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At-home sample collection kit may be used for easy and convenient diagnosis of COVID-19.
The Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) on 15 May.2020, to a renowned diagnostic health testing services organization for its COVID-19 Test Home Collection Kit.
This kit will only be available by prescription to people screened via an online questionnaire and reviewed by a healthcare provider. Nasal swabs for sample collection and a tube filled with saline to transport samples back to a particular CLIA-certified lab are included in this kit. Thereafter, the results will be provided through the organization’s physician network and online portal within 48 hours. The designated laboratories (Fulgent Therapeutics and Assurance Scientific Laboratories) will test samples collected. In future, additional tests and labs may be allowed for use with the kit as per the FDA.
As the individuals will be able to use the kit at home, it can help protect others from possible exposure, said director of the FDA’s Center for Devices and Radiological Health. This kit is expected to be available for purchase by the month-end.
Everlywell, Inc
FDA Authorizes At-Home Sample Collection Kit for Use With Multiple COVID-19 Diagnostics
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