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Multi-laboratory evaluation of immunoaffinity LC–MS-based glucagon-like peptide-1 assay: Supplementary data

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posted on 2023-03-24, 15:16 authored by Rika Ishikawa, Kosuke Saito, Hidehisa Tachiki, Ryoya Goda, Koji Arai, Hisao Shimizu, Tomohiro Andou, Kentaro Takahara, Hitoshi Uchiyama, Shin-ichiro Nitta, Masaaki Kakehi, Kozo Hayashi, Naohiro Katagiri, Keiko Kojima, Hisashi Fujita, Kazuhiro Tsuchinaga, Yoshiro Saito

Background: Although the fit-for-purpose approach has been proposed for biomarker assay validation,

practical data should be compiled to facilitate the predetermination of acceptance criteria. Methods:

Immunoaffinity LC–MS was used to analyze glucagon-like peptide-1 as a model biomarker in six

laboratories. Calibration curve, carryover, parallelism, precision, relative accuracy and processed sample

stability were evaluated, and their robustness among laboratories was assessed. The rat glucagon-like

peptide-1 concentrations in four blinded samples were also compared. Results: The obtained results and

determined concentrations in the blinded samples at all laboratories were similar, with a few exceptions,

and robust, despite the difference in optimization techniques among laboratories. Conclusion: The

results provide insights into the predefinition of the acceptance criteria of immunoaffinity LC–MS-based

biomarker assays.

Funding

This work was supported by the Japan Agency for Medical Research and Development (AMED; grant nos. JP17-21ak0101073 and JP22ak0101185). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

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