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CETUXIMAB ELISA (MAB-BASED)

CETUXIMAB ELISA (MAB-BASED)

Enzyme immunoassay for the specific and quantitative determination of free Cetuximab (Erbitux®) in serum and plasma.
The solid phase (MTP) is coated by a highly specific monoclonal antibody directed against Cetuximab. Therefore any cross reactivity to the other therapeutical monoclonal antibodies is excluded.
 
Required Volume (µL) 10
Incubation Time (min) 100
Sample Serum or Plasma
Plate Size96 Tests
Standard Range (ng/mL, 10x) 0-2000
Detection Limit (ng/mL)5
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.
 
Erbitux® is a trademark of ImClone LLC.

  • SPECIFICITY

    There is no cross reaction with any other proteins present in native human serum. A screening test was performed with 48 different native human sera. All produced OD450/620 nm values (ranged from 0.011 to 0.058) less than the mean OD (0.125) of standard D (6 ng/mL). In addition, binding of Cetuximab is inhibited by recombinant human epidermal growth factor receptor (hEGFR) protein in a concentration dependent manner. Therefore, the ImmunoGuide Cetuximab ELISA (mAb-Based) measures the biologically active free form of Cetuximab, i.e. not pre-occupied by human EGF Receptor. No cross reaction was observed with sera spiked with the other therapeutic antibodies including Infliximab, Adalimumab, Etanercept, Rituximab, Tocilizumab, Trastuzumab, Aflibercept and Bevacizumab at concentrations up to 2 mg/mL. All produced mean OD450/620 nm values ranged from 0.009 to 0. 027.

     

    SENSITIVITY

    The lowest detectable level that can be clearly distinguished from the zero standard is 2 ng/mL (zero standard +2SD read from the curve) under the above-described conditions. Analytical sensitivity is 2 ng/mL, and corresponding to the detection limit (limit of quantification) of 2 µg/mL for undiluted clinical samples because the serum or plasma samples are instructed to be diluted at 1:1000 before starting the assay.

     

    PRECISION

    Intra-assay CV: <10%.

    Inter-assay CV: <10%.

     

    RECOVERY

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

     

    AUTOMATION

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

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