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