First Saliva Test for COVID-19 Approved for Emergency Use by FDA | Laboratory Medicine | Scoop.it

The search for SARS-CoV-2 RNA in 60 saliva samples yielded the same results as conventional nasal swab tests taken from the same patients. There are now more options for COVID-19 testing as the US Food and Drug Administration gave emergency use authorization on April 13 for a saliva-based test, providing an alternative to the swab testing currently performed.

 

“You want to be in all types of situations with all types of options so that we can have as much testing as possible in whatever form is suitable,” Amesh Adalja, who works on infectious disease and pandemic preparedness at Johns Hopkins University and is not involved with the development of the test, tells the Associated Press. Currently, testing for COVID-19 involves a healthcare professional inserting a swab into each nostril, one at a time, to the nasopharynx at the back of the nasal cavity, gently scraping the tissue to collect material, and sending off for analysis, according to UC Davis Health. This method is cumbersome as it needs to be done by a qualified worker wearing fresh gloves and other personal protective equipment (PPE), which are in short supply. Additionally, many areas are experiencing a lack of tests available or a large backlog of samples to process.

 

The collection of a saliva sample requires spitting into a tube, resulting in a much less invasive procedure without tying up large amounts of PPE. Per the Food and Drug Administration’s (FDA) instructions, the testing would still occur in a healthcare setting under the supervision of a qualified professional....

 

Performance Letter by FDA:

https://www.fda.gov/media/136875/download


Via Juan Lama