Shanghai ZhiBei Information Consulting Co., Ltd

News

Faster, safer! FDA APPROVES FIRST COVID-19 SALIVA test product
Release time: 2020-08-05 10:04:12  Hits: 13

You're not going to be able to do that

On April 13, Rucdr Infinite Biologics, a division of the Rutgers Institute, and its collaborators received an FDA emergency use authorization (EUA) to test saliva for the novel coronavirus. This is the first FDA-approved Saliva test for COVID-19, which will be used for a wider range of population screening than the current nasal and pharynx swab test.

360截图20200805100417284.jpg

The new saliva collection test was developed by Rucdr in collaboration with Spectrum Solutions and the Accurate diagnostic laboratory (Adl) . NEW CORONAVIRUS RNA is usually detected in respiratory specimens from patients during the acute phase of infection.

On the one hand, the saliva test uses a Spectrum DNA saliva collection and preservation kit, which the researchers say must be stored or transported at ambient temperature and tested within 48 hours of collection. The result was the same as a nasopharynx Swab, a painful procedure for sampling, by testing specific RNA sequences associated with the virus.

The Rutgers test, on the other hand, is based on a previously licensed test called COVID-19, which uses the same PCR hardware and chemistry as the TaqPath kit, it's a real-time polymerase chain reaction test. The TaqPath kit was awarded by the FDA in 2017 for the qualitative detection of Zika virus RNA and diagnosis of infection through the collection of human serum and urine samples.

RUCDR Infinite Biologics, part of the Human genetics in Rogers, New Jersey, is the world's largest university based repository of cells and DNA. The laboratory is dedicated to understanding the genetic causes of common and complex diseases and to finding ways to diagnose, treat and cure them. Previously, RUCDR had started a genetic testing service for the new coronavirus, and the new saliva test could increase the number of samples tested to tens of thousands a day.

Andrew Brooks, Chief Operating Officer and director of Technology Development at Rucdr, said: "The impact of this approval is significant and means that there is no longer a need for health care workers to risk collecting samples, and the usual collection of Nasopharynx or Oropharynx may increase the risk of infection for health care professionals. Saliva testing will help reduce the global shortage of swabs for sampling, and since self-collection of saliva is faster and more scalable than swab collection, it could significantly increase the number of people tested each day."

RUCDR's founder, CEO and Scientific Director, and professor of genetics at Rutgers University, New Brunswick, Jay A. Tischfield also said: "The test uses RUCDR Infinite Biologics analysis to help hospitals and private doctors accurately assess the infection status of more patients. "

Although many vaccines are under development, optimistic projections are that most products will not be available until 2021 or later. In the absence of a vaccine, the most likely way to stave off a pandemic would be to conduct large-scale testing and antibody testing, followed by contact tracing to identify and isolate people who test positive for the disease.

The COVID-19 pandemic has attracted wide attention from life sciences companies, and the United States has now approved virus diagnostic tests and serum antibody detection tools, including the first serum Test, qSARS-CoV-2 IGG/IGM Rapid Test, approved on 3 April from Cellex, to determine whether people have been exposed to the virus or are immune to the disease. People who test positive for antibodies to the virus are thought to be immune, but it is not clear how long that immunity will last.

Source:

1.FDA Approves Rutgers’ Saliva Test for COVID-19

2.Emergency use authorization granted for new biomaterial collection approach

3.Rutgers' saliva-based test nets FDA green light for COVID-19

2-1(1).jpg

Previous: So far, only emergency use has be...

Next: What happens to the patient with ...