Multi-laboratory evaluation of immunoaffinity LC-MS-based glucagon-like peptide-1 assay.

Bioanalysis 2023 Feb

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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.

Citation

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. Multi-laboratory evaluation of immunoaffinity LC-MS-based glucagon-like peptide-1 assay. Bioanalysis. 2023 Feb;15(4):207-218