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ADALIMUMAB ELISA (MAB-BASED)

ADALIMUMAB ELISA (MAB-BASED)

Enzyme immunoassay for the specific and quantitative determination of free Adalimumab (Humira®) in serum and plasma.
The solid phase (MTP) is coated with a highly specific monoclonal antibody against Adalimumab.
Therefore any cross reactivity to the other therapeutical monoclonal antibodies is excluded.
 
Required Volume (µL)10
Incubation Time (min)105
SampleSerum or Plasma
Plate Size96 Tests
Standard Range (ng/mL, 10x)0-1500
Sensitivity (ng/mL)3
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.
 
Humira® is a trademark of Abbott Laboratories.
 

  • SPECIFICITY

    There is no cross reaction with any other proteins present in native human serum. A screening test was performed with 80 different native human sera. All produced OD450/620 nm values less than the mean OD of standard D. No cross reaction was observed with sera spiked with the other therapeutic antibodies including Infliximab, Golimumab, Etanercept, Vedolizumab, Tocilizumab, Aflibercept, Rituximab, Trastuzumab, Bevacizumab, Nivoluzimab, Omalizumab and Cetuximab each tested up to 2mg/mL. All produced mean OD450/620 nm values less than the mean OD of standard D. Because the conjugate, i.e. POD-1B5, used in the AB103 ELISA system is specific for the Fc part of human IgG, cross reaction with Certolizumab Pegol (CZP) could not be evaluated. Therefore, cross reaction of the IG-3D12b monoclonal antibody with CZP was tested using a different but a convenient conjugate, i.e. peroxidase labeled anti human kappa monoclonal antibody, and the result was negative as well.

     

    SENSITIVITY

    The lowest detectable level that can be clearly distinguished from the zero standard is 3 ng/mLL (zero standard +2SD read from the curve) under the above-described conditions. Analytical sensitivity is 3 ng/mL, and corresponding to the detection limit of 0.3 µg/mL for undiluted clinical samples because the serum or plasma samples are instructed to be diluted at 1:100 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 Adalimumab.

     

    AUTOMATION

    The ImmunoGuide Adalimumab ELISA is suitable also for being used by an automated ELISA processor.

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