SHIKARI® T-CAP Nab Assay™-Adalimumab ELISA Kit
ADA-TCAP-NAb-HUM
Target Capture Neutralizing Antibodies Immunoassay-Adalimumab
Enzyme immunoassay to detect neutralizing antibodies to adalimumab in serum and plasma samples
This kit has been developed for detecting ‘Free’ neutralizing antibodies to adalimumab. 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 | |
| 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 (2022): 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 20.6 (2022): 1306-1314. | 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 | |
| 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 | |
| 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 | |
| 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." J Crohn’s Colitis 13 (2019): S449-S45050. | 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 | |
| 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 | |
| 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 (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, 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 | |
| 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 | |
| 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 | |
| Bodini, Giorgia, et al. "Adalimumab trough levels and response to biological treatment in patients with inflammatory bowel disease: a useful cutoff in clinical practice." Official journal of the American College of Gastroenterology| ACG 110.3 (2015): 472- | 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 | |
| Khanna, Reena, et al. "Therapeutic drug monitoring of TNF antagonists in inflammatory bowel disease." Gastroenterology & Hepatology 10.8 (2014): 478. | 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 | |
| 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 | |
| Romero, Gabriela, et al. "Poly (L actide‐co‐G lycolide) Nanoparticles, Layer by Layer Engineered for the Sustainable Delivery of AntiTNF‐α." Macromolecular bioscience 13.7 (2013): 903-912. | 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 | |
| Bodini, Giorgia, et al. "Sa2045 Relationship between drug serum concentration and clinical activity in patients with Crohn disease who achieved remission with adalimumab-a prospective study." Gastroenterology 5.142 (2012): S-388. | 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 | |
| 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 | |
| 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. "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 | |
| Julsgaard, M., et al. "Intra-uterine exposure to anti-TNF-alpha therapy (ERA study): Neonatal levels of TNF antibodies correlate with duration of therapy in pregnancy." (2013). | 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 | |
| Julsgaard, Mette, et al. "Adalimumab and Infliximab levels in neonates correlate with duration of treatment in pregnancy (ERA study)." United European Gastroenterology Journal (2014). | Visit Link | |
| Bodini, Giorgia, et al. "Tu1169 Correlation Between Adalimumab Trough Serum Concentration, Anti-Adalimumab Antibodies and TNF-α Levels With Clinical Outcome in Patients Affected by Crohn's Disease." Gastroenterology 5.144 (2013): S-780. | 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 | |
| SALDIVAR, EMMANUEL ANTONIO ORTIZ. "Asociación entre el perfil de citocinas pro-inflamatorias, los eventos inmunogénicos y la actividad clínica en pacientes con artritis reumatoide tratados con infliximab y adalimumab." (2019). | Visit Link | |
| Szántó, Kata Judit. Crucial Steps for Treatment Optimization and Decision Making in Inflammatory Bowel Disease Management. Diss. Szegedi Tudomanyegyetem (Hungary), 2022. | 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 |
