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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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A stable isotope labelled (SIL) form of an analyte protein is widely regarded as the optimal internal standard (IS) for absolute quantification of proteins using LC-MS; SIL proteins are often cited as being the “gold standard IS”.
SIL proteins have the same physiochemical behavior as the target proteins analyte. The internal standard can be introduced at the start of the sample preparation workflow and will be processed along with the analyte protein throughout the entire analytical procedure. This allows control for variations due to immunoaffinity or other isolation techniques, enzymatic digestion, other pre-analytical treatments as well as the LC and mass spectrometric ionization.
EMA guidelines recommend the use of a SIL-protein IS whenever possible for LC-MS/MS methods. Beyond this, there is a growth in scientific literature that strongly supports the use of full length, recombinant SIL proteins as internal standards.
