April 14, 2012 - RUCDR infinite Biologics, a division of Rutgers University, has received emergency use authorization from the U.S. Food and Drug Administration for a new test for the New Crown Pneumonia Virus (NCPV), according to the official website of Rutgers University. The method, jointly developed by RUCDR infinite Biologics, Spectrum Solutions, and Accurate Diagnostic Labs, focuses on testing through saliva. A press release on the Rutgers University website states that the saliva test is capable of more widespread use relative to current nasal and throat swab methods.
RUCDR Infinite Biologics, part of the Rutgers Institute of Human Genetics, part of Rutgers University, is the world's largest university-based cell and DNA repository, and focuses on understanding the genetic causes behind common, complex diseases and finding diagnostics and and treatments for them. rucdr infinite biologics partners with public and private sector researchers around the world. *** and private sector researchers to provide scientific and technical support. Rutgers University is the largest institution of higher learning in New Jersey, USA.
The FDA's official website shows that under Section 564 of the Federal Food, Drug, and Cosmetic Act, the FDA may permit the use of unapproved medical products or unapproved uses of medical products for the diagnosis, treatment, or prevention of serious, life-threatening illnesses under emergency situations when there are no adequate, approved, and available alternatives.
According to Xinhua, nucleic acid testing is indispensable for confirming the diagnosis of C.N.C.P. and determining whether an infected person has met the criteria for discharge from the hospital, and throat swab collection is one of the most important and critical steps in nucleic acid testing, which is considered one of the most high-risk operations in which occupational exposure is most likely to occur, and those who collect the swabs have been referred to as "those who deal with the Grim Reaper. "
UCDC is the first to have a swab collection program.
Andrew Brooks, COO and director of technology development at UCDR infinite Biologics and a professor in the Department of Genetics at Rutgers University's College of Arts and Sciences, said the saliva-based approach means that pharyngeal swabbing, which puts healthcare professionals at risk, is no longer necessary, and that valuable PPE can be saved for patient care rather than for testing. patient care rather than for testing.
Andrew Brooks said that the number of people tested every day could be greatly increased in the future because saliva is easier to self-collect than throat swabs, and Brooks added that saliva testing could also help to alleviate the shortage of swabs that the world is facing.
Under the saliva testing method, test subjects are given a plastic tube to take the saliva, which is then given to a health care provider for laboratory processing, according to the Associated Press. For its part, Rutgers University tested 60 people with both saliva and throat swabs, and the saliva test yielded identical results to the throat swabs.
The saliva test is now available to RWJBarnabas, a large New Jersey health system that Rutgers partners with. Beginning Wednesday, Rutgers will work with Middlesex County government and RWJBarnabas to make the test available to county residents.
The Associated Press reports that the FDA said in its authorization letter to Rutgers that the test should be used in a health care setting "under the supervision of a trained health care provider," and that the FDA has not approved any new coronavirus tests that can be performed at home to date.
Confirmed cases of C. neoformans pneumonia in the United States have continued to rise since the mass testing was implemented.
According to real-time statistics from Johns Hopkins University, as of about 9 p.m. Beijing time on April 14, the cumulative number of confirmed cases of neocoronavirus pneumonia in the world stood at 19,188,855, with a cumulative total of 119,588 deaths. In the United States, there were 581,679 confirmed cases of new coronavirus pneumonia and 23,604 cumulative deaths.
The surging news reporter Chen Yuxi comprehensive report
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