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

Author:

Wan Hsiao-HsuanORCID,Zhu Haochen,Chiang Chao-ChingORCID,Xia XinyiORCID,Li Jian-SianORCID,Ren Fan,Tsai Cheng-Tse,Liao Yu-Te,Chou Tai-Cheng,Neal Dan,Esquivel-Upshaw Josephine F.

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.

Funder

National Institute of Dental and Craniofacial Research

Hsinchu Science Park Bureau, Ministry of Science and Technology, Taiwan

Publisher

The Electrochemical Society

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