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.

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.