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BEVACIZUMAB ELISA

BEVACIZUMAB ELISA

Enzyme immunoassay for the quantitative determination of free Bevacizumab (Avastin®) in serum and plasma.
The solid phase (MTP) is coated by the target molecule, in this case VEGF.
 
Required Volume (µL)10
Incubation Time (min)105
SampleSerum or Plasma
Plate Size96 Tests
Standard Range (µg/mL, 1000x)0-200
Sensitivity (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, diagnostic and biosimilar uses. It is suitable for Therapeutical Drug Monitoring (TDM) purposes.
 
Avastin® is a trademark of Genentech Inc./Roche.

  • SPECIFICITY

    There is no cross reaction with native serum immunoglobulins. Thirty seven native human sera were screened and all produced OD450/620 nm lower than 0.112. Other therapeutic antibodies (Omalizumab, Golimumab, Infliximab, Trastuzumab, Rituximab, Etanercept, Adalimumab and Tocilizumab) are also tested at the concentrations up to 400 μg/mL and observed that there are no cross reactions (OD 450/620nm values were less than 0.112). In addition, interference of Ranibizumab, binds to the same antigen VEGF-A, was tested at 25 ng/mL (nearly ten times of the serum Cmax of Ranibizumab) and no measurable inhibition was observed.

     

    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 Bevacizumab at 200 µg/mL, 60 µg/mL, 20 µg/mL or 6 µg/mL.

     

    AUTOMATION

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

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