Harvard-Designed Injection-Molded Nasopharyngeal Swabs For COVID-19 Enter Human Trials

Researchers at the Wyss Institute at Harvard University (Boston, MA, USA) have designed a new, fully injection-molded nasopharyngeal swab that can be manufactured quickly and inexpensively at high volume to help address the shortage of swabs for COVID-19 testing and research.

While other teams have leveraged 3D printing, the Wyss team set out to create a new design that could be manufactured using injection molding rather than 3D printing, because injection molding is faster, less expensive, and is routinely used by a broad range of experienced medical device manufacturers worldwide. Initially, the Wyss team developed and tested new swab designs that they 3D printed to eventually settle on a design with a flexible, honey-dipper-like tip that could be injection-molded.

The Wyss team has now sent prototype injection-molded swabs to eight hospitals and health centers for preclinical testing, in which clinicians are evaluating the swabs' performance on a variety of fronts including their comfort and ease of use, as well as their ability to collect a large enough sample with detectable amounts of viral RNA.

The swabs are now being tested in human subjects who will receive a normal swab in one nostril and a prototype of the Wyss-designed swab in the other. If the new swabs can collect a sample that contains detectable genetic information while being as easy-to-use and comfortable as the existing swabs, IPB will ramp up production of the final injection-molded design, which will be used in future clinical trials and, the team hopes, become widely adopted by the medical community in testing patients for COVID-19. Meanwhile, medical device manufacturer IPB, Inc. has been working around the clock to ramp up production of the new swabs to reach 200,000 per day by May 15.

"Experts have recently estimated that the United States needs to more than triple the number of daily COVID-19 tests in order for the country to be safely reopened by mid-May, but the current swabs are complicated to make, and producers just don't have the ability to increase production to that level in such a short period of time," said Richard Novak, Ph.D., a Senior Staff Engineer at the Wyss Institute who has been leading the multi-institutional effort to develop a fully injection-molded swab, working with the Wyss Institute's Founding Director Donald Ingber, M.D., Ph.D. "These new swabs can help meet the critical need for collecting samples, both to diagnose patients and to study the virus itself so that treatments and a vaccine can be found sooner."

Related Links:
Wyss Institute at Harvard University