Hot Topics in Public Health
MSDC Member Spotlight Series
FDA Approves First COVID-19 Saliva Test
On Friday, the Food and Drug Administration (FDA) announced the first approval of a saliva test for COVID-19 using its emergency use authorization authority (EUA).
Researchers at Rutgers University (NJ) received the approval for the antigen test. The process will permit patients to spit into a tube multiple times, and the saliva samples can be tested in an approved laboratory. This process has the potential to save essential PPE for healthcare workers as the process has less exposure than the current nasal swab process.
Currently the test is limited to the Rutgers University system. The FDA is also recommending to patients that a negative test result using the antigen method should be confirmed with a second established testing method. This is because the test has about a 15% false negative rating.
Prior to this approval, the FDA had issued EUAs for two types of tests. The first was the polymerase chain reaction (PCR) test, "a molecular diagnostic testing technique that detects genetic materiel from the virus". The second type of test are serological tests "that look for antibodies to the virus, which can help identify individuals who have developed an adaptive immune response to the virus".
The antigen test approvals comes at the same time some private labs have publicly committed to unveiling at-home tests in the near future. The FDA still encourages antigen testing to be done in a healthcare setting, but further expansion could pave the way for more antigen testing in different locations.
Public Health News
FDA Approves First COVID-19 Saliva Test
On Friday, the Food and Drug Administration (FDA) announced the first approval of a saliva test for COVID-19 using its emergency use authorization authority (EUA).
Researchers at Rutgers University (NJ) received the approval for the antigen test. The process will permit patients to spit into a tube multiple times, and the saliva samples can be tested in an approved laboratory. This process has the potential to save essential PPE for healthcare workers as the process has less exposure than the current nasal swab process.
Currently the test is limited to the Rutgers University system. The FDA is also recommending to patients that a negative test result using the antigen method should be confirmed with a second established testing method. This is because the test has about a 15% false negative rating.
Prior to this approval, the FDA had issued EUAs for two types of tests. The first was the polymerase chain reaction (PCR) test, "a molecular diagnostic testing technique that detects genetic materiel from the virus". The second type of test are serological tests "that look for antibodies to the virus, which can help identify individuals who have developed an adaptive immune response to the virus".
The antigen test approvals comes at the same time some private labs have publicly committed to unveiling at-home tests in the near future. The FDA still encourages antigen testing to be done in a healthcare setting, but further expansion could pave the way for more antigen testing in different locations.
Leave a comment