The Food and Drug Administration (FDA) authorized the first home-made sample collection kit on Saturday for testing by various tests for the coronavirus.
The $ 135 kit from Everlywell, Inc can be used by an individual to collect nasal samples at home and then send them to specialized laboratories that would detect the presence of COVID-19.
Authorized laboratories to analyze samples are Fulgent Therapeutics and Assurance Scientific Laboratories. The results will be released through Everlywell’s network of independent physicians and the company’s online portal.
The “Everlywell COVID-19 Test Home Collection Kit”, which contains nasal swabs and a tube of saline, may be used by people who have previously been examined through an online questionnaire that is reviewed by a specialist.
“Authorizing a COVID-19 home collection kit that can be used with multiple tests in multiple laboratories not only provides greater patient access to tests, but also protects others from possible exposure,” said Jeffrey. Shuren, director of the FDA’s Center for Devices and Radiological Health.
The kit and associated tests are available only by prescription.
The FDA has provided new guidelines to the White House in the face of new information that a rapid COVID-19 test used by President Donald Trump and others every day can provide inaccuracies and false negative results.
The FDA also authorized two diagnostic tests for COVID-19, performed in specific laboratories, for use with samples collected using the Everlywell COVID-19 Test Home Collection Kit.
Previously, the FDA announced other home sample collection tests: one that tests a nasal sample and another that allows the analysis of a saliva sample collected by the patient at home.
However, this kit would be the only one that can be used with multiple authorized diagnostic tests of COVID-19.
The FDA approved the kit, which would soon be available for free sale to the public.