检测英夫利西单抗、阿达木单抗和抗药性抗体:在多参数仪器上开发和验证新型单测法、自动测定法

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY Practical Laboratory Medicine Pub Date : 2024-03-01 DOI:10.1016/j.plabm.2024.e00374
Helena Cerutti , Giulia Tesi , Francesco Petrini , Tommaso Bandini , Alessandra Cartocci , Andrea Ianniello , Alessia Bogi , Chiara Muzzi , Alessandra Brogi
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引用次数: 0

摘要

目的将手动 ELISA 试剂盒转换为全自动免疫测定,以定量检测血清中英夫利昔单抗和阿达木单抗的药物水平和抗药抗体水平(CHORUS Promonitor 试剂盒)。设计与方法将CHORUS Promonitor INFLIXIMAB、CHORUS Promonitor ADALIMUMAB、CHORUS Promonitor ANTI-INFLIXIMAB和CHORUS Promonitor ANTI-ADALIMUMAB试剂盒与相应的Promonitor试剂盒进行比较,以确定测定的灵敏度和特异性。对于自动测试,从样品稀释到最终读数的整个过程均由 CHORUS TRIO 仪器(意大利 DIESSE 公司)完成。来自临床实验室检查的残留人体血清样本和添加特定药物(IFX 或 ADL)或抗药物抗体(抗-IFX 或抗-ADL)的样本被用于鉴定和验证检测结果。所有检测结果都准确且可重复,因为在运行内、运行间、批次和仪器之间都观察到了可接受的变异性。结论在临床前开发过程中,这些试剂盒灵敏、特异、准确,能够定量检测参比药物或相应的生物仿制药。所有这些特点都支持将它们用于临床实践,对接受 IFX 或 ADL 治疗的炎症性疾病患者进行治疗药物监测。
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Detection of infliximab, adalimumab, and anti-drug antibodies: Development and validation of new monotest, automated assays on multiparametric instrument

Objective

To convert manual ELISA kits to fully automated immunoassays that quantify serum drug levels and anti-drug antibodies levels of infliximab and adalimumab (CHORUS Promonitor kits).

Desing and methods

CHORUS Promonitor INFLIXIMAB, CHORUS Promonitor ADALIMUMAB, CHORUS Promonitor ANTI-INFLIXIMAB, and CHORUS Promonitor ANTI-ADALIMUMAB kits were compared with the corresponding Promonitor kits to determine sensitivity and specificity of the assays. For the automated assays, the entire procedure -from samples dilution to final readouts-was performed by CHORUS TRIO instrument (DIESSE, Italy). Residual human serum samples from clinical laboratory investigations and samples resulting from the addition of specific drugs (IFX or ADL) or anti-drug antibodies (anti-IFX or anti-ADL) were used for the characterization and validation of the tests.

Results

CHORUS Promonitor kits showed an excellent agreement (Cohen's coefficient = 1) with the Promonitor kits and were linear within predefined ranges. All assays were accurate and repeatable, as an acceptable variability were observed within runs, between runs, lots, and instruments. No difference in detecting the reference drug or biosimilars emerged.

Conclusion

During preclinical development, these kits resulted as sensitive, specific, accurate, and able to quantify either the reference drug or the corresponding biosimilars. All these features support their use in clinical practice for therapeutic drug monitoring of patients with inflammatory diseases under treatment with IFX or ADL.

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来源期刊
Practical Laboratory Medicine
Practical Laboratory Medicine Health Professions-Radiological and Ultrasound Technology
CiteScore
3.50
自引率
0.00%
发文量
40
审稿时长
7 weeks
期刊介绍: Practical Laboratory Medicine is a high-quality, peer-reviewed, international open-access journal publishing original research, new methods and critical evaluations, case reports and short papers in the fields of clinical chemistry and laboratory medicine. The objective of the journal is to provide practical information of immediate relevance to workers in clinical laboratories. The primary scope of the journal covers clinical chemistry, hematology, molecular biology and genetics relevant to laboratory medicine, microbiology, immunology, therapeutic drug monitoring and toxicology, laboratory management and informatics. We welcome papers which describe critical evaluations of biomarkers and their role in the diagnosis and treatment of clinically significant disease, validation of commercial and in-house IVD methods, method comparisons, interference reports, the development of new reagents and reference materials, reference range studies and regulatory compliance reports. Manuscripts describing the development of new methods applicable to laboratory medicine (including point-of-care testing) are particularly encouraged, even if preliminary or small scale.
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