: Massachusetts Institute Of Technology or MIT has developed a new fast and easy diagnostic tests for the Covid-19 disease that is caused by the SARS-CoV-2 coronavirus. The newly developed diagnostic is paper -based with a turn around time of less than 15 minutes.
The patents and commercial aspects of the test are handled by a Cambridge based startup company created by MIT called E25Bio. The technology for the diagnostics was developed by MIT’s Institute for Medical Engineering and Science or IMES.
The new diagnostic would be extremely useful for poorer countries or regions and areas that do not have expensive PCR machines or thermocyclers that are needed of the current NATs or nucleic acid test and also do away with costly test kits. (current NAT test kits costs between US$ 25 to US$ 49 per test kit, depending on the supplier and also the nature and protocols of the test)
E25Bio is now preparing to submit it to the US FDA for “emergency use authorization,” which would grant temporary approval for using the device on patient samples during public health emergencies.
The new technology behind the new E25Bio’s Covid-19 diagnostic was developed by Dr Lee Gehrke, the Hermann L.F. von Helmholtz Professor at IMES, and other members of his lab, including Dr Irene Bosch, a former IMES research scientist who is now the CTO of E25Bio.
Dr Gehrke and Dr Bosch, and others in the lab for the past several years, have been working on diagnostic devices that work similar to a pregnancy test but can identify viral proteins from patient samples.
The biotech researchers have used this technology, known as lateral flow technology, to create tests for Ebola, dengue fever, and Zika virus, among other infectious diseases.
Basically, the new diagnostic tests consist of strips of paper that are coated with antibodies that bind to a specific viral protein. A second antibody is attached to gold nanoparticles, and the patient’s sample is added to a solution of those particles. The diagnostic test strip is then dipped in this solution. If the viral protein is present, it attaches to the antibodies on the paper strip as well as the nanoparticle-bound antibodies, and a colored spot appears on the strip within 20 minutes.
At the moment there are only, there are two primary types of Covid-19 diagnostics available. One such diagnostic screens patient blood samples for antibodies against the SARS-CoV-2 coronavirus. However, antibodies are often not detectable until a few days after symptoms begin.
The other type of diagnostic test looks for viral DNA in a sputum sample. These tests can detect the virus earlier in the infection, but they require polymerase chain reaction (PCR), a technology that amplifies the amount of DNA to detectable levels and takes several hours to perform. Also the machines involved are expensive as well as the production of the test kits and reagents required.
Dr Gehrke commented, “Our hope is that, similar to other tests that our team have developed, this will be usable on the day that a person is infected. We do not have to wait for antibodies or symptoms of the virus to come up.”
E25Bio would start testing the diagnostic with patient samples, once the US Food and Drug Administration grant the emergency authorization.
Once those are successful, then only will it be adopted in mass usage for actual clinical diagnosis.
One significant advantage of this approach is that the paper tests can be easily and inexpensively manufactured in large quantities.
Results of the US FDA ruling should known by mid next week.
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