Monday, May 11, 2020 (HealthDay News)-First Emergency Use Authorization COVID-19 (New Coronavirus Infection) The antigen test was issued by the US Food and Drug Administration.
Antigen testing is a new category of testing for use in coronavirus pandemics that quickly detects protein fragments from the virus in samples collected with a cotton swab from people’s noses.
Approval by Quidel Corp for Sophia on Friday.Published in SARS Antigen FIA is licensed for use in laboratories of high and moderate complexity certified by the Laboratory Improvement and Modification (CLIA), and in the Point of Care. [ie, doctor’s office] “Test”, according to the FDA news release.
Dr. Ashishger, director of the Harvard University Global Health Institute, said: New York Times.. “Many of us were looking forward to this moment.”
“This is a very quick test that can be used in the clinic,” former FDA Commissioner Scott Gottlieb explained at CBS’s “Face the Nation” on Sunday. “Doctors currently have about 40,000 of these Sophia machines in their offices.” Streptococcal pharyngitis And influenza, He explained.
The FDA said it plans to issue more Emergency Use Authorizations (EUA) for antigen testing during pandemics.
Authorities issued an EUA for two other tests during the coronavirus pandemic. they are: Polymerase chain reaction (((PCR) A test that detects genetic material from a virus and is useful for active diagnosis COVID-19 (New Coronavirus Infection) Infections, often performed using a nasal swab.And serological [blood] A test to look for antibodies to the virus. This helps identify people who are infected or who have developed an immune response to the virus.
The FDA states that each type of test has a role to play in combating the coronavirus pandemic.
“”PCR The test is incredibly accurate, running Testing and analyzing the results can be time consuming. One of the main benefits of antigen testing is the speed of the test, which can produce results in minutes, “the authorities explained.
“But not all active infections can be detected because antigen testing does not work as well as PCR testing. Antigen testing is very virus-specific, but more sensitive than molecular PCR testing. No. Antigen testing is very accurate, but a negative result does not rule out infection because of the high likelihood of false negatives, “said the FDA.
“With this in mind, negative antigenic test results may need to be confirmed by PCR before deciding on treatment or to prevent the spread of the virus due to false negatives,” the FDA said. Stated.
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Source: US Food and Drug Administration, News Release, May 8, 2020. CBS; New York Times
FDA approves first antigen test to detect coronavirus infection quickly
Source link FDA approves first antigen test to detect coronavirus infection quickly