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article imageFDA fast-tracks novel coronavirus test to speed up diagnosis

By Tim Sandle     Mar 18, 2020 in Science
As the cases of the novel coronavirus spread, researchers are developing new tests designed to speed up detection of the virus. Developments include the use of synthetic RNA and a new rapid test for nucleic acid.
In order to help fight the spread of coronavirus, testing is very important as this helps those infected to get the right care and for epidemiologists to track the disease. While symptoms can provide a clue (where symptoms of coronavirus are a cough, a high temperature and shortness of breath), these take time to develop (typically between 5 and 11 days). Hence, designing new tests is a key part of infection control.
SARS-CoV-2 or COVID-19?
The novel coronavirus that is now at pandemic levels is called severe acute respiratory syndrome coronavirus 2, shortened to SARS-CoV-2 9as named by the International Committee on Taxonomy of Viruses). The disease caused by the virus is termed COVID-19 (as named by the World Health Organization). Here the ‘CO’ stands for ‘corona,’ ‘VI’ for ‘virus,’ ‘D’ for disease and 19 indicates the year that the disease was discovered.
Coronavirus test developments
Digital Journal looks at three areas of development for the detection of the novel coronavirus.
Synthetic RNA to track the virus
The biotechnology company Microbiologics has developed a synthetic RNA to be used for the detection of SARS-CoV-2 (RNA is ribonucleic acid, a nucleic acid present in all living cells). The aim here is assist laboratories with the monitoring of the spread of COVID-19, as well as helping to accelerate diagnostics and therapeutic research.
The new RNA material is designed to mimic viral nucleic acid based on the precise targets needed in order to detect the novel coronavirus. The new material contains 1044 nucleotide RNA markers, which are specific for the SARS-CoV-2 N (nucleocapsid) gene. This includes the three markers (coded N1, N2 and N3) needed for the primary test kit, which is the Real-Time RT PCR Panel for Detection of 2019 Novel Coronavirus.
Novel coronavirus test
The technology is based on polymerase chain reaction (PCR). This molecular biology method can make millions to billions of copies of a specific DNA sample. This high-volume of replication enables scientists to amplify a sufficiently large enough amount of material in order to detect it and to study it in detail.
With SARS-CoV-2 specifically, virologists can use the test to hone in on specific genetic clues that identify the novel coronavirus associated with this outbreak.
Pennsylvania Commonwealth microbiologist Kerry Pollard performs a manual extraction of the coronavir...
Pennsylvania Commonwealth microbiologist Kerry Pollard performs a manual extraction of the coronavirus inside the extraction lab at the Pennsylvania Department of Health Bureau of Laboratories on Friday, March 6, 2020.
governortomwolf (CC BY 2.0)
Generally these tests are robust, with a low false-positive and a low false-negative rate. However, the tests are not 100 percent accurate and it is possible for someone who first tests as negative to later develop the COVID-19 disease (as per the journal Radiology: "Chest CT for Typical 2019-nCoV Pneumonia: Relationship to Negative RT-PCR Testing").
FDA fast tracks new test
The U.S. Food and Drug Administration has fast tracked a novel coronavirus test. This test comes from the life sciences company Thermo Fisher Scientific and its use has been granted via an emergency use authorization, meaning that the test can be used immediately in the U.S.
The designed is designed to detect nucleic acid from SARS-CoV-2, the virus that causes COVID-19, and it is not specific for any other viruses.
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