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OMALIZUMAB ELISA (MAB-BASED)

OMALIZUMAB ELISA (MAB-BASED)

Enzyme immunoassay for the specific quantitative determination of free Omalizumab (Xolair®) in serum and plasma.
The solid phase (MTP) is coated by a highly specific monoclonal antibody directed against Omalizumab.  Therefore any cross reactivity to the other therapeutical monoclonal antibodies is excluded.
 
Required Volume (µL)10
Incubation Time (min)100
SampleSerum or Plasma
Plate Size96 Tests
Standard Range (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, diagnostic and biosimilar uses. It is suitable for Therapeutical Drug Monitoring (TDM) purposes.
 
Xolair® is a trademark of Genentech Inc.

  • SPECIFICITY

    There is no cross reaction with any other proteins present in native human serum. A screening test was performed with different native human sera. All produced OD450/620 nm values less than the mean OD of standard D (3 ng/mL). In addition, human IgE antibody was also separately tested at concentrations up to 100 µg/mL and cross reaction was NOT observed. No cross reaction was observed with sera spiked with the other therapeutic antibodies including Infliximab, Adalimumab, Etanercept, Rituximab, Trastuzumab, Tocilizumab and Bevacizumab at concentrations up to 2 mg/mL. All produced mean OD450/620 nm values less than the mean OD of standard D.

     

    SENSITIVITY

    The lowest detectable level that can be clearly distinguished from the zero standard is 1 ng/mL (zero standard +2SD read from the curve) under the above-described conditions. Analytical sensitivity is 1 ng/mL, and corresponding to the detection limit (limit of quantification) of 1 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 OF THE KIT

    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 Omalizumab.

     

    AUTOMATION

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

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