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Performance Evaluation of the Third-Generation Elecsys FT4 III Assay for Free Thyroxine

Title
Performance Evaluation of the Third-Generation Elecsys FT4 III Assay for Free Thyroxine
Authors
Kim, Soo-KyungJeong, Tae-Dong
Ewha Authors
정태동김수경
Issue Date
2020
Journal Title
CLINICAL LABORATORY
ISSN
1433-6510JCR Link
Citation
CLINICAL LABORATORY vol. 66, no. 8, pp. 1635 - 1638
Keywords
evaluationfree thyroxineperformance
Publisher
CLIN LAB PUBL
Indexed
SCIE; SCOPUS WOS
Document Type
Article
Abstract
Background: Roche Diagnostics has recently released the Elecsys FT4 III, Roche's third-generation reagent for free thyroxine. We aim to evaluate the analytical performance of the Elecsys FT4 III. Methods: The precision and linearity of the Elecsys FT4 III assay were evaluated according to Clinical and Laboratory Standards Institute procedures. The results of the third-generation assay were compared with that of Roche's second-generation assay (Elecsys FT II) on a Roche cobas e801 modular analyzer. Results: The coefficient of variation of within-laboratory variation was less than 2.6% for the control materials and patient samples. The linearity was confirmed over a range of 0.41 to 7.52 ng/dL. The mean difference between the second- and third-generation reagents was 0.0026 ng/dL (95% confidence interval, -0.0172 to +0.0224 ng/dL). Conclusions: The analytical performance of the Elecsys FT4 III assay for free thyroxine is clinically acceptable.
DOI
10.7754/Clin.Lab.2020.191103
Appears in Collections:
의과대학 > 의학과 > Journal papers
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