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Coronavirus test kits: Effective way to monitor and manage the pandemic

Article-Coronavirus test kits: Effective way to monitor and manage the pandemic

Countries around the world have ramped up the production of testing kits to diagnose Coronavirus.

According to the World Health Organization (WHO), until an effective coronavirus vaccine becomes available, testing would be the best way to monitor and manage the pandemic. “We have a simple message to all countries – test, test, test,” WHO Director-General Tedros Adhanom Ghebreyesus was quoted saying.

Countries around the world have ramped up the production of testing kits and are opening up different avenues for people to get tested. For instance, in the UAE, both Abu Dhabi and Dubai have opened drive-through testing centres. Moreover, inspired by South Korea’s testing centres, the state of Kerala in India has set up Walk-in Sample Kiosks (WISK), to collect samples from those with COVID-19 symptoms. And in the UK, a home test will apparently go on sale very soon.

Types of Coronavirus tests

Since the symptoms of COVID-19 are similar to those of other diseases, testing is the only way to know for sure if someone is infected. There are two ways to perform a Coronavirus test. One is through Molecular tests that look for signs of an active infection and involve taking a sample from the back of the throat with a cotton swab. The sample then undergoes a polymerase chain reaction (PCR) test. This detects signs of the virus’s genetic material.

A PCR test can confirm a diagnosis of COVID-19 if it identifies two specific SARS-CoV-2 genes. If it identifies only one of these genes, it will produce an inconclusive result. It can help diagnose only current cases and won’t be able to tell whether someone has had the infection and recovered.

There are also the Serological tests that can detect antibodies that the body produces to fight the virus. These antibodies are present in anyone who has recovered from COVID-19. A serological test usually requires a blood sample and are useful for detecting cases of infection with mild or no symptoms.

According to reports, faster genetic tests, typically based on a method called loop mediated isothermal amplification (LAMP), which takes less than half an hour, are also currently being developed. Reportedly, handheld LAMP tests could be used in homes and airports and may become available within weeks.

Below is a look at some test kits being used around the world to diagnose COVID-19:

FTD SARS-CoV-2 from Siemens Healthineers

Siemens Healthineers recently announced the availability of its molecular Fast Track Diagnostics (FTD) SARS-CoV-2 Assay test kit that will be used to aid in the diagnosis of COVID-19. Test kits are reportedly being shipped within the European Union for Research Use Only (RUO) to expedite availability while the company continues to pursue Emergency Use Assessment and Listing (EUAL) from the WHO for clinical use. The company has also begun discussions with the U.S. Food and Drug Administration (FDA) for release of the test under Emergency Use Authorization (EUA). Both applications are in progress.

Sebastian Kronmueller, Head of Molecular Diagnostics at Siemens Healthineers said: “The Siemens Healthineers assay is designed to help researchers positively identify the virus in less than three hours so that healthcare professionals can proceed as quickly as possible with the necessary next steps on their patients’ triage paths.”

The FTD SARS-CoV-2 Assay has been optimised on the Biomerieux EasyMag Extraction System and the Applied Biosystems 7500 Real-time PCR Thermocycler. It can be run in laboratories simultaneously with FTD Respiratory Pathogens 21, a molecular syndromic testing panel from Siemens that identifies 21 different upper respiratory pathogens that can cause acute respiratory infections.

BGI’s Real-Time SARS-CoV-2 Test

BGI Genomics. Co. Ltd. and its U.S. subsidiary BGI Americas Corp. recently announced that the U.S. FDA has issued an EUA for its RT-PCR kit for detecting SARS-CoV-2. The highly sensitive test can return results within three hours. It is intended for the qualitative detection of SARS-CoV-2, in bronchoalveolar lavage fluid (BALF) and throat swabs.

BGI Real-Time Coronavirus Test.jpg

“The authorisation of our diagnostic test for COVID-19 in the U.S. will provide high-quality, high-volume testing capabilities to the U.S., and enable medical professionals to respond quickly to diagnose patients, preventing further spread of infection,” Ye Yin, CEO of BGI Genomics was quoted saying. “As one of the first responders to the outbreak in China, we quickly scaled up our production and have deployed large numbers of kits for testing in China and globally in countries where our test kit has been approved.”

ADS Biotec’s test offers results in 15 minutes

In partnership with Japanese firm Kurabo, ADS Biotec has launched new SARS-CoV-2 Antibody Detection Kits (IgM / IgG) using an immunochromatographic method, providing an easy-to-use test for indications of COVID-19 within 15 minutes.

It consists of two types of kits, detecting IgM and IgG antibodies of coronavirus in human blood samples. The kits come complete with all required reagents and are easy to use, providing qualitative visual interpretation. The IgM and IgG antibodies detected by the test are specific to the SARS-CoV-2 virus, and a positive result would be indicative of the patient having contracted COVID-19.

ThermoFisher Scientific’s TaqPath Kit

ThermoFisher Scientific has developed a new multiplex real-time RT-PCR diagnostic kit to enable clinical and public health laboratories to quickly diagnose COVID-19. The Applied Biosystems TaqPath COVID-19 CE-IVD RT-PCR Kit was approved for in vitro diagnostic use throughout Europe. It contains both the assays, controls and master mix required for the real-time PCR detection of RNA from the SARS-CoV-2 virus.

The kit can be used by laboratories to evaluate up to 94 patient specimens in under 2 hours. It is approved for use with RNA extracted from nasopharyngeal swabs, nasopharyngeal aspirate (nasal aspirate), and bronchoalveolar lavage (BAL) from patients at risk of exposure or with signs and symptoms of COVID-19.

Abbott launches molecular test

Abbott recently announced that the U.S. FDA issued an EUA for the fastest available molecular point-of-care test for the detection of novel coronavirus (COVID-19), delivering positive results in as little as five minutes and negative results in 13 minutes. The test will run on the company's ID NOW platform, providing rapid results in a wide range of healthcare settings. The ID NOW platform is small, lightweight (6.6 pounds) and portable (the size of a small toaster), and uses molecular technology, which is known for its high degree of accuracy.

Roche’s cobas SARS-CoV-2 test

Roche recently announced that the U.S. FDA has issued an EUA for the cobas SARS-CoV-2 Test. It is intended for the qualitative detection of SARS-CoV-2, in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria for testing.

The Roche’s cobas 6800/8800 Systems, which are used to perform the cobas SARS-CoV-2 Test, provide test results in three and half hours and offer fastest time-to-results with the highest throughput providing up to 96 results in about three hours and a total of 384 results for the cobas 6800 System and 960 results for the cobas 8800 System in 8 hours.

Spartan Bioscience’s test can detect COVID-19 in half-hour

A Medlab Middle East 2020 exhibitor, Spartan Bioscience, recently announced that it has received Health Canada approval for its rapid, accurate and portable COVID-19 test. Approval by Health Canada means that tests can now be shipped to Spartan’s federal and provincial government partners starting immediately. The test can reportedly detect the novel coronavirus in as little as half an hour.

In fact, Canada’s Prime Minister Justin Trudeau in a recent announcement said that Spartan Bioscience, an Ottawa-based company, will supply tens of thousands of kits per month and potentially more as production increases.

Spartan’s test consists of a portable DNA analyzer called the Spartan Cube, which is the size of a coffee cup. The Cube performs the test with Spartan’s COVID-19 test cartridges and proprietary swabs. The automated test can be operated by non-laboratory personnel in settings such as airports, border crossings, doctors’ offices, pharmacies, clinics, and remote communities.

The technology is currently in use by organisations such as the U.S. Centers for Disease Control (CDC), the New York State Department of Health, and Mayo Clinic. It has been published in medical journals including The Lancet and The New England Journal of Medicine. Spartan’s technology has regulatory approvals worldwide, including FDA 510(k), European CE IVD Mark, and Health Canada.

Unique Precise International's FDA approved test

Unique Precise International recently signed an agreement with an FDA approved Rapid Testing kit for COVID-19, which is reportedly ready to be supplied in the UAE. The test, carried out by a device that pricks your finger for blood, works this out by testing your blood. One kit is for one test and the result is delivered in 10 minutes. It has an approximate accuracy of 95 per cent.

QPS announces novel testing capability

QPS, a global contract research organization (CRO) that provides GLP-compliant discovery, preclinical, and clinical drug development services, has announced a newly developed capability to conduct COVID-19 testing. The company has developed and validated a quantitative polymerase chain reaction (QPCR) assay to identify active novel coronavirus infections. The assay is registered as a CLIA-certified assay in all U.S. states requiring COVID-19 testing notifications. After an initial ramp-up, the laboratory has a projected run-rate of up to 15,000 samples per month.

Simple COVID-19 home-test under development by The University of Manchester

University of Manchester.jpg

Manchester biotech researchers are currently working towards developing a test for COVID-19 that could be used at home like a domestic pregnancy test. This prototype test is based on the fact sugars coat all human cells and could be used in the fight to detect infectious agents like coronavirus. This new screening new approach can help identify the COVID-19 virus – not by its genetic code, which can mutate, but by using its reliance on chains of sugars on human cells, which are constant.

Sugars coat all cells in the human body and they are the first layer a bacteria or virus encounters. Professor Rob Field and his team are interested in how to use the sugars to identify and even block a virus from penetrating the cell – and so preventing further infection.

Professor Field and his team at The University of Manchester are now working with spin-out company Iceni Diagnostics to get their new test ready and officially validated ready for the autumn. An autumn launch this year is key, as the application of this screening kit can support diagnoses of 'flu vs coronavirus', given the typical trend of flu season which can initially present similar symptoms.

When should you get tested?

Anyone with the following symptoms – cough, shortness of breath, and fever should ideally get tested, especially those with a chronic health condition and who are over the age of 60.

 You can also browse through the latest Test Kits on Omnia Health Global Medical Directory

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