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INFLIXIMAB ELISA

INFLIXIMAB ELISA

Enzyme immunoassay for the quantitative determination of free Infliximab (Remicade®, Remsima®) in serum and plasma.
The solid phase (MTP) is coated by the target molecule, in this case TNF-alpha.
 
Required Volume (µL)10
Incubation Time (min)105
SampleSerum or Plasma
Plate Size96 
Standard Range (ng/mL, 10x)0-2000
Detection Limit (ng/mL)5
Spike Recovery (%)>95
Shelf Life (years)2
 
Intended Use: This kit has been developed for the measurement of drug levels in research, diagnostic and biosimilar 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 naïve serum. Because the solid phase is coated with rhTNF-alpha, 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 0.5 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%.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 is suitable also for being used by an automated ELISA processor.

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