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

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.

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Publication Details

Journal
Clinical Infectious Diseases
Published
2025-09-12
DOI
https://doi.org/10.1093/cid/ciaf510
Primary Topic
Ethics in Clinical Research
Type
article
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article

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

Kevin P. Delaney, Kara Palamountain, Stuart C. Ray, Richard E. Rothman et al.
Clinical Infectious Diseases
Ethics in Clinical Research
article

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

Kevin P. Delaney, Kara Palamountain, Stuart C. Ray, Richard E. Rothman, Rebecca P. Kirby, Matthew M. Hamill, Yukari Carol Manabe, Yu‐Hsiang Hsieh, William O. Osburn, Sally M. McFall, Joanne D. Stekler, David A. Katz, Joyce L Jones, Chad J. Achenbach
article en

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.

Clinical Infectious DiseasesVol. 82(1)
Northwestern University (US), Centers for Disease Control and Prevention (US), Johns Hopkins University (US), University of Washington (US), Johns Hopkins Medicine (US), Kellogg's (Canada) (CA)
Openalex Percentile: Top 59%
Ethics in Clinical Research
DOISourceOpenAlex
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