The Beckman Coulter Access hsTnI assay demonstrated excellent analytical performance, with a 99th percentile URL of 15.8 ng/L and measurable cTnI values in 98.9% of healthy subjects.
Cross-Sectional (n=175)
Does the Beckman Coulter Access hsTnI immunoassay provide reliable analytical performance for measuring cardiac troponin I compared to existing commercial assays?
The novel Beckman Coulter Access hsTnI immunoassay demonstrates excellent analytical performance and high sensitivity for measuring cardiac troponin I.
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.
Lippi et al. (2017) conducted a cross-sectional in Healthy (n=175). Beckman Coulter Access hsTnI high-sensitivity immunoassay vs. AccuTnI+3 and Siemens Dimension Vista cTnI was evaluated on Analytical performance including limit of blank, limit of detection, functional sensitivity, imprecision, linearity, and 99th percentile URL. The Beckman Coulter Access hsTnI assay demonstrated excellent analytical performance, with a 99th percentile URL of 15.8 ng/L and measurable cTnI values in 98.9% of healthy subjects.