Helena Cerutti , Giulia Tesi , Francesco Petrini , Tommaso Bandini , Alessandra Cartocci , Andrea Ianniello , Alessia Bogi , Chiara Muzzi , Alessandra Brogi
{"title":"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","authors":"Helena Cerutti , Giulia Tesi , Francesco Petrini , Tommaso Bandini , Alessandra Cartocci , Andrea Ianniello , Alessia Bogi , Chiara Muzzi , Alessandra Brogi","doi":"10.1016/j.plabm.2024.e00374","DOIUrl":null,"url":null,"abstract":"<div><h3>Objective</h3><p>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).</p></div><div><h3>Desing and methods</h3><p>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.</p></div><div><h3>Results</h3><p>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.</p></div><div><h3>Conclusion</h3><p>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.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"39 ","pages":"Article e00374"},"PeriodicalIF":1.7000,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000209/pdfft?md5=5a0d77dccb5d4f96d63fe3c41f27ee35&pid=1-s2.0-S2352551724000209-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Detection of infliximab, adalimumab, and anti-drug antibodies: Development and validation of new monotest, automated assays on multiparametric instrument\",\"authors\":\"Helena Cerutti , Giulia Tesi , Francesco Petrini , Tommaso Bandini , Alessandra Cartocci , Andrea Ianniello , Alessia Bogi , Chiara Muzzi , Alessandra Brogi\",\"doi\":\"10.1016/j.plabm.2024.e00374\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objective</h3><p>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).</p></div><div><h3>Desing and methods</h3><p>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.</p></div><div><h3>Results</h3><p>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.</p></div><div><h3>Conclusion</h3><p>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.</p></div>\",\"PeriodicalId\":20421,\"journal\":{\"name\":\"Practical Laboratory Medicine\",\"volume\":\"39 \",\"pages\":\"Article e00374\"},\"PeriodicalIF\":1.7000,\"publicationDate\":\"2024-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S2352551724000209/pdfft?md5=5a0d77dccb5d4f96d63fe3c41f27ee35&pid=1-s2.0-S2352551724000209-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Practical Laboratory Medicine\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2352551724000209\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICAL LABORATORY TECHNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Practical Laboratory Medicine","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2352551724000209","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}
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.
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.