COVID-19 antigen assays, a new category of diagnostics for use in the present pandemic, have received their initial emergency use authorization EUA,antigenski test methods that use swabs taken from the nasal passage to test for protein fragments present on or inside the pathogen are rapid and accurate.
Quidel Corporation received the EUA for SARS Antigen FIA late on Friday, utilized in high and moderate complex laboratories approved by the Clinical Laboratory Improvement Amendments aka CLIA, and in facilities operating under CLIA Certificate of Waiver is permitted for this test.
Corona Virus is a Threat to Everyone!
COVID-19 is a major threat to the United States, and the FDA maintains to take steps to ensure that life-saving diagnostic tests are obtainable, including by issuing Emergency Use Authorizations also known as EUAs. In this pandemic, the FDA has authorized EUAs for two types of tests:
1st PCR tests, can detect the virus’s genetic material and can assist in diagnosing an active COVID-19 infection.
2nd The sort of test is a serological test that looks for antibodies from the virus, that can assist identify people who have acquired an immune reaction to the virus as a result of either a present infection or former infections.
Easy and Quick Test Kit
An antigenski test, a new diagnostic method for COVID-19, has been approved by the Food and Drug Administration FDA, to defeat this infection, every type of diagnostic test plays a specific role. It can take a long time to run and analyze PCR testing, but the findings can be extremely accurate.
An antigen test’s quickness is one of its key advantages since it can offer results in minutes, some current infections may escape detection by an antigen test because they do not function in the same manner as PCR testing.
Molecular PCR testing is more sensitive, but antigen tests are more specific to a particular virus. A larger probability of false negatives indicates that negative antigen testing does not completely rule out infection and to avoid the spread of the virus as a result of a false negative, it may be necessary to validate negative antigen test results with a PCR test before making treatment decisions.
For example, antigen tests may be produced at a cheaper price than PCR testing and can be scaled to screen millions of Citizens per day because of their simpler design, this will assist our country in better assessing infection rates in real-time and help us respond to COVID-19 as quickly as possible.
Wait for the Future Technology to Immerse
There will be more antigen tests permitted in the future. As with other test types, we plan to develop a generic antigen EUA template to help streamline submissions and speed evaluation and issuing of new EUAs.
Conclusion
Covid-19 antigen testing plays a key role, and we’ll continue to facilitate the progress of accurate tests, as well as monitor and review marketed diagnostics to verify their accuracy while keeping in mind the essential need for these crucial diagnostics in this struggle.
Protecting public health by ensuring the safety, efficacy, and secureness of human and animal medications, vaccines, and other biological intended for human use, and medical devices is the primary mission of the FDA Food safety and security, cosmetics, dietary supplements, electronic radiation products, and tobacco products are all under the agency’s purview.