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INFLIXIMAB ELISA (MAB-BASED)

INFLIXIMAB ELISA (MAB-BASED)

Certification
Enzyme immunoassay for the specific and quantitative determination of free Infliximab (Remicade®, Remsima®) in human serum and plasma.
The solid phase (MTP) is coated by a highly specific monoclonal antibody directed against Infliximab. Therefore any cross reactivity to the other therapeutical monoclonal antibodies is excluded.
 
Required Volume (µL)10
Incubation Time (min)100
SampleSerum or Plasma
Plate Size96
Standard Range (ng/mL, 10x)0-1500
Sensitivity (ng/mL)3
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.
 
Remicade® is a trademark of Janssen Biotech, Inc./Merck & Co.
Remsima® is a trademark of CellTrion Inc.

  • 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 less than the mean OD of standard D. No cross reaction was observed with sera spiked with the other therapeutic antibodies including Golimumab, Adalimumab, and Etanercept up to 0.5mg/mL. All produced mean OD450/620 nm values less than the mean OD of standard D. In addition, binding of Infliximab is inhibited by recombinant human TNF-alpha in a concentration dependent manner. Therefore, the ImmunoGuide Infliximab ELISA (mAb-based) measures the biologically active free form of Infliximab.

     

    SENSITIVITY

    The lowest detectable level that can be clearly distinguished from the zero standard is 3 ng/mL (zero standard +2SD read from the curve) under the above-described conditions. Analytical sensitivity is 3 ng/mL, and corresponding to the detection limit of 0.3 µg/mL for undiluted clinical samples because the serum or plasma samples are instructed to be diluted at 1:100 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 Infliximab.

     

    AUTOMATION

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

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