Evaluating Random-Access CLIA for Anti-TNF Drug Monitoring: a Comparison with Traditional ELISA

Area of Science:

• Clinical Chemistry
• Immunology
• Pharmacology

Background:

• Accurate therapeutic drug monitoring (TDM) of anti-tumor necrosis factor (anti-TNF) biologics like infliximab and adalimumab is crucial for managing inflammatory diseases.
• Monitoring corresponding antibodies is essential for optimizing patient treatment efficacy and safety.

Purpose of the Study:

• To evaluate the analytical and clinical performance of the new i-TRACK10 chemiluminescence immunoassay (CLIA) system.
• To compare the i-TRACK10 system with established LISA Tracker enzyme-linked immunosorbent assay (ELISA) kits for TDM of anti-TNF agents.

Main Methods:

• Analyzed 200 clinical serum samples for infliximab, adalimumab, and their antibodies using both i-TRACK10 and ELISA platforms.
• Assessed method agreement using Deming regression, Bland-Altman analysis, and Lin's concordance correlation, adhering to CLSI EP09-A3 guidelines.
• Calculated positive/negative agreement and precision using sample sets and controls.

Main Results:

• The i-TRACK10 showed strong association (Pearson's r: 0.91-0.95) and high positive/negative agreement (>95%) with ELISA.
• Concordance varied (Lin's CCC: 0.75-0.93) due to method biases, confirmed by Deming regression and Bland-Altman analysis.
• Demonstrated low intra- and inter-assay variability (CV < 5%), rapid turnaround, expanded ranges, and random-access operation.

Conclusions:

• The i-TRACK10 analyzer is a reliable and accurate alternative to ELISA for anti-TNF biologic TDM.
• Its enhanced automation and performance characteristics facilitate integration into routine clinical laboratory workflows.
• The system offers an efficient solution for optimizing anti-TNF therapy management.