New Paper-Based Rapid Test for COVID-19 Awaiting FDA EUA Approval

The test is based on technology developed at MIT’s Institute for Medical Engineering and Science (IMES) and will be submitted to the FDA for “emergency use authorization,” granting temporary approval for using the device on patient samples during public health emergencies.

For the past several years, IMES researchers have been working on diagnostic devices that operate like a pregnancy test but are able to identify viral proteins from patient samples. The technology, known as lateral flow technology, has been used by the researchers to develop tests for various infectious diseases, including Ebola, dengue fever, and Zika virus. The tests comprise strips of paper coated with antibodies that bind to a specific viral protein. A second antibody is attached to specialized nanoparticles while the patient’s sample is added to a solution of those particles. After this, the test strip is dipped in this solution. In case 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 is visible on the strip in about 20 minutes. In addition to delivering rapid results, paper tests can also be easily and inexpensively manufactured in large quantities

“Our hope is that, similar to other tests that we’ve developed, this will be usable on the day that symptoms develop,” said Lee Gehrke, the Hermann L.F. von Helmholtz Professor at IMES who developed the technology behind the test. “We don’t have to wait for antibodies to the virus to come up.”

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