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TRASTUZUMAB ELISA (MAB-BASED)

TRASTUZUMAB ELISA (MAB-BASED)

Enzyme immunoassay for the quantitative determination of free Trastuzumab (Herceptin®, Herclon®) in serum and plasma.
The solid phase (MTP) is coated by a highly specific monoclonal antibody directed against Trastuzumab. 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.
 
Herceptin® and Herclon® are trademarks Genentech Inc.
 

  • SPECIFICITY

    There is no cross reaction with any other proteins present in native human serum. A screening test was performed with 36 different native human sera. All produced OD450/620 nm values less than the mean OD of standard D (6 ng/mL). No cross reaction was observed with sera spiked with the other therapeutic antibodies including Infliximab, Adalimumab, Etanercept, Rituximab, Tocilizumab, Omalizumab and Bevacizumab at concentrations up to 2mg/mL. All produced mean OD450/620 nm values less than the mean OD of standard D (6 ng/mL). In addition, binding of Trastuzumab is inhibited by recombinant human HER2 in a concentration dependent manner. Therefore, the ImmunoGuide Trastuzumab ELISA (mAb-based) measures the biologically active free form of Trastuzumab, i.e. not pre-occupied by HER2.

     

    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 Trastuzumab.

     

    AUTOMATION

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

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