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ANTIBODY TO CERTOLIZUMAB PEGOL ELISA
Enzyme immunoassay for the quantitative and qualitative determination of free antibodies to Certolizumab Pegol (Cimzia®) in serum and plasma.
The solid phase (MTP) is coated by the drug Certolizumab Pegol. Due to the assay design this test measures the free antibodies which are not bound to Certolizumab Pegol. Results could be expressed in both qualitative and quantitative manner (nanogram per mililiter-ng/mL).
| Required Volume (µL) | 50 |
| Incubation Time (min) | 135 |
| Sample | Serum, Plasma |
| Plate Size | 96 |
| Results in | Qualitative & Quantitative (ng/mL) |
| Shelf Life (years) | 2 |
Cimzia® is a trademark of UCB.
ESSAY CHARACTERISTICS
ANALYTICAL SENSITIVITY-THRESHOLD VALUE
The Detection Threshold for the assay is 20 ng/mL.
The assay sensitivity for undiluted clinical samples corresponds to 40 ng/mL
Because the serum or plasma samples are instructed to be diluted at two-fold (1:2) before starting the assay.
ASSAY RANGE
For anti-Certolizumab Pegol antibodies in serum and plasma, the method has been demonstrated to be linear from 0 to 1000 ng/mL.
ASSAY PRECISION
Intra-assay CV:
Mean
CV (%)
1000 <10 300 <10 100 <10
Inter-assay CV: <10%.
ASSAY RECOVERY
Recovery rate was found to be 85-110% using native serum and plasma samples spiked with exogenous Anti Drug Antibody (ADA) positive samples.
AUTOMATION
The ImmunoGuide ADA ELISA is suitable also for being used by an automated ELISA processor.
REFERENCES
1. Vande Casteele N, Gils A. Pharmacokinetics of anti-TNF monoclonal antibodies in inflammatory bowel disease: Adding value to current practice. J Clin Pharmacol. 2015; 55 Suppl 3: S39-50.
2. Derer S, Till A, Haesler R, Sina C, Grabe N, Jung S, Nikolaus S, Kuehbacher T, Groetzinger J, Rose-John S, Rosenstiel PC, Schreiber S. mTNF reverse signalling induced by TNFα antagonists involves a GDF-1 dependent pathway: implications for Crohn's disease. Gut. 2013; 62(3): 376-86.
3. Molinelli E, Campanati A, Ganzetti G, Offidani A. Biologic Therapy in Immune Mediated Inflammatory Disease: Basic Science and Clinical Concepts. Curr Drug Saf. 2016; 11(1): 35-43.
4. Lichtenstein GR. Comprehensive review: antitumor necrosis factor agents in inflammatory bowel disease and factors implicated in treatment response. Therap Adv Gastroenterol. 2013; 6(4): 269-93.
5. Jani M, Isaacs JD, Morgan AW, Wilson AG, Plant D, Hyrich KL, Chinoy H, Barton A; BRAGGSS. High frequency of antidrug antibodies and association of random drug levels with efficacy in certolizumab pegol-treated patients with rheumatoid arthritis: results from the BRAGGSS cohort. Ann Rheum Dis. 2016 May 31. pii: annrheumdis-2015-208849. doi: 10.1136/annrheumdis-2015-208849.
6. Shu Q, Amin MA, Ruth JH, Campbell PL, Koch AE. Suppression of endothelial cell activity by inhibition of TNFα. Arthritis Res Ther. 2012; 14(2): R88.
7. Atreya R, Zimmer M, Bartsch B, Waldner MJ, Atreya I, Neumann H, Hildner K, Hoffman A, Kiesslich R, Rink AD, Rau TT, Rose-John S, Kessler H, Schmidt J, Neurath MF. Antibodies against tumor necrosis factor (TNF) induce T-cell apoptosis in patients with inflammatory bowel diseases via TNF receptor 2 and intestinal CD14⁺ macrophages. Gastroenterology. 2011; 141(6): 2026-38.
8. Nielsen OH, Bjerrum JT, Seidelin JB, Nyberg C, Ainsworth M. Biological treatment of Crohn's disease. Dig Dis. 2012; 30 Suppl 3: 121-33.
9. Loftus EV Jr, Colombel JF, Schreiber S, Randall CW, Regueiro M, Ali T, Arendt C, Coarse J, Spearman M, Kosutic G. Safety of Long-Term Treatment With Certolizumab Pegol in Patients with Crohn's Disease, Based on a Pooled Analysis of Data From Clinical Trials. Clin Gastroenterol Hepatol. 2016 Jul 24. pii: S1542-3565(16)30440-2. doi: 10.1016/j.cgh.2016.07.019.
10. Lee SD, Rubin DT, Sandborn WJ, Randall C, Younes Z, Schreiber S, Schwartz DA, Burakoff R, Binion D, Dassopoulos T, Arsenescu R, Gutierrez A, Scherl E, Kayhan C, Hasan I, Kosutic G, Spearman M, Sen D, Coarse J, Hanauer S. Reinduction with Certolizumab Pegol in Patients with Crohn's Disease Experiencing Disease Exacerbation: 7-Year Data from the PRECiSE 4 Study. Inflamm Bowel Dis. 2016; 22(8): 1870-80.
11. Cassinotti A, Ardizzone S, Porro GB. Certolizumab pegol: an evidence-based review of its place in the treatment of Crohn's disease. Core Evid. 2008; 2(3): 209-29.
INSTRUCTIONS FOR USE
SAFETY DATA SHEET
BATCH/LOT INFORMATION