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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