Matriks Biotek：(Q-ADA)阿达木单抗ELISA试剂盒

发布者：艾美捷科技发布时间：2024-01-22

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抗体药（Monoclonal Antibody Drugs）是一类相对新型的生物制剂，是一类使用人工合成的单克隆抗体作为药物治疗的药物。抗体药这些抗体药物通过特异性地结合目标分子或细胞表面受体，发挥治疗作用。抗体药物具有高度的特异性和亲和力，可以选择性地结合目标分子或细胞表面受体，从而干扰或调节生物过程。因此，检测抗体药血药浓度及机体针对抗体药产生的抗体水平对指导治疗和个性化用药具有重要意义。目前，大量的临床和制药企业都在从事该项研究。

Monoclonal Antibody Drugs.png

抗体药物已被广泛应用于多种疾病的治疗，包括肿瘤、自身免疫性疾病、传染病等。它们可以作为单独的治疗药物使用，也可以与其他药物联合应用，以增强治疗效果。其中应用特别广泛的阿达木单抗（Adalimumab）是一种生物制剂，属于抗肿瘤坏死因子-alpha（TNF-α）的单克隆抗体。它被用于治疗多种自身免疫性疾病，包括类风湿性关节炎、银屑病关节炎、强直性脊柱炎、乾癣性关节炎、肠道炎症性疾病（如克罗恩病和溃疡性结肠炎）等。

TNF-α.png

阿达木单抗通过结合和中和TNF-α，一种引起炎症和免疫反应的细胞因子，来减轻炎症症状和疾病进展。

Shikari (Q-ADA) Adalimumab ELISA

酶免疫分析法用于血清和血浆中阿达木单抗(Humira )的定量测定。该试剂盒专门用于定量测定血清和血浆样品中Cmin和Cmax浓度范围之间的阿达木单抗。阿达木单抗药物库登录号为DB00051

【基本信息】

样本：血清、血浆

灵敏度:与零标准区分的zui低检测限(LOD)为10ng /mL

功能灵敏度(定量限- loq): 30 ng/mL

特异性:与天然血清免疫球蛋白无交叉反应

灵敏度:CVs <30%

Inter和intra assay CV符合FDA & EMEA要求

低样品量(10-25 ?l)，即使小样品量也能满足检测要求

所有所需液体和试剂都在试剂盒中提供

试剂盒为96孔板形式，每个试剂盒可以检测90个样。

保质期至少一年，常温运输。

无放射性

Shikari(Q-ADA) Adalimumab ELISA.png

【标准曲线】

所有试剂盒符合ISO 13485质量标准，具有CE IVD标示。

校准曲线(线性、稀释线性):r2 >0.95

CE IVD.png

【参考文献】

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).

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).

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).

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.

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.

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