Moneo Mikel, Ruiz Del Agua Ainhoa, Ruiz-Argüello Begoña, Rapun Noelia, Nagore Daniel, El Hamss Rachid
Product Development and Support, Progenika Biopharma, SA, Derio, Spain.
Research and Development, Progenika Biopharma, SA, Derio, Spain.
Clin Chem Lab Med. 2025 Jan 9;63(6):1160-1168. doi: 10.1515/cclm-2024-1258. Print 2025 May 26.
To compare a new ready-to-use monotest immunoassay, CHORUS Promonitor, for the quantification of serum biological drug levels and anti-drug antibodies of anti-TNF agents, against the reference batch-based ELISA test, Promonitor.
Blood samples were collected from patients treated with anti-TNF agents, infliximab (IFX) or adalimumab (ADL). IFX and ADL levels, as well as anti-IFX and anti-ADL antibodies were quantified and compared between the standard ELISA reference test, Promonitor, and the automated monotest ELISA assay, CHORUS Promonitor. Data analysis included both qualitative and quantitative comparison between both tests. For the qualitative comparison, overall percent agreement (OPA) was calculated. For the quantitative comparison, Passing-Bablok regression analysis and Bland-Altman analysis were used.
For IFX and ADL levels, the qualitative overall agreement between methods was 100 % (Cohen's coefficient=1). For anti-IFX and anti-ADL antibodies, OPA was 98.8 % and 97.3 %, respectively. Quantitative comparison indicated a very strong correlation between both assays: IFX (r=0.97, n=74), ADL (r=0.95, n=54), anti-IFX (r=0.93, n=72), and anti-ADL (r=0.97, n=61). The regression analysis determined an excellent comparability of drug levels between methods. Bland-Altman analysis showed a bias difference between assays of 6 % for IFX, 0 % for ADL, 24 % for anti-IFX, and 14 % for anti-ADL.
Monotest CHORUS Promonitor was a reliable assay to quantify IFX, ADL, anti-IFX and anti-ADL in samples with comparable results to those obtained with the reference batch-based ELISA technique.
比较一种新的即用型单一检测免疫测定法CHORUS Promonitor与基于批次的参考酶联免疫吸附测定法（ELISA）Promonitor，用于定量血清中生物药物水平以及抗TNF药物的抗药物抗体。
采集接受抗TNF药物英夫利昔单抗（IFX）或阿达木单抗（ADL）治疗的患者的血样。对IFX和ADL水平以及抗IFX和抗ADL抗体进行定量，并在标准ELISA参考检测Promonitor和自动化单一检测ELISA测定法CHORUS Promonitor之间进行比较。数据分析包括两种检测方法的定性和定量比较。对于定性比较，计算总体一致性百分比（OPA）。对于定量比较，采用Passing-Bablok回归分析和Bland-Altman分析。
对于IFX和ADL水平，两种方法之间的定性总体一致性为100%（科恩系数=1）。对于抗IFX和抗ADL抗体，OPA分别为98.8%和97.3%。定量比较表明两种测定法之间具有非常强的相关性：IFX（r=0.97，n=74），ADL（r=0.95，n=54），抗IFX（r=0.93，n=72），抗ADL（r=0.97，n=61）。回归分析确定了两种方法之间药物水平具有良好的可比性。Bland-Altman分析显示，两种检测方法之间的偏差差异为：IFX为6%，ADL为0%，抗IFX为24%，抗ADL为14%。
单一检测CHORUS Promonitor是一种可靠的测定法，用于定量样本中的IFX、ADL、抗IFX和抗ADL，其结果与基于批次的参考ELISA技术相当。
