Self-Swab Kit for COVID-19 Test Granted Emergency Use Authorization by FDA

A kit that allows individuals to collect their own nasal swabs and ship the specimens to a lab for COVID-19 testing has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA).

The COVID-19 self-testing kit was used by researchers at Stanford Medicine (Stanford, CA, USA) in the Community Alliance to Test Coronavirus at Home (CATCH) Study that aimed to better understand the demographics of COVID-19 infection, as well as to determine if at-home sample-collection kits could boost access to accurate testing. The Vera COVID-19 Unsupervised Collection Kit was developed by Stanford University and the Chan Zuckerberg Biohub. The test kits provide organizations with a cost-effective approach to testing individuals swiftly, reliably and securely for COVID-19.

The CATCH Study also utilized the Vera Cloud Testing Platform, a COVID-19 testing and tracking tool that Stanford Medicine is using to provide testing services to multiple organizations. With the kit, individuals can self-collect a sample using a safe and gentle nasal swab in the front their nostrils. The samples are returned to the Stanford Health Care Virology Laboratory by courier or FedEx, where they are tested for SARS-CoV-2, the coronavirus that causes COVID-19. The COVID-19 self-testing kit and Vera Cloud Testing Platform are also designed to be able to integrate with other labs and organizations for broader public health monitoring.

Data from a pilot study, which involved 43 adults across a wide spectrum of age, race, ethnicity and education, showed that self-collection was reliable and easy for all participants. Every participant was able to successfully collect a sample. An EUA allows experimental treatments and tests to be used outside of research studies. With the EUA, the self-collection kit provides another tool to broaden the availability of COVID-19 testing. The self-testing kit can now be disseminated broadly to organizations, businesses and individuals, as long as samples can be returned to the Stanford Virology Laboratory, or other participating laboratories, within 48 hours. The kit can help organizations outside Stanford Medicine, such as nursing homes, companies and colleges, reliably test for the presence of SARS-CoV-2, said Patrick Arensdorf, who is director of the CATCH study.

“This emergency-use authorization creates another avenue for testing that is less resource-intensive and doesn’t require a health care worker to observe or help,” said Christina Kong, MD, vice chair of clinical affairs and medical director of Stanford Health Care’s pathology and clinical laboratories.

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