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GOLIMUMAB ELISA (MAB-BASED)

GOLIMUMAB ELISA (MAB-BASED)

Enzyme immunoassay for the specific and quantitative determination of free Golimumab (Simponi®) in serum and plasma.
The solid phase (MTP) is coated by a highly specific monoclonal antibody directed against Golimumab. Therefore any cross reactivity to the other therapeutical monoclonal antibodies is excluded.
 
Required Volume (µL)10
Incubation Time (min)100
SampleSerum or Plasma
Package Size96 Tests
Standard Range (ng/mL, 10x)0-1500
Sensitivity (ng/mL)4
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.
 
Simponi® is a trademark of Janssen Biotech, Inc./Merck & Co.

  • 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 of standard D. In addition, binding of Golimumab is inhibited by recombinant human TNF-alpha in a concentration dependent manner. Therefore, the ImmunoGuide Golimumab ELISA (mAb-Based) measures the biologically active free form of Golimumab, i.e. not pre-occupied by TNF-alpha. No cross reaction was observed with sera spiked with the other therapeutic antibodies including Infliximab, Adalimumab, Etanercept, Rituximab, Trastuzumab, Tocilizumab, Omalizumab and Bevacizumab at concentrations up to 2 mg/mL.

     

    SENSITIVITY

    The lowest detectable level that can be clearly distinguished from the zero standard is 4 ng/mL (zero standard +2SD read from the curve) under the above-described conditions. Analytical sensitivity is 4 ng/mL, and corresponding to the detection limit of 0.2 µg/mL for undiluted clinical samples because the serum or plasma samples are instructed to be diluted at 1:50 before starting the assay.

     

    PRECISION

    Intra-assay CV: <10%.

    Inter-assay CV: <10%.

     

    RECOVERY

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

     

    AUTOMATION

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

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