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NIVOLUMAB ELISA (MAB-BASED)

NIVOLUMAB ELISA (MAB-BASED)

Enzyme immunoassay for the specific and quantitative determination of free Nivolumab (Opdivo®) in serum and plasma.
The solid phase (MTP) is coated by a highly specific monoclonal antibody directed against Nivolumab. Therefore any cross reactivity to the other therapeutical monoclonal antibodies is excluded.
 
Required Volume (µL)10
Incubation Time (min)105
SampleSerum or Plasma
Package Size96 Tests
Standard Range (ng/mL, 10x)0-6000
Detection Limit (ng/mL)15
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.
 
Opdivo® is a trademark of Bristol-Myers Squibb Company.

  • 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 (ranged from 0.043 to 0.100) less than the mean OD (0.150) of standard D (20 ng/mL). In addition, binding of Nivolumab to the solid phase is inhibited by recombinant human PD-1 protein in a concentration dependent manner. Therefore, the ImmunoGuide Nivolumab ELISA (mAb-Based) measures the biologically active free form of Nivolumab, i.e. not pre-occupied by human PD-1 antigen. No cross reaction was observed with sera spiked with the other therapeutic antibodies including Cetuximab, Aflibercept, Rituximab, Trastuzumab, Bevacizumab, Vedolizumab, Infliximab and Adalimumab at concentrations up to 200 µg/mL. All produced mean OD450/620 nm values (ranged from 0.024 to 0.030) less than standard D.

     

    SENSITIVITY

    The lowest detectable level that can be clearly distinguished from the zero standard is 15 ng/mL (zero standard +2SD read from the curve) under the above-described conditions. Analytical sensitivity is 15 ng/mL, and corresponding to the detection limit (limit of quantification) of 3 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 Nivolumab.

     

    AUTOMATION

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

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