Reducing hepatitis C diagnostic disparities with a fully automated deep learning-enabled microfluidic system for HCV antigen detection.

Journal: Science advances
PMID: 40106555

Abstract

Viral hepatitis remains a major global health issue, with chronic hepatitis B (HBV) and hepatitis C (HCV) causing approximately 1 million deaths annually, primarily due to liver cancer and cirrhosis. More than 1.5 million people contract HCV each year, disproportionately affecting vulnerable populations, including American Indians and Alaska Natives (AI/AN). While direct-acting antivirals (DAAs) are highly effective, timely and accurate HCV diagnosis remains a challenge, particularly in resource-limited settings. The current two-step HCV testing process is costly and time-intensive, often leading to patient loss before treatment. Point-of-care (POC) HCV antigen (Ag) testing offers a promising alternative, but no FDA-approved test meets the required sensitivity and specificity. To address this, we developed a fully automated, smartphone-based POC HCV Ag assay using platinum nanoparticles, deep learning image processing, and microfluidics. With an overall accuracy of 94.59%, this cost-effective, portable device has the potential to reduce HCV-related health disparities, particularly among AI/AN populations, improving accessibility and equity in care.

Authors

  • Hui Chen
    Xiangyang Central HospitalAffiliated Hospital of Hubei University of Arts and Science Xiangyang 441000 China.
  • Yuxin Gao
    Division of Engineering in Medicine, Division of Renal Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02139, USA.
  • Gaojian Li
    Division of Engineering in Medicine, Division of Renal Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02139, USA.
  • Manasvi Alam
    Division of Engineering in Medicine, Division of Renal Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02139, USA.
  • Srisruthi Udayakumar
    Division of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital and, Harvard Medical School, Boston, Massachusetts 02139, USA. hshafiee@bwh.harvard.edu.
  • Qazi Noorul Mateen
    Division of Engineering in Medicine, Division of Renal Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02139, USA.
  • Sahar Rostamian
    Division of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital and, Harvard Medical School, Boston, Massachusetts 02139, USA. hshafiee@bwh.harvard.edu.
  • Katherine Cilley
    Division of Engineering in Medicine, Division of Renal Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02139, USA.
  • Sungwan Kim
    Department of Biomedical Engineering, Seoul National University College of Medicine, Seoul, Republic of Korea.
  • Giwon Cho
    Division of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital and, Harvard Medical School, Boston, Massachusetts 02139, USA. hshafiee@bwh.harvard.edu.
  • Juyong Gwak
    Division of Engineering in Medicine, Division of Renal Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02139, USA.
  • Yixuan Song
    Key Laboratory of High Efficiency and Clean Mechanical Manufacture (Ministry of Education), School of Mechanical Engineering, Shandong University, Jinan 250061, China; National Demonstration Center for Experimental Mechanical Engineering Education, Shandong University, Jinan 250061, China.
  • Joseph Michael Hardie
    Division of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital and, Harvard Medical School, Boston, Massachusetts 02139, USA. hshafiee@bwh.harvard.edu.
  • Manoj Kumar Kanakasabapathy
    Division of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. hshafiee@bwh.harvard.edu.
  • Hemanth Kandula
    Division of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. hshafiee@bwh.harvard.edu.
  • Prudhvi Thirumalaraju
    Division of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. hshafiee@bwh.harvard.edu.
  • Younseong Song
    Division of Engineering in Medicine, Division of Renal Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02139, USA.
  • Azim Parandakh
    Division of Engineering in Medicine, Division of Renal Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02139, USA.
  • Arafeh Bigdeli
    Department of Chemistry , Sharif University of Technology , Tehran , 11155-9516 , Iran.
  • Gregory P Fricker
    Liver Center, Gastrointestinal Division, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.
  • Jenna Gustafson
    Liver Center, Gastrointestinal Division, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.
  • Raymond T Chung
    Liver Center, Gastrointestinal Division, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts 02114, United States.
  • Jorge Mera
    Infectious Diseases, Cherokee Nation Health Services, Tahlequah, OK, 74464, USA.
  • Hadi Shafiee
    Division of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. hshafiee@bwh.harvard.edu and Department of Medicine, Harvard Medical School, Boston, MA, USA.

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