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 received an emergency-use authorization from the Food and Drug Administration.
The COVID-19 self-swab kit used by Stanford Medicine researchers in the Community Alliance to Test Coronavirus at Home (CATCH) Study was granted emergency-use authorization by the Food and Drug Administration on Nov. 24.
The purpose of the CATCH Study is 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 kits provide organizations with a cost-effective approach to testing individuals swiftly, reliably and securely for COVID-19.
The CATCH Study, led by Yvonne Maldonado, MD, professor of pediatric infectious diseases and of health research and policy; Stephen Quake, PhD, professor of bioengineering and of applied physics; and Lorene Nelson, PhD, associate professor of health research and policy, 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 self-swab kit and Vera Cloud Testing Platform are also designed to be able to integrate with other labs and organizations for broader public health monitoring.
An emergency-use authorization allows experimental treatments and tests to be used outside of research studies. The self-swab kit received emergency-use authorization with help from Color, a health technology company that collaborated on the early kit development and facilitated the FDA application process. Technical assistance was provided by the Bill & Melinda Gates Foundation
“I am thrilled to see this work translate from research to clinical application,” said Quake, Lee Otterson Professor in the School of Engineering and co-president of the Chan Zuckerberg Biohub, and one of the project leaders.
The kits use a nasal swab provided by Parkdale-Mills subsidiary U.S. Cotton and SteriPack. This swab was developed through a clinical program supported by UnitedHealth Group, the Gates Foundation and Quantigen. 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.
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.
With the emergency-use authorization, the self-collection kit provides another tool to broaden the availability of COVID-19 testing. 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.
Development of the self-collection kit and Vera Cloud Platform has also benefited from technological contributions from many vendors and collaborators, including Gauss Surgical, ixLayer, Nuvalence, SenPex, DaklaPackand Microsoft.
More information is available on the Vera website.
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