US: FDA authorises first at-home COVID-19 test that uses saliva samples

The US Food and Drug Association (FDA) on May 8 authorised the first diagnostic test with the option of using home-collected saliva samples for COVID-19. According to the press note on FDA website, the association issued an emergency use authorisation to Rutgers Clinical Genomics Laboratory for their COVID-19 laboratory-developed test as well. With the test, people can collect their own saliva at home and send the sample to a lab for results. 

FDA Commissioner Stephen M. Hahn, M.D said, "Authorizing additional diagnostic tests with the option of at-home sample collection will continue to increase patient access to testing for COVID-19. This provides an additional option for the easy, safe and convenient collection of samples required for testing without travelling to a doctor’s office, hospital or testing site”. 

Stephen further added, "We will continue to work around the clock to support the development of accurate and reliable tests, as we have done throughout this pandemic. The FDA has authorized more than 80 COVID-19 tests and adding more options for at-home sample collection is an important advancement in diagnostic testing during this public health emergency”. 

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‘Not a general authorisation’ test

Rutgers University reportedly said that with the FDA approval, the saliva test can help in expanding access to testing for people. While speaking to an international media outlet, Andrew Brooks, the chief operating officer at the RUCDR, said that the test includes on how to spit into a funnel to collect a saliva sample and seal with a cap to preserve the sample. Brooks further explained that a preservation agent will appear, blue in colour, and once the whole sample is blue, it is supposed to be put back in a biohazard bad provided with the kit and sent to a lab for testing. 

The FDA press note also mentioned that RUCDR’s test is currently the only authorised COVID-19 diagnostic test that uses saliva samples to test for the deadly virus. The association also noted that the test is ‘not a general authorisation’ for at-home collection of a patient sample using other collection methods, saliva collection devices, or tests, or for tests fully conducted at home. 

(Image credit: AP) 

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