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ANTIBODY TO ADALIMUMAB ELISA
Enzyme immunoassay for the quantitative and qualitative determination of free antibodies to Adalimumab (Humira®) in serum and plasma.
The solid phase (MTP) is coated by the drug Adalimumab. Due to the assay design this test measures the free antibodies which are not bound to Adalimumab. Results could be expressed in both qualitative and quantitative manner (nanogram per mililiter-ng/mL).
| Required Volume (µL) | 50 |
| Incubation Time (min) | 135 |
| Sample | Serum, Plasma |
| Package Size | 96 |
| Results in | Qualitative & Quantitative (ng/mL) |
| Shelf Life (years) | 2 |
Intended Use: This kit has been developed for the detection of anti-drug antibodies in research and diagnostic uses. It is suitable for Therapeutical Drug Monitoring (TDM) purposes.
Humira® is trademark of Abbott Laboratories.
ESSAY CHARACTERISTICS
ANALYTICAL SENSITIVITY-THRESHOLD VALUE
The Detection Threshold for the assay is 2,5 ng/mL.
The assay sensitivity for undiluted clinical samples corresponds to 5 ng/mL
Because the serum or plasma samples are instructed to be diluted at two-fold (1:2) before starting the assay.
ASSAY RANGE
For anti-Adalimumab antibodies in serum and plasma, the method has been demonstrated to be highly (>0.99 %) linear from 0 to 150 ng/mL.
ASSAY PRECISION
Intra-assay CV:
Mean
CV (%)
150 <10 50 <10 15 <10
Inter-assay CV: <10%.
ASSAY RECOVERY
Recovery rate was found to be 85-110% using native serum and plasma samples spiked with exogenous Anti Drug Antibody (ADA) positive samples.
AUTOMATION
The ImmunoGuide ADA ELISA is suitable also for being used by an automated ELISA processor.
REFERENCES
1. Romero G, Ochoteco O, Sanz DJ, Estrela-Lopis I, Donath E, Moya SE. Poly(lactide-co-glycolide) nanoparticles, layer by layer engineered for the sustainable delivery of antiTNF-α. Macromol Biosci. 2013 Jul;13(7):903-12.
2. Takahashi H, Tsuji H, Ishida-Yamamoto A, Iizuka H. Plasma trough levels of adalimumab and infliximab in terms of clinical efficacy during the treatment of psoriasis. J Dermatol. 2013;40(1):39-42.
3. Gutiérrez A, Scharl M, Sempere L, Holler E, Zapater P, Almenta I, González-Navajas JM, Such J, Wiest R, Rogler G, Francés R. Genetic susceptibility to increased bacterial translocation influences the response to biological therapy in patients with Crohn's disease. Gut. 2014;63(2):272-80.
4. Oh K, Ito S, Unno M, Kobayashi D, Azuma C, Abe A, Otani H, Ishikawa H, Nakazono K, Narita I, Murasawa A. The rate of decrease in the disease activity of rheumatoid arthritis during treatment with adalimumab depends on the dose of methotrexate. Intern Med. 2015;54(9):1035-41.
5. Chen DY, Chen YM, Hsieh TY, Hung WT, Hsieh CW, Chen HH, Tang KT, Lan JL. Drug trough levels predict therapeutic responses to dose reduction of adalimumab for rheumatoid arthritis patients during 24 weeks of follow-up. Rheumatology (Oxford). 2015 Aug 31. pii: kev298.
6. Brandse JF, Vos LM, Jansen J, Schakel T, Ponsioen CI, van den Brink GR, D'Haens GR, Löwenberg M. Serum Concentration of Anti-TNF Antibodies, Adverse Effects and Quality of Life in Patients with Inflammatory Bowel Disease in Remission on Maintenance Treatment. J Crohns Colitis. 2015;9(11):973-81.
7. Eng GP, Bendtzen K, Bliddal H, Stoltenberg M, Szkudlarek M, Fana V, Lindegaard HM, Omerovic E, Højgaard P, Jensen EK, Bouchelouche PN. Antibodies to infliximab and adalimumab in patients with rheumatoid arthritis in clinical remission: a cross-sectional study. Arthritis. 2015;2015:784825. doi: 10.1155/2015/784825.
8. Bodini G, Savarino V, Peyrin-Biroulet L, de Cassan C, Dulbecco P, Baldissarro I, Fazio V, Giambruno E, Savarino E. Low serum trough levels are associated with post-surgical recurrence in Crohn's disease patients undergoing prophylaxis with adalimumab. Dig Liver Dis. 2014;46(11):1043-6.
9. Tanida S, Mizoshita T, Nishie H, Ozeki K, Katano T, Kubota E, Kataoka H, Kamiya T, Joh T. Combination Therapy With Adalimumab Plus Intensive Granulocyte and Monocyte Adsorptive Apheresis in Patients With Refractory Ulcerative Colitis. J Clin Med Res. 2015;7(11):884-9.
10. Sohn IW, Kim ST, Kim B, Lee HJ, Park SJ, Hong SP, Kim TI, Kim WH, Cheon JH. Efficacy of Adalimumab in Korean Patients with Crohn's Disease. Gut Liver. 2015 Oct 19. doi: 10.5009/gnl15165.
11. Fox JD, Baquerizo-Nole KL, Keegan BR, Macquhae F, Escandon J, Espinosa A, Perez C, Romanelli P, Kirsner RS. Adalimumab treatment leads to reduction of tissue tumor necrosis factor-alpha correlated with venous leg ulcer improvement: a pilot study. Int Wound J. 2015 Sep 24. doi: 10.1111/iwj.12497.
INSTRUCTIONS FOR USE
SAFETY DATA SHEET
BATCH/LOT INFORMATION