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Abstract

Performance Evaluation of the FRENDTM Cardiac Triple Cartridge on the FREND™ System by Kyunghoon Lee, Minje Han, Sang Hoon Song, Kyoung Un Park, Woon Heung Song, Junghan Song

Background: We evaluated the performance of the FREND™ Cardiac Triple cartridge on the FREND™ system in the detection of cardiac markers-myoglobin, cardiac troponin I (cTnI), and creatine kinase-MB (CK-MB).
Methods: Quantitative immunoassays were performed using the FRENDTM system (NanoEnTek, Seoul, Korea) and its cartridge. The precision, detection limits, linearity, and correlation with the Siemens Dimension Vista® 500 (Siemens Healthcare Diagnostics, Deerfield, IL, USA) were evaluated. The cutoff value for each marker was calculated in healthy individuals (men and women, n = 138 each).
Results: The coefficients of variation for imprecision were less than 19.0% at low and high serum concentrations. The lower limits of quantification for myoglobin, cTnI, and CK-MB were 3.11, 0.073, and 0.70 ng/mL, respectively. Acceptable linearity was achieved for each marker (R2 < 0.99). The results from the FRENDTM system were in good agreement with those from the Siemens Dimension Vista (correlation coefficients > 0.9). The cutoff values in male and female individuals (n = 138 each) were 104.3 and 98.9 ng/mL, respectively, for myoglobin, and 4.35 and 5.37 ng/mL, respectively, for CK-MB. The cutoff value for cTnI was 0.073 ng/mL.
Conclusions: The FREND™ Cardiac Triple cartridge exhibited good precision, clinically acceptable linearity, and reliable correlation with the Dimension Vista.

DOI: 10.7754/Clin.Lab.2015.150841