The US Food and Drug Administration (FDA) announced on Monday that it has issued an emergency use authorization for the ACON Laboratories Flowflex COVID-19 Home Test.
Over-the-counter (OTC) COVID-19 antigen tests are added to the list of tests that can be used at home without a prescription.
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Authorities expect approval to double rapid home inspection capabilities in the coming weeks, with ACON capable of over 100 million monthly inspections by the end of the year and 200 million monthly inspections by February. He said he had sex. 2022.
“This action underscores our ongoing commitment to increasing the availability of adequately accurate and reliable OTC testing to meet public health needs and increase consumer access to testing. “Masu,” said Jeffrey E. Schlen, director of the FDA’s Device and Radiation Health Center., Said in a statement.
Since March 2020, the FDA has reportedly approved more than 400 COVID-19 testing and sampling equipment.
Most antigen tests for home use allow the same person to be tested or tested multiple times in a row within a few days.
Based on asymptomatic personal data, the ACON Laboratories Flowflex COVID-19 home test does not require continuous testing.
These approvals follow the previous commitment to streamline the path of the COVID-19 screening tool, Supplementary template For test developers seeking emergency use authorization for specific tests for serial test screening and publishing Fact sheet This outlines the considerations when choosing a test to use in a screening test program.
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With that release, the FDA reminded patients and users that all tests can experience false negatives and false positives.—Positive result.
Authorities also emphasized the importance of home diagnostic testing in the fight against coronavirus.
“We believe that home diagnostic testing plays an important role in the fight against COVID-19. We help develop properly accurate and reliable tests for all Americans. We will continue to provide support and expertise to drive increased access to testing, “Schlen wrote.
San Diego-based ACON Laboratories Inc. said in its own accompanying statement that nasal swab tests will soon be available for purchase at major retailers and online, with nasal swabs collected by individuals over the age of 14 or adults. Said it will be used. Children up to 2 years old.
“Flow, as opposed to other home tests (a process known as serial screening) that require two tests within a 2-3 day period.flex The COVID-19 Antigen Home Test is approved for use as a single test by an individual, with or without symptoms. This will allow us to distribute more affordable single test packages and improve access to home testing, “says ACON Laboratories.
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In a December speech, President Biden promised that the government would purchase 280 million tests and use the Defense Production Act to ensure that manufacturers have access to the raw materials needed for the tests. Emphasized rapid testing.
The government is spending about $ 2 billion on this initiative.
The Associated Press contributed to this report.
FDA approves another COVID-19 home inspection
Source link FDA approves another COVID-19 home inspection