User:Jamirulabd


 * 1) MAR _ Technical review

Coronavirus (SARS-CoV-2):

Test Kits detect of COVID-19

Key points:

Within seven weeks of the first reported case of COVID-19, there had been 76,769 people infected with the virus and 2,249 deaths caused by the virus.

Most qPCR assays have three targets; Orf1, E-gene and N-gene.

Check what authorizations a kit has, many kits are Research Use Only (RUO)

But manufacturers can apply for emergency use authorization (EUA) from the US FDA for clinical diagnostic use.

In the EU, manufacturers can obtain CE marking for In Vitro Diagnostic use

Introduction: SARS-CoV-2 (novel coronavirus) was first reported on 31st Dec 2019 in the city of Wuhan, China. Initial cases were linked to a seafood market in Wuhan, and within two weeks, China and international airports began screening passengers coming from the area with infrared thermometer devices.

Although efforts were made to contain its spread, incidences of infection were reported in neighbouring countries, i.e. Korea and Japan. In one notable case, where government health officials were criticized for mishandling the containment of the virus, and where the virus was allowed to be spread between people, was on the Diamond Princess cruise ship.

In this incident, passengers were told they could not leave the cruiser after it was found that one person who departed a week previously, had shown positive for the virus. The ship was then used to 'quarantine' the remaining passengers until they were all tested. However, this had an undesired effect, as more people on the ship showed positive for the virus, it was clear that this impromptu quarantine holding was acting more like an incubator for the virus and allowed its transmission between people on board.

By the 30th of January, WHO had declared SARS-2-CoV, the virus that causes the disease Covid-19, a public health emergency of international concern.

The virus has been designated SARS-CoV-2 by the Coronavirus Study Group (CSG) of the International Committee on Taxonomy of Viruses. The CSG formally recognizes this virus as a sister to severe acute respiratory syndrome coronaviruses (SARS-CoVs) of the species Severe acute respiratory syndrome-related coronavirus and designates it as Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Infection by the virus can cause respiratory symptoms, fever, and fatigue. But in severe cases, especially people with compromised immune systems, the virus can cause severe acute respiratory syndrome (SARS), organ failure and even death.

Coronaviruses are enveloped viruses with a positive-sense, single-stranded RNA genome belonging to the Coronaviridae family. The virus belongs to the 2B group of the betacoronavirus family, which is the same family as SARS-CoV and MERS-CoV and has 70% similarity in genetic sequence to SARS. These viruses are given the name corona (Latin for crown) because they possess a crown-like coat ( club-shaped glycoprotein spikes protruding from it's surface). These spikes allow the viruses to bind to certain receptors on our cells.

The structure of SARS-CoV-2; consists of a spike protein; which includes two regions, S1 and S2, where S1 is for host cell receptor binding and S2 is for membrane fusion. The spike protein is a typical target for neutralizing with antibodies and vaccines. It been reported that SARS-CoV-2 can infect the human respiratory epithelial cells 100-1000 times more than previous coronavirus strains and does so by interacting with human ACE2 receptors.

The Nucleocapsid Protein is the most abundant protein in SARS-CoV-2. The N-protein is a highly immunogenic phosphoprotein and rarely changes. The N protein of SARS-CoV-2 is often used as a marker in diagnostic assays.

There is also the hemagglutinin-esterase dimer, a membrane glycoprotein, an envelope protein,  and RNA.

(RUO).

COVID-19 Immunoassays:

ANTIGEN TESTS : These tests are new to the market and rely on the detection of viral proteins in swab samples They consist of monoclonal antibodies specific for the viral antigens and results are seen by the naked eye by way of chromatographic particles. There have only been a few of these tests commercialized and normally require a high viral count to work effectively. There were reports in the media, that national health authorities who had purchased these tests, could not rely on the results due to its poor accuracy upon validating them.

COVID-19 Tests In development:

Near ‘patient care’ or near POC assays that test for SARS-CoV-2 are currently in development and are awaiting approval by regulatory agencies in the form of a EUA or CE-IVD certification. There has so far been one POC test given FDA-EUA. These kits need to be used on a small analyser the hospital laboratory would need to have. On average, results are returned within the hour after taking a sample from the patient.

There is also nanosensor diagnostics platforms in development to test for the virus, which would replace thermal screening guns, currently screening for high fever in people coming through airports and border controls. This technology, which will be in the form of a hand-held device, claims to give results specific for this virus and can produce a result within one minute. It does this by detecting the nucleocapsid protein specific for this virus by nanosensor and aptamer technology.

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