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VEDOLIZUMAB ELISA (MAB-BASED)

VEDOLIZUMAB ELISA (MAB-BASED)

Enzyme immunoassay for the specific and quantitative determination of free Vedolizumab (Entyvio®) in serum and plasma.
The solid phase (MTP) is coated by a highly specific monoclonal antibody directed against Vedolizumab. Therefore any cross reactivity to the other therapeutical monoclonal antibodies is excluded.
 
Required Volume (µL)10
Incubation Time (min)105
SampleSerum or Plasma
Plate Size96 Tests
Sensitivity (ng/mL, 10x)0-1000
Detection Limit (ng/mL)2
Spike Recovery (%)>95
Shelf Life (years)2
 
Intended Use: This kit has been developed for the measurement of drug levels in research and diagnostic uses. It is suitable for Therapeutical Drug Monitoring (TDM) purposes.
 
Entyvio® is a trademark of Takeda Pharmaceuticals Inc.

  • SPECIFICITY

    There is no cross reaction with any other proteins present in native human serum. A screening test was performed with 24 different native human sera. All produced OD450/620 nm valuesless than the mean OD of standard D. In addition, binding of Vedolizumab to the solid phase is inhibited by recombinant human alpha4beta7 integrin protein in a concentration dependent manner. Therefore, the ImmunoGuide Vedolizumab ELISA (mAb-based) measures the biologically active free form of Vedolizumab, i.e. not pre-occupied by human alpha4beta7 integrin antigen. No cross reaction was observed with sera spiked with the other therapeutic antibodies including Infliximab, Adalimumab, Etanercept, Bevacizumab, Cetuximab, Tocilizumab, Rituximab, and Nivolumab at concentrations up to 100 µg/mL. All produced mean OD450/620 nm values (ranged from 0.035 to 0.058) less than standard D.

     

    SENSITIVITY

    The lowest detectable level that can be clearly distinguished from the zero standard is 4 ng/mL mL (zero standard +2SD read from the curve) under the above-described conditions. Analytical sensitivity is 4 ng/mL, and corresponding to the detection limit of 2 µg/mL for undiluted clinical samples because the serum or plasma samples are instructed to be diluted at 1:500 before starting the assay.

     

    PRECISION

    Intra-assay CV: <10%.

    Inter-assay CV: <10%.

     

    RECOVERY

    Recovery rate was found to be >95% with native serum and plasma samples when spiked with exogenous Vedolizumab.

     

    AUTOMATION

    The ImmunoGuide Vedolizumab ELISA (mAb-based) is suitable also for being used by an automated ELISA processor.

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