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Title:

At-Home Diagnostic Testing for Infectious Diseases: A Tool for Accelerating COVID Diagnosis and Building Pandemic Preparedness for the Future

At Home Diagnostic Testing for Infectious Diseases: A Tool for Accelerating COVID Diagnosis and Building Pandemic Preparedness for the Future
Authors:
Amesh A. Adalja; Matthew Watson; Anita Cicero; Tom Inglesby
Date posted:
June 25, 2020
Publication type:
Report
Publisher:
The Johns Hopkins Center for Health Security
See also:
Introduction:

Background and Purpose of Report

Before an infectious disease outbreak of any size can be addressed and before illness can be treated, it must be first be identified through the diagnosis of cases. Diagnostic testing is a mainstay of not only clinical medicine but also epidemiologic investigation. Limitations surrounding access to diagnostic testing have dominated much of the current response to COVID-19 and highlight the need to have more rapid, convenient, and equitable access to testing. Looking ahead, through the increasing diffusion of health technology to consumers and patients, it is becoming more feasible for diagnostic testing to be placed in the hands of the patient. Such tests when used to diagnose infectious disease, and coupled to information technology, could have a transformative benefit for future pandemic response.

The Johns Hopkins Center for Health Security conducted this study to develop an expert assessment of the promise and challenges posed by at home infectious diagnostic technologies. A major aim of this study is to inform pandemic preparedness activities that rely on diagnostic technologies and determine how at home approaches can integrate with and augment the existing diagnostic paradigm.

Findings

Home testing for human immunodeficiency virus (HIV) is a successful precedent for at home infectious disease diagnostic testing.

The development of new at home diagnostics tests will be greatly simplified by the fact that a successful at home HIV diagnostic has been on the market for several years. It is the only FDA-approved at home diagnostic test for an infectious disease. Though there are important distinctions between HIV, pandemic influenza, or other infectious disease threats, the benefits that have accrued by the availability of the HIV test are uncontested. As companies develop tests against new infectious disease targets, studying, understanding, and building off of this precedent will be important to bring new at home diagnostic products to market.

At-home influenza testing is now being pursued, largely to improve antiviral prescribing and infection control.

There are currently no at home diagnostic tests for seasonal influenza, but companies and healthcare stakeholders are keen to develop them. The current drive for at home influenza diagnostic testing is to improve both infection control and antiviral prescribing -- two important aspects of seasonal influenza response that merit improvement. Antiviral prescribing is often haphazard and not clearly evidence-based, often excluding people who would benefit from antivirals. Infection control in outpatient settings is often inadequate and provides ample opportunity for influenza transmission. By delimiting these exposures, at home tests may also decrease the force of spread of influenza.

At-home influenza testing could be harnessed to improve pandemic preparedness for COVID, influenza and beyond.

As home influenza diagnostic testing becomes available and improves seasonal influenza response, it will have direct positive impacts on pandemic influenza response. Such tests will have the capacity to identify novel influenza A strains, some of which may have pandemic potential, some of which may have regional importance, and others which will be novel excursions into humans. By employing home influenza tests, the healthcare community will improve antiviral prescribing, infection control guidance, and diagnostic capacity. All of these improvements can be harnessed to improve pandemic response. Additionally, such technologies may have the potential to be relatively easily expanded to target other respiratory viruses that may have pandemic potential. This could be accomplished through the use of platform diagnostic devices or the development of stand-alone diagnostic testing for new targets.

The novel coronavirus pandemic affords an opportunity to harness this technology in real-time. This can be accomplished by accelerating development and adapting the at home diagnostic technology to the novel coronavirus. This would serve to augment diagnostic capacity during this pandemic as well as increase crucial situational awareness about the spread of the virus. Already, there are saliva-based testing methods and at-home unsupervised nasal swab collection devices approved for use. There has been strong interest in self-testing during this pandemic and this energy could be channeled to develop such a testing capacity by increasing funding for this technology and beginning pilot projects with the end goal of having a system in place for further waves of this virus and future threats.

At-home diagnostic testing will face challenges regarding linkage to public health, costs, and uptake.

A rate limited step to the success of at home diagnostics may be their cost and the willingness of the public to utilize them. It will be important for developers to keep costs in mind and consider avenues for third-party payers to cover some or all of the costs. If costs are not prohibitive, public acceptance and use will likely occur especially after the advent of the COVID-19 pandemic in which diagnostic testing became the major issue in the early days of the pandemic.

 

 

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