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INFLIXIMAB ELISA (MAB-BASED)
Enzyme immunoassay for the specific and quantitative determination of free Infliximab (Remicade®, Remsima®) in human serum and plasma.
The solid phase (MTP) is coated by a highly specific monoclonal antibody directed against Infliximab. Therefore any cross reactivity to the other therapeutical monoclonal antibodies is excluded.
| Required Volume (µL) | 10 |
| Incubation Time (min) | 100 |
| Sample | Serum or Plasma |
| Plate Size | 96 |
| Standard Range (ng/mL, 10x) | 0-1500 |
| Sensitivity (ng/mL) | 3 |
| Spike Recovery (%) | >95 |
| Shelf Life (years) | 2 |
Intended Use: This kit has been developed for the measurement of drug levels in research and diagnostic 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.
ESSAY CHARACTERISTICS
SPECIFICITY
There is no cross reaction with any other proteins present in native human serum. A screening test was performed with 48 different native human sera. All produced OD450/620 nm values less than the mean OD of standard D. No cross reaction was observed with sera spiked with the other therapeutic antibodies including Golimumab, Adalimumab, and Etanercept up to 0.5mg/mL. All produced mean OD450/620 nm values less than the mean OD of standard D. In addition, binding of Infliximab is inhibited by recombinant human TNF-alpha in a concentration dependent manner. Therefore, the ImmunoGuide Infliximab ELISA (mAb-based) measures the biologically active free form of Infliximab.
SENSITIVITY
The lowest detectable level that can be clearly distinguished from the zero standard is 3 ng/mL (zero standard +2SD read from the curve) under the above-described conditions. Analytical sensitivity is 3 ng/mL, and corresponding to the detection limit of 0.3 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%.
RECOVERY
Recovery rate was found to be >95% with native serum and plasma samples when spiked with exogenous Infliximab.
AUTOMATION
The ImmunoGuide Infliximab ELISA (mAb-based) is suitable also for being used by an automated ELISA processor.
REFERENCES
1. Lee YS, Baek SH, Kim MJ, Lee YM, Lee Y, Choe YH. Efficacy of Early Infliximab Treatment for Pediatric Crohn's Disease: A Three-year Follow-up. Pediatr Gastroenterol Hepatol Nutr. 2012; 15(4):243-9.
2. Bortlik M, Machkova N, Duricova D, Malickova K, Hrdlicka L, Lukas M, Kohout P, Shonova O, Lukas M. Pregnancy and newborn outcome of mothers with inflammatory bowel diseases exposed to anti-TNF-α therapy during pregnancy: three-center study. Scand J Gastroenterol. 2013; 48(8):951-8.
3. Grosen A, Julsgaard M, Kelsen J, Christensen LA. Infliximab concentrations in the milk of nursing mothers with inflammatory bowel disease. J Crohns Colitis. 2014; 8(2):175-6.
4. Krajcovicova A, Hlavaty T, Zelinkova Z, Letkovsky J, Huorka M. Delayed hypersensitivity reaction after initial dose of infliximab: a case report. Eur J Gastroenterol Hepatol. 2014; 26(4):485-7.
5. Ducourau E, Mulleman D, Paintaud G, Chu Miow Lin D, Lauféron F, Antibodies toward infliximab are associated with low infliximab concentration at treatment initiation and poor infliximab maintenance in rheumatic disease. Arthritis Research & Therapy 2011; 13:R105.
6. Farkas K, Rutka M, Bálint A, Nagy F, Bor R, Milassin Á, Szepes Z, Molnár T. Efficacy of the new infliximab biosimilar CT-P13 induction therapy in Crohn's disease and ulcerative colitis - experiences from a single center. Expert Opin Biol Ther. 2015; 15(9):1257-62.
7. Lee YM, Kang B, Lee Y, Kim MJ, Choe YH. Infliximab "Top-Down" Strategy is Superior to "Step-Up" in Maintaining Long-Term Remission in the Treatment of Pediatric Crohn Disease. J Pediatr Gastroenterol Nutr. 2015;60(6):737-43.
8. Gecse KB, Végh Z, Lakatos PL. Optimizing biological therapy in Crohn's disease. Expert Rev Gastroenterol Hepatol. 2015 Oct 16:1-9.
9. Choe JY, Prodanovic N, Niebrzydowski J, Staykov I, Dokoupilova E, Baranauskaite A, Yatsyshyn R, Mekic M, Porawska W, Ciferska H, Jedrychowicz-Rosiak K, Zielinska A, Choi J, Rho YH, Smolen JS. A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2015. pii: annrheumdis-2015-207764.
10. Thomas SS, Borazan N, Barroso N, Duan L, Taroumian S, Kretzmann B, Bardales R, Elashoff D, Vangala S, Furst DE. Comparative Immunogenicity of TNF Inhibitors: Impact on Clinical Efficacy and Tolerability in the Management of Autoimmune Diseases. A Systematic Review and Meta-Analysis. BioDrugs. 2015; 29(4):241-58.
11. Plasencia C, Jurado T, Villalba A, Peitedado D, Casla MT, Nuño L, Bonilla MG, Martínez-Feito A, Martín-Mola E, Pascual-Salcedo D, Balsa A. Effect of Infliximab Dose Increase in Rheumatoid Arthritis at Different Trough Concentrations: A Cohort Study in Clinical Practice Conditions. Front Med (Lausanne). 2015 Oct 8;2:71. doi: 10.3389/fmed.2015.00071.
12. Minar P, Saeed SA, Afreen M, Kim MO, Denson LA. Practical Use of Infliximab Concentration Monitoring in Pediatric Crohn's Disease. J Pediatr Gastroenterol Nutr. 2015 Nov 5.doi: 10.1097/MPG.0000000000001029.
13. Plasencia C, Jurado T, Villalba A, Peitedado D, Casla MT, Nuño L, Bonilla MG, Martínez-Feito A, Martín-Mola E, Pascual-Salcedo D, Balsa A. Effect of Infliximab Dose Increase in Rheumatoid Arthritis at Different Trough Concentrations: A Cohort Study in Clinical Practice Conditions. Front Med (Lausanne). 2015 Oct 8;2:71. doi: 10.3389/fmed.2015.00071.
14. Van Stappen T, Billiet T, Vande Casteele N, Compernolle G, Brouwers E, Vermeire S, Gils A. An Optimized Anti-infliximab Bridging Enzyme-linked Immunosorbent Assay for Harmonization of Anti-infliximab Antibody Titers in Patients with Inflammatory Bowel Diseases. Inflamm Bowel Dis. 2015; 21(9):2172-7.
15. Elberdín L, Outeda M, Salvador P, Paradela S, Fernández-Torres RM, Iglesias R, Fonseca E, Martín I. Infliximab drug and antibody levels in patients with dermatological conditions. Int J Clin Pharm. 2015; 37(2):320-6.
16. Van Stappen T, Brouwers E, Tops S, Geukens N, Vermeire S, Declerck PJ, Gils A Generation of a Highly Specific Monoclonal Anti-Infliximab Antibody for Harmonization of TNF-Coated Infliximab Assays. Ther Drug Monit. 2015; 37(4):479-85.
17. Steenholdt C, Bendtzen K, Brynskov J, Thomsen OØ, Ainsworth MA Clinical implications of measuring drug and anti-drug antibodies by different assays when optimizing infliximab treatment failure in Crohn's disease: post hoc analysis of a randomized controlled trial. Am J Gastroenterol. 2014; 109(7): 1055-64.
18. Marits P, Landucci L, Sundin U, Davidsdottir L, Nilsson J, Befrits R, Wikström AC, Eberhardson M Trough s-infliximab and antibodies towards infliximab in a cohort of 79 IBD patients with maintenance infliximab treatment. J Crohns Colitis. 2014; 8(8):881-9.
19. Steenholdt C, Ainsworth MA, Tovey M, Klausen TW, Thomsen OO, Brynskov J, Bendtzen K Comparison of techniques for monitoring infliximab and antibodies against infliximab in Crohn's disease. Ther Drug Monit. 2013; 35(4):530-8.
20. Wang SL, Ohrmund L, Hauenstein S, Salbato J, Reddy R, Monk P, Lockton S, Ling N, Singh S Development and validation of a homogeneous mobility shift assay for the measurement of infliximab and antibodies-to-infliximab levels in patient serum. J Immunol Methods. 2012; 382(1-2):177-88.
INSTRUCTIONS FOR USE
SAFETY DATA SHEET
BATCH/LOT INFORMATION