First Saliva Test for COVID-19 Approved for Emergency Use by FDA
First Saliva Test for COVID-19 Approved for Emergency Use by FDA

First Saliva Test for COVID-19 Approved for Emergency Use by FDA

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.

Lisa Winter
Lisa Winter
Apr 14, 2020

ABOVE: PHOTO COURTESY OF SPECTRUM SOLUTIONS

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.

See “Logistical Hurdles Leave COVID-19 Test Kits Unused” 

“Saliva testing will help with the global shortage of swabs for sampling and increase testing of patients, and it will not require health care professionals to be put at risk to collect samples,” Andrew Brooks, the chief operating officer of RUCDR Infinite Biologics, a biorepository backed by Rutgers University that developed the spit test, explains in a statement

The saliva test builds on the existing TaqPath SARS-CoV-2 Assay used in existing COVID-19 testing to identify RNA from the virus.

Brooks explains that in addition to identifying carriers of the virus, this form of testing could also make it easier to re-test people who have recovered so they can end their isolation.  

According to validation results provided to the FDA, 60 patient samples taken from saliva and swab tests were in agreement as to the presence of the coronavirus. The agency notes that independent testing by the New Jersey State Health Department of 10 samples agreed with RUCDR’s findings.

USA Today reports that the saliva tests could be given to patients as soon as April 15. Until further notice, the tests can only be administered by RUCDR in New Jersey.

Clarification (April 16): The stock image used at the time of publication was replaced by an image of the actual product.