SalivaDirect test approved by USFDA

The US health watchdog has approved the emergency use of an expensive new saliva-based laboratory diagnostic test for COVID-19 that could be a game changer in diagnosing infection, as will allow it quick tests between more people easily.

Stephen Hahn, commissioner of the Food and Drug Administration, said the new saliva test would increase efficiency and avoid a shortage of crucial test components such as reagents.
Providing this kind of flexibility to process saliva samples to detect COVID-19 infection is revolutionary in efficiency and avoids a shortage of crucial test components like reagents, it said in a statement.
The agency has previously authorized four more tests using saliva for sampling, but they have returned mixed results. The approval of the new test comes amid continued confusion over COVID-19 testing.
The United States has been plagued by an inconsistent strategy to detect the virus, in part due to persistent shortages and the use of a variety of different tests that have sometimes yielded unreliable results.
The new method called SalivaDirect is being validated as a test for asymptomatic people through a program that tests players and staff of the National Basketball Association (NBA).
SalivaDirect is simpler, less expensive and less invasive than the traditional method for this type of test known as a nasopharyngeal swab (PN). So far, the results have shown that SalivaDirect is very sensitive and produces results similar to NP swabs.
With FDA emergency use authorization, the test method is immediately available to other diagnostic labs who want to start using the new test, which can be rapidly expanded for use across the country and may be more there in the coming weeks, the researchers said.
A key feature of SalivaDirect, the researchers note, is that the method has been validated with reagents and instruments from multiple vendors. This flexibility allows for ongoing testing if certain suppliers experience supply chain problems as they did at the start of the pandemic.
This is a big step forward in making testing more accessible, said Chantal Vogels, a Yale postdoctoral fellow, who led the development and validation of the lab with Doug Brackney, a clinical assistant professor.
It started as an idea in our lab shortly after we discovered that saliva was a promising sample type for the detection of SARS-CoV-2, and that it now has the potential to be used on a large scale to help protect public health.
We are delighted to make this contribution to the fight against coronavirus, he said.
The development of SalivaDirect as a means of rapidly expanding testing for SARS-CoV-2 was led this spring by Nathan Grubaugh and Anne Wyllie, respectively, assistant professor and research associate at the Yale School of Public Health.
After discovering that saliva was a promising sample type for detecting SARS-CoV-2, they wanted to further improve the method. Since saliva is quick and easy to collect, we realized that it could be a game changer in diagnosing COVID-19, Wyllie said. Because testing was urgently needed, the Yale team was determined to reduce both testing time and cost to make testing widely accessible.
Generalized testing is essential to our control efforts. We have simplified the test to cost just a few dollars for reagents and we expect labs to charge only about $ 10 per sample.
If cheap alternatives like SalivaDirect can be rolled out across the country, we will finally be able to control this pandemic, even before a vaccine, Grubaugh said. Grubaugh and Wyllie said they were not looking to commercialize the method, but instead wanted the simplified test method to help those who need it most.
Testing for SARS-CoV-2 has been a major hurdle in the fight against the pandemic, with long delays and a dearth of testing.
Some experts have said that up to 4 million tests are needed per day and SalivaDirect provides a path towards this goal, the researchers said. With SalivaDirect, our lab can double our testing capacity, said Professor Chen Liu, Yale president of pathology, who oversaw the clinical validation of the study. Globally, coronavirus has infected 20,950,402 people while the disease has killed so far 760,213 others.