Procter & Gamble Co. is licensing its recently developed, injection molded nasal swab for home COVID-19 testing to Rhinostics Inc. to launch the product.
P&G developed the swab with its Imflux business to address supply shortages, streamline lab workflow and lower costs, Cheri Walker, CEO and president of Rhinostics, told Plastics News.
"Rhinostics plans to register the P&G polypropylene nasal swab as a Class I Exempt medical device and will pursue emergency use authorization for home collection with rPT-PCR testing" for detection of the SARS-CoV-2 infection, a Jan. 22 news release said.
The problem laboratories are facing amid the pandemic is throughput "on the segment of bringing the samples into the laboratories," Walker said.
"There haven't been a lot of improvements made in collection device materials in 20 or 30 years," she said.
"People are still transferring virus in viral transport media to keep them alive," Walker said, but PCR and antigen-based assays don't need the virus alive when they arrive at the lab for testing.
P&G began production of the new polypropylene swabs, which can be manufactured quickly to meet demand, and are "hydrophobic," which allows for dry transport without VTM, she said.
"You collect the sample, put it in the collection tube dry, you don't have to deal with liquid and it's stable for 72 hours," Walker said.
The swab also features an attached screw cap for the collection tube.
"You collect holding on to the screw cap, put it directly into the tube and screw it in. You don't need to put another cap on," she said.
The caps fit into a "de-capper" robot, which automates the process of removing the caps, reducing human labor and repetitive movement to "get more samples into the lab faster," Walker said. An automated scanner will scan the identifying bar codes of a rack of 96 samples.
"You also don't have the exposure of people to the virus [during testing]," she added. "You can reduce down to about five people doing the whole automated line."
Rhinostics expects the automation line to be able to process 25,000 samples in one day, with about 25 percent time savings for the labs, Walker said.
"The founders and I want to make a difference to COVID-19 testing; we want to impact and speed it up, enable more labs to be able to get in more samples and ultimately impact this pandemic," Walker said.
"When we began this program, our intention was simply to help relieve bottlenecks in COVID-19 swab supply and bring a novel collection device to bear on the problem," Mary Wagner, senior vice president at P&G and CEO of Imflux, said in the release.
"We believe there is a significant opportunity to bring new collection devices like the P&G nasal swab to clinical laboratory workflow," Walker said in the release. "Not only does the nasal swab production help to relieve supply chain bottlenecks, the new design and polypropylene materials allow for comfortable collection and sample concentration due to dry shipment and improved release of viral particles. We are excited to bring this innovation to the clinical laboratory market."