CIRI-Centre International de Recherche en Infectiologie, Team GIMAP (Saint-Etienne), Université Claude Bernard Lyon 1, Inserm, U1111, CNRS, UMR5308, ENS Lyon, UJM, F69007 Lyon, France.
CIC Inserm 1408 Vaccinology, F42023 Saint-Etienne, France.
Int J Mol Sci. 2022 Aug 24;23(17):9561. doi: 10.3390/ijms23179561.
. Monitoring of biological TNF inhibitors is a very important tool to guide clinical decisions using specialized algorithms, especially in gastroenterology. A new chemiluminescent instrument (i-TRACK from Theradiag) could replace ELISA techniques to calculate the dosage of drugs and anti-drug antibodies. In this bi-centric study, we explored the analytical performances of i-TRACK using manual or automated (DS2) ELISA Lisa-Tracker assays, and compared the results. . Intra- and inter-run performances were evaluated with i-TRACK in two different laboratories and for two different ranges of values for infliximab, adalimumab, and their respective antibodies. Patients' samples were used in the labs to compare the results obtained between the new instrument and either the manual Lisa-Tracker or the automated DS2. . Intra- and inter-run performances were satisfactory, with values between 1.8% and 16.1% (for inter-run imprecision at low/medium values of infliximab). Results were generally comparable between assays. with the lowest value of correlation at 0.59 (anti-adalimumab dosage between i-TRACK and manual ELISA). Most often, values of drugs and anti-drug antibodies were higher with i-TRACK than with manual ELISA assay, and correlation values were better with automated ELISA. Agreements were globally acceptable, and the lowest coefficients of 0.7 was obtained for adalimumab values between i-TRACK and the two ELISA methods, and for anti-adalimumab values between i-TRACK and manual ELISA. The type of assay can potentially induce a change in the class of patients and lead to divergent therapeutic decisions. . The new random-access instrument i-TRACK presents many advantages in a routine laboratory: rapidity, the possibility of standardization, usability, and expansion of the measurement range. Despite the relatively good agreement of results, it is preferable to use the same assay in longitudinal follow-up of a patient, because quantitative results were not completely equivalent especially for anti-drug antibodies.
. 生物 TNF 抑制剂的监测是指导临床决策的重要工具，特别是在胃肠病学领域。一种新的化学发光仪器（Theradiag 的 i-TRACK）可以替代 ELISA 技术来计算药物和抗药物抗体的剂量。在这项双中心研究中，我们使用手动或自动化（DS2）ELISA Lisa-Tracker 测定法探索了 i-TRACK 的分析性能，并比较了结果。. 在两个不同的实验室中，使用 i-TRACK 评估了批内和批间性能，并比较了结果。在实验室中使用患者样本来比较新仪器与手动 Lisa-Tracker 或自动化 DS2 之间获得的结果。. 批内和批间性能令人满意，值介于 1.8%至 16.1%之间（在低/中值时，批间精密度为 infliximab）。结果在测定法之间通常具有可比性，相关性最低值为 0.59（i-TRACK 和手动 ELISA 之间的抗 adalimumab 剂量）。通常，与手动 ELISA 测定法相比，药物和抗药物抗体的值用 i-TRACK 更高，并且与自动化 ELISA 的相关性值更好。总体而言，一致性是可以接受的，并且 i-TRACK 与两种 ELISA 方法之间的 adalimumab 值以及 i-TRACK 与手动 ELISA 之间的抗 adalimumab 值的相关性系数最低为 0.7。测定法的类型可能会导致患者分类的变化，并导致治疗决策的分歧。. 新的随机存取仪器 i-TRACK 在常规实验室中具有许多优势：快速、标准化的可能性、易用性和测量范围的扩展。尽管结果具有较好的一致性，但在患者的纵向随访中最好使用相同的测定法，因为定量结果并不完全等效，特别是对于抗药物抗体。
