The FDA has taken steps to further support the development of COVID-19 tests for at-home self-collection by including a voluntary EUA template for at-home sample collection kits to its website.
As explained in FDA’s guidance, Policy for COVID-19 Tests During the Public Health Emergency (Revised), this template reflects FDA’s current thinking on the data and information that developers should submit to facilitate the EUA process. In particular, this template includes recommendations for use by laboratories and commercial manufacturers who may use it to facilitate the preparation and submission of an EUA request.
Currently, developers can offer a COVID-19 test for at-home self-collection under emergency use authorization (EUA), and COVID-19 tests for at-home self-collection may also be used as part of an Institutional Review Board (IRB)-approved study.
“During this pandemic, the FDA has remained supportive of making accurate and reliable tests widely available,” said said Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. “Home collection raises unique concerns about safety and accuracy – for example, can the sample be collected safely and properly by a layperson, can the sample be shipped in a way that’s stable to ensure an accurate result once it reaches the lab, among other factors – which is why these tests require FDA review, to ensure they work as they should and are safe for all involved.
“An at-home test that returns false results could be harmful to an individual patient, and hinder broader public health efforts to mitigate the spread of COVID-19. We’ll continue to support ways of making our review processes as streamlined as possible, while continuing to protect patients and the public health.”
For COVID-19 diagnostic tests that use at-home specimen collection kits and are intended for use in clinical decision making, developers are generally required to submit a request for an EUA prior to distribution and use of such test. In cases where the developer has not obtained an EUA, these tests may be used as part of a research study that complies with FDA’s regulatory requirements for device investigations, including applicable requirements for IRB review.
The FDA has authorized several COVID-19 tests for use with at-home collection of samples — such as from the nose or saliva — that can then be sent to a lab for processing and test reporting, and the agency is also aware of developers who are conducting IRB-approved studies of COVID-19 tests that use at-home collection of test samples.
However, there are not currently any tests that are authorized to be used completely at-home.
Image credit: NIAID. Novel Coronavirus SARS-CoV-2. Colorized scanning electron micrograph of an apoptotic cell (green) heavily infected with SARS-COV-2 virus particles (red), isolated from a patient sample. Image captured and color-enhanced at the NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland.