First coronavirus saliva test approved by FDA



An emergency use authorization was granted by federal health authorities for the first coronavirus test that relies on saliva samples. It’s a breakthrough in coronavirus testing. The test was developed by Rutgers’ RUCDR Infinite Biologics and its collaborators, Spectrum Solutions and Accurate Diagnostic Labs.

Rutgers University announced Monday that the FDA quickly authorized the tests which can expand testing options. A key bonus is that the test also reduces risks of infection for health care workers.

The current approach to screening for COVID-19 requires health care workers to take a swab from a patient’s nose or throat. To lessen infection risks, many hospitals and clinics instruct staff to discard gloves and masks after close contact with anyone who may have the virus. And many institutions are struggling with shortages of basic medical supplies, including gloves, masks and swabs.

With the new saliva-based test, patients are given a plastic tube into which they spit several times. They then hand the tube back to the health care worker for laboratory processing.

“This prevents health care professionals from having to actually be in the face of somebody that is symptomatic,” said Andrew Brooks, who directs the Rutgers lab that developed the test.

The test will be much more comfortable for patients than current tests that use swabs. Instead of a health care worker putting a swab up your nose or in your throat, this new test allows the patient to spit into a tube. The accuracy rate of the saliva test is good – in a sample of 60 people taking both saliva and swab tests, there was no difference in the results. The saliva test results were 100% matches with the swab tests. If you’re thinking, hey, that sounds like the test I took for Ancestry.com or another genealogy company, it is because the Rutgers lab used saliva collection kits from Spectrum Solutions, a Utah company that provides similar devices for DNA-based ancestry testing services. (I did it for Ancestry.) The Rutgers lab can currently process 10,000 patient samples per day.

The FDA agreed to fast track the saliva test with two conditions. The tests will only be performed “in a health care setting under the supervision of a trained health care provider.” The second condition is certainly reasonable, too. If a patient tests negative using the saliva test, the FDA asks that that person follow up with a second testing method. Similar saliva tests have been used for HIV and other viruses.

The new test has gained attention from the White House coronavirus task force, as well as other infectious disease experts.

An infectious disease expert, Dr. Tom Moore, told CNBC that the potential impact from such a test being widely available is “enormous.”

“The release of any reliable test, expanded capacity of tests or introduction of new tests … will go a really long way toward curbing the pandemic,” said Moore, a Wichita, Kansas, physician who previously served on the board of the Infectious Diseases Society of America.

“This may be a real breakthrough,” Moore said.

The test initially will be available through hospitals and clinics affiliated with Rutgers University. Beginning Wednesday, the test will be made available to county residents at a drive-thru testing facility in Edison, New Jersey.

There have been no at-home tests developed for distribution yet but scientists are working on that.

The FDA is beginning to approve point-of-care COVID-19 tests. A counter-top kitchen appliance-size machine runs the material collected. Then the device transmits the results to a connected computer. This lessens the time a patient has to wait for results.

Let’s hope the new saliva test works and is available throughout the country soon.





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