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RITUXIMAB ELISA (MAB-BASED)

RITUXIMAB ELISA (MAB-BASED)

Enzyme immunoassay for the specific and quantitative determination of free Rituximab (Rituxan®, Mabthera®) in serum and plasma.
The solid phase (MTP) is coated by a highly specific monoclonal antibody directed against Rituximab. 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)0-2000
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.
 
Rituxan® and Mabthera® are trademarks of Biogen Idec/Genentech Inc.

  • 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 less than the mean OD (0.204) of standard D (6 ng/mL). In addition, binding of Rituximab is inhibited by recombinant human CD20 protein. Therefore, the ImmunoGuide Rituximab ELISA (mAb-Based) measures the biologically active free form of Rituximab, i.e. not pre-occupied by human CD20 antigen. No cross reaction was observed with sera spiked with the other therapeutic antibodies including Infliximab, Adalimumab, Golimumab, Etanercept, Bevacizumab and Trastuzumab at concentrations up to 500 µg/mL.

     

    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 4 µg/mL for undiluted clinical samples because the serum or plasma samples are instructed to be diluted at 1:2000 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 Rituximab.

     

    AUTOMATION

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

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