Cargando…
Validation Study of a New Random-Access Chemiluminescence Immunoassay Analyzer i-TRACK10(®) to Monitor Infliximab and Adalimumab Serum trough Levels and Anti-Drug Antibodies
Background. 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(10®) from Theradiag) could replace ELISA techniques to calculate the dosage of drugs and a...
Autores principales: | , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9455629/ https://www.ncbi.nlm.nih.gov/pubmed/36076966 http://dx.doi.org/10.3390/ijms23179561 |
_version_ | 1784785621037875200 |
---|---|
author | Berger, Anne Emmanuelle Gleizes, Aude Waeckel, Louis Roblin, Xavier Krzysiek, Roman Hacein-Bey-Abina, Salima Soriano, Alessandra Paul, Stephane |
author_facet | Berger, Anne Emmanuelle Gleizes, Aude Waeckel, Louis Roblin, Xavier Krzysiek, Roman Hacein-Bey-Abina, Salima Soriano, Alessandra Paul, Stephane |
author_sort | Berger, Anne Emmanuelle |
collection | PubMed |
description | Background. 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(10®) 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(10®) using manual or automated (DS2(®)) ELISA Lisa-Tracker(®) assays, and compared the results. Patients and methods. Intra- and inter-run performances were evaluated with i-TRACK(10®) 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. Results. 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(10®) and manual ELISA). Most often, values of drugs and anti-drug antibodies were higher with i-TRACK(10®) 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(10®) and the two ELISA methods, and for anti-adalimumab values between i-TRACK(10®) and manual ELISA. The type of assay can potentially induce a change in the class of patients and lead to divergent therapeutic decisions. Conclusions. The new random-access instrument i-TRACK(10®) 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. |
format | Online Article Text |
id | pubmed-9455629 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-94556292022-09-09 Validation Study of a New Random-Access Chemiluminescence Immunoassay Analyzer i-TRACK10(®) to Monitor Infliximab and Adalimumab Serum trough Levels and Anti-Drug Antibodies Berger, Anne Emmanuelle Gleizes, Aude Waeckel, Louis Roblin, Xavier Krzysiek, Roman Hacein-Bey-Abina, Salima Soriano, Alessandra Paul, Stephane Int J Mol Sci Article Background. 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(10®) 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(10®) using manual or automated (DS2(®)) ELISA Lisa-Tracker(®) assays, and compared the results. Patients and methods. Intra- and inter-run performances were evaluated with i-TRACK(10®) 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. Results. 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(10®) and manual ELISA). Most often, values of drugs and anti-drug antibodies were higher with i-TRACK(10®) 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(10®) and the two ELISA methods, and for anti-adalimumab values between i-TRACK(10®) and manual ELISA. The type of assay can potentially induce a change in the class of patients and lead to divergent therapeutic decisions. Conclusions. The new random-access instrument i-TRACK(10®) 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. MDPI 2022-08-24 /pmc/articles/PMC9455629/ /pubmed/36076966 http://dx.doi.org/10.3390/ijms23179561 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Berger, Anne Emmanuelle Gleizes, Aude Waeckel, Louis Roblin, Xavier Krzysiek, Roman Hacein-Bey-Abina, Salima Soriano, Alessandra Paul, Stephane Validation Study of a New Random-Access Chemiluminescence Immunoassay Analyzer i-TRACK10(®) to Monitor Infliximab and Adalimumab Serum trough Levels and Anti-Drug Antibodies |
title | Validation Study of a New Random-Access Chemiluminescence Immunoassay Analyzer i-TRACK10(®) to Monitor Infliximab and Adalimumab Serum trough Levels and Anti-Drug Antibodies |
title_full | Validation Study of a New Random-Access Chemiluminescence Immunoassay Analyzer i-TRACK10(®) to Monitor Infliximab and Adalimumab Serum trough Levels and Anti-Drug Antibodies |
title_fullStr | Validation Study of a New Random-Access Chemiluminescence Immunoassay Analyzer i-TRACK10(®) to Monitor Infliximab and Adalimumab Serum trough Levels and Anti-Drug Antibodies |
title_full_unstemmed | Validation Study of a New Random-Access Chemiluminescence Immunoassay Analyzer i-TRACK10(®) to Monitor Infliximab and Adalimumab Serum trough Levels and Anti-Drug Antibodies |
title_short | Validation Study of a New Random-Access Chemiluminescence Immunoassay Analyzer i-TRACK10(®) to Monitor Infliximab and Adalimumab Serum trough Levels and Anti-Drug Antibodies |
title_sort | validation study of a new random-access chemiluminescence immunoassay analyzer i-track10(®) to monitor infliximab and adalimumab serum trough levels and anti-drug antibodies |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9455629/ https://www.ncbi.nlm.nih.gov/pubmed/36076966 http://dx.doi.org/10.3390/ijms23179561 |
work_keys_str_mv | AT bergeranneemmanuelle validationstudyofanewrandomaccesschemiluminescenceimmunoassayanalyzeritrack10tomonitorinfliximabandadalimumabserumtroughlevelsandantidrugantibodies AT gleizesaude validationstudyofanewrandomaccesschemiluminescenceimmunoassayanalyzeritrack10tomonitorinfliximabandadalimumabserumtroughlevelsandantidrugantibodies AT waeckellouis validationstudyofanewrandomaccesschemiluminescenceimmunoassayanalyzeritrack10tomonitorinfliximabandadalimumabserumtroughlevelsandantidrugantibodies AT roblinxavier validationstudyofanewrandomaccesschemiluminescenceimmunoassayanalyzeritrack10tomonitorinfliximabandadalimumabserumtroughlevelsandantidrugantibodies AT krzysiekroman validationstudyofanewrandomaccesschemiluminescenceimmunoassayanalyzeritrack10tomonitorinfliximabandadalimumabserumtroughlevelsandantidrugantibodies AT haceinbeyabinasalima validationstudyofanewrandomaccesschemiluminescenceimmunoassayanalyzeritrack10tomonitorinfliximabandadalimumabserumtroughlevelsandantidrugantibodies AT sorianoalessandra validationstudyofanewrandomaccesschemiluminescenceimmunoassayanalyzeritrack10tomonitorinfliximabandadalimumabserumtroughlevelsandantidrugantibodies AT paulstephane validationstudyofanewrandomaccesschemiluminescenceimmunoassayanalyzeritrack10tomonitorinfliximabandadalimumabserumtroughlevelsandantidrugantibodies |