The Certus System is for in-house pathogen detection by small and mid-sized food processing plants.
The base technology is part of a collaboration between Certus and BD (Becton, Dickinson and Company).
An exclusive worldwide license agreement allows Certus to use the patented nanoparticle Surface-Enhanced Raman Spectroscopy (SERS) system for the food safety industry. BD continues to apply the technology to other markets.
The SERS nanoparticles act as the detection modality for a specific immunoassay.
Assay reagent and media development is between Certus and Solus Scientific.
The system can detect live and dead pathogens with live ones being the target organism.
FSMA compliance
Certus said due to FSMA compliance requirements small and medium-sized producers face expensive outsourced testing that takes days or need to invest in bio-safe labs, expensive equipment and skilled lab technicians.
John Coomes, president of Certus, said Solus is helping with the R&D of the immunoassay using the technology it is licensing from BD.
About Certus
Certus is part of the Toho Technology group of companies as a brand specializing in food safety. Founded in 1819, Toho is a privately-held company that provides engineering, manufacture, distribution and support of industrial and life-science technologies. The company has facilities in Chicago, Illinois; Japan; Shanghai, China and Jakarta, Indonesia. Certus has R&D, operations and sales in Chicago with 12 staff, four in the UK helping with design of the assay and four in the manufacturing, design and engineering team in Japan.
“Our goal was to take this simple methodology that BD had created and come up with a way for anyone, whether you are a microbiologist or whether you are a technician in a food plant, to make this a simple workflow," he told FoodQualityNews.
“So you take an environmental swab and swab a surface just like people in the industry do every day and once the sample is collected there is a selective single enrichment media which is put into a detection tube and the swab is put into the tube.
“Once that is sealed with the Bio-Lock cap all you need to do is put it into the detection unit, which is what we call the instrument, and from that point on the rest is done for you. You let the machine begin to raise the temperature to culture the Listeria sample and as soon as there is a detected positive you will get a signal right away.”
If no pathogens are present time to negativity is in the 24-27 hour range. Time to positive will depend on pathogen load but could be within eight to 12 hours.
Certus reduces environmental testing, monitoring time and cost by eliminating media and sample preparation, courier expense and risk of opening an enriched sample in the plant.
The user will swab a surface, add media to the Bio-Lock Detection Tube and insert the tube into the Certus Detection Unit to start getting results during the enrichment cycle.
There is no need for centrifuges, incubators, pipettes, stomachers, bags and ancillary items.
2018 launch and sights on Salmonella and food products
Coomes said it has five or six prototypes currently going through final testing.
“We are going to be releasing beta-units into the marketplace in late fall so we are selecting customers in the US and Europe that will be working with us as beta-test site customers,” he said.
“Listeria is a serious problem and one that every food producer struggles with. The market has a strong demand to prevent outbreaks of Listeria. Especially at the small to medium producer level with FSMA regulations coming into full application for everyone, we see this as high demand so it was what we wanted to provide first.
“Current development is for Listeria species and our data shows it will cover species including mono, grayi, innocua, ivanovii and welshimeri.”
Initial research from BD showed promise on food products, said Coomes.
“They had conclusive studies on the ability to detect in about 20 different food matrixes so we had that research foundation to build on. Our choice is to start with Listeria species for environmental sampling because the industry is trending towards prevention and that is what our focus is,” he said.
“Our development roadmap does include, as well as other environmental pathogen detection, to be able to detect pathogens in the end product in the first two to three years. That can be done on the same machine, it’ll be a slightly different vessel but it will still be the same bio-contained tube that goes into the instrument and detects the pathogen in food.
“We are targeting future development of environmental Salmonella in [2018] and then end product testing. We intend to release this worldwide with US as our base, then in Europe and then Asia.”
Continuous monitoring
The company's patented Grow, Read, Detect continuous monitoring process combines enrichment and detection in a homogenous, no-wash format for real-time monitoring.
It enables the processor to do on-site testing, receive instant alerts and take action to remediate, said Coomes.
CDC on Listeria
Listeriosis is a serious infection usually caused by eating food contaminated with the bacterium Listeria monocytogenes. An estimated 1,600 people get listeriosis each year and about 260 die. People with invasive listeriosis usually report symptoms starting one to four weeks after eating contaminated food.
“Inside the detection tube the temperature is precisely controlled to optimize the growth of the target pathogen, in this case Listeria species,” he said.
“While that is happening inside this Bio-Lock tube the immunological sandwich - a combination of SERS tags and nanoparticles that have conjugated antibodies and the target pathogens are drawn together by a magnet.
“Once these pallets of these immunological sandwiches are drawn together they are interrogated by a laser every 10 minutes. After the interrogation is complete there is a dispersion that happens to allow for another sampling.
“They are drawn together again by this magnet and once the signal is strong enough, and this is a Raman spectroscopy signal, as per a software algorithm that we developed with BD, it will indicate there is a positive.
“That positive is sent to any user through text or email messages telling them the exact location of the sample, the time of the sample, the technician who took the sample and any other data they want to program.
“At the same time this message is sent out a red light goes on over the detection unit showing the sample slot that had the positive and correspondingly the user interface, which is an iPad, emits a warning message that tells the responsible party, probably a quality control manager, to initiate any remediation steps. All this is recorded within the unit to be FSMA compliant with reporting requirements.”
More data without the cost and wait
Coomes said while there is a lot of ATP testing, research shows the medium sized user wants to have more data at their fingertips without having to spend a lot and wait for third party labs.
“ATP testing does provide you with information that there is a problem but it doesn’t specify in many cases what exactly the problem is. As the industry demands more data, more recording and more granulator at their fingertips at a good price point we are going to capture market share,” he said.
“We’ve been engaging with AOAC consultants, we are preparing for AOAC submission in the next month or so, and we’ve discussed with consultants who have speciality in AFNOR.
“Prior to our launch into the marketplace in the last year we have done a lot of market research and BD did extensive research by bringing this technology in front of global players in the food and beverage industry, so there has been thousands of hours spent on making sure customers see the value.
“While it is new and different and that is a challenge I won’t hide that, getting people to switch from something they depend on now and is working to a new technology is always a challenge, but our research and that of BD and the response we are getting from initial discussions with customers is people are excited about the simplicity.
“The need to be FSMA compliant and prevent outbreaks is real and the ability to do it yourself without sending it out to a third party is an attractive feature.”