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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