Point-of-Care Detection of HER2 and CA 15-3 in Breast Cancer Patients: Dual-Channel Biosensor Implementation

Abstract

Breast cancer remains a considerable health challenge, affecting numerous individuals annually. This research introduces an innovative method for detecting breast cancer utilizing dual-channel test strips capable of simultaneously assessing two key biomarkers—HER2 and CA 15-3. The test strip utilized in this study is not only cost-effective but also entirely non-invasive. The reusable device employs a printed circuit board with metal-oxide-semiconductor field-effect transistor amplification and Arduino-based control to convert voltage signals from test strips into digital readings efficiently. The device utilizes double-pulse measurement instead of direct current, effectively mitigating the screening effect. The detection limit for both biomarkers is exceptionally low at 10−15 g ml−1, surpassing commercial enzyme-linked immunoassay kits by four orders of magnitude. The sensor demonstrates remarkable sensitivity, with 78/dec for HER2 and 56/dec for CA 15-3. Human sample tests were conducted to validate the efficacy of the dual-channel strip, successfully distinguishing between healthy and cancerous groups. The results reveal significant p-values for both HER2 and CA 15-3 tests, underscoring the significance of this research. Note that this is a rapid testing process, completed in less than 2 s. These findings offer a promising avenue for swift and accurate breast cancer detection, furnishing crucial insights for early diagnosis and subsequent treatment.