CL0010R

Anti-Infliximab CLIA Kit

Description

This Chemiluminescence Immunoassay (CLIA) kit is intended for the quantitative determination of Anti-Infliximab levels in serumusing the ECL100 or ECL25 Immunoassay analyzer. The test is used as an aid in monitoring dosing during Infliximab therapy.

Infliximab is a monoclonal antibody used as a drug treatment to decrease or prevent the inflammatory effects of tumor necrosis factor-alpha, or TNF-alpha, in certain patients who have Rheumatoid Arthritis, Crohn’s Disease, Ankylosing Spondylitis, Psoriatic Arthritis, Plaque Psoriasis, or Ulcerative Colitis. While undergoing treatment, some patients will develop antidrug antibodies that can bind to Infliximab, neutralizing its therapeutic effects3. Increased concentration of anti-Infliximab antibodies can lower the drug concentration in the body by increasing drug clearance, decrease the likelihood of reaching and sustaining remission, and potentially cause infusion reactions. Measurement of anti-Infliximab antibodies can provide more insight into how the body is reacting to Infliximab, and how to move forward with the treatment.

For research use only. Not for use in diagnostics procedures.

Background


This CLIA is designed, developed, and produced for the quantitative measurement of Infliximab in serum samples. The assay utilizes a two-site “sandwich” technique with two antibodiesthat bind to different epitopesof Anti-Infliximab.

Assay calibrators, controls, or patient samples are added directly to a reaction vessel containing streptavidin coated magnetic particles. Anacridinium ester antibody and a biotin antibodyare added. The magnetic particles capture the biotin antibody as well as an immuno complex in the form of “magnetic particles – biotin Infliximab antibody –Anti Infliximab– acridinium ester Infliximab antibody”.

​​​​​​​The materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the trigger solution is added to the reaction vessel and light generated by the reaction is measured with the ECL100 or ECL25 analyzer. The relative light units (RLU) are proportional to the concentration of Infliximab in the sample. The amount of analyte in the sample is determined from a stored, multi-point calibration curve and reported in serum Infliximab concentration.

Specifications

Catalog no. CL0010R
Target Anti-Infliximab
Species Human
Method Sandwich CLIA
Tests Per Kit 100 tests
Detection Flash AE Chemiluminescence
Sensitivity / LLOD 1.03 ng/mL
Dynamic Range 0 - 20.00 ng/mL
Total Incubation Time <30 min
Sample Type Serum
Sample Volume 15 µL
Storage Temperature 2-8 °C

Selected Literature

1. van Hogezand RA, Verspaget HW. The future role of anti-tumour necrosis factor-alpha products in the treatment of Crohn's disease. Drugs. 1998 Sep;56(3):299-305. doi: 10.2165/00003495-199856030-00001. Erratum in: Drugs 1999 Jan;57(1):79. PMID: 9777308.
2. MEDICATION GUIDE Infliximab for injection, for intravenous use. (n.d.). Available at: https://www.janssenlabels.com/package-insert/product-patient-information/Infliximab medication-guide.pdf.
3. Therapeutic drug monitoring countering the effect of anti-infliximab antibodies. Hooijberg, Femke et al. The Lancet Rheumatology, Volume 6, Issue 4, e193 - e194
​​​​​​​4. Clinical consequences of infliximab immunogenicity and the effect of proactive therapeutic drug monitoring: exploratory analyses of the randomised, controlled NOR DRUM trials. Brun, Marthe Kirkesæther et al. The Lancet Rheumatology, Volume 6, Issue 4, e226 - e236
For research use only. Not for use in diagnostics procedures.
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