Thermo Fisher Scientific Inc. has launched a surveillance system that can detect SARS-CoV-2 in ambient air in indoor spaces, providing a potential complement to individual testing and other COVID-19 safety protocols.
The system, called the Aerosolsense Sampler, works by capturing a sample of the ambient air on a cartridge using Thermo Fisher’s collection substrate. The cartridge can then be analyzed using polymerase chain reaction (PCR) methodology. Customers have the option to conduct the PCR analysis using their own onsite laboratory, a third-party laboratory, or Thermo Fisher’s testing service.
The sampling device, which is about the size of a desktop printer, costs $4,995. Thermo Fisher is selling the cartridges for $45 each, exclusive of the cost of running the PCR tests. The company estimates the total cost to customers for each cartridge plus PCR testing by an outside laboratory would be around $150 per test.
The surveillance system is being positioned as one element of broader COVID-19 safety efforts, including ventilation, masking, individual testing and vaccination. The Aerosolsense Sampler is meant to provide timely indicators about potential exposure and to validate whether existing safety protocols are working, according to John Lesica, president of Thermo Fisher’s Chemical Analysis Division.
“It provides confidence to a business, a school administrator, a hospital, to validate their safety protocols because they really don’t have a capability to do it today,” Lesica told BioWorld. “It’s about reducing that anxiety and kind of building that trust in all of us to get back to normal.”
Validating the system
The Aerosolsense Sampler is not a diagnostic tool, so it does not require regulatory clearance. However, the company submitted a notification of intent to market the surveillance system to the U.S. FDA on March 3, 2021.
The system was validated by scientists at the University of Oregon who tested it in a laboratory bench-scale setting and a room-scale environment. They found that its ability to detect SARS-CoV-2 in aerosols was consistent and reproducible, and the amount of dust present did not impact the ability of the system to detect the virus. The findings, which are currently available as a preprint, have not been peer reviewed.
The Waltham, Mass-based company also conducted a real-life evaluation of the system at the University of Massachusetts field hospital in Worcester. Officials at the field hospital were looking to confirm that their safety protocols were working to keep SARS-CoV-2 out of the air in areas without COVID-19 patients. Using the Aerosolsense Sampler, they were able to validate that SARS-CoV-2 was present in the air in their “hot area” where COVID-19 patients were being treated, but not in “cold areas” like the ICU, Lesica explained.
“It provided them that confidence that their air handling was working,” Lesica said. “It also reinforced that if you’re in the hot area, you need to be wearing the appropriate [personal protective equipment], you need to be following the right protocols.”
System aids contact tracing
Thermo Fisher recommends that the system be run for a minimum of two hours to provide for adequate sample collection, but sampling time is dependent on the facility and the application. For example, a hospital that is seeking to validate safety protocols in certain areas would likely only sample for two hours. If the system were in use in an office or a nursing home, the customer would likely sample for the length of one shift, Lesica said.
The company recommends running the system for every shift so that if the sample comes back positive for SARS-CoV-2, the customer can identify everyone who was potentially exposed, and they can be tested individually. “That’s the way you really can validate your safety protocols and action it. If you go for any extended period of time, the quality of being able to contact trace and validate what was taking place in that environment, is a lot harder,” Lesica said.
The focus of the initial launch of the product will be in hospitals and nursing homes, according to Thermo Fisher. But the company sees a large market for the system in academic institutions, detention centers, manufacturing facilities, and restaurants, as well as employee break rooms at many types of businesses.
Going forward, Lesica said they expect the system will be used to detect other in-air pathogens, such as influenza, but that will require additional validation.