1Assistant Professor, Department of Biomedical Engineering, Easwari Engineering College, M.E., (Ph.D). Email: shruthikumar2710@gmail.com
2Assistant Professor, Department of Biomedical Engineering, Dr. NGP Institute of Technology, M.E. Email: vishnumee94@gmail.com
3Assistant Professor, Department of Electronics and Communication Engineering, Nandha College of Technology, M.E., (PhD Pursuing). Email: stamilselviece@gmail.com
4Assistant Professor, Department of Electronics and Communication Engineering, Jawaharlal College of Engineering and Technology, M.E., PhD. Email: boopathi.0052@gmail.com
5Assistant Professor, Department of Biomedical Engineering, Bannari Amman Institute of Technology Sathyamangalam, M.E., (PhD pursuing). Email: syedalthaf@bitsathy.ac.in
6Assistant Professor, Department of Biomedical Engineering, Karpagam Academy of Higher Education, M.Tech., Ph.D. Email: mohanarathinam@gmail.com
Corresponding Author: Dr. Mohanarathinam A, Assistant Professor, Department of Biomedical Engineering, Karpagam Academy of Higher Education. Email: 0208pavithra@gmail.com
Background: Timely and accurate detection of cancer biomarkers plays a crucial role in early diagnosis, monitoring, and management of malignant diseases. Conventional diagnostic platforms, although highly sensitive, are often limited by their dependence on centralized laboratory infrastructure, trained personnel, and extended processing times.
Objective: To address these limitations, this study presents a technically feasible design for a self-administered, multiplex lateral flow assay (LFA) capable of detecting six clinically relevant tumor markers: prostate-specific antigen (PSA), cancer antigens CA 125, CA19 9, CA 15 3/27 29, carcinoembryonic antigen (CEA), and Tumor M2 Pyruvate Kinase (M2 PK). These biomarkers are commonly associated with prostate, ovarian, breast, colorectal, and pancreatic cancers and are frequently used in oncology for screening, prognosis, and disease monitoring.
Platform Design: The proposed LFA platform is based on a conventional strip format composed of four primary components: the sample pad, conjugate pad, nitrocellulose membrane with defined test and control lines, and an absorbent pad. To enhance detection performance, the assay incorporates nanomaterial-based labels such as gold nanoparticles, quantum dots, and magnetized carbon nanotubes, which facilitate increased signal intensity and lower detection thresholds. Published prototypes and experimental studies have demonstrated detection limits for individual biomarkers ranging from 10 pg/mL for PSA to 0.02–0.04 U/mL for CA125 and CA19 9—values significantly below established clinical cutoffs.
Sample Processing and Detection: The system is designed to support dual sample types: finger-prick whole blood for PSA, CA 125, CEA, CA19 9, and CA 15 3/27 29; and stool samples for Tumor M2 PK, using an integrated sample preparation and extraction kit. A multiplex format is employed on the nitrocellulose membrane to allow simultaneous detection of multiple analytes, each aligned with dedicated antibody test lines. A smartphone-compatible optical reader or handheld reader device will be used to quantify line intensities and translate them into semi-quantitative results, expressed in approximate U/mL concentrations, with clinical interpretation guidance provided via a digital interface or mobile application. Estimated detection time for the complete assay is within 20 to 35 minutes, making it suitable for point-of-care (POC) and at-home testing scenarios. The components can be lyophilized and housed in a sealed cassette format to ensure reagent stability and extend shelf life under various environmental conditions.
Challenges and Future Directions: Despite promising analytical performance demonstrated in prototype systems, several challenges must be addressed for real-world deployment. These include variability in sample matrices, the need for robust calibration and quality control, potential cross-reactivity in multiplex configurations, and ensuring ease of use by non-professional users. Regulatory compliance, including CE marking and FDA clearance, will require clinical validation studies to assess diagnostic accuracy, sensitivity, specificity, and usability in intended populations.
Conclusion: In conclusion, this self-testing LFA platform represents a promising direction in decentralized cancer diagnostics. It combines the accessibility of rapid testing with the sophistication of multiplex biomarker detection, enhanced by nanotechnology and digital integration.
Keywords: Lateral Flow Assay (LFA), Self-testing, Cancer Biomarkers, PSA, CA 125, CEA, CA19 9, CA 15 3/27 29, Tumor M2 PK, Multiplex Detection, Nanoparticles, Point-of-Care Testing (POCT), Early Cancer Diagnosis, Biosensor, Clinical Sensitivity, At-Home Diagnostics.
How to cite this article: Shruthi K, Vishnulakshmi K, Tamilselvi S, Boopathi Raja K, Syed Althaf S, Mohanarathinam A. Advanced Self-Testing Lateral Flow Platform for Multiplex Detection of Oncological Biomarkers Using Nanomaterial Enhancements. Int J Drug Deliv Technol. 2026;16(12s): 658-664. DOI: 10.25258/ijddt.16.12s.78
Source of support: Nil.
Conflict of interest: None