This article develops a novel lateral flow immunoassay platform (SBFIA) enabling rapid, sensitive detection of neutralizing anti-infliximab antibodies (nαIFX) with excellent drug tolerance and specificity. Through sequential binding strategies, the platform effectively avoids drug interference and demonstrates potential for point-of-care testing (POC) applications.
Literature Overview
This article titled 'Drug-Tolerant, Chemiluminescent Lateral Flow Immunoassay Platform for the Determination of Neutralizing Anti-Drug Antibodies' published in Small reviews recent technological advancements in detecting neutralizing anti-infliximab antibodies (nαIFX) induced by anti-tumor necrosis factor (TNF) monoclonal antibody therapies. The study focuses on developing rapid detection methods without acid dissociation pretreatment to improve clinical decision-making accuracy and timeliness.
Background Knowledge
Infliximab is a widely used TNF inhibitor for treating autoimmune diseases such as inflammatory bowel disease and rheumatoid arthritis. However, long-term treatment may induce anti-drug antibodies (ADA), particularly neutralizing anti-infliximab antibodies (nαIFX), which accelerate drug clearance and reduce therapeutic efficacy. Traditional detection methods like ELISA and electrochemiluminescence (ECL) exhibit drug sensitivity issues in nαIFX detection, typically requiring acid dissociation steps that limit their clinical applicability. While lateral flow immunoassay (LFA) technology offers convenience, it has yet to effectively distinguish nαIFX from drug-bound states. The proposed SBFIA platform addresses these challenges through sequential binding principles combined with chemiluminescent detection, offering new possibilities for rapid point-of-care diagnostics.
Research Methods and Experiments
The research team developed the SBFIA platform by immobilizing infliximab on the sample pad (SP) to capture free nαIFX antibodies, followed by binding with Reporter (R)-labeled anti-human IgG antibodies. A three-zone detection strategy was implemented on nitrocellulose membranes using tumor necrosis factor (TNF), infliximab (IFX), and anti-human Fc antibody (AHFc). During optimization, the team adjusted immobilized IFX concentration and spatial distribution to minimize background signals and enhance detection sensitivity.
Key Conclusions and Perspectives
Research Significance and Prospects
This study introduces a rapid, portable, and sensitive detection method for anti-drug antibodies, suitable for point-of-care testing (POC) applications that significantly reduce clinical decision-making timelines. Future research will focus on optimizing platform stability and expanding its application to other monoclonal antibody therapies, thereby advancing personalized treatment strategies.
Conclusion
This study introduces an innovative lateral flow immunoassay platform (SBFIA) capable of specifically and sensitively detecting neutralizing anti-drug antibodies (nαIFX) without acid dissociation pretreatment. The platform effectively eliminates drug interference through sequential binding strategies, demonstrating excellent drug tolerance and specificity. Compared to conventional ELISA, SBFIA offers significant advantages in detection speed, operational convenience, and clinical applicability, particularly for rapid diagnostics and personalized treatment decisions. This research provides new directions for anti-drug antibody detection and establishes a foundation for future POC technology development. The platform's potential extends to multiple monoclonal antibody therapies through receptor replacement.
