NEW YORK – The US Food and Drug Administration said on Friday it has added a template to its website intended to facilitate submission of requests for Emergency Use Authorization of at-home sample collection kits for molecular diagnostic testing to detect SARS-CoV-2.
The template describes the data and information that labs and commercial manufacturers should submit for EUA of collection kits or tests with a home self-collection component.
Home sample collection can be submitted as part of an EUA for an RT-PCR test for SARS-CoV-2, or submitted as an amendment to an existing EUA. At-home self-sampling collection kits can also be submitted separately from molecular diagnostic tests.
The template specifies the information sample collection kit developers should provide, such as how patients will order the kits.
It notes certain sample stability studies do not need to be performed by the developers, and instead, they can use COVID-19 swab stability data from a study by Quantigen Biosciences that is offered to all developers under a right of reference.
Developers must, however, perform studies to validate the collection kits using contrived samples, 10 with high concentration of virus and 20 with low concentration. The template notes that diluted clinical samples can be used for spiking, preferably in a matrix closely replicating the clinical specimen.
The developers must add 10 negative samples as well, then perform a shipping study that includes subjecting the samples to varying temperatures.
The template also offers guidance for "alternative samples," such as saliva, that can be validated for home collection.
Finally, developers must perform a usability study in which the kits are used by at least 30 people "in an actual use environment or simulated environment." The participants should represent varying education levels and ages, and have no prior lab or medical experience or experience with self-collecting samples.
"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 Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement.
The agency noted that 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 a test.
These tests may also be used as part of a research study that complies with FDA's regulatory requirements for device investigations, including applicable requirements for IRB review, in cases where the developer has not obtained an EUA.
To date, the FDA has authorized several COVID-19 tests for use with at-home collection of samples that can then be sent to a lab for processing and test reporting. These include at-home self-collection authorizations to Laboratory Corporation of America, Everlywell, Rutgers University, Quest Diagnostics, and LetsGetChecked. The agency noted it is also aware of developers who are conducting IRB-approved studies of COVID-19 tests that use at-home collection of test samples.
However, the agency emphasized that the self-collected samples must be mailed to a lab for testing; there are no tests currently authorized to be used completely at-home.