Performance evaluation of the third-generation elecsys FT4 III assay for free thyroxine

Soo Kyung Kim, Tae Dong Jeong

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

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.

Original languageEnglish
Pages (from-to)1635-1638
Number of pages4
JournalClinical Laboratory
Volume66
Issue number8
DOIs
StatePublished - 2020

Bibliographical note

Publisher Copyright:
© 2020 Verlag Klinisches Labor GmbH. All rights reserved.

Keywords

  • Evaluation
  • Free thyroxine
  • Performance

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