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TOCILIZUMAB ELISA (MAB-BASED)

TOCILIZUMAB ELISA (MAB-BASED)

Enzyme immunoassay for the specific and quantitative determination of free Tocilizumab (Actemra®) in serum and plasma.
The solid phase (MTP) is coated by a highly specific monoclonal antibody directed against Tocilizumab. Another POD-labelled specific monoclonal antibody is used as conjugate.
Therefore any cross reactivity to the other therapeutical monoclonal antibodies is excluded.
 
Required Volume (µL)10
Incubation Time (min)130
SampleSerum or Plasma
Plate Size96
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.

  • SPECIFICITY

    There is no cross reaction with any other proteins present in native human serum. A screening test was performed with 32 different native human sera. All produced OD450/620nm 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 Adalimumab, Golimumab, Infliximab, Etanercept, Rituximab, Bevacizumab, Trastuzumab and Omalizumab at concentrations up to 1 mg/mL. All produced OD450/620nm values less than the mean OD of standard D.

     

    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 OF THE KIT

    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 Tocilizumab.

     

    AUTOMATION

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

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