The U.S. Food and Drug Administration (FDA) on August 15, 2020 granted an emergency use authorisation to a new, rapid diagnostic test for the novel coronavirus that uses saliva samples.
The inexpensive test, called SalivaDirect is developed by a team from the Yale School of Public Health.
It 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.
In contrast, tests using nasopharyngeal swabs lead to false negative results due to errors at the time of sample collection. The sensitivity of the new test was about 93%, according to a preprint posted on medRxiv.
How is it a game-changer?
The new saliva test would increase efficiency and avoid shortage of crucial test components such as reagents.
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.
(Source: The Hindu)
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