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ETANERCEPT ELISA (MAB-BASED)

ETANERCEPT ELISA (MAB-BASED)

Enzyme immunoassay for the specific and quantitative determination of free Etanercept (Enbrel®) in serum and plasma.
The solid phase (MTP) is coated by a highly specific monoclonal antibody directed against Etanercept. 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.
 
Enbrel® is a trademark of Amgen.
 

  • SPECIFICITY

    There is no cross reaction with any other proteins present in native human serum and no cross reaction was observed with the other therapeutic antibodies including Infliximab, Adalimumab and Golimumab tested at concentrations up to 500 µg/mL.

     

    SENSITIVITY

    The lowest detectable level that can be clearly distinguished from the zero standard is 5 ng/mL (zero standard +2SD read from the curve) under the above-described conditions. Analytical sensitivity is 5 ng/mL, and corresponding to the detection limit (limit of quantification) of 0.25 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%.10

     

    RECOVERY

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

     

    AUTOMATION

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

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