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

Ishikawa R, Saito K, Saito Y et al. | Bioanalysis, 13(20), 1533-1546 (2021) Keywords: • biomarker assay • interlaboratory reproducibility • LC/MS • lysophosphatidylcholine • multilaboratory validation 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...