On December 4, the U.S. Food and Drug Administration (FDA) announced about authorization of the first diagnostic test for at home collection of patient samples to detect both COVID-19 and influenza A and B (flu).
During the pandemic FDA tries maximally diagnostic population for flu, or COVID-19 infection. “The FDA authorized Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for prescription use with the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu by individuals who are suspected of respiratory viral infection consistent with COVID-19 when home collection is determined to be appropriate by an individual’s healthcare provider,” – the Administration comment.
COVID-19 Test Kits Statistics
Testing is our window onto the pandemic and how it is spreading. It is one of the most important tools in the fight to slow and reduce the spread and impact of the virus. Tests allow us to identify infected individuals, guiding the medical treatment that they receive. It enables the isolation of those infected and the tracing and quarantining of their contacts, and it can help allocate medical resources and staff more efficiently.
As of December 4, 2020, the United States had performed the second most COVID-19 tests per one million populations among the countries most severely impacted by the pandemic. The U.S. has conducted over 201 million COVID-19 tests in total.
At now the number of daily coronavirus tests being conducted in the United States is 52 percent of the level considered necessary to mitigate the spread of the virus, as many states struggle to increase testing. An average of 1 193 000 tests per day were performed over the past week, according to data collected by the Covid Tracking Project, well below the current nationwide target of 2.3 million daily tests.
COVID-19 and Flu Testing’s At Home
Since this testing’s clients can do at home, they need to be careful, and do it only under a health care provider’s order, patients can collect a sample at home and ship it to a Quest Diagnostics laboratory for analysis following the instructions included with the self-collection kit.
“Today’s authorization for a COVID-19 plus flu test using samples collected at home is a significant step toward FDA’s nationwide response to COVID-19. With the authorization of this test, the FDA is helping to address the ongoing fight against COVID-19 while in the middle of the flu season, which is important for many, including the most vulnerable of Americans. This is another example of the FDA working with test developers to bring important diagnostics to Americans,” said FDA Commissioner Stephen M. Hahn, M.D.
“With just one swab or sample, combination tests that are authorized for use with home-collected samples can be used to get answers to Americans faster, in the comfort and relative safety of their home, which allows patients to continue to quarantine while awaiting results. This efficiency can go a long way to providing timely information for those sick with an unknown respiratory ailment.”
Testing operations in the United States were delayed at the start of the outbreak after tests developed by the Centers for Disease Control and Prevention were found to be faulty. Since then, testing levels have steadily increased across the country, but many states have struggled to stay ahead of new outbreaks as overwhelmed labs report processing delays and shortages of crucial testing supplies. The resulting backlog can leave sick people undiagnosed, with the potential to further spread the virus as states reopen.