A Novel, Quick, and Reliable Smartphone-Based Method for Serum PSA Quantification: Original Design of a Portable Microfluidic Immunosensor-Based System

SIMPLE SUMMARY: Prostate cancer (PCa) is the most frequently diagnosed malignancy and second most common cause of cancer-related death in males. An early diagnosis is crucial to improve the prognosis. Prostate-Specific Antigen (PSA) is the most widely used biomarker for PCa, but this type of biomarker analysis is performed in centralized laboratories, delaying the diagnosis and initiation of treatment. Our team has developed a miniaturized platform for portable PSA quantification to overcome this shortcoming. It includes a microfluidic chip, immune capture of PSA by magnetic microbeads, and electrochemical quantification. The utilization of a micro-potentiostat allows PSA levels to be read on a smartphone in less than 30 min. This technique was found to offer a fast, easy, specific, sensitive, and reproducible method for PSA quantification. Further research is warranted to verify these findings and explore its potential application at all health care levels. ABSTRACT: We describe a versatile, portable, and simple platform that includes a microfluidic electrochemical immunosensor for prostate-specific antigen (PSA) detection. It is based on the covalent immobilization of the anti-PSA monoclonal antibody on magnetic microbeads retained in the central channel of a microfluidic device. Image flow cytometry and scanning electron microscopy were used to characterize the magnetic microbeads. A direct sandwich immunoassay (with horseradish peroxidase-conjugated PSA antibody) served to quantify the cancer biomarker in serum samples. The enzymatic product was detected at −100 mV by amperometry on sputtered thin-film electrodes. Electrochemical reaction produced a current proportional to the PSA level, with a linear range from 10 pg mL(−1) to 1500 pg mL(−1). The sensitivity was demonstrated by a detection limit of 2 pg mL(−1) and the reproducibility by a coefficient of variation of 6.16%. The clinical performance of this platform was tested in serum samples from patients with prostate cancer (PCa), observing high specificity and full correlation with gold standard determinations. In conclusion, this analytical platform is a promising tool for measuring PSA levels in patients with PCa, offering a high sensitivity and reduced variability. The small platform size and low cost of this quantitative methodology support its suitability for the fast and sensitive analysis of PSA and other circulating biomarkers in patients. Further research is warranted to verify these findings and explore its potential application at all healthcare levels.