Yoon Jiyeol, Song Jason Jungsik, Lee Sang-Won, Park Hee Jin, Park Yong-Beom
Division of Rheumatology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul 03722, Republic of Korea.
Institute for Immunology and Immunological Diseases, Yonsei University College of Medicine, Seoul 03722, Republic of Korea.
Int J Mol Sci. 2025 Sep 8;26(17):8741. doi: 10.3390/ijms26178741.
To evaluate the analytical performance and clinical utility of the automated fluorescence-based POC immunoassay system (AFIAS), compared with established enzyme-linked immunosorbent assay (ELISA) methods for measuring adalimumab and anti-adalimumab antibodies (AAAs) in patients with rheumatoid arthritis and ankylosing spondylitis. 96 patients receiving adalimumab for rheumatoid arthritis (RA) or ankylosing spondylitis (AS) were consecutively recruited. Measurements of adalimumab trough levels and AAAs were taken before the patients' scheduled adalimumab injection. Three ELISA techniques (RIDASCREEN, IDKmonitor, and LISA TRACKER) were compared with the AFIAS method. Statistical analyses included Bland-Altman, Passing-Bablok regression, kappa values, and intraclass correlation coefficients. Clinical and demographic characteristics were examined to determine the association between adalimumab concentration and AAA detection. The diagnoses included 58 RA diagnoses and 38 AS diagnoses. The median concentrations were 9.33, 7.4, 7.4, and 9.38 µg/mL for RIDASCREEN, IDKmonitor, LISA TRACKER, and AFIAS, respectively. Strong correlations were observed between the techniques. Bland-Altman analysis revealed bias differences of 0.85, 2.03, and 2.76 µg/mL, and the Passing-Bablok regression slopes were 1.046, 1.391, and 1.274 for RIDASCREEN, IDKmonitor, and LISA TRACKER, respectively, compared with AFIAS. Agreement in AAA detection showed kappa values of 0.81 and 0.75 for AFIAS versus IDKmonitor and LISA TRACKER, respectively. A high body mass index, extended injection interval, and RA diagnosis were associated with low adalimumab concentrations in the multivariate analysis. Antinuclear antibody positivity, a higher rheumatoid factor, and disease activity were associated with AAA positivity in univariate analysis. The AFIAS POC measurement method demonstrated time-efficient and highly agreeable results for adalimumab and AAA measurements compared with the results of commercial ELISA methods.
为评估基于自动荧光的即时检验免疫分析系统（AFIAS）的分析性能和临床实用性，将其与用于测量类风湿关节炎和强直性脊柱炎患者体内阿达木单抗及抗阿达木单抗抗体（AAA）的成熟酶联免疫吸附测定（ELISA）方法进行比较。连续招募了96例接受阿达木单抗治疗类风湿关节炎（RA）或强直性脊柱炎（AS）的患者。在患者预定注射阿达木单抗之前，测量其阿达木单抗谷浓度和AAA。将三种ELISA技术（RIDASCREEN、IDKmonitor和LISA TRACKER）与AFIAS方法进行比较。统计分析包括Bland-Altman分析、Passing-Bablok回归分析、kappa值和组内相关系数。检查临床和人口统计学特征，以确定阿达木单抗浓度与AAA检测之间的关联。诊断包括58例RA诊断和38例AS诊断。RIDASCREEN、IDKmonitor、LISA TRACKER和AFIAS的中位浓度分别为9.33、7.4、7.4和9.38µg/mL。各技术之间观察到强相关性。与AFIAS相比，Bland-Altman分析显示RIDASCREEN、IDKmonitor和LISA TRACKER的偏差差异分别为0.85、2.03和2.76µg/mL，Passing-Bablok回归斜率分别为1.046、1.391和1.274。在AAA检测方面，AFIAS与IDKmonitor和LISA TRACKER的一致性kappa值分别为0.81和0.75。多变量分析显示，高体重指数、延长注射间隔和RA诊断与低阿达木单抗浓度相关。单变量分析显示，抗核抗体阳性、较高的类风湿因子和疾病活动度与AAA阳性相关。与商业ELISA方法的结果相比，AFIAS即时检验测量方法在阿达木单抗和AAA测量方面显示出高效且高度一致的结果。
