and the influence of hemodialysis on the cTnI concentration were evaluated. Within-assay CVs were 3.2%–10.9%, and between-assay precision ranged from 4.0% to 17.2% for cTnI. The functional sensitivity(CV=20%)and the concentration giving CV of 10% were approximated to be 0.02 and 0.04, respectively. The assay was found to be linear within the tested range of 0.063–111.6μg/L. The correlations between the second-generation Innotrac Aio!, Access, and AxSYM cTnI assays were good (rcoefficients 0.947–0.966), but involved differences in the measured concentrations, and the biases were highest with cTnI at low concentrations. The second-generation Innotrac Aio! cTnI assay was found to be superior to the first-generation assay with regard to precision in the low concentration range. The stability of the cTnI level was best in the serum, lithium-heparin plasma, and lithium-heparin whole blood samples (n=10, decrease<10%in 24 hours at+20°Cand at+4°C. There was no remarkable influence of hemodialysis on the cTnI release. False-positive cTnI values occurred in the presence of very high rheumatoid factor values, that is, over 3000 U/L. The 99th percentile of the apparently healthy reference group was≤0.03 μg/L. The results demonstrate the very good analytical performance of the second-generation Innotrac Aio! cTnI assay.


2018 ◽  
Vol 56 (9) ◽  
pp. e229-e231 ◽  
Author(s):  
Veronica Musetti ◽  
Silvia Masotti ◽  
Concetta Prontera ◽  
Simona Storti ◽  
Rudina Ndreu ◽  
...  

2013 ◽  
Vol 420 ◽  
pp. 82-88 ◽  
Author(s):  
Moltu J. Guy ◽  
Yi-Chen Chen ◽  
Laura Clinton ◽  
Han Zhang ◽  
Jiang Zhang ◽  
...  

Author(s):  
Francesca Di Serio ◽  
Marco Caputo ◽  
Martina Zaninotto ◽  
Cosimo Ottomano ◽  
Mario Plebani

2011 ◽  
Vol 57 (4) ◽  
pp. 603-608 ◽  
Author(s):  
Fred S Apple ◽  
Stephen W Smith ◽  
Lesly A Pearce ◽  
Karen M Schulz ◽  
Ranka Ler ◽  
...  

BACKGROUND We assessed the ability of myeloperoxidase (MPO) to identify the risk for major adverse cardiac events (MACE) in patients who present with ischemic symptoms suggestive of acute coronary syndrome and have a normal cardiac troponin I (cTnI) value. METHODS We used Siemens (n = 400) and Abbott (n = 350) assays to measure MPO and cTnI in plasma samples from 400 patients. Event rates (myocardial infarction, cardiac death, percutaneous coronary intervention, coronary artery bypass grafting) were estimated by the Kaplan–Meier method and compared with the log-rank statistic. RESULTS At the 30-day follow-up, the adjusted hazard ratios for MACE were 3.9 (P &lt; 0.001) for increased cTnI and 2.7 (P = 0.006) for increased MPO for the Siemens assays and were 5.5 (P &lt; 0.001) for increased cTnI and 2.9 (P = 0.001) for increased MPO for the Abbott assays. Similar findings were observed with 6 months of follow-up. Patients who initially had a normal cTnI value and an increased Siemens MPO value demonstrated a higher rate of MACE at 30 days than those in whom both values were normal (16.1% vs 3.6%, P = 0.002) and 6 months (18.1% vs 5.0%, P = 0.002). Similarly, patients who had an increased Abbott MPO result demonstrated a higher MACE rate at 30 days (12.3% vs 3.9%, P = 0.03) and at 6 months (16.2% vs 5.1%, P = 0.01) than those with normal values. CONCLUSIONS A combination of MPO and cTnI allowed the identification of a greater proportion of patients at risk for MACE than the use of cTnI alone. Increased MPO values remained predictive of future cardiac events even when the cTnI value was normal.


2010 ◽  
Vol 43 (12) ◽  
pp. 998-1002 ◽  
Author(s):  
M.M. Arrebola ◽  
J.A. Lillo ◽  
M.J. Diez De Los Ríos ◽  
M. Rodríguez ◽  
A. Dayaldasani ◽  
...  

2017 ◽  
Vol 80 (6) ◽  
pp. 347-352 ◽  
Author(s):  
Li-Hua Li ◽  
Chorng-Kuang How ◽  
Wei-Fong Kao ◽  
Yu-Hui Chiu ◽  
Chen Meng ◽  
...  

2004 ◽  
Vol 345 (1-2) ◽  
pp. 123-127 ◽  
Author(s):  
Fred S. Apple ◽  
MaryAnn M. Murakami ◽  
Robert H. Christenson ◽  
John L. Campbell ◽  
Cary J. Miller ◽  
...  

Author(s):  
Giuseppe Lippi ◽  
Anna Ferrari ◽  
Giorgio Gandini ◽  
Matteo Gelati ◽  
Claudia Lo Cascio ◽  
...  

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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