On-Site Therapeutic Drug Monitoring for Program Death-1 Antibody Using a Quantum Dot Nanobeads-Based Lateral Flow...

Area of Science:

• Biomedical Engineering
• Analytical Chemistry
• Immunology

Background:

• Therapeutic drug monitoring (TDM) of program death-1 (PD-1) inhibitors is crucial for optimizing cancer treatment efficacy and managing adverse reactions.
• Traditional methods like LC-MS/MS and ELISA for antibody drug monitoring are time-consuming and labor-intensive, hindering rapid clinical decision-making.

Purpose of the Study:

• To develop a rapid, accurate, and point-of-care assay for monitoring PD-1 inhibitor drugs.
• To compare the performance of competitive and indirect immunoassay formats for PD-1 antibody drug monitoring.

Main Methods:

• Development of a quantum dot nanobeads-based lateral flow immunoassay (LFIA).
• Investigation and optimization of both competitive and indirect immunoassay formats.
• Validation of the optimized assay using parameters such as limit of detection, linear range, recovery, and precision.
• Assessment of assay specificity against potential interferents.
• Method comparison with ELISA using human plasma samples.

Main Results:

• The optimized competitive LFIA achieved a detection limit of 5.1 μg/mL and a linear range of 10-100 μg/mL.
• High recovery rates (99.2%-113.9%) and low coefficients of variation (<14.5%) demonstrated assay accuracy and precision.
• The assay showed negligible cross-reactivity with various biological interferents and other monoclonal antibodies.
• A good correlation (r = 0.87) was observed when comparing the LFIA results with ELISA in human plasma samples.

Conclusions:

• The developed quantum dot nanobeads-based LFIA provides a rapid (15 min) and reliable method for monitoring PD-1 antibody drugs.
• This assay is a versatile tool for personalized cancer therapy, enabling timely adjustments to treatment at the point of care.
• The LFIA offers a significant advantage over traditional methods in terms of speed and ease of use for clinical applications.