Immundiagnostik：英夫利昔单抗(Infliximab)药物浓度及药效检测试剂盒

【前期回顾】：Immundiagnostik常见单抗类药物与抗药物抗体(ADA)检测工具汇总

英夫利昔单抗(Infliximab)与抗Infliximab抗体: 

英夫利昔单抗(Infliximab)是一类抑制TNFα的药物，主要用于克罗恩病, 类风湿关节炎, 强直性脊柱炎，牛皮癣关节炎，溃疡性结肠炎的缓解和治疗。抗TNFα治疗的临床疗效通常与治疗性抗体的谷浓度相关，即下一次应用抗TNFα抗体之前的药物浓度。有几个因素影响谷浓度，其中包括抗TNFα拮抗剂输注的剂量和频率、疾病活动度、个体药代动力学和免疫反应（形成抗药物抗体，ADA）。人们认为，ADA在功能性上中和了治疗性抗体或诱导其快速消除。ADA形成的后果可能是治疗失败和抗TNFα抗体应用期间的过敏反应。  

检测的意义：检测抗英夫利昔单抗(Infliximab)药物水平可帮助监测药物水平（尤其是谷浓度），以确保药物在循环中有足够的浓度，并在必要时调整其剂量。此外，在治疗过程中，谷浓度降低表明存在药物抗体。   如果患者体内产生抗英夫利昔单抗(Infliximab)抗体，则使用抗体药的疗法会导致无用的免疫反应。这可能导致过敏反应，导致疗效降低以及治疗失败。对抗英夫利昔单抗(Infliximab)抗体水平的监测有利于早期干预（例如，增加药物剂量或频率，增加给药免疫抑制药物，切换另一种药物），从而实现有效治疗，降低副作用。   

在这里艾美捷为大家提供知名的诊断试剂和服务供应商Immundiagnostik（IDK）公司研发的爆款产品——抗英夫利昔单抗(Infliximab)药物水平检测试剂盒和抗英夫利昔单抗(Infliximab)ADA水平检测试剂盒：

相关产品推荐：

*以上产品仅用于科研，不得做医疗及诊断用途  

储存条件及有效期：本产品在2-8℃下保存可稳定至所标示的有效期。 工作洗液配制后须储存于密封容器中，在2-8℃下可保存1个月。 结合物稀释后不稳定，无法保存，须现配现用。 生产日期及失效日期见试剂盒标签。  

适用仪器：适用于具有450nm、620nm波长的所有全自动、半自动酶标仪。  

样本类型：EDTA血浆和血清

样本保存：新鲜采集的EDTA血浆或血清在室温（15-30℃）或2-8℃下可保存7天，若须长期保存，请置于-20℃下保存。 已稀释的EDTA血浆或血清样本在室温下可保存7天，在2-8℃可保存15天，在-20℃至少可保存7周。应尽量避免反复冻融，冻融次数不超过3次  

K 9655部分引文：

1. Afif W, Loftus E V, Faubion WA, Kane S V, Bruining DH, Hanson KA, et al. Clinical utility of measuring infliximab and human anti-chimeric antibody concentrations in patients with inflammatory bowel disease. The American journal of gastroenterology. 2010/02/11. 2010 May;105(5):1133–9.

2. Beglinger C, Binek J, Braegger C, Michetti P, Rogler G, Sauter B, et al. InfliximabMonotherapie versus Kombinationstherapie mit Immunmodulatoren. The medical journal. 2008;1:32–4.

3. Bender NK, Heilig CE, Dr?ll B, Wohlgemuth J, Armbruster F-P, Heilig B. Immunogenicity, efficacy and adverse events of adalimumab in RA patients. Rheumatology international. 2006/09/29. 2007 Jan 11;27(3):269–74.

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5. Bradley JR. TNF-mediated inflammatory disease. The Journal of pathology. 2008 Jan;214(2):149–60.

6. St Clair EW, Wagner CL, Fasanmade A a, Wang B, Schaible T, Kavanaugh A, et al. The relationship of serum infliximab concentrations to clinical improvement in rheumatoid arthritis: results from ATTRACT, a multicenter, randomized, doubleblind, placebo-controlled trial. Arthritis and rheumatism. 2002 Jun;46(6):1451–9.

7. Chang JT, Lichtenstein GR. Drug insight: antagonists of tumor-necrosis factor-alpha in the treatment of inflammatory bowel disease. Nature clinical practice Gastroenterology & hepatology. 2006 Apr;3(4):220–8.

8. Colombel J-F, Loftus E V, Tremaine WJ, Egan LJ, Harmsen WS, Schleck CD, et al. The safety profile of infliximab in patients with Crohn’s disease: the Mayo clinic experience in 500 patients. Gastroenterology. 2004 Jan;126(1):19–31.

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10. Cornillie F, Shealy D, D’Haens G, Geboes K, Van Assche G, C

K 9654部分引文：

1. Afif W, Loftus EV, Jr., Faubion WA, Kane SV, Bruining DH, Hanson KA, Sandborn WJ (2010). Clinical utility of measuring infliximab and human anti-chimeric antibody concentrations in patients with inflammatory bowel disease. Am J Gastroenterol 105(5): 1133-1139.

2. Kopylov U, Mazor Y, Yavzori M, Fudim E, Katz L, Coscas D, Picard O, Chowers Y, Eliakim R, Ben-Horin S (2012). Clinical utility of antihuman lambda chain-based enzyme-linked immunosorbent assay (ELISA) versus double antigen ELISA for the detection of anti-infliximab antibodies. Inflamm Bowel Dis 18(9): 1628-1633.

3. Tak PP (2012). A personalized medicine approach to biological treatment of rheumatoid arthritis: a preliminary treatment algorithm. Rheumatology 51(4): 600-609.

4. Ordas I, Mould DR, Feagan BG, Sandborn WJ (2012) Anti-TNF monoclonal antibodies in inflammatory bowel disease: pharmacokinetics-based dosing paradigms. Clin Pharmacol Ther 91(4): 635-646.

5. Bender NK, Heilig CE, Droll B, Wohlgemuth J, Armbruster FP, Heilig B (2007). Immunogenicity, efficacy and adverse events of adalimumab in RA patients. Rheumatol Int 27(3): 269-274.

K 9650部分引文：

1. Afif, W. et al., 2010. Clinical utility of measuring infliximab and human anti-chimeric antibody concentrations in patients with inflammatory bowel disease. The American journal of gastroenterology, 105(5), pp.1133–9.

2. Kopylov, U. et al., 2012. Clinical utility of antihuman lambda chain-based enzymelinked immunosorbent assay (ELISA) versus double antigen ELISA for the detection of anti-infliximab antibodies. Inflammatory bowel diseases, 18(9), pp.1628–33.

3. Tak, P.P., 2012. A personalized medicine approach to biologic treatment of rheumatoid arthritis: a preliminary treatment algorithm. Rheumatology (Oxford, England), 51(4), pp.600–9.

4. Ordás, I. et al., 2012. Anti-TNF monoclonal antibodies in inflammatory bowel disease: pharmacokinetics-based dosing paradigms. Clinical pharmacology and therapeutics, 91(4), pp.635–46.

5. Bender, N.K. et al., 2007. Immunogenicity, efficacy and adverse events of adalimumab in RA patients. Rheumatology international, 27(3), pp.269–74.

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