LAWRENCE – Researchers at the University of Kansas aim to bring a saliva-based home testing unit for COVID-19 to the commercial market in early 2022.
Consumers would place saliva on a tiny test chip that would be analyzed by a reusable portable electronic device similar in size to a cell phone. Results would be available within 15 minutes. Disposable chips could cost around $ 10, while the reader could cost around $ 50.
Documentation on the reliability of this portable system is expected to be presented to the U.S. Food and Drug Administration later this year. The FDA is expected to provide emergency clearance to bring it to market. Funding for the research was provided by the National Institutes of Health.
Steven Soper, a distinguished KU professor with joint appointments in mechanical engineering and chemistry, said the project was being developed by a private company, BioFluidica, in conjunction with a medical manufacturing company with experience in portable units. and chip technology. The identity of the production partner was not disclosed by KU.
“They are building the handheld instrument right now,” Soper said. “Following our successful proof of concept tests with NIH funding, it will go into production and marketed by BioFluidica. “
Work on the reader began in June 2020 and involved half a dozen KU graduate students in chemistry and bioengineering. The fast-spinning COVID-19 test unit would reuse technology previously designed to help doctors diagnose health issues.
Soper received a doctorate in bioanalytical chemistry from KU in 1989 and returned to university as a faculty member five years ago. He brought in his company, BioFluidica, which previously created products to test for breast, colon and prostate cancer.
He said the technology suitable for detecting COVID-19 could be modified to track the delta variant as well as other modifications of the virus.
“We’re making sure we’re ready to handle any variant that might be generated that might appear in the United States,” Soper said. “Not everyone gets vaccinated. There will always be a population that will not be vaccinated.
The FDA has granted emergency use authorization for more than 30 home or self-administered tests for COVID-19.
Demand for home testing increased after the emergence of the delta variant, which created supply and distribution issues. Demand for testing had declined after the U.S. Centers for Disease Control and Prevention recommended that people vaccinated without symptoms should not need testing despite possible exposure to the virus.
The CDC then revised the guidelines to say that those vaccinated should be tested three to five days after potential exposure to the virus and wear a mask in indoor public spaces for 14 days or until they test negative.