Quantification of emicizumab by mass spectrometry in plasma of people with hemophilia A: A method validation study.
Anouk A M T DonnersLászló GerencsérKim C M van der ElstAntoine C G EgbertsMoniek P M de MaatAlbert HuismanRolf T UrbanusMohsin El AmraniPublished in: Research and practice in thrombosis and haemostasis (2022)
The LC-MS/MS method demonstrated linearity over a wide range of emicizumab concentrations, far exceeding the concentrations observed in people with hemophilia A. Precision and accuracy were excellent, and all other validation parameters were also within the acceptance EMA criteria. Cross validation showed that the LC-MS/MS method and the OSA-based method can be used interchangeably for drug monitoring of emicizumab without the application of a correction factor.