Diagnostics firms developing tests for the novel coronavirus got two new tools from the US Food and Drug Administration on 29 May, as the agency released an emergency use authorization (EUA) template for tests using at-home sample collection kits, as well as a COVID-19 reference panel.
The voluntary EUA template makes recommendations for labs and commercial manufacturers hoping to submit EUA requests for molecular diagnostics using at-home sample collection kits. The 14-page document can be used to write EUAs discussing test kits that use saliva and nasal swab samples, while developers of potential tests using other sample types would need to contact the FDA individually.
In addition to providing such standard information as intended use and performance evaluation details, manufacturers completing the template are asked to discuss how patients will be selected for the test and who will write needed prescriptions, as well as how the sample will be protected during shipping. Further, the test kits should incorporate a control ensuring the collected sample is sufficient for testing.
“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.” – Jeff ShurenThe FDA authorized the first test kit allowing home sample collection in April, and a saliva-based at-home test kit followed in May. At least six tests using at-home sample collection have received EUAs. (Also see "FDA Authorizes First At-Home COVID-19 Saliva Sample Collection Kit" - Medtech Insight, 8 May, 2020.)
However, FDA device center director Jeff Shuren noted in a statement that the tests still pose additional risks. “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,” he said. “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.”
Separately, the agency announced the release of a COVID-19 (formally known as SARS-CoV-2) reference panel, which will give developers access to well-characterized reagents that can be used to compare the performance of different molecular diagnostic tests under the same conditions. Reagent panels are an extra step in the diagnostic development process that can help ensure test quality, validate new assays, calibrate tests and monitor assay performance, the agency said.
The new reference panel be available to commercial and lab developers who are working with the FDA through a pre-EUA process. The agency has provided similar reference panels in previous outbreaks, such as 2015’s Zika outbreak.