Evidence map›Paper›PMID 41128485›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2026

The Critical Importance of Clinical Use Case to Inform Point-of-Care Technology Development: A Case Study of HIV Nucleic Acid Assays in the United States.

Yukari C Manabe, Matthew M Hamill, Kara M Palamountain, Chad J Achenbach, Kevin P Delaney, Yu-Hsiang Hsieh, Joyce L Jones, Rebecca P Kirby, Sally M McFall, William O Osburn and 4 more

Abstract read
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 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. Review
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

14 authors.

Yukari C ManabeDivision of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0001-8619-5598
Matthew M HamillDivision of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0002-1277-819X
Kara M PalamountainKellogg School of Management, Northwestern University, Evanston, Illinois, USA.ORCID 0000-0002-8055-9706
Chad J AchenbachDivision of Infectious Diseases, Department of Medicine, Havey Institute for Global Health, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.
Kevin P DelaneyUS Centers for Disease Control, Atlanta, Georgia, USA.
Yu-Hsiang HsiehDepartment of Emergency Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0002-1616-8014
Joyce L JonesDivision of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0001-5882-0907
Rebecca P KirbyKellogg School of Management, Northwestern University, Evanston, Illinois, USA.ORCID 0000-0001-8724-7871
Sally M McFallCenter for Innovation in Point-of-Care Technologies for HIV/AIDS at Northwestern University, Evanston, Illinois, USA.ORCID 0000-0001-5554-6615
William O OsburnDivision of Cardiology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0002-7472-3805
Stuart C RayDivision of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0002-1051-7260
Richard E RothmanDepartment of Emergency Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Joanne D SteklerDepartment of Medicine, University of Washington, Seattle, Washington, USA.ORCID 0000-0001-8064-3011
David A KatzDepartment of Medicine, University of Washington, Seattle, Washington, USA.

Funding

University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI Grace C. John-Stewart · 1988 to 2026
$104.9M
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 Susan Anne Tuddenham · 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 Kara M Palamountain · 2018 to 2026
$24.0M
CDC HHS JHU - 6 U01PS005204-01-0HIV Prevention Trials Network UM1AI068613Johns Hopkins University 5P30AI094189Johns Hopkins University P30AI117943Johns Hopkins University UM1AI069471NCHHSTP CDC HHS U01 PS005196NIAID NIH HHS P30 AI027757NIAID NIH HHS UM1 AI068613NIBIB NIH HHS U54 EB007958NIBIB NIH HHS U54 EB027049NIH HHS 3U54EB027049-07S1NIH HHS U54EB007958-16NIH HHS U54EB027049-07S1University of Washington U01 PS005203)
6 · The paper itself

Abstract

In global settings, both the clinical use case and value proposition have been well articulated. This has led to the development of many point-of-care (POC) diagnostics for infectious diseases. However, in the United States, more than 80% of infectious disease diagnostics are performed in reference laboratories that have high throughput but relatively long turnaround times. As the cost of POC assays has decreased with nucleic acid test (NAT) innovation catalyzed by the coronavirus disease 2019 pandemic, we sought to develop clinical use cases for human immunodeficiency virus (HIV) NATs and the technical specifications that would tip the value proposition toward commercialization and meaningful adoption. Without POC HIV NATs, we are unlikely to achieve our collective goal of HIV elimination in the United States.

Indexed as

HIV InfectionsNucleic Acid Amplification TechniquesPoint-of-Care SystemsPoint-of-Care TestingCOVID-19HumansMolecular Diagnostic TechniquesRNA, ViralSARS-CoV-2United StatesRNA, Viralclinical use casediagnosticsHIVpoint-of-caretechnical product profile

Identifiers

PMID41128485
PMCPMC13276488

What OpenQuestion holds

Textmetadata
LicenceTDM
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 OpenQuestion graph.