FDA releases EUA template for COVID-19 home sample collection kits
The US Food and Drug Administration (FDA) on Friday released a new emergency use authorization (EUA) template to assist test makers in developing at-home sample collection kits for use with tests for coronavirus disease (COVID-19).The new template comes after FDA authorized several tests and a standalone sample collection kit for at-home sample collection from testing companies including LabCorp, Quest Diagnostics, Everlywell and PrivaPath Diagnostics. (RELATED: FDA authorizes first COVID-19 test for at-home sample collection, Regulatory Focus 21 April 2020; FDA issues EUA for saliva-based COVID-19 test, provides path for wider home sample collection, Regulatory Focus 8 May 2020; Standalone at-home COVID-19 nasal swab kit receives EUA, Regulatory Focus 18 May 2020).
The template specifically applies to home sample collection for molecular diagnostic testing and does not extend to nonprescription or over-the-counter tests for COVID-19. Additionally, the template only covers home collection kits that use anterior nares swab or saliva specimens; test makers looking to develop tests for at-home sample collection using other sample types are instructed to contact FDA to discuss their validation strategy.
Within the template, FDA explains what data and information should be included in an EUA submission to support the use of a home collection kit.
FDA also explains that tests for COVID-19 featuring home-sample collection can only be used under an EUA or an institutional review board-approved study.
“During this pandemic, the FDA has remained supportive of making accurate and reliable tests widely available. 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,” said FDA’s Center for Devices and Radiological Health Director Jeff Shuren.
FDA