USFDA clears simple saliva test for faster detection of COVID-19

US health watchdog has authorised emergency use of a new and expensive saliva based laboratory diagstic test for COVID-19 that could be a game changer in diagsis of infection as it will enable rapid testing amongst more people easily.

Stephen Hahn, Food and Drugs ministration Commissioner, said new saliva test would increase efficiency and avoid short of crucial test components like rents.

“Providing this of flexibility for processing saliva samples to test for COVID-19 infection is groundbreaking in terms of efficiency and avoiding shorts of crucial test components like rents,” he said in a statement.

ncy has previously authorised four or tests that use saliva for sampling, but se yielded varying results. Authorisation of new test occurs amid ongoing disarray over COVID-19 testing.

US has been plagued by an inconsistent strategy for detecting virus, thanks in part to persistent shorts and use of a variety of different tests that have sometimes yielded unreliable results.

new method called Salivirect is being furr validated as a test for asymptomatic individuals through a programme that tests players and staff from National Basketball Association (NBA).

Salivirect is simpler, less expensive and less invasive than tritional method for such testing kwn as nasopharyngeal (NP) swabbing.

Results so far have found that Salivirect is highly sensitive and yields similar outcomes as NP swabbing. With FDA’s emergency use authorisation, testing method is immediately available to or diagstic laboratories that want to start using new test, which can be scaled up quickly for use across nation and, perhaps, beyond — in coming weeks, researchers said.

A key component of Salivirect, researchers te, is that method has been validated with rents and instruments from multiple vendors.

This flexibility enables continued testing if some vendors encounter supply chain issues as experienced early in pandemic.

“This is a huge step forward to make testing more accessible,” said Chantal Vogels, a Yale postdoctoral fellow, who led laboratory development and validation along with Doug Brackney, an junct assistant clinical professor.

“This started off as an idea in our lab soon after we found saliva to be a promising sample of detection of SARS-CoV-2, and w it has potential to be used on a large scale to help protect public health. We are delighted to make this contribution to fight against coronavirus,” he said.

Development of Salivirect as a means of rapidly expanding SARS-CoV-2 testing was spearheed this spring by Nathan Grubaugh and Anne Wyllie, assistant professor and associate research scientist, respectively, at Yale School of Public Health.

After finding saliva to be a promising sample for SARS-CoV-2 detection, y wanted to improve method furr.

“With saliva being quick and easy to collect, we realised it could be a game-changer in COVID-19 diagstics,” said Wyllie.

With testing urgently needed, Yale team was determined to decrease both testing times and costs, to make testing widely accessible.

“Wide-spre testing is critical for our control efforts. We simplified test so that it only costs a couple of dollars for rents and we expect that labs will only charge about USD 10 per sample. If cheap alternatives like Salivirect can be implemented across country, we may finally get a handle on this pandemic, even before a vaccine,” said Grubaugh.

Grubaugh and Wyllie said that y are t seeking to commercialise method rar want simplified testing method to help those most in need.

Testing for SARS-CoV-2 has been a major stumbling block in fight against pandemic, with long delays and shorts of testing.

Some experts have said that up to 4 million tests are needed per day and Salivirect provides one pathway toward that goal, researchers said.

“Using Salivirect, our lab can double our testing capacity,” said Professor Chen Liu, chair of Yale Pathology, who oversaw clinical validation of study.

Globally, coronavirus has infected 20,950,402 people while disease has killed so far 760,213 ors.