CL0014R

Adalimumab CLIA Kit

Description

This Chemiluminescence Immunoassay (CLIA) kit is intended for the quantitative determination of Adalimumab levels in serum using the ECL100 or ECL25 Immunoassay analyzer. The test is used as an aid in monitoring dosing during

Adalimumab is an IgG1 monoclonal antibody that is used to treat several conditions including plaque psoriasis, ulcerative colitis, ankylosing spondylitis, Crohn’s disease, rheumatoid arthritis, psoriatic arthritis, hidradenitis suppurative, uveitis, and polyarticular juvenile idiopathic arthritis. Adalimumab is a tumor necrosis factor blocker, specifically it is used to inhibit TNF-a. TNF-a regulates inflammatory responses, and triggers other inflammatory molecules. TNF-a serves an important role in immune response and regulation, but when in excess or produced inappropriately, can lead to disease. Adalimumab blocks TNF-a from binding to receptors, due to its IgG1 structure, and therefore reduces inflammatory responses and symptoms.

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

Background


This CLIA is designed, developed, and produced for the quantitative measurement of Adalimumab in serum samples. The assay utilizes a two-site “sandwich” technique with two antigens that bind to different paratopes of Adalimumab. Assay calibrators, controls, or patient samples are added directly to a reaction vessel containing streptavidin coated magnetic particles. An acridinium ester antigen and a biotin antigen are added. The magnetic particles capture the biotin antigen as well as an immuno complex in the form of “magnetic particles – biotin TNF-alpha antigen –Adalimumab– 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 Adalimumab in the sample. The amount of analyte in the sample is determined from a stored, multi point calibration curve and reported in serum Adalimumab concentration.

Specifications

Catalog no. CL0014R
Target Adalimumab
Species Human
Method Sandwich CLIA
Tests Per Kit 100 tests
Detection Flash AE Chemiluminescence
Sensitivity / LLOD 0.19 µg/mL
Dynamic Range 5.00 - 8.00 µg/mL
Total Incubation Time < 20 min
Sample Type Serum
Sample Volume 40 µL
Storage Temperature 2-8 °C

Selected Literature

1. Adalimumab: Uses, dosage, side effects, warnings. Drugs.com. (n.d.). https://www.drugs.com/adalimumab.html
2. HUMIRA. (n.d.). MEDICATION GUIDE HUMIRA (adalimumab) injection, for subcutaneous use. https://www.rxabbvie.com/pdf/humira_medguide.pdf
3. Jang DI, Lee AH, Shin HY, Song HR, Park JH, Kang TB, Lee SR, Yang SH. The Role of Tumor Necrosis Factor Alpha (TNF-α) in Autoimmune Disease and Current TNF-α Inhibitors in Therapeutics. Int J Mol Sci. 2021 Mar 8;22(5):2719. doi: 10.3390/ijms22052719. PMID: 33800290; PMCID: PMC7962638.
​​​​​​​4. Ellis, C. R., & Azmat, C. E. (2023, November 12). Adalimumab. StatPearls - NCBI Bookshelf. https://www.ncbi.nlm.nih.gov/sites/books/NBK557889/
For research use only. Not for use in diagnostics procedures.
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