Evidence map›Paper›PMID 41369203›Full record

ArticleThe Journal of infectious diseases2026

Development of a Rapid Automated Point-of-Care Test for Hepatitis C Viral RNA on the DASH Rapid Polymerase Chain Reaction System.

Jennifer L Reed, Matthew A Butzler, Claudia A Hawkins, Yukari C Manabe, Jeffrey Holden, David L Thomas, Andrea L Cox, Sally M McFall

Abstract read
In one paragraph

Article in The Journal of infectious diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. Development of a Rapid Automated Point-of-Care Test formedRxiv : the preprint server for health sciences · 2026
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors.

Jennifer L ReedCenter for Innovation in Global Health Technologies, Robert J. Havey Institute for Global Health, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Matthew A ButzlerCenter for Innovation in Global Health Technologies, Robert J. Havey Institute for Global Health, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Claudia A HawkinsCenter for Global Communicable and Emerging Infectious Diseases, Robert J. Havey Institute for Global Health, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Yukari C ManabeDivision of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0001-8619-5598
Jeffrey HoldenDivision of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
David L ThomasDivision of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Andrea L CoxDivision of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0002-9331-2462
Sally M McFallCenter for Innovation in Global Health Technologies, Robert J. Havey Institute for Global Health, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.ORCID 0000-0001-5554-6615

Funding

LC: HIV Prevention Trials Network - Laboratory Support for the SARS-CoV-2 Seroprevalence Study (CoVPN 5002)UM1AI068613 · NIAID · JOHNS HOPKINS UNIVERSITY · PI SUSAN H ESHLEMAN, Mark A Marzinke · 2011 to 2026
$100.2M
TrainingU54EB007958 · NIBIB · JOHNS HOPKINS UNIVERSITY · PI Matthew Hamill · 2007 to 2026
$34.6M
The Center for Innovation in Point-of-Care Technologies for HIV/AIDS atNorthwestern University (C-THAN) Supplemental RequestU54EB027049 · NIBIB · NORTHWESTERN UNIVERSITY · PI Chad J Achenbach · 2018 to 2026
$24.0M
The development and pre-clinical assessment of novel HCV vaccines to generate T and B cell immunityU19AI159822 · NIAID · JOHNS HOPKINS UNIVERSITY · PI COX, ANDREA L · 2021 to 2025
$14.4M
Active HCV diagnosis to support prevention of HCC in LMICsU01CA292771 · NCI · NORTHWESTERN UNIVERSITY · PI Claudia A Hawkins, SALLY Maureen MCFALL · 2024 to 2026
$1.7M
National Institute of Allergy and Infectious DiseasesNational Institute of Biomedical EngineeringNCI NIH HHS U01 CA292771NIAID NIH HHS UM1 AI068613NIBIB NIH HHS U54 EB027049NIH HHS 1U01CA292771NIH HHS U19AI159822NIH HHS U54EB007958NIH HHS U54 EB027049
6 · The paper itself

Abstract

backgroundHepatitis C virus (HCV) infection is a major public health problem despite the availability of highly effective and curative direct-acting antiviral treatments. Low diagnostic rates, driven in part by a 2-step diagnostic process and the need for molecular confirmation, pose a significant barrier to timely treatment. Here we describe the development, analytical characterization, and a preliminary clinical validation study of a rapid, user-friendly, sensitive, qualitative molecular test for point-of-care HCV testing.

methodsThis study evaluated the analytical performance of a 15-minute time to result qualitative molecular test for HCV on the sample-to-answer point-of-care DASH Rapid PCR System. The dynamic range, limit of detection, analytical specificity, and the equivalent detection of genotypes 1-6 were assessed. A small clinical validation study was independently conducted by Johns Hopkins University investigators using retrospectively collected specimens.

resultsThe Research Use Only DASH HCV assay has wide dynamic range, can detect HCV genotypes 1-6, and has a detection limit of 200 IU/mL with 100 μL specimen volume addition. In a preliminary study of 97 plasma specimens, the DASH HCV assay demonstrated 100% positive percent agreement and 100% negative percent agreement when compared to commercial platforms.

conclusionsThe DASH HCV test holds potential to enable same-day diagnosis and treatment in support of HCV elimination efforts.

Indexed as

HepacivirusHepatitis CMolecular Diagnostic TechniquesPoint-of-Care SystemsPoint-of-Care TestingPolymerase Chain ReactionRNA, ViralGenotypeHumansRetrospective StudiesSensitivity and SpecificityRNA, Viraldiagnosishepatitis Cpoint-of-carerapid

Identifiers

PMID41369203
PMCPMC13175626

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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 Socratic graph.