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USTEKINUMAB ELISA (MAB-BASED)

USTEKINUMAB ELISA (MAB-BASED)

Enzyme immunoassay for the specific and quantitative determination of free Ustekinumab (Stelara®) in serum and plasma.
The solid phase (MTP) is coated by a highly specific monoclonal antibody directed against Ustekinumab. Therefore any cross reactivity to the other therapeutical monoclonal antibodies is excluded.
 
Required Volume (µL)10
Incubation Time (min)135
SampleSerum or Plasma
Package Size96 Tests
Standard Range (ng/mL, 10x)0-1000
Detection Limit (ng/mL)2
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.
 
Stelara® is a trademark of Janssen Biotech.

  • SPECIFICITY

    There is no cross reaction with any other proteins present in native human serum. A screening test was performed with 21 different native human sera. All produced OD450/620 nm values less than the mean OD of standard D. In addition, binding of Ustekinumab to the solid phase is inhibited by p40-containing recombinant human interleukin-12 (hIL-12) protein. Therefore, the ImmunoGuide Ustekinumab ELISA (mAb-Based) measures the biologically active free form of Ustekinumab, i.e. not pre-occupied by human IL-12 or IL-23 antigen. No cross reaction was observed with sera spiked with the other therapeutic antibodies including Infliximab, Rituximab, Cetuximab, Vedolizumab, Tocilizumab, Trastuzumab, Nivolumab and Bevacizumab at concentrations tested up to 40 µg/mL. All produced mean OD450/620 nm values less than 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 0.4 µg/mL for undiluted clinical samples because the serum or plasma samples are instructed to be diluted at 1:200 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 Ustekinumab.

     

    AUTOMATION

    The ImmunoGuide Ustekinumab ELISA (mAb-based) is suitable also for beingused by an automated ELISA processor.

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