San Diego (KGTV)-A company in San Diego has just received emergency authorization from the U.S. Food and Drug Administration (FDA) to sell a self-inspection program for COVID-19, which can completely return home within 10 minutes.
Initially, the QuickVue At-Home COVID-19 test provided by Quidel Corporation can only be used under a doctor’s prescription, but the company’s CEO Douglas Bryant said that the company will be in the next few months. China seeks a second authorization to sell over-the-counter drugs.
He said in an interview: “If we can conduct frequent tests at home, we can protect the community and enable all of us to safely go to restaurants and schools.”
The Biden administration stated that complete at-home testing like Quidel is an emerging part of the diagnostic field, and the Biden administration stated that this is essential to normalizing life.
Over the past few months, consumers have been able to use dozens of “home collection tests”, and users can wipe them and send samples back to external laboratories for processing. However, tests for rapid tests (such as pregnancy tests) performed at home have not been widely used.
Quidel’s test is the fourth test approved by the FDA in recent weeks. Other tests include Lucira COVID-19 all-in-one test kit, Ellume COVID-19 home test and BinaxNOW COVID-19 Ag card home test.
Compared with the development of vaccines, the development of testing is slower. Critics pointed to the amount of federal funds allocated during the Trump administration. As of August last year, the National Institutes of Health had allocated US$374 million to testing companies, and pledged US$9 billion to vaccine manufacturers.
Tim Manning, a member of the White House COVID Response Team, said: “The country is far behind where we need to conduct tests, especially rapid home testing, which allows us all to return to normal work, such as Go to school and go to school.”, said last month.
The Biden administration is working hard to increase production. The US government announced an agreement last month to purchase 8.5 million home tests from an Australian company, Ellume, for $231 million. The Ellume test is currently the only test that can be used without a prescription.
The US government said it is in talks with six other unnamed companies to conduct 61 million tests before the end of the summer.
Bryant said he could not confirm whether Kidd was one of the six finalists, but he said that the company has been negotiating with the federal government to purchase a quick home test and providing an offer. Quidel has not publicly announced the price of the QuickVue test.
Like most quick tests, Quidel’s QuickVue is an antigen test that can detect the surface characteristics of the virus.
Compared to the slower polymerase chain reaction (PCR) test, which is considered the gold standard, the antigen test comes at the expense of accuracy. PCR tests can amplify tiny fragments of genetic material. This process can increase sensitivity, but requires laboratories and increases time.
Quidel said that in people with symptoms, the rapid test matches the PCR results more than 96% of the time. However, in asymptomatic people, a study found that the test found positive cases only 41.2% of the time.
Bryant said: “The medical community knows that accuracy may not be perfect, but if we have the ability to conduct frequent tests, then the frequency of such tests can overcome the lack of perfection.”
On Monday, the FDA’s authorization allowed Quidel to provide doctors with a doctor’s prescription test within six days of the first symptoms. Bryant said the authorization will enable the company to participate in multiple clinical trials to support the application of an over-the-counter drug, including a trial using a companion phone application to help users interpret the results.
At the same time, he said, doctors can prescribe “blank” prescriptions for examinations so that people who have no symptoms can enter for examinations.
He said: “According to a comprehensive prescription, doctors can authorize the use of the test they deem appropriate.”
Quidel increased the output of these tests with the help of its new manufacturing facility in Carlsbad. By the fourth quarter of this year, they plan to conduct more than 50 million QuickVue quick tests every month.
Post time: Mar-05-2021