Interlaboratory evaluation of LC–MS-basedbiomarker assays: supplementary materials

Validation of biomarker assays is crucial for effective drug development and clinical applications.Interlaboratory reproducibility is vital for reliable comparison and combination of data from differentcenters. This review summarizes interlaboratory studies of quantitative LC–MS-based biomarker assa...

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Hauptverfasser: Saito, Kosuke, Goda, Ryoya, Arai, Koji, Asahina, Kota, Kawabata, Mitsuhiko, Uchiyama, Hitoshi, Andou, Tomohiro, Shimizu, Hisao, Takahara, Kentaro, Kakehi, Masaaki, Yamauchi, Saki, Nitta, Shin-ichiro, Suga, Takahiro, Fujita, Hisashi, Ishikawa, Rika, Saito, Yoshiro
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creator Saito, Kosuke
Goda, Ryoya
Arai, Koji
Asahina, Kota
Kawabata, Mitsuhiko
Uchiyama, Hitoshi
Andou, Tomohiro
Shimizu, Hisao
Takahara, Kentaro
Kakehi, Masaaki
Yamauchi, Saki
Nitta, Shin-ichiro
Suga, Takahiro
Fujita, Hisashi
Ishikawa, Rika
Saito, Yoshiro
description Validation of biomarker assays is crucial for effective drug development and clinical applications.Interlaboratory reproducibility is vital for reliable comparison and combination of data from differentcenters. This review summarizes interlaboratory studies of quantitative LC–MS-based biomarker assaysusing reference standards for calibration curves. The following points are discussed: trends in reports,reference and internal standards, evaluation of analytical validation parameters, study sample analysisand normalization of biomarker assay data. Full evaluation of these parameters in interlaboratory studiesis limited, necessitating further research. Some reports suggest methods to address variations in biomarkerassay data among laboratories, facilitating organized studies and data combination. Method validationacross laboratories is crucial for reducing interlaboratory differences and reflecting target biomarkerresponses.
doi_str_mv 10.25402/bio.25196069
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title Interlaboratory evaluation of LC–MS-basedbiomarker assays: supplementary materials
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