FDA Adds At-Home Self-Collection Template to SARS-CoV-2 Emergency Use Authorization Guidance

The US Food and Drug Administration said 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.

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.

Source: https://www.genomeweb.com/regulatory-news-fda-approvals/fda-adds-home-self-collection-template-sars-cov-2-emergency-use