A fully automated, ultrasensitive luminescence cascade sensor to address hepatitis C diagnostic disparity

Viral hepatitis poses a significant global health burden, with chronic hepatitis B and C causing about 1 million annual deaths from liver cancer and cirrhosis. Over 1.5 million new hepatitis C virus (HCV) cases arise yearly, especially among vulnerable groups like American Indians and Alaska Natives (AI/AN). Despite effective direct-acting antivirals, early HCV diagnosis remains challenging, particularly in resource-limited settings. Current two-step testing methods are costly and prone to patient dropout. Point-of-care (POC) HCV antigen (Ag) testing offers a promising early detection approach, but no US Food and Drug Administration (FDA)-approved POC test meets the sensitivity and specificity needed for low viral loads. To address this, we developed a fully automated bioluminescence-based POC assay using a cascade-based signal amplification strategy. Evaluated on 71 AI/AN samples, it showed 97% sensitivity, 94% specificity, and 96% accuracy. This technology can improve health equity by enabling accessible and reliable HCV testing for disproportionately affected populations.

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Publication Details

Journal
The Innovation
Published
2025-05-15
DOI
https://doi.org/10.1016/j.xinn.2025.100952
Primary Topic
Hepatitis C virus research
Type
article
Field-Weighted Citation Impact
0.00

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article

A fully automated, ultrasensitive luminescence cascade sensor to address hepatitis C diagnostic disparity

Gregory P. Fricker, Raymond T. Chung, Manoj Kumar Kanakasabapathy, Joseph Hardie et al.
The Innovation
Hepatitis C virus research
article

A fully automated, ultrasensitive luminescence cascade sensor to address hepatitis C diagnostic disparity

Gregory P. Fricker, Raymond T. Chung, Manoj Kumar Kanakasabapathy, Joseph Hardie, Jaebaek Lee, Hemanth Kandula, Hadi Shafiee, Jenna Gustafson, Juhyeon Chun, Prudhvi Thirumalaraju, Sungwan Kim, Jorge Mera, Adharsh Chellappaa
article en

Abstract

Viral hepatitis poses a significant global health burden, with chronic hepatitis B and C causing about 1 million annual deaths from liver cancer and cirrhosis. Over 1.5 million new hepatitis C virus (HCV) cases arise yearly, especially among vulnerable groups like American Indians and Alaska Natives (AI/AN). Despite effective direct-acting antivirals, early HCV diagnosis remains challenging, particularly in resource-limited settings. Current two-step testing methods are costly and prone to patient dropout. Point-of-care (POC) HCV antigen (Ag) testing offers a promising early detection approach, but no US Food and Drug Administration (FDA)-approved POC test meets the sensitivity and specificity needed for low viral loads. To address this, we developed a fully automated bioluminescence-based POC assay using a cascade-based signal amplification strategy. Evaluated on 71 AI/AN samples, it showed 97% sensitivity, 94% specificity, and 96% accuracy. This technology can improve health equity by enabling accessible and reliable HCV testing for disproportionately affected populations.

The InnovationVol. 6(8)
Brigham and Women's Hospital (US), Harvard University (US), Massachusetts General Hospital (US)
National Institutes of Health, National Heart, Lung, and Blood Institute, National Institute of Allergy and Infectious Diseases, National Institute of Biomedical Imaging and Bioengineering
Openalex Percentile: Top 84%
Hepatitis C virus research
DOIOpen Access PDFOpenAlex
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