The United States Food and Drug Administration has approved the emergency use of a saliva-based test for detecting the coronavirus, PTI reported on Sunday.
Food and Drugs Administration Commissioner Stephen Hahn said the new saliva test will increase efficiency and avoid shortage of crucial test components like reagents. “Providing this type of flexibility for processing saliva samples to test for Covid-19 infection is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents,” he said in a statement.
The FDA had earlier approved four other saliva tests for Covid-19 testing, but these showed varying results in individuals. The new method, called SalivaDirect, has been validated as a test for asymptomatic patients. It was first part of a programme that tests players and staff from the National Basketball Association for viral infections.
The FDA believes SalivaDirect produces results similar to nasopharyngeal testing, which is the traditional method used in collection of samples. SalivaDirect is also cheaper, simpler and less invasive.
“This started off as an idea in our lab soon after we found saliva to be a promising sample type of the detection of SARS-CoV-2, and now it has the potential to be used on a large scale to help protect public health,” said Chantal Vogels, a Yale postdoctoral fellow, who led the laboratory development and validation of the test. “We are delighted to make this contribution to the fight against coronavirus.”
Professor Chen Liu, chairperson of Yale Pathology, who oversaw the clinical validation of the study, said that the SalivaDirect can double the testing capacity for Covid-19.
The United States has the highest number of coronavirus cases in the world. As of Sunday, it had reported over 53 lakh cases and more than 1.69 lakh deaths, according to the Johns Hopkins University. Globally, over 2.14 crore people have been affected, and more than 7.71 lakh have died.