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Shikari® (Q-INFLIXI) Infliximab ELISA

Enzyme immunoassay for the quantitative determination of Infliximab (Remicade®) in serum and plasma.

This kit has been especially developed for the quantitative determination of infliximab in serum and plasma samples between the Cmin and Cmax range of concentrations.

 

Infliximab Drug Bank Accession Number is DB00065.

Infliximab is a monoclonal anti-tumor necrosis factor alpha antibody used in the treatment of a wide variety of inflammatory conditions such as rheumatoid arthritis, Crohn's disease and ankylosing spondylitis. Infliximab binds with high affinity to soluble and transmembrane forms of TNF-α to disrupt the proinflammatory cascade signaling. Binding of antibodies to TNF-a prevents TNF-a from interacting with its receptors and helps the patient recover. Measurement of biological drug trough levels and antibody to biological drug gained high importance during the course of treatment. These measurements enable dose adjustments and switch to another class of biological drug when necessary.

All SHIKARI® ELISA kits are suitable for biosimilar work.

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) 70
Sample Serum, plasma
Sample Number 96
Detection Limit (ng/mL) 10
Spike Recovery (%) Between 85-115
Shelf Life (year) 1
Assay type Quantitative
Species Reactivity Human
Storage conditions Store at +4°C. Please refer to protocols.
Shipping conditions At room temperature
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Instructions For Use Download
Safety Data Sheet (SDS) Download
Validation Report Download

Publications with this drug

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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 (2022). 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 (2022). 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). 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 (2022). 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 (2021): 795272-795272. 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.APA 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, A., Upadhyaya, S., Dawar, R., Dadhaniya, N., Sood, I., Gupta, S. J., Handa, R. 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 (2019) Visit Link
Yang Wu, 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, Volume 3, Issue 3, (2021) Visit Link
Tae Jong Jeong, Eun Sil Kim et al. Discontinuation of Azathioprine Could Be Considered in Pediatric Patients with Crohn’s Disease who Have Sustained Clinical and Deep Remission, Scientific Reports (2021) 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 (2021): 1-4. 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 (2021). 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 Behçet Syndrome: A Controlled Study." Frontiers in Immunology 11 (2020): 3378. 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 (2020). 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." JOURNAL OF CROHNS & COLITIS. Vol. 13. GREAT CLARENDON ST, OXFORD OX2 6DP, ENGLAND: OXFORD UNIV PRESS, 2019. 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 (2019). 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 (2019). 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 (2018): 1-10. 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 (2018). Visit Link
Bálint, Anita, et al. "Infliximab biosimilar CT-P13 therapy is effective in maintaining endoscopic remission in ulcerative colitis–results from multicentre observational cohort." Expert opinion on biological therapy just-accepted (2018). 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 (2018). 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
M. Kolar et al., "Pregnancy outcomes in women with inflammatory bowel disease treated with biosimilar infliximab" Gastroent Hepatol (2018) 72(1): 20-26 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 (2017): 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 95.11 (2017): 1227-1236. Visit Link
Štefan Raffáč et al., "Detection of anti-infliximab antibodies in Slovak IBD patients and its costs saving effect" Neuroendocrinology Letters Volume 38 Suppl. 1 (2017) 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 J, Hradsky O, Zarubova K, Copova I, Bukovska P, Prusa R, Malickova K and Bronsky J. Evaluation of Infliximab Therapy in Children with Crohn's Disease Using Trough Levels Predictors. Dig Dis. Aug 18, 2017. Visit Link
Al-Karkhi MA, Al-Ani MM, Jassim NA, Mahdi BM, Association Between HLA-DRB1 alleles and development of antibodies to infliximab in Iraqi patients with rheumatoid arthritis, Basic Research Journals, 6(3): 30-35, 2017. Visit Link
Bálint A, Rutka M, Végh Z, 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):885-890, 2017. Visit Link
Kolar M, Duricova D, Bortlik M, et al., Infliximab Biosimilar (Remsima TM ) in Therapy of Inflammatory Bowel Diseases Patients: Experience from One Tertiary Inflammatory Bowel Diseases Centre, Digestive Disease, 35:91–100, 2017. Visit Link
Gibellini L, De Biasi S, Bianchini E, et al. Anti-TNF-α Drugs Differently Affect the TNFα-sTNFR System and Monocyte Subsets in Patients with Psoriasis. Richard Y, ed. PLoS ONE. 11(12), 2016 Visit Link
Julsgaard M, Christensen LA, Gibson PR, Bell SJ. Concentrations of Adalimumab and Infliximab in Mothers and Newborns, and Effects on Infection. Gastroenterology. Jul;151(1):110-9, 2016. Visit Link
Choi SY, Kang B, Lee JH, Choe YH. Clinical Use of Measuring Trough Levels and Antibodies against Infliximab in Patients with Pediatric Inflammatory Bowel Disease. Gut Liver, 2016. Visit Link
Kang B., et al., Mucosal Healing in Paediatric Patients with Moderate-to-Severe Luminal Crohn’s Disease Under Combined Immunosuppression: Escalation versus Early Treatment Visit Link
Farkas K., et al., Efficacy of infliximab biosimilar CT-P13 induction therapy on mucosal healing in ulcerative colitis. Journal of Crohn's and Colitis Advance Access published, 2016. Visit Link
Gutiérrez A, Zapater P, Francés R. Gut Bacterial DNA Translocation is an Independent Risk Factor of Flare at Short Term in Patients with Crohn's Disease. Am J Gastroenterol.,111(4):529-40, 2016. Visit Link
Won Jae Song, Ben Kang, So Yoon Choi, and Yon Ho Choe. Adalimumab Treatment in Pediatric-Onset Crohn’s Disease Patients after Infliximab Failure: A Single Center Study. Pediatr Gastroenterol Hepatol Nutr.; 19(2): 116–122, 2016. Visit Link
Hayashi S, et al., Early Prognostic Factors Associated with the Efficacy of Infliximab Treatment for Patients with Rheumatoid Arthritis with Inadequate Response to Methotrexate. Rheumatol Ther., 3:155–166, 2016. Visit Link
Kui R, Gál B, Gaál M, Kiss M, Kemény L1, Gyulai R. Presence of antidrug antibodies correlates inversely with the plasma tumor necrosis factor (TNF)-α level and the efficacy of TNF-inhibitor therapy in psoriasis. J Dermatol.,43(9):1018-23, 2016. Visit Link
Al-Karkhi M.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) : 95-100, 2015. Visit Link
Juanola O., 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. J Gastroenterol,50:758–768, 2015. Visit Link
Malíckova K, 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 2015. Visit Link
Lee Y.M. et al, Infliximab ‘‘Top-Down’’ Strategy is Superior to ‘‘Step-Up’’ in Maintaining Long-Term Remission in the Treatment of Pediatric Crohn Disease. JPGN 60: (737–743), 2015. Visit Link
Al-Karkhi M.A., et al., Development of Antibodies against Infliximab in Iraqi Patients with Rheumatoid Arthritis. J Fac Med Baghdad, 57: (241-243), 2015 Visit Link
Kozub P, Curkova AK, Zuzulova M, Simaljakova M, Management of Infliximab Treated Patients with Psoriasis Based On Infliximab Plasma Levels and Antibodies to Infliximab, Clinical & Experimental Dermatology Research, 5(2), 2014. Visit Link
Pallagi-Kunstár É. et al., Utility of serum TNF-a, infliximab trough level, and antibody titers in inflammatory bowel disease. World J Gastroenterol. 20(17): (5031-5035), 2014. Visit Link
Krajcovicova A. et al., Delayed hypersensitivity reaction after initial dose of infliximab: a case report. European Journal of Gastroenterology& Hepatology, 26:(485-487), 2014. Visit Link
Bortlik M, 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. Inflamm Bowel Dis 20 : (495-451), 2014. Visit Link
Gutierrez A, et al, Genetic susceptibility to increased bacterial translocation influences the response to biological therapy in patients with Crohn’s disease, Gut 0:1–9, 2013 Visit Link
Grosen A., et al, Infliximab concentrations in the milk of nursing mothers with inflammatory bowel disease, J Crohns Colitis 2013. Visit Link
Bortlik M et al, “Pregnancy and newborn outcome of mothers with inflammatory bowel diseases exposed to anti-TNF-a therapy during pregnancy: three-center study”, Scandinavian Journal of Gastroenterology. 48: 951–958, 2013. Visit Link
Bortlik M, et al, Infliximab trough levels may predict sustained response to infliximab in patients with Crohn's disease, Journal of Crohn's and Colitis, 2012. Visit Link
Malickova K, et al, Phosphatidylserine-dependent anti-prothrombin antibodies (aPS/PT) in infliximab-treated patients with inflammatory bowel diseases, Autoimmun Highlights, 2012. Visit Link
Takahashi H, et al, Plasma trough levels of adalimumab and infliximab in terms of clinical efficacy during the treatment of psoriasis, Journal of Dermatology, 39: 1- 4, 2012. Visit Link
Seok Lee Y, et al, “Efficacy of Early Infliximab Treatment for Pediatric Crohn’s Disease: A Three-year Follow-up”, Pediatric Gastroenterology, Hepatology & Nutrition, 15(4):243-249, 2012. Visit Link
Molnar T, et al, “Importance of trough levels and antibody titers on the efficacy and safety of Infliximab therapy in inflammatory bowel disease”, Z Gastroenterol, 50 - A53, 2012. Visit Link
Kato S, et al, “Elevated Serum IgE Prior to Acute Severe Infusion Reaction During Infliximab Maintenance Therapy in a Crohn’s Disease Patient”, Crohn’s & Colitis Foundation of America, 2011. Visit Link
Adisen E, et al, “Anti-infliximab antibody status and its relation to clinical response in psoriatic patients”: A pilot study, Journal of Dermatology, 37: 708–713, 2010. Visit Link
Patil A, Upadhyaya SK, Dawar R, et al., Through Infiliximab Levels and Anti-Infiliximab Antibodies in Spondyloarthritis Patients on Treatment with Low Dose Infiliximab: A Single Centre Cross-Sectional Study, BMJ Journals, Annals of the Rheumatic Diseases,(2017). Visit Link
Malickova K, Duricova D , Kolar M, et al., No difference in immunogenicity of the original and biosimilar infliximab in patients with inflammatory bowel disease: short-term results, First Medical Faculty and General Teaching Hospital, Charles University, Institute of Medical Biochemistry and Laboratory Diagnostics, Prague, Czech Republic, 2 ISCARE, IBD clinical and research centre, Prague, Czech Republic, (2017). 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, Predictors of sub-therapeutic infliximab oradalimumab trough levels and anti-drug antibodies and their influence on therapeutic decisions, ECCO 2014 Inflammatory Bowel Disease. Visit Link
Szepes Z., et al, 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, ECCO 2014 Inflammatory Bowel Disease. 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 M, et al, Anti-infliximab antibodies in routine clinical practice is it worth to assess them, Czech Republic 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
A BIOLÓGIAI TERÁPIA HATÉKONYSÁGA ÉS KORLÁTAI KÜLÖNBÖZŐ TÍPUSÚ GYULLADÁSOS BÉLBETEGSÉGEKBEN Dr. Molnár Tamás Visit Link
A PIKKELYSÖMÖR KLINIKAI, BIOKÉMIAI, IMMUNOLÓGIAI ÉS GENETIKAI JELLEGZETESSÉGEINEK VIZSGÁLATA Dr. Gyulai Rolland Visit Link
INVESTIGATION OF THE PATHOMECHANISM OF DIARRHOEA-RELATED DISEASES Dr. ÉVA PALLAGI 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): 1-5. 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 (2022): 10-1097. 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
CRUCIAL STEPS FOR TREATMENT OPTIMIZATION AND DECISION MAKING IN INFLAMMATORY BOWEL DISEASE MANAGEMENT. 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 H, Nishimura K, Saito Y, Ishii-Watabe A. Comparison of Immunochemical Reactions of Infliximab Innovator and Biosimilars on an Infliximab Detection Kit Used for Therapeutic Drug Monitoring. Biol Pharm Bull. 2023;46(4):621-629. Visit Link
Nguyen AL, Gibson PR, Upton RN, Mould DR, Sparrow MP. Application of a precision-dosing model to a real-world cohort of patients on infliximab maintenance therapy: Drug usage and cost analysis. J Clin Pharmacol. 2023 Nov 15. Visit Link
Choi SY, Kwon Y, Choi S, Lee SM, Choe BH, Kang B. 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. Front Immunol. 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 Visit Link