The U.S Food and Drug Administration (FDA) has issued an emergency authorization allowing the first coronavirus at-home sample collection kit. According to Gizmodo's latest report, FDA announced on Saturday, May 16, that COVID-19 at-home sample collection kit is approved that will allow consumers to collect their own nasal sample at the premises of their house and then sending them off to their assigned medical experts for further testing and observation.
The FDA's website announced that the emergency use authorization (EUA) was provided to EverlyWell Incorporated for its COVID-19 Test Home Collection Kit. It also clarified that only those who are screened using an online questionnaire and reviewed by the health care provider will be allowed to use the at-home sample collection kit.
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The EverlyWell COVID-19 Test Home Collection Kit will be done at specific laboratories. This at-home collection kit may also be authorized in the future. The data demonstrate each trial's effectiveness when used by EverlyWell at the home-collection kit-- it already been submitted in a EUA request.
FDA says yes to COVID-19 at-home sample collection kit issuing emergency authorization for self-collect nasal samples
Jeffrey Shuren, J.D., M.D., and director of the FDA's Center for Devices and Radiological Health, stated that the approval of FDA for EverlyWell at-home collection kit can be used with multiple samples at multiple labs. It does not only provide at-home accessibility but lessens physical contact to protect other people from potential exposure, including medical experts and other front line workers.
"Today's action is also another great example of public-private partnerships in which data from a privately funded study was used by industry to support a EUA request, saving precious time as we continue our fight against this pandemic," said Jeffrey.
The EUA provided by FDA permits the testing of samples from inside the patient's nose, which collected by the EverlyWell COVID-19 Test Home Collection Kit. The nasal swabs will be collected and stored in a tube filled with saline. Then be transported back to a specific CLIA-certified laboratory. One of the in vitro diagnostic molecular tests, which can be used with the EverlyWell at-home collection kit authorized under separate EUA, will also be conducted in the CLIA-certified lab; FDA also authorizes assurance Scientific Laboratories and Fulgent Therapeutics lab.
EverlyWell's independent physician network and its online portal will send back the results to the patients. The home-collection kit of EverlyWell is currently the only authorized at-home sample collection kit. However, Associated tests and the kit itself is only available by prescription.