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.
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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.
