Performance Evaluation of the Third-Generation Elecsys FT4 III Assay for Free Thyroxine
- 주제(키워드) evaluation , free thyroxine , performance
- 주제(기타) Medical Laboratory Technology
- 설명문(일반) [Kim, Soo-Kyung; Jeong, Tae-Dong] Ewha Womans Univ, Dept Lab Med, Coll Med, 260 Gonghang Daero, Seoul 07804, South Korea
- 등재 SCIE, SCOPUS
- 발행기관 CLIN LAB PUBL
- 발행년도 2020
- 총서유형 Journal
- URI http://www.dcollection.net/handler/ewha/000000174570
- 본문언어 영어
- Published As http://dx.doi.org/10.7754/Clin.Lab.2020.191103
- PubMed https://pubmed.ncbi.nlm.nih.gov/32776729
초록/요약
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.
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