SHIKARI® T-CAP Nab Assay™-Infliximab ELISA Kit
INF-TCAP-NAb-REMI
Target Capture Neutralizing Antibodies Immunoassay-Infliximab
Enzyme immunoassay to detect neutralizing antibodies to infliximab in serum and plasma samples
This kit has been developed for detecting ‘Free’ neutralizing antibodies to infliximab. The kit is composed of 4 different controls,
- Positive control: It contains netralizing antibody
- Negative control
- Cut-Off control: Contains certain amounted neutralizing antibody. Corresponse to lower limit of detection (LLOD)
- Non-Neutralizing Antibody Negative Control: Contains non-neutralizing antibodies binding to the drug
With these controls, the kit provides reliable results.
The Cut Off serum contains the LLOD amount and provides accurate true positive or negative results.
A non-neutralising antibody that binds to the drug without affecting the test results can be considered as a negative control.
The kit was also checked with various negative serum samples, including RF(+), CRP(+), ANA(+) sera. All these negative sera did not interfere with the test system. Please refer to the validation report.
We strictly recommend taking sample just before the next dose administration from the patient.
All SHIKARI® ELISA kits are produced under ISO 13485 quality system and have CE IVD mark.
For technical inquiry, please contact techsupport@matriksbiotek.com
| Required Volume (µl) | 10 |
| Total Time (min) | 140 |
| Sample | Serum, plasma |
| Sample Number | 96 |
| Detection Limit (ng/mL) | 20 |
| Spike Recovery (%) | - |
| Shelf Life (month) | 6 |
| Assay type | Qualitative |
| Species Reactivity | Human |
| Storage conditions | Store at +4°C. Please refer to protocols. |
| Shipping conditions | At room temperature |
| # | File | Action |
|---|---|---|
| Instruction For Use | Download | |
| SDS | Download | |
| Validation Report | Download |
Publications with this drug
| # | File | Action |
|---|---|---|
| Liu, Zheng, et al. "Timing of live attenuated vaccination in infants exposed to infliximab or adalimumab in utero: a prospective cohort study in 107 children." Journal of Crohn's and Colitis 16.12 (2022): 1835-1844. | Visit Link | |
| Kita, Toshihiro, et al. "Adrenomedullin for biologic‐resistant Crohn's disease: A randomized, double‐blind, placebo‐controlled phase 2a clinical trial." Journal of Gastroenterology and Hepatology 37.11 (2022): 2051-2059. | Visit Link | |
| Iwasaki, Takeshi, et al. "Dynamics of type I and type II interferon signature determines responsiveness to anti-TNF therapy in rheumatoid arthritis." Frontiers in immunology 13 (2022): 901437. | Visit Link | |
| Cantarelli, Lorenzo, et al. "Definition of a therapeutic range for predicting long-term infliximab response in patients with inflammatory bowel disease." Medicina Clínica 160.3 (2023): 107-112. | Visit Link | |
| Kawamoto, Ami, et al. "Serum Levels of Infliximab Biosimilar in a Child Delivered From a Mother Treated for Ulcerative Colitis." Inflammatory Bowel Diseases 28.8 (2022): 1298-1299. | Visit Link | |
| Orts, Beatriz, et al. "Clinical and Immunological Factors Associated with Recommended Trough Levels of Adalimumab and Infliximab in Patients with Crohn’s Disease." Frontiers in Pharmacology 12 (2022): 795272. | Visit Link | |
| MOHSEN, ENAS RIYADH, and NAAEL H. ALI. "IMPACT OF TH17/TREGFOXP3 CELLS RATIO ON RHEUMATOID ARTHRITIS PATIENTS RECEIVING ANTI TNF-THERAPY-." Journal of Duhok University 24.2 (2021): 90-102. | Visit Link | |
| Нуриахметова, Т. Ю., et al. "Особенности ответа на инфликсимаб пациентов с воспалительными заболеваниями кишечника и анкилозирующим спондилитом." Русский медицинский журнал. Медицинское обозрение 5.2 (2021): 64-70. | Visit Link | |
| Patil, Abhishek, et al. "Anti‐drug antibodies and low serum trough infliximab levels correlate with disease activity measures in spondyloarthritis patients on an as‐needed infliximab treatment." International Journal of Rheumatic Diseases 22.9 (2019) | Visit Link | |
| Wu, Yang, et al. "Management Decisions in Crohn’s Disease Are Changed by Knowledge of Proactive and Reactive Testing of Antitumor Necrosis Factor Drug Levels." Crohn's & Colitis 360 3.3 (2021): otab042. | Visit Link | |
| Jeong, Tae Jong, et al. "Discontinuation of azathioprine could be considered in pediatric patients with Crohn’s disease who have sustained clinical and deep remission." Scientific Reports 12.1 (2022): 507. | Visit Link | |
| Alañón Pardo, M. M., et al. "Monitorización farmacocinética de terapias biológicas en enfermedad inflamatoria intestinal." Revista de la OFIL 31.1 (2021): 49-57. | Visit Link | |
| Little, Robert D., et al. "De-escalation from dose-intensified anti-TNF therapy is successful in the majority of IBD patients at 12 months." Digestive Diseases and Sciences 67 (2022): 259-262. | Visit Link | |
| Ward, Mark G., et al. "Comparison of SB2-infliximab with originator-infliximab in the measurement of serum concentrations: a short communication." Therapeutic Drug Monitoring 43.5 (2021): 692-695. | Visit Link | |
| Judit Szántó, Kata, et al. "Advances in the optimisation of therapeutic drug monitoring using serum, tissue and faecal anti-tumour necrosis factor concentration in patients with inflammatory bowel disease treated with TNF-α antagonists." Expert Opinion on Biological Therapy (2021). | Visit Link | |
| Esatoglu, Sinem Nihal, et al. "Immunogenicity of infliximab among patients with behcet syndrome: a controlled study." Frontiers in Immunology 11 (2020): 618973. | Visit Link | |
| Luber, Raphael P., et al. "Thiopurines and their optimization during infliximab induction and maintenance: A retrospective study in Crohn's disease." Journal of Gastroenterology and Hepatology (2020). | Visit Link | |
| Yokoyama, Yoko, et al. "Efficacy of granulocyte and monocyte adsorptive apheresis in patients with inflammatory bowel disease showing lost response to infliximab." Journal of Crohn's and Colitis 14.9 (2020): 1264-1273. | Visit Link | |
| Seong, Gyeol, et al. "Changes in the intestinal microbiota of patients with inflammatory bowel disease with clinical remission during an 8-week infliximab infusion cycle." Microorganisms 8.6 (2020): 874. | Visit Link | |
| Flanagan, E., et al. "Stability of serum concentrations of infliximab and adalimumab across pregnancy in IBD." J Crohn’s Colitis 13 (2019): S449-S45050. | Visit Link | |
| Choi, So Yoon, Ben Kang, and Yon Ho Choe. "Serum infliximab cutoff trough level values for maintaining hematological remission in pediatric inflammatory bowel disease." Gut and Liver 13.5 (2019): 541. | Visit Link | |
| Zapater, Pedro, et al. "Actual anti-TNF Trough levels relate to serum IL-10 in drug-responding patients with Crohn’s disease." Inflammatory bowel diseases 25.8 (2019): 1357-1366. | Visit Link | |
| Vasudevan, Abhinav, et al. "Higher mucosal healing with tumor necrosis factor inhibitors in combination with thiopurines compared to methotrexate in Crohn’s disease." Digestive Diseases and Sciences 64 (2019): 1622-1631. | Visit Link | |
| Kang, Ben, et al. "Infliximab trough levels are associated with mucosal healing during maintenance treatment with infliximab in paediatric Crohn’s disease." Journal of Crohn's and Colitis 13.2 (2019): 189-197. | Visit Link | |
| Bálint, Anita, et al. "Infliximab biosimilar CT-P13 therapy is effective in maintaining endoscopic remission in ulcerative colitis–results from multicenter observational cohort." Expert Opinion on Biological Therapy 18.11 (2018): 1181-1187. | Visit Link | |
| Kang, Ben, et al. "Long-term outcomes after switching to CT-P13 in pediatric-onset inflammatory bowel disease: a single-center prospective observational study." Inflammatory bowel diseases 24.3 (2018): 607-616. | Visit Link | |
| Duricova, Dana, et al. "Safety of anti-TNF-alpha therapy during pregnancy on long-term outcome of exposed children: a controlled, multicenter observation." Inflammatory bowel diseases 25.4 (2019): 789-796. | Visit Link | |
| Pérez, Irene, et al. "Reliability evaluation of four different assays for therapeutic drug monitoring of infliximab levels." Therapeutic Advances in Gastroenterology 11 (2018): 1756284818783613. | Visit Link | |
| Bolia, Rishi, et al. "Secondary loss of response to infliximab in pediatric Crohn disease: does it matter how and when we start?." Journal of pediatric gastroenterology and nutrition 66.4 (2018): 637-640. | Visit Link | |
| Kang, Ben, et al. "Subtherapeutic infliximab trough levels and complete mucosal healing are associated with sustained clinical remission after infliximab cessation in paediatric-onset Crohn’s disease patients treated with combined immunosuppressive therapy." Journal of Crohn's and Colitis 12.6 (2018): 644-652. | Visit Link | |
| Kolar, M., et al. "Pregnancy outcomes in women with inflammatory bowel disease treated with biosimilar infliximab." Age 28.4.1 (2018): 23-38. | Visit Link | |
| Beswick, Lauren, et al. "Exploration of predictive biomarkers of early infliximab response in acute severe colitis: a prospective pilot study." Journal of Crohn's and Colitis 12.3 (2018): 289-297. | Visit Link | |
| Piñero, Paula, et al. "IL26 modulates cytokine response and anti-TNF consumption in Crohn’s disease patients with bacterial DNA." Journal of Molecular Medicine 95 (2017): 1227-1236. | Visit Link | |
| Raffáč, Štefan, et al. "Detection of anti-infliximab antibodies in Slovak IBD patients and its costs saving effect." Neuro Endocrinol Lett 38 (2017): 5-9. | Visit Link | |
| Aomori, Tohru, et al. "Suppression of infliximab antibody levels by azathioprine in patients with rheumatoid arthritis." Die Pharmazie-An International Journal of Pharmaceutical Sciences 72.2 (2017): 95-97. | Visit Link | |
| Ohem, Jan, et al. "Evaluation of infliximab therapy in children with Crohn's disease using trough levels predictors." Digestive Diseases 36.1 (2018): 40-48. | Visit Link | |
| Al-Karkhi, M. A., et al. "Association between HLA-DRB1 alleles and development of antibodies to infliximab in Iraqi patients with rheumatoid arthritis." research Journals od medicine and clinical sciences. Basic Res. J. Med. Clin. Sci 6.3 (2017): 30-35. | Visit Link | |
| Bálint, Anita, et al. "Frequency and characteristics of infusion reactions during biosimilar infliximab treatment in inflammatory bowel diseases: results from Central European nationwide cohort." Expert opinion on drug safety 16.8 (2017): 885-890. | Visit Link | |
| Kolar, M., et al. "Infliximab biosimilar (Remsima™) in therapy of inflammatory bowel diseases patients: experience from one tertiary inflammatory bowel diseases centre." Digestive Diseases 35.1-2 (2017): 91-100. | Visit Link | |
| Gibellini, Lara, et al. "Anti-TNF-α drugs differently affect the TNFα-sTNFR system and monocyte subsets in patients with psoriasis." PLoS One 11.12 (2016): e0167757. | Visit Link | |
| Julsgaard, Mette, et al. "Concentrations of adalimumab and infliximab in mothers and newborns, and effects on infection." Gastroenterology 151.1 (2016): 110-119. | Visit Link | |
| Choi, So Yoon, et al. "Clinical use of measuring trough levels and antibodies against infliximab in patients with pediatric inflammatory bowel disease." Gut and Liver 11.1 (2017): 55. | Visit Link | |
| Kang, Ben, et al. "Mucosal healing in paediatric patients with moderate-to-severe luminal Crohn’s disease under combined immunosuppression: escalation versus early treatment." Journal of Crohn's and Colitis 10.11 (2016): 1279-1286. | Visit Link | |
| Farkas, Klaudia, et al. "Efficacy of infliximab biosimilar CT-P13 induction therapy on mucosal healing in ulcerative colitis." Journal of Crohn's and Colitis 10.11 (2016): 1273-1278. | Visit Link | |
| Gutiérrez, Ana, et al. "Gut bacterial DNA translocation is an independent risk factor of flare at short term in patients with Crohn’s disease." Official journal of the American College of Gastroenterology| ACG 111.4 (2016): 529-540. | Visit Link | |
| Song, Won Jae, et al. "Adalimumab treatment in pediatric-onset Crohn's disease patients after infliximab failure: A single center study." Pediatric Gastroenterology, Hepatology & Nutrition 19.2 (2016): 116-122. | Visit Link | |
| Hayashi, Satoko, et al. "Early prognostic factors associated with the efficacy of infliximab treatment for patients with rheumatoid arthritis with inadequate response to methotrexate." Rheumatology and therapy 3 (2016): 155-166. | Visit Link | |
| Kui, Róbert, et al. "Presence of antidrug antibodies correlates inversely with the plasma tumor necrosis factor (TNF)‐α level and the efficacy of TNF‐inhibitor therapy in psoriasis." The Journal of Dermatology 43.9 (2016): 1018-1023. | Visit Link | |
| Al-Karkhi, Mohammed A., et al. "Correlation between Anti-infliximab and Anti-CCP Antibodies Development in Patients with Rheumatoid Arthritis Treated with Infliximab in Baghdad Teaching Hospital." IOSR Journal of Dental and Medical Sciences 14.11 (2015) | Visit Link | |
| Juanola, Oriol, et al. "Anti-TNF-alpha loss of response is associated with a decreased percentage of FoxP3+ T cells and a variant NOD2 genotype in patients with Crohn’s disease." Journal of gastroenterology 50 (2015): 758-768. | Visit Link | |
| Malíčková, Karin, et al. "Serum trough infliximab levels: a comparison of three different immunoassays for the monitoring of CT-P13 (infliximab) treatment in patients with inflammatory bowel disease." Biologicals 44.1 (2016): 33-36. | Visit Link | |
| Lee, Yoo Min, et al. "Infliximab “top-down” strategy is superior to “step-up” in maintaining long-term remission in the treatment of pediatric Crohn disease." Journal of pediatric gastroenterology and nutrition 60.6 (2015): 737-743. | Visit Link | |
| Al-Karkhi, Mohammed A., Muhammed M. Al-Ani, and Nizar A. Jassim. "Development of Anti-bodies against Infliximab in Iraqi Patients with Rheumatoid Arthritis." Journal of the Faculty of Medicine Baghdad 57.3 (2015): 241-243. | Visit Link | |
| Kozub, Peter, et al. "Management of infliximab treated patients with psoriasis based on infliximab plasma levels and antibodies to infliximab." J Clin Exp Dermatol Res 5 (2014): 214. | Visit Link | |
| Pallagi-Kunstár, Éva, et al. "Utility of serum TNF-α, infliximab trough level, and antibody titers in inflammatory bowel disease." World Journal of Gastroenterology: WJG 20.17 (2014): 5031. | Visit Link | |
| Krajcovicova, Anna, et al. "Delayed hypersensitivity reaction after initial dose of infliximab: a case report." European Journal of Gastroenterology & Hepatology 26.4 (2014): 485-487. | Visit Link | |
| Bortlik, Martin, et al. "Impact of anti–tumor necrosis factor alpha antibodies administered to pregnant women with inflammatory bowel disease on long-term outcome of exposed children." Inflammatory bowel diseases 20.3 (2014): 495-501. | Visit Link | |
| Gutiérrez, Ana, et al. "Genetic susceptibility to increased bacterial translocation influences the response to biological therapy in patients with Crohn's disease." Gut 63.2 (2014): 272-280. | Visit Link | |
| Grosen, Anne, et al. "Infliximab concentrations in the milk of nursing mothers with inflammatory bowel disease." Journal of Crohn's and Colitis 8.2 (2014): 175-176. | Visit Link | |
| Bortlik, Martin, et al. "Pregnancy and newborn outcome of mothers with inflammatory bowel diseases exposed to anti-TNF-α therapy during pregnancy: three-center study." Scandinavian journal of gastroenterology 48.8 (2013): 951-958. | Visit Link | |
| Bortlik, Martin, et al. "Infliximab trough levels may predict sustained response to infliximab in patients with Crohn's disease." Journal of Crohn's and Colitis 7.9 (2013): 736-743. | Visit Link | |
| Malíčková, Karin, et al. "Phosphatidylserine-dependent anti-prothrombin antibodies (aPS/PT) in infliximab-treated patients with inflammatory bowel diseases." Autoimmunity Highlights 4 (2013): 27-32. | Visit Link | |
| Takahashi, Hidetoshi, et al. "Plasma trough levels of adalimumab and infliximab in terms of clinical efficacy during the treatment of psoriasis." The Journal of dermatology 40.1 (2013): 39-42. | Visit Link | |
| Lee, Yun Seok, et al. "Efficacy of early infliximab treatment for pediatric Crohn's disease: a three-year follow-up." Pediatric gastroenterology, hepatology & nutrition 15.4 (2012): 243-249. | Visit Link | |
| Molnár, T., et al. "Importance of trough levels and antibody titers on the efficacy and safety of Infliximab therapy in inflammatory bowel disease." Zeitschrift für Gastroenterologie 50.05 (2012): A53. | Visit Link | |
| Kato, Shingo, et al. "Elevated serum IgE prior to acute severe infusion reaction during infliximab maintenance therapy in a crohn's disease patient." Inflammatory Bowel Diseases 17.12 (2011): E156-E157. | Visit Link | |
| Adişen, Esra, et al. "Anti‐infliximab antibody status and its relation to clinical response in psoriatic patients: a pilot study." The Journal of dermatology 37.8 (2010): 708-713. | Visit Link | |
| Patil, A., et al. "AB0683 Trough infliximab levels and anti-infliximab antibodies in spondyloarthritis patients on treatment with low dose infliximab: a single centre cross-sectional study." (2017): 1292-1292. | Visit Link | |
| Malickova, Karin, et al. "Sa1958 No Difference in Immunogenicity of the Original and Biosimilar Infliximab in Patients With Inflammatory Bowel Disease: Short-Term Results." Gastroenterology 150.4 (2016): S416. | Visit Link | |
| Perez I, Fernandez L, Sanchez-Ramón S, P551 Comparison of 4 assay kits for measuring infliximab trough levels and antibodies to infliximab in patients with inflammatory bowel disease,Hospital Clínico San Carlos, IBD Unit, Madrid, Spain, Hospital Clínico San Carlos, Clinical Immunology, IdiSSC, IBD Unit, Gastroenterology,2016 Madrid, Spain. | Visit Link | |
| Goldberg, R., et al. "P378 Predictors of sub-therapeutic infliximab or adalimumab trough levels and anti-drug antibodies and their influence on therapeutic decisions." Journal of Crohn's and Colitis 8 (2014): S223. | Visit Link | |
| Szepes, Z., et al. "P274 Clinical utility of measuring serum TNF alpha level, anti TNF alpha levels and antibody titers in critical situations in inflammatory bowel disease and in psoriasis." Journal of Crohn's and Colitis 7.Supplement_1 (2013): S118-S119 | Visit Link | |
| Duricova D, et al, Predictors of sustained response to infliximab with Crohn’s disease: A single cohort study, Czech Republic | Visit Link | |
| Lukas, Milan, et al. "W1212 Anti-Infliximab Antibodies in Routine Clinical Practice-Is It Worth to Assess Them?." Gastroenterology 5.136 (2009): A-679. | Visit Link | |
| Malickova K, et al, Relationship between serum trough infliximab levels, serum antibodies to infliximab, serum albumin levels and clinical response to infliximab treatment in patients with inflammatory bowel diseases, Charles University in Prague Czech Republic. (2011) | Visit Link | |
| Malickova K, et al, Formation of antiphospholipid antibodies and antibodies to infliximab in anti-TNF-alpha antibody-treated patients with inflammatory bowel diseases, Charles University in Prague Czech Republic (2011). | Visit Link | |
| Malickova K, et al,. Monitoring patients treated with infliximab: Assessing Anti-Infliximab antibodies, Czech Republic. EUROMEDLAB. Autoimmune diseases 2009. S115 | Visit Link | |
| Molnár, Tamás. A biológiai terápia hatékonysága és korlátai különböző típusú gyulladásos bélbetegségekben. Diss. SZTE ÁOK, 2016. | Visit Link | |
| Gyulai, Rolland. A pikkelysömör klinikai, biokémiai, immunológiai és genetikai jellegzetességeinek vizsgálata. Diss. PTE, 2017. | Visit Link | |
| Pallagi-Kunstár, Éva. Investigation of the pathomechanism of diarrhoea-related diseases. Diss. Szegedi Tudomanyegyetem (Hungary), 2015. | Visit Link | |
| Pękala, Anna, Rafał Filip, and David Aebisher. "Anti-drug antibodies in patients with inflammatory bowel diseases treated with biosimilar infliximab: A prospective cohort study." Journal of Clinical Medicine 10.12 (2021): 2653. | Visit Link | |
| Sakane, Hideo, et al. "Anti-drug antibodies and rheumatoid factor level in patients with rheumatoid arthritis using the infliximab biosimilar CT-P13." BMC rheumatology 6.1 (2022): 74. | Download | |
| Rentsch, Clarissa A., et al. "Pharmacist-Driven Therapeutic Infliximab Monitoring at the Point of Care Using Rapidly Assessed Drug Levels in Patients with Inflammatory Bowel Disease." Therapeutic Drug Monitoring 45.3 (2023): 383-391. | Visit Link | |
| Maspero, Marianna, et al. "S79 Long Term Outcomes of Straight Ileoanal Anastomoses Converted to Ileal Pouch Anal Anastomoses." Official journal of the American College of Gastroenterology| ACG 117 (2022): S21. | Download | |
| Szántó, Kata Judit. Crucial Steps for Treatment Optimization and Decision Making in Inflammatory Bowel Disease Management. Diss. Szegedi Tudomanyegyetem (Hungary), 2022. | Visit Link | |
| M Zviaglova and others, P453 The significance of the concentration of antibodies to infliximab on the frequency of loss of response when alternating the original drug infliximab and its biosimilar in patients with ulcerative colitis. | Visit Link | |
| Shibata, Hiroko, et al. "Comparison of Immunochemical Reactions of Infliximab Innovator and Biosimilars on an Infliximab Detection Kit Used for Therapeutic Drug Monitoring." Biological and Pharmaceutical Bulletin 46.4 (2023): 621-629. | Visit Link | |
| Nguyen, Anke L., et al. "Application of a Precision‐Dosing Model to a Real‐World Cohort of Patients on Infliximab Maintenance Therapy: Drug Usage and Cost Analysis." The Journal of Clinical Pharmacology 64.4 (2024): 399-409. | Visit Link | |
| Choi, So Yoon, et al. "Infliximab trough levels are associated with endoscopic healing but not with transmural healing at one year treatment with infliximab in pediatric patients with Crohn’s disease." Frontiers in Immunology 14 (2023): 1192827. | Visit Link | |
| Evaluation of selected serum biomarkers levels in response to the infliximab reference product (Remicade®) versus its biosimilar (Remsima®) in a sample of ulcerative colitis patients: a cross-sectional study | Visit Link | |
| Efficacy of tumor necrosis factor-α inhibitors in the treatment of various immunoinflammatory diseases:focus on immunogenicity/Эффективность ингибиторов фактора некроза опухоли α в лечении различных иммуновоспалительных заболеваний:фокус на иммуногенность | Visit Link | |
| Wu, Yang. Therapeutic drug monitoring to optimise treatment of inflammatory bowel disease with tumour necrosis factor inhibitors. Diss. UNSW Sydney, 2021. | Visit Link | |
| Akçadağ, Gülşah, et al. "Study on Cloning and Expression of TNF-α Variants in E. coli: Production, Purification, and Interaction with Anti-TNF-α Inhibitors." Protein and Peptide Letters 31.5 (2024): 395-408. | Visit Link |
