Detection of infliximab levels and anti-infliximab antibodies: a comparison of three different assays
Detection of infliximab levels and anti-infliximab antibodies: a comparison of three different assays
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DOI：
10.1111/apt.12030
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发表时间：
2012-10-01
影响因子：
7.6
通讯作者：
Dijkstra, G.
中科院分区：
文献类型：
--
作者：
Casteele, N. Vande;Buurman, D. J.;Dijkstra, G.
背景：英夫利昔单抗(ATI)抗体的形成与功能性药物水平和临床结果呈负相关。药物水平的比较和抗药物抗体的监测因缺乏标准化而受到阻碍。目的确定英夫利昔单抗与血管紧张素转换酶抑制剂(ATI)三种不同测定方法之间的相关性。方法采用荷兰Sanquin阿姆斯特丹公司(A)、比利时鲁汶大学药物生物学实验室(B)和法国巴黎生物医学诊断公司(BMD)提供的试剂盒(C)和荷兰格罗宁根大学医学中心(UMCG)开发的英夫利昔单抗和ATI试剂盒(C)，对62例血清标本和加标对照进行盲法检测。结果所有英夫利昔单抗检测结果均呈线性相关(A与B、A与C、B与C的皮尔森相关系数分别为0.91、0.83、0.73)。试验C在A和B未检测到的11个样本(18%)中检测到英夫利昔单抗，包括仅含有ATI的样本。所有ATI检测均显示良好的线性相关性(A与B、A与C、B与C的Pearson r分别为0.95、0.99、0.97)。A法在B、C法未检出的5例低ATI患者标本中检测到ATI，B法未根据A、C法检测到3例低ATI患者的ATI。结论英夫利昔单抗与英夫利昔单抗抗体测定之间有很好的相关性。然而，生物医学诊断试剂盒在18%的样本中检测到英夫利昔单抗水平的假阳性。
Background Formation of antibodies to infliximab (ATI) inversely correlates with functional drug levels and clinical outcome. Comparison of drug levels and anti-drug antibody monitoring is hampered by lack of standardisation. Aim To determine the correlation between three different assays for measuring infliximab and ATI. Methods Serum samples and spiked controls (total 62) were evaluated in a blinded way in infliximab and ATI assays developed by Sanquin Amsterdam, Netherlands (A), Laboratory for Pharmaceutical Biology, KU Leuven, Belgium (B) and a commercially available kit from Biomedical Diagnostics (BMD), Paris, France (C) performed by the University Medical Center Groningen (UMCG), Netherlands. Results All infliximab assays showed a linear quantitative correlation (Pearson r = 0.91 for A vs. B, 0.83 for A vs. C and 0.73 for B vs. C). Assay C detected infliximab in 11 samples (18%) not detected by A and B, including samples containing only ATI. All ATI assays showed a good linear correlation (Pearson r = 0.95 for A vs. B, 0.99 for A vs. C and 0.97 for B vs. C). Assay A detected ATI in five samples with low ATI that were not detected by assays B and C. Assay B did not detect ATI in three patient samples with low ATI according to assays A and C. Conclusions There is a good correlation of infliximab and antibodies to infliximab measurements between these assays. Nevertheless, the Biomedical Diagnostics kit detected false positive infliximab levels in 18% of the samples.