Aim: Although the fit-for-purpose approach has been proposed for validation procedures and acceptance criteria for biomarker assays, practical biomarker assays to facilitate clinical application and regulatory documents on biomarker assays remain limited. Materials & methods: We assigned six independent laboratories and selected three lysophosphatidylcholines (LPCs): LPC(16:0), LPC(18:0) and LPC(18:1) as model biomarkers. Using LC–MS, the following key validation parameters were evaluated: calibration curve, carryover, parallelism, precision and relative accuracy and these values were similar among all laboratories. Further, we determined LPC levels in six lots of rat plasma at unknown concentrations and compared them among the laboratories. Conclusion: Our multilaboratory validation and reproducibility data are useful for the development of future biomarker assay validation procedures, as well as regulatory documents.

Keywords:

Papers of special note have been highlighted as: • of interest; •• of considerable interest

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Vol. 13, No. 20

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Received 6 July 2021

Accepted 13 October 2021

Published online 26 October 2021

Published in print October 2021

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Acknowledgments

The authors would like to thank C Sudo (National Institute of Health Sciences) for administrative assistance and M Kojima and R Kaneko (National Institute of Health Sciences) for their analytical assistance.

Financial & competing interests disclosure

This work was supported by the Japan Agency for Medical Research and Development (AMED) (grant number; JP20-21mk0101173 and JP17-21ak0101073). 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.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.

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A multilaboratory validation study of LC/MS biomarker assays for three lysophosphatidylcholines

Abstract

References