英夫利昔（inlfiximab）抗體ELISA試劑盒說明書

Infliximab，注冊商標為Remicade，中文名字為英利昔單抗、英夫利昔、因福利美、瑞米凱德、類克。

英夫利昔單抗（Infliximab，Remicade）是一類相對新型的生物制劑。為高親和性結合腫瘤壞死因子alpha (TNF-α)的嵌合體單抗，其被廣泛應用于治療自身免疫性疾病。因此，檢測英夫利昔單抗、抗英夫利昔抗體血藥濃度及水平在治療和個性化用藥上具有重要意義。

Matriks Biotechnology專門生產針對抗體藥的ELISA試劑盒，用于檢測抗體藥的體內濃度或因用該抗體藥產生的抗體的體內濃度。Matriks Biotek®, SHIKARI®和KLONART®為Matriks Biotechnology注冊的產品商標。其產品達到ISO 13485 & CE IVD標準。

英夫利昔(Infliximab， Remicade®) ELISA (Specific) 試劑盒

    英文名稱：SHIKARI® QS-INFLIXI ELISA KIT； 貨號：TR-QS-INFLIXlv1； 規格：96T

英文描述：Enzyme immunoassay for the quantitative determination of Infliximab (Remicade®) in serum and plasma and other biological fluids

中文描述：ELISA方法特異性定量測定血清、血漿或其他生物液體中的英夫利昔單抗(Infliximab， Remicade®)的濃度

SHIKARI Q-INFLIXI ELISA KIT使用單克隆抗體高專一性結合血清、血漿或其他生物液中的英夫利昔單抗(Infliximab， Remicade®)，是當前*一款用于定量檢測英夫利昔(Infliximab， Remicade®)體內濃度的特異性ELISA試劑盒。

引用文獻：

#		PEER REVIEWED JOURNAL ARTICLES:
1		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.**
4		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. Sep 9 2016.**
6		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 April 21, 2016.
7		Gutiérrez A, Zapater P, Juanola O, Sempere L, García M, Laveda R, Martínez A, Scharl M, González-Navajas JM, Such J, Wiest R, Rogler G, 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. Apr;111(4):529-40, 2016.
8		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. Jun; 19(2): 116–122, 2016.**
9		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 (2016) 3:155–166 **
10		Bortlik M., et al., Discontinuation of anti-tumor necrosis factor therapy in inflammatory bowel disease patients: a prospective observation. Scandinavian Journal of Gastroenterology, 2016 vol. 51, no. 2, 196–202.
11		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, Volume 14, Issue 11 Ver. IV (Nov. 2015), PP 95-100.**
14		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 (2015) 50:758–768.
16		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.
17		Farkas K. et al, Efficacy of the new infliximab biosimilar CT-P13 induction therapy in Crohn’s disease and ulcerative colitis experiences from a single center. Expert Opin. Biol. Ther. 15:(9) 2015.
18		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.
19		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.**
22		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. **
23		Khanna R., et al., Therapeutic Drug Monitoring of TNF Antagonists in Inflammatory Bowel Disease. Gastroenterology & Hepatology, August (478-489),2014. **
24		Krajcovicova A. et al., Delayed hypersensitivity reaction after initial dose of infliximab: a case report. European Journal of Gastroenterology& Hepatology 26:(485-487), 2014.
27		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.
29		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. **
30		Grosen A., et al, Infliximab concentrations in the milk of nursing mothers with inflammatory bowel disease, J Crohns Colitis 2013. **
33		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
34		Bortlik M, et al, Infliximab trough levelsmay predict sustained response to infliximab in patients with Crohn's disease, Journal of Crohn's and Colitis 2012. **
35		Malickova K, et al, Phosphatidylserine-dependent anti-prothrombin antibodies (aPS/PT) in infliximab-treated patients with inflammatory bowel diseases, Autoimmun Highlights, 2012. **
36		Takahashi H, et al, Plasma trough levels of adalimumab and infliximab in terms of clinical efficacy during the treatment of psoriasis, Journal of Dermatology 2012; 39: 1- 4. **
37		Seok Lee Y, et al, “Efficacy of Early Infliximab Treatment for Pediatric Crohn’s Disease: A Three-year Follow-up”, Pediatric Gastroenterology, Hepatology & Nutrition 2012; 15(4):243-249 **
38		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 2012; 50 - A53
39		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
40		Adisen E, et al, “Anti-infliximab antibody status and its relation to clinical response in psoriatic patients”: A pilot study, Journal of Dermatology 2010; 37: 708–713.

Matriks Biotechnology——抗體藥的藥效及個體化應用專家

抗體藥是一類相對新型的生物制劑。檢測抗體藥及其抗體水平在治療和個性化用藥上具有重要意義。大量的臨床和制藥公司都在致力于抗體藥物的濃度水平和療效的研究。Matriks生物技術公司專門生產針對抗體藥的ELISA試劑盒，用于檢測抗體藥的體內含量或因用于產生的針對相應抗體藥的抗體的體內含量。Matriks Biotek?, SHIKARI?和KLONART?為Matriks生物技術公司注冊的產品商標。其產品達到ISO 13485 & CE IVD標準。

Matriks生產用于檢測抗體藥在體內的濃度和療效的試劑盒主要針對如下幾種抗體藥。

1. Infliximab注冊商標為Remicade，由Schering-Plough生產，中文名字為英利昔單抗、英夫利昔、因福利美、瑞米凱德、類克。

Infliximab為高親和性結合腫瘤壞死因子alpha (TNF-α)的嵌合體單抗，其被廣泛應用于治療自身免疫性疾病。Matriks Biotek Shikari Infliximab ELISA使用單克隆抗體高專一性結合血清、血漿和其他生物液中的Infliximab，是當前*的一款用于定量檢測Infliximab (Remicade?)體內含量的特異性ELISA試劑盒。

2. Adalimumab注釋商標為Humira, 為Abbott Laboratories產品，中文名阿達木單抗、修美樂。

Adalimumab為特異性結合TNF-α的人源性抗體，Adalimumab通過阻止TNF-α與其細胞表面受體相結合，發揮抗炎作用。

Matriks Biotek shikari抗體檢測抗Adalimumab抗體，用于檢測治療過程中抗Adalimumab抗體狀況，為醫師提供時機以減少抗Adalimumab抗體產生（例如添加免疫抑制性藥物），以阻止抗體藥失效。

3. Etanercept商標為Enbrel和Altebrel，中文名依那西普，恩利.

是一種干擾TNF-α、用于自身免疫性疾病治療的生物藥物。針對Etanercept的特異性單抗用于檢測血樣中Etanercept量。Matriks Biotek Shikari Q-ETA是市面上用于定量檢測Etanercept的ELISA試劑盒。

4. 人腫瘤壞死因子及受體

Matriks Biotek開發的高敏感度、專一性TNF-α檢測試劑盒，該試劑盒基于固定在固相面上的針對TNF-alpha的單抗和標記了馬辣根過氧化物酶的另一單抗經三明治夾心法檢測TNF-α。

5. Bevacizumab商標名為Avastin?，由Genentech/Roche生產，中文名為阿瓦斯汀、貝伐單抗、安維汀、癌思停。

Bevacizumab為血管生成抑制劑，在包括結腸和直腸癌、肺癌、乳腺癌、腎癌、卵巢癌等多種腫瘤中被批準使用。Matriks Biotek Shikari Q-BEVA Enzyme Immunoassay用于檢測血清或血漿中游離bevacizumab含量。以便保證其有效的血藥濃度。

6. Rituximab商標為Rituxan, Mabthera, Zytux，中文名為利妥昔單抗注射劑、美羅華、利妥昔單抗、利克散、賀普丁、莫須瘤。

Rituximab為針對B細胞表面抗原CD20蛋白的嵌合型單克隆抗體。Rituximab可破壞B細胞，從而用于治療包括多種白血病、淋巴瘤、移植排斥和自身免疫失調性疾病等多種因B細胞過量、B細胞高反應性和B細胞功能失調引起的疾病。Rituximab的使用可引起機體產生相應抗體。Matriks Biotek Rituximab-ELISA和Rituximab抗體分別用于測定機體內rituximab及其抗體的水平，從而為維持有效rituximab的血藥濃度和提供抗抗體措施提供預防性舉措。

7. Trastuzumab商標名為Herclon, Herceptin，中文名為赫賽汀、賀癌平、曲妥珠單抗。

Trastuzumab為干擾HER2/neu受體的單克隆抗體，其主要用于乳腺癌的治療。Trastuzumab的使用可導致機體產生抗Trastuzumab抗體。Matriks Biotek Trastuzumab-ELISA和抗體分別用于檢測機體trastuzumab和其抗體的濃度。

Matriks Biotek抗體藥個性化用藥測試盒產品目錄

我們公司zui大優勢是強大的采購，

1：基本什么都能進口，血清，抗體，耗材，還有部分限制進口的，

2：貨品全，現經營過700多個品牌，基本所有生物試劑耗材都可以進口，特別是冷偏的產品那就更有優勢，

3：提供加急服務，一般1-2周到貨，超過時限加急費全免

4：價格公道，絕大部分價格有優勢，當然不能保證100%產品都是,因為意味著沒有服務.

5：良好的信譽，大部分客戶我們提供貨到付款服務，客戶包括清華，北大 交大 復旦，中山等100多所大學，ROCHE，阿斯利康，國藥 ，fisher等500多家公司

6：我們還是Santa,Advanced Biotechnologies Inc, Sorachim ,bangs,BBInternational,crystalchem,dianova,FD Neurotechnologies,Inc. Dako,Inc, GePromegaridege, Glycotope Biotechnology GmbH; iduron,Innovative Research of America, Ludger, neuroprobe,Sorachim , Polysciences,prospecbi, QA-BIO,quickzyme,FULLERLABS,INC,sterlitech；sysy,TriLink BioTechnologies,Inc；worthington-biochem,zyagen等幾十家國外公司授權代理。
7：我們還是invitrogen,qiagen,Sorachim am,sigma;Promega,roche,merck, rnd,BD, GE,pierce,BioLegend等*批發，歡迎合作。

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