SPECIFICITY

There is no cross reaction with any other proteins present in naïve serum. Because the solid phase is coated with rhTNF-, other therapeutic anti-TNF antibodies cause full cross reaction. However, a quantification of other therapeutic antibodies is possible only by using the drug-specific standards, which are available as separate kits from ImmunoGuide.

 

SENSITIVITY

The lowest detectable level that can be clearly distinguished from the zero standard is 5 ng/mL (zero standard +2SD read from the curve) under the above-described conditions. Analytical sensitivity is 5 ng/mL, and corresponding to the detection limit (limit of quantification) of 0.25 µg/mL for undiluted clinical samples because the serum or plasma samples are instructed to be diluted at 1:50 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 Golimumab.

 

AUTOMATION

The ImmunoGuide Golimumab ELISA is suitable also for being used by an automated ELISA processor.

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