Comparison of two different technologies measuring the same analytes in view of the <i>In Vitro</i> Diagnostica Regulation (IVDR)-Reference-Cited by-同舟云学术

Comparison of two different technologies measuring the same analytes in view of the In Vitro Diagnostica Regulation (IVDR)

Published:2024-08-02 Issue: Volume: Page:
ISSN:2567-9430
Container-title:Journal of Laboratory Medicine
language:en
Short-container-title:

Author:

Stierlin Noel¹²,Hemmerle Andreas²,Jung Karin²,Thumfart Jörg²,Risch Martin²³,Risch Lorenz¹²^ORCID

Affiliation:

1. 215013 Private University in the Principality of Liechtenstein , Triesen , Liechtenstein

2. Dr. Risch Medical Laboratory , Buchs , Switzerland

3. Division of Laboratory Medicine , Kantonsspital Graubünden , Chur , Switzerland

Abstract

Abstract Objectives This study systematically compared the performance and comparability of two medical laboratory analytical instruments, the conventional wet chemistry analyzer (cobas) and the dry slide technology (Vitros), across various clinical chemistry assays. Methods The evaluation focused on assessing imprecision, inaccuracy, recovery, and method comparison using leftover patient serum samples. Results The results indicated good to very good agreement for most clinical chemistry analytes, with larger differences observed for comparison of serum patient samples on albumin and protein. Conclusions Understanding and acknowledging method-specific variations, are crucial for accurate result interpretation in clinical laboratories. This study contributes valuable insights to ongoing discussions on method standardization.

Publisher

Walter de Gruyter GmbH

Link

https://www.degruyter.com/document/doi/10.1515/labmed-2024-0052/pdf

Reference21 articles.

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