Validation Study of a New Random-Access Chemiluminescence Immunoassay Analyzer i-TRACK10^® to Monitor Infliximab and Adalimumab Serum trough Levels and Anti-Drug Antibodies.

ABSTRACT: 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

SUBMITTER: Berger AE 

PROVIDER: S-EPMC9455629 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature