Interlaboratory evaluation of LC-MS-based biomarker assays

被引：0

作者：

Saito, Kosuke ^{[1
]}

Goda, Ryoya ^{[2
]}

Arai, Koji ^{[3
]}

Asahina, Kota ^{[4
]}

Kawabata, Mitsuhiko ^{[5
]}

Uchiyama, Hitoshi ^{[6
]}

Andou, Tomohiro ^{[7
]}

Shimizu, Hisao ^{[8
]}

Takahara, Kentaro ^{[9
]}

Kakehi, Masaaki ^{[8
]}

Yamauchi, Saki ^{[4
]}

Nitta, Shin-ichiro ^{[3
]}

Suga, Takahiro ^{[2
]}

Fujita, Hisashi ^{[8
]}

Ishikawa, Rika ^{[1
]}

Saito, Yoshiro ^{[1
]}

机构：

[1] Natl Inst Hlth Sci, Kawasaki, Kanagawa, Japan

[2] Daiichi Sankyo Co Ltd, Tokyo, Japan

[3] LSI Medience Corp, Tokyo, Japan

[4] Japan Tobacco Inc, Osaka, Japan

[5] Shin Nippon Biomed Labs Ltd, Tokyo, Japan

[6] Towa Pharmaceut Co Ltd, Osaka, Japan

[7] Axcelead Drug Discovery Partners Inc, Fujisawa, Kanagawa, Japan

[8] Takeda Pharmaceut Co Ltd, Fujisawa, Kanagawa, Japan

[9] Thermo Fisher Sci KK, Tokyo, Japan

来源：

BIOANALYSIS | 2024年 / 16卷 / 06期

关键词：

biomarker assay; calibration curve; interlaboratory differences; LC-MS; validation; LIQUID-CHROMATOGRAPHY; HUMAN SERUM; VALIDATION; STANDARDIZATION; D-3;

D O I：

10.4155/bio-2023-0173

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

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 different centers. This review summarizes interlaboratory studies of quantitative LC-MS-based biomarker assays using reference standards for calibration curves. The following points are discussed: trends in reports, reference and internal standards, evaluation of analytical validation parameters, study sample analysis and normalization of biomarker assay data. Full evaluation of these parameters in interlaboratory studies is limited, necessitating further research. Some reports suggest methods to address variations in biomarker assay data among laboratories, facilitating organized studies and data combination. Method validation across laboratories is crucial for reducing interlaboratory differences and reflecting target biomarker responses.

引用

页码：389 / 402

页数：14

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