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Shikari® (S-ATA) Anti-Adalimumab ELISA w/confirmation

Enzyme immunoassay for the quantitative determination of antibodies to Adalimumab (Humira®) in serum and plasma with confirmation.

This kit has been especially developed for the quantitative determination of antibodies to Adalimumab in serum and plasma samples.

Adalimumab (Humira®) was associated to the development of anti-Adalimumab antibodies, even some were reported to be neutralizing, in various percentages of patients during therapy with the drug Humira®. This might lead to severe complications. This kit can be efficiently used for monitoring anti-Adalimumab antibodies during therapy and offers the clinician a tool for decision on possible preventive measures such as possible addition of immunosuppressive drug to reduce anti-Adalimumab antibodies.

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

Required Volume (µl) 20
Total Time (min) 140
Sample Serum, plasma
Sample Number 96
Detection Limit (ng/mL) 7,5
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
Validation Report Download
Safety Data Sheet (SDS) 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
Linares, Raquel, et al. "Transcriptional regulation of chemokine network by biologic monotherapy in ileum of patients with Crohn’s disease." Biomedicine & Pharmacotherapy 147 (2022): 112653. Visit Link
Kim, Eun Sil, et al. "Albumin-to-Globulin Ratio at 1 Year after Anti-Tumor Necrosis Factor α Therapy Can Serve as a Prognostic Biomarker in Pediatric Crohn’s Disease Patients." Gut and Liver 16.1 (2022): 71. 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
De Gregorio, Michael, et al. "Higher Anti-tumor Necrosis Factor-α Levels Correlate With Improved Radiologic Outcomes in Crohn’s Perianal Fistulas." Clinical Gastroenterology and Hepatology (2021). 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
Pękala, Anna, and Rafał Filip. "Anti-Drug Antibodies in Patients with Inflammatory Bowel Diseases Treated with Biosimilar Infliximab: A Prospective Cohort Study" Journal of Clinical Medicine (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
Kim, Mi Jin, et al. "Therapeutic Drug Monitoring of Adalimumab During Long-term Follow-up in Paediatric Patients With Crohn Disease." Journal of Pediatric Gastroenterology and Nutrition 72.6 (2021): 870-876. 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
Choi, So Yoon, et al. "Potential Utility of Therapeutic Drug Monitoring of Adalimumab in Predicting Short-Term Mucosal Healing and Histologic Remission in Pediatric Crohn's Disease Patients." Journal of Korean Medical Science 35.16 (2020). 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
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
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
Shirai, Shimpei, et al. "Immunogenicity of Quadrivalent Influenza Vaccine for Patients with Inflammatory Bowel Disease Undergoing Immunosuppressive Therapy." Inflammatory bowel diseases 24.5 (2018): 1082-1091. Visit Link
Sugita, Naoko, et al. "Efficacy of a concomitant elemental diet to reduce the loss of response to adalimumab in patients with intractable Crohn's disease." Journal of gastroenterology and hepatology 33.3 (2018): 631-637. 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
Ward, M. G., et al. "Intra-patient variability in adalimumab drug levels within and between cycles in Crohn's disease." Alimentary pharmacology & therapeutics 45.8 (2017): 1135-1145. 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
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
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
Bodini G., Edoardo G. Giannini, Edoardo V. Savarino, and Vincenzo Savarino. Adalimumab Trough Levels and Response to Biological Treatment in Patients With Infl ammatory Bowel Disease: A Useful Cutoff in Clinical Practice. Am J Gastroenterol., Vol.110, 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
Khanna R., et al., Therapeutic Drug Monitoring of TNF Antagonists in Inflammatory Bowel Disease. Gastroenterology & Hepatology, (478-489),2014. Visit Link
Avdeeva A.A., Aleksandrova E.N., Karateev D.E., Luchikhina E.L., Novikov A.A., Cherkasova M.V., Nasonov E.L. Efficacy Of Adalimumab In Early Rheumatoid Arthritis In Relation To Its Serum Level And The Presence Of Anti-Drug Antibody, Rheumatology Science and Practice, 52(6):624–630, 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
Romero G., et al, Poly(Lactide-co-Glycolide) Nanoparticles, Layer by Layer Engineered for the Sustainable Delivery of AntiTNF-α. Macromol. Biosci. 13: (903–912), 2013. Visit Link
Bodini G, Savarino V, Fazio V, et al. Relationship Between Drug Serum Co ncentration and Clinical Activity in Patients With Crohn Disease Who Achieved Remission With Adalimumab – a Prospective Study,Aga, Volume 142, Issue 5, Supplement 1, Page S-388, 2012. Visit Link
Choi, So Yoon, et al. "Potential Utility of Therapeutic Drug Monitoring of Adalimumab in Predicting Short-Term Mucosal Healing and Histologic Remission in Pediatric Crohn's Disease Patients." Journal of Korean Medical Science 35.17 (2020). Visit Link
Little, R., et al. "P709 Is there a difference in adalimumab drug levels according to pen vs. syringe use: An international, multi-centre retrospective analysis." Journal of Crohn's and Colitis 12.supplement_1 (2018): S469-S470. 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
Julsgaard M., et al, Intra-uterine Exposure to Anti-TNF-alpha therapy (ERA study):Infliximab and adalimumab cord blood levels correlate with maternal levels at birth, 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
Julsgaard M, et al, Time since last drug exposure in pregnancy determines Adalimumab and Infliximab levels in neonates(Era Study), Italy 2014. Visit Link
Bodini G, et al, Correlation between Adalimumab trough serum concentration, Anti-Adalimumab antibodies and TNF-Alpha levels with clinical outcome in patients affected by Crohn’s disease,. United European Gastroenterology. Italy 2013. 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