Sam Melissa Joyce, Connor Susan Jane, Ng Watson Wa-Sang, Toong Catherine Mei-Ling
Immunology Laboratory, Department of Haematology, NSW Health Pathology, Liverpool Hospital.
Department of Medicine, South Western Sydney Clinical School, University of New South Wales; and.
Ther Drug Monit. 2020 Dec;42(6):821-828. doi: 10.1097/FTD.0000000000000795.
Therapeutic drug monitoring of tumor necrosis factor inhibitors, such as adalimumab (ADM), is increasingly being performed for the management of autoimmune diseases. However, there can be significant variation in drug and antibody concentrations obtained by different assay methods. The aim of this study was to compare the performance of 4 enzyme-linked immunosorbent assay (ELISA) kits for measuring ADM and anti-ADM antibodies.
Dilutions of ADM or anti-ADM spiked sera were assessed for recovery rate and precision using the following 4 kits: LISA-Tracker (Theradiag, Croissy-Beaubourg, France), Promonitor (Grifols, Barcelona, Spain), Ridascreen (R-Biopharm, Darmstadt, Germany), and Shikari (Matriks Biotek, Gölbaşi/Ankara Turkey). Interference samples were also assessed.
At the therapeutic concentration, ADM detection was comparable among the 4 ELISA kits. Lisa-Tracker and Shikari kits produced low-range false positive results in normal sera. Infliximab and etanercept caused false positives in Lisa-Tracker and Shikari kits. Anti-ADM antibody ELISA kits performed differently with spiked samples because of different measuring units and ranges. Ridascreen and Shikari kits were dose responsive across the entire standard curve and correlated well with each other (r = 0.997). Cross reactivity was observed in rheumatoid factor positive sera tested on the Promonitor anti-ADM kit.
All ADM kits tested were dose responsive within the therapeutic range and correlated well. The significance of observed low-range false positives and cross reactivity with infliximab in LISA-Tracker and Shikari kits is dependent on the indications received for testing in the laboratory. Anti-ADM ELISA kits produced varied results for spiked sera; however, they showed good precision. Inter-kit variability suggested that anti-ADM levels should be compared only when using the same method.
肿瘤坏死因子抑制剂（如阿达木单抗，ADM）的治疗药物监测在自身免疫性疾病管理中的应用日益广泛。然而，不同检测方法所测得的药物和抗体浓度可能存在显著差异。本研究旨在比较4种酶联免疫吸附测定（ELISA）试剂盒检测ADM及抗ADM抗体的性能。
使用以下4种试剂盒评估ADM或抗ADM加标血清的稀释液的回收率和精密度：LISA-Tracker（法国Theradiag公司，克鲁瓦西-博堡）、Promonitor（西班牙Grifols公司，巴塞罗那）、Ridascreen（德国R-Biopharm公司，达姆施塔特）和Shikari（土耳其Matriks Biotek公司，戈尔巴希/安卡拉）。同时也对干扰样本进行了评估。
在治疗浓度下，4种ELISA试剂盒对ADM的检测结果相当。Lisa-Tracker和Shikari试剂盒在正常血清中产生低范围假阳性结果。英夫利昔单抗和依那西普在Lisa-Tracker和Shikari试剂盒中导致假阳性。抗ADM抗体ELISA试剂盒对加标样本的检测结果因测量单位和范围不同而有所差异。Ridascreen和Shikari试剂盒在整个标准曲线上呈剂量反应，且相互之间相关性良好（r = 0.997）。在Promonitor抗ADM试剂盒检测的类风湿因子阳性血清中观察到交叉反应。
所有测试的ADM试剂盒在治疗范围内均呈剂量反应，且相关性良好。在Lisa-Tracker和Shikari试剂盒中观察到的低范围假阳性以及与英夫利昔单抗的交叉反应的意义取决于实验室检测所接受的指示。抗ADM ELISA试剂盒对加标血清的检测结果各不相同；然而，它们显示出良好的精密度。试剂盒间的变异性表明，只有使用相同方法时才能比较抗ADM水平。
