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Total Infliximab (Remicade®) ELISA Assay Kit

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$895.00
SKU:
IG-TA101

 Product Description

Package insert view pdf

 

 

Total Infliximab (Remicade®) ELISA Assay Kit: 
For Research Use Only

Size:  1 x 96 wells
Sensitivity:  10 tAU/mL
Cut-off Control
Incubation Time:  1.5 hours

Sample Type:  Serum, Plasma
Sample Size: 10 µL

Intended Use

The Eagle Biosciences Total Infliximab (Remicade®) ELISA Assay Kit is an Enzyme immunoassay for the semi-quantitative determination of total (free and drug-bound) antibodies to Infliximab (ATI) in serum and plasma samples.  The Total Infliximab (Remicade®) ELISA Assay Kit is for Research Use Only and is not for use in diagnostics procedures.
 

Assay Background

The drug Infliximab (trade name Remicade® and Remsima®) is a chimeric monoclonal antibody and used to treat auto-immune disorders. One of the major concerns, despite of its wide usage, is the potential development of anti-Infliximab antibodies (ATI) which in turn may interfere with the drug efficacy as mainly judged by observing the relapse of signs and symptoms of disease and necessitate dose-escalation or potentially ending up the treatment.

The ImmunoGuide Total Antibody to Infliximab ELISA Kit can be efficiently used for measuring free and Infliximab-bound antibodies against the drug Infliximab. In combination with the drug level determination, the Total Antibody to Infliximab ELISA Kit has been designed for the measurement of free antibodies against this drug. It also detects such antibodies which already are bound to the drug, even if the drug is present in a 20 fold excess.

Assay Principle

The Eagle Biosciences Total Antibody to Infliximab ELISA Assay Kit serves for the determination of total antibodies (free and Infliximab-bound) against Infliximab in serum and plasma samples. During sample preparation, the Infliximab-bound anti-Infliximab antibodies are dissociated from the complex in order to acquire free anti-Infliximab antibodies. During the incubation period, antibodies to Infliximab (ATI) are replaced and bridged in the well with its Fab arms, between the Infliximab coated on the well and the conjugate Infliximab labelled with peroxidase. After washing away the components the bound enzymatic activity is detected by addition of tetramethylbenzidine (TMB) chromogen-substrate. Finally, the reaction is terminated with stop solution. The positive reaction is related with the presence of ATI in the sample.

  1. Pipette 100 µL of Assay Buffer into each of the wells to be used.
  2. Pipette 50 µL of Enzyme Conjugate (HRP-Infliximab) into each well.
  3. Pipette 40 µL of dissociation buffer-mixed (as described in section 10.2) Negative Control, Positive Control and Samples into the respective wells of the microtiter ELISA plate.
  4. Cover the plate with adhesive seal. Shake plate carefully. Incubate 60 min at room temperature (RT) (20-25°C).
  5. Remove adhesive seal. Aspirate or decant the incubation solution. Wash the plate 3 X 300 μL of Diluted Wash Buffer per well. Remove excess solution by tapping the inverted plate on a paper towel.
  6. Pipette 100 µL of Ready-to-Use TMB Substrate Solution into each well.
  7. Incubate 15 min at RT. Avoid exposure to direct sunlight..
  8. Stop the substrate reaction by adding 100 µL of Stop Solution into each well. Briefly mix contents by gently shaking the plate. Color changes from blue to yellow.
  9. Measure optical density (OD) with a photometer at 450 nm (Reference at OD620 nm is optional) within 15 min after pipetting the Stop Solution.

LITERATURE REFERENCES:

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Gecse KB, Végh Z, Lakatos PL. Optimizing biological therapy in Crohn's disease. Expert Rev Gastroenterol Hepatol. 2015 Oct 16:1-9.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

 

 

 
 
 

 

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Nashua, NH 03063
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International: +617-419-2019

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