Montagna M, Avanzini M A, Visai L, Locatelli F, Montillo M, Morra E, Regazzi M B
Clinical Pharmacokinetics Unit, IRCCS-Fondazione Policlinico S. Matteo, Pavia, Italy.
Int J Immunopathol Pharmacol. 2007 Apr-Jun;20(2):363-71. doi: 10.1177/039463200702000217.
Alemtuzumab is a humanized (IgG(1)) rat monoclonal antibody to CD52 antigen and is currently used in the treatment of chronic lymphocytic leukemia (CLL) and other CD52-positive lymphoproliferative disorders. Various techniques have been developed to measure Alemtuzumab levels in human serum/plasma. The authors report on the validation of a very sensitive enzyme-linked immunosorbent assay (ELISA) to measure serum concentrations of the humanized IgG(1) using a rabbit polyclonal antibody specifically produced against the rat sequence of Alemtuzumab after papain digestion. The assay was successfully applied to test the serum samples of patients with B-lymphocyte CLL who received Alemtuzumab subcutaneously. This ELISA assay could be easily used to determine human serum levels of Alemtuzumab pre- and post-treatment to optimize dosing and scheduling and to study the relationship between dose and clinical response.
阿仑单抗是一种针对CD52抗原的人源化（IgG(1)）大鼠单克隆抗体，目前用于治疗慢性淋巴细胞白血病（CLL）和其他CD52阳性淋巴细胞增殖性疾病。已经开发了各种技术来测量人血清/血浆中的阿仑单抗水平。作者报告了一种非常灵敏的酶联免疫吸附测定（ELISA）的验证情况，该测定使用经木瓜蛋白酶消化后针对阿仑单抗大鼠序列特异性产生的兔多克隆抗体来测量人源化IgG(1)的血清浓度。该测定已成功应用于检测皮下注射阿仑单抗的B淋巴细胞CLL患者的血清样本。这种ELISA测定可轻松用于确定治疗前后人血清中的阿仑单抗水平，以优化给药剂量和方案，并研究剂量与临床反应之间的关系。
