U.S. FDA issues emergency use authorisation for 10-minute rapid home-test kit for COVID-19
With the Quidel QuickVue test, individuals no longer need to send a sample to the laboratory as they could have the results in just 10 minutes.
Determining whether one is infected with COVID-19 could now become much easier. The U.S. Food and Drug Administration (FDA) issued an emergency use authorisation on a rapid home-test kit that will yield the result in a matter of 10 minutes.
One can avail of these tests through a prescription and those who can use it are individuals who are 14 years old and older. Although those who are eight years old and above can also use the test, the presence of an adult is a requirement to collect the nasal swab sample among younger individuals.
Fox News stated that health care providers can now issue the prescription to secure the Quidel QuickVue At-Home COVID-19 Test. Those who may be eligible are those who are suspected to have been infected with COVID-19 and are within six days of onset of the symptoms.
The FDA news release issued on Monday revealed that with the Quidel QuickVue test, individuals no longer need to send a sample to the laboratory. They could have the results of the test in a matter of 10 minutes. Quidel also announced in February that it would be establishing a manufacturing facility in Carlsbad, California. The facility will be dedicated to its QuickVue products.
"The FDA continues to prioritise the availability of more at-home testing options in response to the pandemic," stated Jeff Shuren, M.D., J.D., the FDA's Center for Devices and Radiological Health's director.
Shuren also said that the test simply shows that the agency is working with developers of tests with a goal to bring essential diagnostics to people.
Quidel, the company that developed the quick at-home test, also received an EUA in December 2020. It was for the QuickVue SARS Antigen Test. The test received an authorisation for use in labs that are certified under the Clinical Laboratory Improvement Amendments (CLIA). Every year, it aims to produce around 600 million of the QuickVue SARS rapid antigen test.
Douglas Bryant, president and CEO of Quidel, said that from the first days of the pandemic, it stepped up to meet the challenges posed by the pandemic, producing innovative diagnostic technologies that can detect coronavirus infections. He also said that the opening of its huge QuickVue manufacturing plant is the company's boldest move yet.
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