Food and Drug Administration approved rapid saliva test for novel coronavirus

The U.S. Food and Drug Administration issued an emergency use authorization (EUA) to Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 infection.

Daily Current Affairs Quiz 2020

Key-Points

The inexpensive test, called SalivaDirect, developed by a team from the Yale School of Public Health, has high sensitivity and can detect the virus even when the number of virus copies in the saliva sample is as low as 6-12 copies per microlitre.

Collecting and testing saliva samples involves three steps — collecting saliva without preservative buffers, proteinase K treatment and heat inactivation, and dualplex RT-qPCR virus detection.

The testing protocol has been provided as an “open source”, allowing laboratories in the U.S. to perform the tests. Thus, SalivaDirect will be free to use by diagnostic labs.

The new saliva test would increase efficiency and avoid shortage of crucial test components such as reagents.

The new test makes sample collection non-invasive and reduces the need for trained healthcare workers to collect the samples, reducing the risk of infection during collection.

In contrast, tests using nasopharyngeal swabs lead to false negative results due to errors at the time of sample collection.