Evidence map›Paper›PMID 40814338›Full record

ArticleInnovation (Cambridge (Mass.))2025

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

Sungwan Kim, Adharsh Chellappaa, Juhyeon Chun, Jaebaek Lee, Joseph M Hardie, Manoj K Kanakasabapathy, Hemanth Kandula, Prudhvi Thirumalaraju, Gregory P Fricker, Jenna Gustafson and 3 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Innovation (Cambridge (Mass.)), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Sungwan KimDivision of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02139, USA.
Adharsh ChellappaaDivision of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02139, USA.
Juhyeon ChunDivision of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02139, USA.
Jaebaek LeeDivision of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02139, USA.
Joseph M HardieDivision of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02139, USA.
Manoj K KanakasabapathyDivision of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02139, USA.
Hemanth KandulaDivision of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02139, USA.
Prudhvi ThirumalarajuDivision of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02139, USA.
Gregory P FrickerLiver Center, Gastrointestinal Division, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.
Jenna GustafsonLiver Center, Gastrointestinal Division, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.
Raymond T ChungLiver Center, Gastrointestinal Division, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.
Jorge MeraInfectious Diseases, Cherokee Nation Health Services, Tahlequah, OK 74464, USA.
Hadi ShafieeDivision of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02139, USA.

Funding

Boston Biomedical Innovation CenterU54HL119145 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI GOLAN, DAVID E., LOSCALZO, JOSEPH · 2013 to 2021
$18.8M
A smartphone-enabled point-of-care HCV Ag diagnostic using catalytic nanoparticles and AI-enhanced image processingR01EB033866 · NIBIB · BRIGHAM AND WOMEN'S HOSPITAL · PI SHAFIEE, HADI · 2022 to 2025
$3.3M
Microchip for HBV testing using HIV-infected blood samplesR01AI138800 · NIAID · BRIGHAM AND WOMEN'S HOSPITAL · PI SHAFIEE, HADI · 2019 to 2023
$3.1M
Rare sperm screening and retrieval with a domain-adaptive deep learning-enabled microwell system.R01HD115677 · NICHD · BRIGHAM AND WOMEN'S HOSPITAL · PI Martin Kathrins, Hadi Shafiee · 2024 to 2026
$2.2M
A mobile health diagnostic device for HIV self-testingR33AI140489 · NIAID · BRIGHAM AND WOMEN'S HOSPITAL · PI SHAFIEE, HADI · 2022 to 2023
$1.8M
Rapid point of care Hepatitis C virus detection using a long-lasting luminescent cascade signal amplificationR01AI187513 · NIAID · BRIGHAM AND WOMEN'S HOSPITAL · PI Hadi Shafiee · 2025 to 2026
$1.8M
A mobile health diagnostic device for HIV self-testingR61AI140489 · NIAID · BRIGHAM AND WOMEN'S HOSPITAL · PI SHAFIEE, HADI · 2019 to 2021
$1.6M
NHLBI NIH HHS U54 HL119145NIAID NIH HHS R01 AI138800NIAID NIH HHS R01 AI187513NIAID NIH HHS R33 AI140489NIAID NIH HHS R61 AI140489NIBIB NIH HHS R01 EB033866NICHD NIH HHS R01 HD115677
6 · The paper itself

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.

Indexed as

bioluminescence-based diagnosticshealth disparityhepatitis C viruspoint-of-care testingviral antigen test

Identifiers

PMID40814338
PMCPMC12347247

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.