CL0009R

Infliximab CLIA Kit

Description

This Chemiluminescence Immunoassay (CLIA) kit is intended for the quantitative determination of 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 that functions to block the actions of TNF-alpha proteins, or tumor necrosis factor-alpha proteins, in the body. TNF-alpha induces inflammation responses, and an increased concentration of this protein is shown in several diseases. Infliximab is used to prevent excessive damage that is caused by the increased concentration of TNF-alpha. Infliximab is approved for use in certain cases of Rheumatoid Arthritis, Crohn’s Disease, Ankylosing Spondylitis, Psoriatic Arthritis, Plaque Psoriasis, and Ulcerative Colitis.
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​​​​​​​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 serumsamples. The assay utilizes a two-site “sandwich” technique with two antigensthat bind to different paratopes ofInfliximab.
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Assay calibrators, controls, or patient samples are added directly to a reaction vessel containing streptavidin coated magnetic particles. Anacridinium ester antigen and a biotin antigenare added. The magnetic particles capture the biotin antigen as well as an immuno complex in the form of “magnetic particles – biotin TNF-alpha antigen –Infliximab– acridinium ester TNF-alpha antigen”.

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. CL0009R
Target Infliximab
Species Human
Method Sandwich CLIA
Tests Per Kit 100 tests
Detection Flash AE Chemiluminescence
Sensitivity / LLOD 0.66 µL/mL
Dynamic Range Population variability
Total Incubation Time <20 minutes
Sample Type Serum or plasma
Sample Volume 40 µL
Storage Temperature 2-8 °C

Selected Literature


1. Drugs.com. (2024). Infliximab Monograph for Professionals. [online] Available at: https://www.drugs.com/monograph/infliximab.html?references=1#r1.
2. 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.
3. 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.
​​​​​​​4. Kaiser, G. (2016). 11.3C: Cytokines Important in Innate Immunity. [online] Biology LibreTexts. Available at: https://bio.libretexts.org/Bookshelves/Microbiology/Microbiology_(Kaiser)/Unit_5%3A_In nate_Immunity/11.4%3A_Early_Induced_Innate_Immunity/11.3C%3A_Cytokines_Impor tant_in_Innate_Immunity.
For research use only. Not for use in diagnostics procedures.
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