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The mAbXmise quantification kits are intended to monitor the concentration of therapeutic monoclonal antibodies (mAbs) in samples from patients treated with these mAbs. The kit is a quantitative assay. The test can be performed on plasma (EDTA, heparin or citrate collection tubes) and serum. Assay results are intended to be used by healthcare professionals. Before use, it is important to carefully read the instructions provided with the product.
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mAbXmise monoclonal antibodies quantification kits are In Vitro Diagnostic Medical Devices for laboratory professional use and CE-IVD labeled for Europe by BSI. Assay results are intended to be used by healthcare professionals. The kits are designed to perform absolute quantification by LC-MS (Liquid Chromatography – Mass spectrometry) of specific therapeutic monoclonal antibodies (mAbs) in a patient sample. Assay results are intended to be used by healthcare professionals. Before use, it is important to carefully read the instructions provided with the product. The products are non-refundable. The mAbXmise Kit described has not been cleared by any regulatory entity for diagnostic purposes outside of Europe. Proteomics mAbXmise Kits are not available for sale in all countries.
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This study is based on unselected real-life patients treated with Rituximab in ANCA-associated vasculitis (AAV). The aim of the authors was to provide a rationale, based on pharmacokinetic and pharmacodynamic, to select the optimal dosing regimens for both induction and maintenance.
121 patients were enrolled in this study, and a total of 296 rituximab concentrations were measured using the combination of mAbXmise OTDM1 kit and LC-MS/MS.
The population modelling approach developed is based on drug plasma levels, MPO-ANCA and PR3-ANCA proteins levels, and gammaglobulins levels.
This PK/PD study can inform clinical decisions regarding the choice between different rituximab induction and maintenance regimens in patients with AAV in daily practice.
