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Abstract

Analytical Performance of the VIDAS® High-Sensitivity Troponin I Assay and the Beckman Coulter Unicel® DXI AccuTnI+3 Assay in a Stat Laboratory by Tze-Kiong Er, Yu-Fa Su, Tzu-Hsien Chan

Background: The aim of this study was to compare the validity of two different cTnI assay methodologies.
Methods: We collected 82 plasma samples from a stat laboratory. The plasma values of cTnI ranged from 0.012 to 29.715 ng/mL when tested on the Access® platform and from 4.5 to >40,000 ng/L when tested on the VIDAS platform. The patients included 34 females ranging in age from 49 to 100 years of age [76.7 ± 12 years] and 48 males ranging from 29 to 97 years of age [69.7 ± 12 years].
Results: Our results showed that the correlation between the two troponin results was r2 = 0.9836 (p < 0.001). In this study, the kappa statistic (0.89) indicated a high degree of agreement between the VIDAS® High-sensitivity Troponin I assay and the Beckman Coulter Unicel® DXI AccuTnI+3 assay.
Conclusions: In summary, the VIDAS® High-sensitivity Troponin I assay is a reliable and feasible method for determining the levels of cTnI in plasma, but it requires manual operation, hands-on technical expertise, and time.

DOI: 10.7754/Clin.Lab.2018.180626