BACKGROUND: 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.
BACKGROUND: 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.
Authors: Marat Fudim; Andrew P Ambrosy; Jie-Lena Sun; Kevin J Anstrom; Bradley A Bart; Javed Butler; Omar AbouEzzeddine; Stephen J Greene; Robert J Mentz; Margaret M Redfield; Yogesh N V Reddy; Muthiah Vaduganathan; Eugene Braunwald; Adrian F Hernandez; Barry A Borlaug; G Michael Felker Journal: J Am Heart Assoc Date: 2018-12-18 Impact factor: 5.501
Authors: W Frank Peacock; Robert Christenson; Deborah B Diercks; Christian Fromm; Gary F Headden; Christopher J Hogan; Erik B Kulstad; Frank LoVecchio; Richard M Nowak; Jon W Schrock; Adam J Singer; Alan B Storrow; Joely Straseski; Alan H B Wu; Daniel P Zelinski Journal: Acad Emerg Med Date: 2020-03-27 Impact factor: 3.451
Authors: Bernard Cook; James McCord; Michael Hudson; Waleed Al-Darzi; Michele Moyer; Gordon Jacobsen; Richard Nowak Journal: Crit Pathw Cardiol Date: 2021-03-01