Monday, August 27, 2018

HP is "Printing" Drugs for the CDC to Speed up Antibiotic Testing

HP Inc. announces its participation in a pilot program run by the Centers for Disease Control and Prevention (CDC) that aims to accelerate the testing of new antibiotics designed to fight antimicrobial resistant bacteria. The pilot uses HP technology to “print” pharmaceutical samples. As part of the pilot, CDC will deploy new HP D300e Digital Dispenser BioPrinters to four regional labs in the Antibiotic Resistance (AR) Lab Network, to develop antimicrobial susceptibility test methods for new drugs. For the first time, regional labs will be able to conduct rapid susceptibility testing for health departments and hospitals nationwide.

“Bacteria continuously develop new ways to resist antibiotics—once a drug is approved for use, the countdown begins until resistance emerges. In fact, resistance has even been detected before FDA approval,” said Jean Patel, PhD, D (ABMM), science team lead of the Antibiotic Resistance Coordination and Strategy Unit at the CDC. “To save lives and protect people, it is vital to make technology accessible to hospital labs nationwide. We hope this pilot will help ensure our newest drugs last longer and put gold-standard lab results in healthcare providers’ hands faster.”

Antimicrobial resistance is an international public health issue. New antibiotics for resistant bacteria can help save lives, but hospitals often do not have access to antimicrobial susceptibility testing to know if the new drug might be effective. The HP printer helps to speed up testing availability at the local level by “printing” the gold standard test plates in a few minutes. When testing is not available, new drugs can be either over-utilized, contributing to antimicrobial resistance, underutilized, not helping patients in need, or mis-utilized, which can lead to side effects or prolonged treatment.

How it Works

The BioPrinter accurately dispenses or “prints” volumes from picoliters to microliters for faster, more reliable dispensing of small molecules and biomolecules to enable drug discovery, genomics, and proteomics research. The following labs within the AR Lab Network will use this technology to develop and perform antimicrobial susceptibility testing for new drugs: New York, Minnesota, Tennessee and Wisconsin. This new capacity can be used by healthcare providers for patient care while commercial methods commonly used in hospital laboratories are developed and implemented.

Testing through CDC will be implemented in the regional laboratories in the first quarter of FY19. CDC will prioritize testing for highly resistant bacteria, with pan-resistant bacteria being the top priority. HP will coordinate with CDC to evaluate the pilot in the regional laboratories of the AR Regional Lab Network, refine the system, and explore and support a larger roll-out of inkjet printing technology in labs nationwide.

Wednesday, August 22, 2018

Purdue Researchers Take on Mosquito Diseases Like Zika and West Nile with New Device

The number of cases in the continental U.S. of mosquito-borne diseases, such as Zika, dengue, West Nile, and chikungunya, has climbed over the past two decades.

To help combat these tropical diseases, a team of researchers at Purdue University has created a startup company — SMK Diagnostics — that is developing a device to rapidly detect and monitor various mosquito-borne diseases.

Many current methods take days or weeks to determine whether a virus is present in a sample. Even then, these techniques often can detect that a flavivirus — a strain of virus often carried by mosquitoes — is present, but cannot discern whether it is Zika, dengue, or chikungunya.

Now Purdue biologists and material scientists are working together to create a biosensor that they hope will improve the speed, specificity, sensitivity, and portability of current testing techniques for a range of mosquito-borne viruses.

“Our device responds within 30 minutes and doesn’t require trained people,” said Lia Stanciu, a material scientist who helped develop the device. “It’s fast and portable.”

How does it work?

To develop their sensor, the researchers take advantage of the fact that many of these mosquito-borne viruses are composed of single-stranded ribonucleic acids, or RNAs. Like DNA, each unit in the RNA sequence can bind to just one other complementary unit — like two puzzle pieces coming together.

The researchers can then create new biomolecule “probes” composed of specific sequences that will match and bind only to a given target RNA virus, for example, Zika or dengue virus. The biomolecule probe acts like a lock that can only be opened by a specific virus key.

The biomolecule probe is attached to an electrode and when a target virus is present, it binds to the probe — opening the door, so to speak — which the electrode senses and alerts the device’s user to the presence of that virus.

“It’s remarkable in that it is very specific and you can control the specificity by your design of your probes,” said Richard Kuhn, co-founder of SMK Diagnostics and a biologist at Purdue University who recently determined the structure of the Zika virus. “It’s incredibly sensitive in that it picks up very low level signals.”

The electrodes are printed on a film that will ultimately be connected to a portable electronic reader. Ideally, multiple electrodes could be printed on a single film, meaning each biosensor unit could be used to look for multiple viruses at a time.

“In any area of technology, we want to do things better and faster,” Kuhn told IndyStar. “What we have here is a fairly rapid and fairly precise assay that out-competes what’s currently being used.”

Rapid identification of certain viruses can support earlier delivery of life-saving treatments. And for viruses such as Zika and dengue that don’t currently have specific anti-viral treatments, identification of the viral infection can still aid in patient care. For example, Zika infection is known to cause serious birth defects. Thus, women testing positive for Zika could make more informed decisions about future or current pregnancies.  

In addition to these diagnostic tests, the researchers envision that their biosensor can be used to ensure blood transfusion safety at blood banks and hospitals, to track or contain disease movement, and to manage mosquito populations.

“If you find infected mosquitoes in one area, you can communicate with the local authorities in that area, and say there is a problem,” Stanciu said. “We can spray there before they go and infect other people or areas.”

Scaling up the manufacture to join the Internet of Things

So far, the startup has patented their biosensor creation technique, and they are now working to optimize the device’s portability and to scale up manufacturing with printing through the Scalable Manufacturing of Aware and Responsive Thin films (SMART) consortium at Purdue University.

This research initiative combines the expertise of industry partners, including Indianapolis-based Eli Lilly and Co. and United Technologies, and university researchers to help fledgling companies, such as SMK Diagnostics, develop scalable, low-cost manufacturing techniques for new sensing technologies.

The mosquito-borne disease sensor created by SMK Diagnostics is just one example of a device that will become part of the burgeoning “Internet of Things.” Often referred to as IoT, it is a network that interconnects sensors embedded in everyday objects that send and receive information among devices.

Just as Silicon Valley revolutionized the computing world, many believe that IoT technology will transform data collection, measurement and optimization for product use and safety in our daily lives.

At Purdue’s Birck Nanotechnology Center, various companies and researchers are creating biosensors with wide-ranging applications: a soil-nitrogen sensor for agriculture, smart packaging for food safety, and human performance monitors for health care, among others.

“Most of our manufacturing today is the conventional type — parts of cars and so on — but if we can bring some of these new factories and technologies for sensors and IoT to the region, we could become the manufacturing hot bed in the U.S. and for the world,” said Ali Shakouri, director of the Birck Nanotechnology Center. “If we keep that here, then the design and new ideas will be here. Who knows, we could be the IoT Plains of the United States.”

By creating a common platform for multiple sensor applications, the SMART consortium will lower the cost of producing this technology for all types of sensors, making it easier for SMK Diagnostics to rapidly make the large numbers of sensors that are required for future stages of field testing of their mosquito-borne disease sensor.

The SMART consortium leaders hope that their efforts will push Indiana to become a global leader and manufacturer in the IoT revolution, giving Silicon Valley a run for its money.As for the founders of SMK Diagnostics, they are excited that their device to detect mosquito-borne diseases could improve human health, both globally and locally.

“People working at companies and universities in Indiana (are) partners in global health. Global health always turns at some point into local health,” said Kuhn, SMK’s co-founder. “Things that might work in India or Thailand (now), probably are going to have a positive impact on people in Indiana at some point.”


Neogen’s One-Hour Listeria Right Now™ Receives AOAC Approval

Neogen’s revolutionary Listeria Right Now™ environmental pathogen detection system has officially achieved AOAC approval, license number #081802.

The approval adds another level of assurance to the food safety community, as the product has now been validated by one of the industry’s leading third-party accreditation groups.

“It’s extremely gratifying to receive this approval,” said John Adent, Neogen’s president and chief executive officer. “It comes as the result of a lot of hard work and ingenuity on the part of Neogen’s R&D and validation groups. The Listeria Right Now system is truly revolutionary, and having this approval validates this new technology platform.”

Listeria Right Now is a complete system for taking environmental Listeria tests with molecular-level accuracy that requires no enrichment, so there’s no need for processors to grow bacteria cultures on-site. The system provides results in under one hour, much faster than traditional methods, which can take up to several days.

The system works so quickly thanks to a technology that targets rRNA, which is present in much greater numbers than the traditional DNA target. An isothermal reaction also causes the replication and amplification to occur at a constant rate instead of the normal thermal-cycle technology from traditional PCR systems. The technology allows food production and processing facilities to seek and eliminate Listeria more quickly, which can reduce the risk of cross-contamination of food products — keeping consumers safe.

Listeria Right Now has now been validated by AOAC and NSF International, and is the winner of the 2018 Innovation Award from the French organization Carrefour des Fournisseurs de l’Industrie Agroalimentaire.

Monday, August 20, 2018

Reliable Point-of-Care Blood Test Can Help Prevent Toxoplasmosis

A recent study, performed in Chicago and Rabat, Morocco, found that a novel finger-prick test for infection with the parasite Toxoplasma gondii during pregnancy — and many other potential applications — is 100 percent sensitive and 100 percent specific for detecting the presence of this life-damaging microorganism.

A positive result from the Toxoplasma ICT IgG-IgM point-of-care test, performed with a drop of a pregnant woman’s blood, can rapidly inform an obstetrician about the need for prompt treatment of toxoplasmosis. Timely intervention before birth can prevent the disease, which can cause death, severe brain damage and loss of sight in an infected fetus.

The test, developed by LDBIO Diagnostic of Lyon, France, “meets the World Health Organization’s criteria for an optimal point-of-care test,” said toxoplasmosis specialist Rima McLeod, MD, a professor of ophthalmology and visual science and pediatrics at the University of Chicago Medicine.

“It is sensitive and specific, quick and easy to perform, equipment-free, and easily utilized,” she said. “Results are available in half an hour while the patient is seeing the doctor. A positive result can be confirmed quickly, so health care providers can immediately begin treatment.”

The test is also inexpensive. It costs $4 to $5 per test. Pregnant women at risk should be tested eight to 10 times — once a month during pregnancy, beginning in the 12th week, then once more four to six weeks after delivery. Total cost for repeated tests is about $40 to $50. Hospitals and clinics in developed countries charge substantially more.

“This well-studied, inexpensive test opens the door to life, sight and cognition-saving treatments for children exposed to the parasite in utero,” said McLeod. By spotting the infection early with monthly testing and alerting physicians to the need for urgent treatment, “it markedly improves outcomes for infants infected in utero,” she said. “This test leads to prevention of the severe consequences of Toxoplasma gondii infection and saves lives.”

“A paper cut,” she added, “is more painful than the finger prick for this test.”

Toxoplasma gondii gains access to human hosts when they eat undercooked contaminated meat or are exposed to material contaminated by feces from an acutely infected cat, which usually goes unrecognized. Current methods of detecting the infection include serum tests, which require blood samples to be processed using technologies that are often cost prohibitive in developing areas and “may be considered too costly even in developed countries,” McLeod said.

In the August 16, 2018 issue of PLOS Neglected Tropical Diseases, a study by researchers based at the University of Chicago Medicine shows that the new test “performed with high sensitivity and specificity. It obviates the need for venipuncture and sample processing.” The test is accurate whether the patients were recently exposed or infected long before testing.

The LDBIO test relies on an immuno-chromatographic lateral-flow assay. This is a paper-based system designed to detect the presence (or absence) of a specific target — in this case the IgG and IgM antibodies — by slowly flowing the liquid sample through a paper matrix and over a substance that binds to the antibodies and causes the appearance of a colored band.

The researchers, including colleagues in the United States, France and Morocco, collected and tested 244 samples from 205 individuals. Overall, 101 of the samples indicated that the patients had developed antibodies against T. gondii. The other 143 samples did not have T. gondii antibodies.

Blood from these volunteer donors was examined in multiple ways. The researchers compared reference tests and standard-of-care serum tests against the finger-stick test. The new test’s results with whole blood exactly matched those from established but more cumbersome methods, even for women with low levels of anti-T. gondii antibodies.

Although the test does not distinguish between acute and chronic infections, it provides valuable information that can guide decisions in outpatient settings at very low cost, enabling rapid diagnosis and treatment for infections acquired just before or during pregnancy.

“Adoption of this type of high functioning point-of-care test would reduce costs substantially and require significantly less infrastructure than conventional testing,” the researchers conclude. “Value also arises from bringing pregnant women into care, leading to screening for other preventable and treatable conditions.”

“Testing of pregnant women for this infection has already changed how this parasite affects babies in France, Austria, Germany and Colombia,” McLeod said. “This test should facilitate similar improvements in patient care and well-being in the U.S. and many other developed and developing countries.”

The makers are submitting the point-of-care test for approval by the U.S. Food and Drug Administration based on recent U.S studies, but it has not yet been approved.

Funding for this study came from the Thrasher Foundation, the National Institutes of Health (NIAID DMID), the Fulbright U.S. Scholar Program (Kamal El Bissati), and the Mann Cornwell, Van Dusen, Morel, Goldberg, Rooney, Taub, Drago and Orlinsky families.

Additional authors were Joseph Lykins, Karen Leahy, Xuan Li, Pauline Levigne, Ying Zhou, Kamal El Bissati, Fatima Clouser, Martine Wallon, Florence Morel, Karen Leahy, Bouchra El Mansouri, Maryam Siddiqui, Nicole Leong, Morgan Michalowski, Erin Irwin, Perpetua Goodall, Mahmoud Ismail, Monica Christmas, El Bachir Adlaoui, Mohamed Rhajaoui, Amina Barkat, Hua Cong, Ian J. Begeman, Bo Shiun Lai, Despina G. Contopoulos-Ioannidis, Jose G. Montoya, Yvonne Maldonado, Raymund Ramirez, Cindy Press and Francois Peyron.

Source: University of Chicago Medical Center

Wednesday, August 15, 2018

UMN Researchers use Green Gold to Rapidly Detect and Identify Harmful Bacteria

Researchers from the University of Minnesota (UMN) have developed a method to screen and identify harmful or antibiotic-resistant bacteria within one hour using a portable luminometer. Traditional diagnostic methods often require complex equipment and lab work that can take days. The new method uses chemiluminescence, or the emission of light during a chemical reaction. It was developed with the food industry in mind and could also be used in healthcare settings.

In a study published in Advanced Healthcare Materials, researchers from the College of Food, Agricultural and Natural Resource Sciences and the College of Science and Engineering at UMN demonstrated the new technology by analyzing surface swabs and urine samples for the presence of small concentrations of methicillin-resistant Staphylococcus aureus (MRSA), a bacteria that causes more than 11,000 deaths in the U.S. every year.

"A big barrier for microbial detection in the food industry is cost and the inability to detect harmful bacteria in a reasonable time," said John Brockgreitens, a graduate student involved in the study from the Department of Bioproducts and Biosystems Engineering. "We're trying to develop an inexpensive and rapid way for microbial detection that can be used without needing extensive training."

To screen for microorganisms, green gold in the form of triangular nanoplates was combined with a reducing agent and luminol. This caused a strong chemiluminescent reaction that was stable for as long as 10 minutes. When researchers introduced MRSA and other microorganisms into the combination, they consumed the gold nanoplates, causing the chemiluminescent intensity to decrease proportionally to the microbial concentration. This indicated a presence of microorganisms.

"Rapid microbial detection in less than two hours is not only vital to prevent food poisoning, but also to fight antimicrobial resistance by helping physicians make informed decisions before prescribing antibiotics," said Abdennour Abbas, a professor in the Department of Bioproducts and Biosystems Engineering, who directed the research. "More work is needed to apply this technology to more complex samples such as food and crops, but we're hopeful that progress will continue in this area."

Researchers also introduced a new concept called microbial macromolecular shielding to specifically identify MRSA. A polymer specific to MRSA was added to the same sample where it engulfed and surrounded the MRSA bacteria, preventing them from consuming the gold nanoplates. This increased chemiluminescence intensity, indicating the presence of MRSA.

More research is needed before the method can be used in real-world applications, but researchers are eager to make this process faster and easier for industry use.

"In the food industry, items like processed meat, cheese, yogurt and milk have a lot of other competing parts such as proteins and other cells that you need to effectively filter out before you could detect what you're looking for," Brockgreitens said. "We know our direction is to keep looking at some of these cellular interactions and how to make this whole process either automated or a one-step process."

This research was funded by the National Science Foundation Award No. 1605191, the University of Minnesota MnDRIVE Global Food Venture, the USDA National Institute of Food and Agriculture Hatch project 1006789, General Mills, the Schwan's Company Graduate Fellowship, and the Midwest Dairy Association.

New E. coli Test Could Change Food Production

The threat of E. coli has prompted a Grand Valley State University researcher to find the bacteria in food before it hits the market for consumption.

Kevin Strychar, an ecological researcher at the university’s Annis Water Resources Institute in Muskegon, was awarded a $96,007 grant from the Michigan Department of Agriculture and Rural Development to test the use of an imaging flow cytometer to discover E. coli contamination in food as it is brought from harvest.

“The imaging flow cytometer has a microscope and a laser,” Strychar said. “Every particle that passes through that laser beam, we get a bunch of information and every time the particle passes, we also get a picture of the particle and it helps to characterize particles like E. coli rapidly.”

Strychar said the tool can identify whether or not a food particle has E. coli bacteria in 20 seconds, which is faster than what is being used now.

Polymerase chain reaction is the technique currently being used by researchers, which takes about two hours to detect bacteria in food, according to Strychar, who has been a researcher at the Annis Water Resources Institute for five years. He said he is focusing on testing water that is sprayed on blueberries.

Strychar said he thinks some farmers are using reclaimed water that goes to the sewage plant and then is treated, cleaned up and screened before being used again by individuals like farmers. Although the water may be treated and cleaned, he said there is a problem when the water is used to water crops because there is an “introduction of E. coli, dangerous E. coli, the ones that can really kill.”

The grant allows Strychar and his research group at GVSU to get blueberries from farms across the state to test them, but he said he and his fellow researchers are unaware of where in Michigan the blueberries are coming from in order to conduct unbiased research.

He said his hope is for the industry to have more than one method of testing.

“The end product is rather than waiting two hours or six hours, which means, in theory, that the sample of the product can spoil, the end product would be that within 60 seconds or less, you can tell a farmer whether their produce is safe for human consumption,” Strychar said. “And if it is not, rather than waiting a few days, the farmer can make an immediate decision whether to re-sterilize or re-irrigate or whatever method they use to clean their produce, they can (make) an on-site, immediate (decision) as opposed to having to wait 12 hours or two days or three days.”

Although the experimental tool is able to detect E. coli, according to Strychar, he said there is a lot more research left to be done, including proving to the state that it works.

“The state will set up trial independent labs, and all three labs will sample and, hopefully, confirm that it works,” he said. “If it does, then it is up to the government, and then, I assume, what the government will then do is institute legislation that would require this method of analysis.”

The research for rapid E. coli testing equipment in Michigan was funded in response to the Food Safety Modernization Act, which was enacted in 2011. Tim Slawinski, director of the food and dairy division of the MDARD, said GVSU’s research is significant because, in January 2022, farmers will be required to test agricultural water for E. coli as part of a series of changes over the next few years that will be implemented in the FSMA.

The first set of requirements were put into place regarding employee hygiene. Before the FSMA, Slawinski said there were no regulatory requirements to test water for E. coli.

“I look forward to the results because the intent is to figure out if (the image flow cytometer) is feasible,” he said. “If this is something that can resolve some logistical concerns and then if it is something that can be used nationwide, if it is determined that it is a reasonable way to test water, then other (companies) across the nation can decide, ‘Hey, I can buy this piece of equipment and maybe implement a program that can use that.’ It could provide another option to test water.”

Indian Government Warns of Malaria Bug that can Dodge Rapid Tests

Indian government scientists have urged intensified vigilance for a genetic mutation in a deadly malaria parasite that renders the bug invisible to rapid diagnostic tests and could lead to infected patients being misleadingly labelled as uninfected.

The mutation in the parasite that causes cerebral malaria, first detected in Peru eight years ago, has since then surfaced in Gujarat, Madhya Pradesh, Maharashtra, Jharkhand and Odisha and could threaten malaria elimination efforts, the scientists have said.

The diagnosis of Plasmodium falciparum infection now relies on rapid diagnostic tests that look for a surface protein on the parasite called histidine-rich protein (HRP) 2, which serves as its molecular signature. But a genetic mutation that has deleted the HRP2 protein allows the parasite to evade detection through the standard rapid diagnostic tests.

"The HRP2 protein is not essential to the parasite's survival - so the mutated parasites continue to infect and cause disease in humans," said Praveen Kumar Bharti, a scientist at the National Institute of Research in Tribal Health (Nirth), Jabalpur.

An infection caused by such a mutated parasite is not picked up by the standard rapid diagnostic tests. So patients with high fever and other malaria symptoms may be misleadingly labelled as uninfected by malaria, leading to likely delays in treatment.

In a report published this week in the journal Lancet Infectious Diseases, the Nirth scientists have called for "timely mapping and monitoring" of parasites without HRP2, saying this will be a crucial step towards malaria elimination.

India's malaria control efforts have helped reduce the number of cases from about 1.9 million in 2004 to 1.1 million in 2014. The Union health ministry's malaria elimination milestones seek to achieve zero local cases and deaths by 2024, interrupt all local transmission of malaria by 2027, and maintain a malaria-free status across India by 2030.

But Nirth director Aparup Das and his colleagues have now cautioned that the deletion of HRP2 in the malaria parasite may make the elimination challenge even more difficult. They have highlighted that India's public health sector alone had during 2016 relied on over 19 million rapid diagnostic tests to look for malaria in patients with suspected symptoms.

The HRP2-deleted parasite appears to have emerged in the Peruvian Amazon in 2010. Within three years, scientists at the National Institute of Malaria Research, New Delhi, reported finding similar mutated parasites in India.

Surveys have since then indicated that up to 8 per cent of parasites picked up from sites in Gujarat, Jharkhand, Madhya Pradesh, Maharashtra and Odisha lack the HRP2 protein.

The scientists have also called for research to design alternative molecular diagnostic tests that could help overcome the deletion of the HRP2 protein.

"Otherwise this hole of Plasmodium falciparum HRP2... deletion might sink the ship of malaria management and elimination in India," they wrote in their report.

New Device Proven to Reduce Risk of Foodborne Pathogens

A user-friendly foodborne pathogen detection device developed by a multidisciplinary team of University of Alberta researchers has been shown to be the fastest and most sensitive, according to new research.

"Most methods for screening foodborne pathogens are relatively slow, requiring 24 to 48 hours for results, and resulting in frequent food recalls if pathogens are found," explained Patrick Pilarski, an engineer in the Faculty of Medicine & Dentistry and a member of the team that was brought together five years ago to design the instrument.

"The results of our recent study set a new standard in rapid and accurate in rapidly and accurately testing for bacteria in a wide range of consumables. It is ready for commercialization. Someone without any expertise in microbiology could perform the test with a single push of a button, and produce results within one shift, for example, at a meat processing plant."

Specifically, in the PLOS One study, the device, called the GelCycler Mark II, was shown to be capable of detecting and reporting E. coli contamination in 41 minutes.

The key to the device, which in rudimentary terms involves placing a small amount of food on a cassette containing desiccated hydrogel, is the elimination of the bacteria enrichment phase currently used in most testing techniques.

"Because most testing platforms cannot detect a single bacterium, enrichment protocols are routinely used in which bacteria obtained from defined amounts of food product are cultured in broth to increase the number of organisms to a level that is detectable," explained Lynn McMullen, a U of A food microbiologist and co-author of the study.

"Usually the enrichment step takes 12 to 48 hours, resulting in significant delays in identifying food products harbouring pathogenic contaminants, whereas our device vastly shortens the time most testing platforms need to detect a single unenriched bacterium per capillary reaction.

"We have coupled the new device with a very short enrichment process that allows us to get a result in less than seven hours."

In addition to detecting E. coli, the device is capable of identifying Salmonella enterica, Campylobacter jejuni and Listeria monocytogenes, said McMullen.

"The reality is that currently, meat processors are often holding product to wait for results. The GelCycler Mark II can help get it out the door quicker and reduce the food safety risks for consumers."

One in eight Canadians will get sick with a foodborne illness, added McMullen.

"As far as I am concerned, there is no excuse for foodborne illness and disease because it is preventable. And prevention starts at the farm and goes through the various production phases to the consumer. So having a rapid testing device that allows processors to be better able to detect problems before they are shipped out the door is an important contribution."

The project was funded by Alberta Innovates and its partners, with the team brought together by Cornelia Kreplin, executive director of sustainable production/food innovation at Alberta Innovates.

"She knew all of our various expertise and strengths and encouraged us to work together.
Otherwise, I wouldn't have applied to the call for proposals because I certainly don't have the expertise to develop a new detection system," said McMullen.

"We have to credit her with seeing the bigger picture and pushing us to form a really interdisciplinary team from diverse areas of research."

"This work is an important step in food safety, and in how an idea is generated to solve a problem," said Kreplin. "We understand that in today's marketplace, the key is to accelerate the timeline from an idea to a product. Bringing researchers from different disciplines together to solve problems is essential to that objective."


Darin Hunt et al. Monitoring food pathogens: Novel instrumentation for cassette PCR testing, PLOS ONE (2018). DOI: 10.1371/journal.pone.0197100

A New Water Monitoring Device Provides Quick Detection of Deadly Bacteria

A new microbial detection device will help water distribution networks speed up the process of measuring their infection. This will lead to significant savings in critical financial resources.

Transmissible infectious diseases are a major problem for human health. Contaminated water can lead to diarrhea, cholera, dysentery, typhoid and poliomyelitis. Drinking water is estimated to cause 502,000 deaths due to diarrhea each year, according to the World Health Organization. This is why rapid detection of microbes and bacteria in water is considered vital.

A team of researchers financially supported by the European Union through funding has created WaterSpy, a device for monitoring tap water in real time. It was a portable water quality analyzer based on the laser that can be used in critical locations in water distribution networks. It can provide safe reading in a few hours rather than in days as usual in traditional ways, helping water services, public authorities and regulators save time and money.

The prototype is ready and the team will test it at two locations in Genoa, Prato’s water treatment plant (a small town in Tuscany) and the entrance to Genoa’s water distribution network.

WaterSpy will focus on tracking three of the most deadly bacterial strains: Escherichia coli, Salmonella and Pseudomonas aeruginosa. As explained in a press release on the project website, these bacteria are often difficult to identify, as the concentration of contaminants can be low.

The current procedure to date involves taking water samples and sending it to a remote lab, it also takes at least another 24 hours to allow microbiologists to locate these bacteria. As a result, a full resolution may take up to 2-3 days. However, the research team says that this whole process will take place in just 6 hours, about 12 times faster than the current standard.

WaterSpy is based on laser, photodetectors and ultrasounds. The same press release explains: “Initially it works by first collecting small traces of bacteria and then using the laser to locate them.” The ultrasound is used to collect the bacteria in the water sample to enhance detection and sensitivity. Then a measurement technique called attenuated total reflex is used, allowing the sample to be examined directly in its liquid state. Infrared beams (IR) are sent to a diamond over which water flows. ”

The WaterSpy handheld device, which is essentially a high sensitivity water analyzer device, was created to develop water-quality photonic analysis technology that is suitable for electronic measurements. According to the group, WaterSpy technology is relatively inexpensive and complies with the stringent European Union requirements regarding susceptibility levels for bacterial detection following the new regulations on drinking water.

Genedrive Partners with Find to Evaluate a Molecular Diagnostic Kit for Hepatitis C

Genedrive plc, a near patient molecular diagnostics company, and the Foundation for Innovation of New Diagnostics (FIND), announced today a study agreement for the performance evaluation of genedrive plc's hepatitis C virus (HCV) Genedrive® HCV ID Kit. The Genedrive® HCV ID Kit is a qualitative HCV diagnostic assay, performed on the company's portable molecular diagnostics platform, Genedrive®. The assay is designed for use in low-resource settings, and delivers results in 90 minutes.

Under today's agreement, FIND will lead evaluation studies in Cameroon and Georgia between September 2018 and May 2019. These studies are designed to confirm the diagnostic accuracy of Genedrive® HCV ID across diverse genotypes, as well as to assess usability in the intended market setting. genedrive plc will provide product in-kind to support the study.

"We are appreciative of the support of FIND in leading these studies," said David Budd, CEO of genedrive plc. "Positive outcomes should further facilitate our commercialisation activities in these regions, as well as providing important clinical field data that others look to as they decide to implement Genedrive® in their own specific settings."

FIND's evaluations of Genedrive® HCV ID Kit will feed into the organization's broader HCV efforts. FIND is the lead partner on a multi-year, multi-country HCV project funded by Unitaid to support the development of simple HCV diagnostic tools for use at the point of care, which can be made widely available to those who need them.

"These studies are a perfect fit with our ongoing efforts to improve the options for affordable, easy-to-use HCV diagnostics," said Francesco Marinucci, Head of HCV and HIV at FIND. "We look forward to the results and to ongoing collaboration with genedrive plc."

The World Health Organization estimated that 71 million people had chronic HCV infections in 2015. If left untreated, HCV can cause serious, lifelong illness or death due to liver cirrhosis. Levels of HCV co-infection with HIV and tuberculosis (TB) are high, meaning failure to address HCV will affect efforts to control both TB and HIV. The global health sector aims to eliminate viral hepatitis as a public health threat by 2030. Given advances in HCV drug development, treatment options have become easier and more affordable. However, similar progress has not been made in HCV diagnostic development. There is a critical lack of easy-to-use, affordable tools for diagnosis at the point of care - an estimated 80% of people living with HCV are not diagnosed.

Sunday, August 05, 2018

"Tornado" Lab-on-a-Chip Technology with Micro Tweezers to Detect Dangerous Viruses, Biological Contaminants

Purdue University researchers have developed a new class of optical nanotweezers that can trap and detect biomolecules, viruses and DNA more rapidly. The technology can also use light to promptly detect cancer or improve the production of medications, an important step forward as nearly half of Americans have used at least one prescription drug within the past month.

The researchers developed a nanostructured plasmonic metafilm by perforating nanoscale holes in a gold film. Then, the metafilm acts as tweezers to capture and trap tiny particles by focusing light onto specific spots on the film and by heating up those spots and creating local thermal gradients in the ambient liquid. This produces a small tornado-like effect.

"All of this is resulting in a revolutionary compact lab-on-a-chip – an innovative approach to detecting and diagnosing a tumor or a viral disease," said Alexander Kildishev, an associate professor with Purdue's School of Electrical and Computer Engineering, who helped lead the research team.

The Purdue plasmonic metafilms use a combination of thermal and electric fields to create hydrodynamic flows that result in the rapid transport of suspended particles, bringing them to the surface of the metal film for easy trapping and detection.

Another advantage of the new system is the increased ability to sort these tiny particles and then collectively detect sorted patterns such as drug contaminants or water impurities. The technology has potential applications for pharmaceuticals, biohazard detection and water quality tests.

"To our knowledge, our plasmonic nanotweezers are more robust in trapping and detecting molecules than previous comparable lab-on-a-chip systems," Kildishev said. "Our system also provides better sensitivity and consumes less laser power. We have created an advanced self-contained lab-on-a-chip platform that allows us to trap and detect dangerous particles such as drug and water contaminants and remove them from liquids."

"Our system is very flexible to control and provides a broad range of functionality," Kildishev said. "We use multifunctional, inexpensive light sources to outperform more expensive alternatives."

Nano-sized Traps Show Promise in Diagnosing Pathogenic Bacterial Infections

A new type of “lab on a chip” developed by McGill University scientists has the potential to become a clinical tool capable of detecting very small quantities of disease-causing bacteria in just minutes.

The device designed by Sara Mahshid, Assistant Professor in the Department of Bioengineering at McGill, is made of nano-sized “islands,” about one tenth of the thickness of a single human hair, which act as bacterial traps or snares.

In collaboration with colleagues from the University of Toronto, Professor Mahshid’s team was able to demonstrate that the system is capable of analyzing very small volumes of culture media containing bacterIa such as E. coli and a strain of S. aureus resistant to methicillin, an antibiotic used to treat bacterial infections.

Bacterial infections are blamed for 700,000 deaths a year, and successful treatment of many disease-causing infections depends largely on rapid detection. Unfortunately, it sometimes takes several days to confirm a diagnosis with the tools currently available to doctors.

“Speed is of the essence because some bacterial infections can cause serious health problems and sometimes lead to death,” Mahshid says. “With a fluorescent microscope, the device we’ve developed can confirm the presence of bacteria in just a few minutes. I hope one day clinicians will use our device to deliver faster diagnostics, start treatment much more quickly and, ultimately, save lives.”

Mahshid and her team, who just published their work in the journal Small, now hope to test their device on clinical samples, a necessary step before doctors are able to use such a device in a hospital setting. Theoretically, this new lab-on-a-chip, which is relatively inexpensive and easy to make, could also analyze samples from urine, blood or nasal swabs.

This work was funded by the Faculty of Engineering at McGill University and the Natural Sciences and  Engineering Research Council of Canada.

The article “A Hierarchical 3D Nanostructured Microfluidic Device for Sensitive Detection of Pathogenic Bacteria” was published in Small.

Chembio Developing Rapid Hepatitis C Test

Medford-based Chembio Diagnostics and the Foundation for Innovative New Diagnostics are developing a rapid diagnostic test for hepatitis C virus.

The foundation is working with three companies on HCV feasibility studies following a request for proposals in the first half of this year.

It plans to assess the outcomes of the feasibility studies in December 2018 and award one company further funding to develop their test.

This initiative is part of the Hepatitis C Elimination Through Access To Diagnostics project supported by a grant from Unitaid.

The foundation is also conducting pilot projects in six countries related to HCV testing and the impact of HCV diagnostics.

“Easy-to-use, accurate and affordable diagnostic tests are essential elements in the drive for HCV elimination,” Catharina Boehme, CEO of the foundation, said.

She said Chembio was selected based on the high sensitivity offered by its technology, “together with the company’s product development, manufacturing and distribution capabilities.”
According to the World Health Organization, 71 million people are living with hepatitis C, mostly in low- and middle-income countries.

The disease kills nearly 400,000 people annually, predominantly through cirrhosis and hepatocellular carcinoma, according to Chembio.

Despite this large death toll, the virus often is undetected, with 80 percent of people infected not aware of their condition, the firm said.

Chembio CEO John Sperzel said he is optimistic that his company’s technology “will serve as a robust platform for the point-of-care detection of HCV.”

AIIMS-led Team Develops Highly Sensitive, Portable Test for TB Meningitis

A diagnostic test for TB meningitis (the most severe form of TB) with nearly 100% sensitivity and about 91% specificity has been developed by a multi-institutional team led by Prof. Jaya Sivaswami Tyagi from the Department of Biotechnology at AIIMS. The performance of the diagnostic test was evaluated in 87 cerebrospinal fluid samples obtained from paediatric subjects (39 TB meningitis patients and 48 controls). The results of the study were published recently in the journal Tuberculosis.

The diagnostic test is based on a derivative of a DNA aptamer (a small single-stranded DNA molecule that binds to a specific target molecule and is a chemical rival of antibodies) that shows high binding affinity in nanomolar range and high specificity to a TB antigen (HspX). Besides higher binding affinity, there is significantly higher load of the HspX antigen in cerebrospinal fluid samples, leading to higher sensitivity.

A rapid, point-of-care diagnostic test for TB meningitis that uses the DNA aptamer has already been adapted to a sensor format and is being evaluated on clinical samples. “It takes all of 30 minutes to get the result as we are using an electrochemical sensing platform,” says Prof. Tyagi.

“While antibodies have to be generated in animals and so will not be of uniform quality, aptamers can be produced in the lab,” says Dr. Tarun Kumar Sharma from the Centre for Biodesign and Diagnostics at Translational Health Science and Technology Institute (THSTI), Faridabad and the other corresponding author of the paper.

The aptamer-based diagnostic test for TB meningitis has been patented by AIIMS and THSTI and licensed to AptaBharat Innovation Pvt Limited, a THSTI spinoff founded by Dr. Sharma.

The currently used diagnostic methods — microscopy and culture of cerebrospinal fluid — suffer from huge limitations in terms of poor sensitivity and long turnaround time of up to eight weeks. Even GeneXpert has only 55% sensitivity. In settings such as India, where the prevalence of TB meningitis is high, one in six patients tested by Xpert will be missed.

Ten-year journey

It has taken the team about 10 years to reach this stage of developing a diagnostic test. Since there are very few bacteria in TB meningitis samples, the researchers wanted to evaluate the utility of using TB DNA for the diagnosis using PCR. In a paper published in 2009 in the Journal of Medical Microbiology, the researchers filtered 167 cerebrospinal fluid samples using a filter paper and studied the filtrate that contains the DNA of TB bacteria. DNA and other components of TB bacteria are present in the filtrate due to disintegration of the bacteria.

“We studied TB bacteria present on the filter paper and the TB DNA present in the filtrate and found TB DNA yielded significantly higher sensitivity of detection (88%) than the whole bacteria (53%). When we saw the filtrate had more DNA we wanted to check for antigens of TB bacteria,” recalls Dr. Sagarika Haldar from the Centre for Biodesign and Diagnostics at THSTI and first author in two papers. She is currently at the Department of Experimental Medicine and Biotechnology, PGIMER, Chandigarh.

In a paper published in 2012 in PLOS ONE, the team studied 532 cerebrospinal fluid samples collected from children and looked for five TB antigens. “Though DNA and antigen were significantly higher in the filtrate compared with TB bacteria, the amount of TB antigens was far higher than DNA,” Dr. Haldar says. Using DNA for diagnosis would involve sophisticated instrument and amplification while antigen detection will be straight forward.

The team found the sensitivity of both tests — DNA and antigen — was similar. Of the five antigens, two were found to be excellent in terms of sensitivity and specificity. “We would need an ELISA reader to detect the antigens. Since we wanted to make a point-of-care diagnostic test for TB meningitis, we turned out attention to DNA aptamers,” says Dr. Haldar.

Using a DNA aptamer to bind to the TB antigen makes ELISA reader redundant in a portable assay format. The aptamer is also more sensitive, specific and stable compared with the antibody. Since the antigen is directly detected, only 5 microlitre of the sample is required.

Twenty-one aptamers were selected from the aptamer libarary and based on specificity one was chosen. Since all the 44 nucleotides of the aptamer don’t interact with the HspX TB antigen, the size of the aptamer was reduced to 28 nucleotides. Reducing the size of the aptamer will in turn reduce the cost of the diagnostic test.

“Once the mutation was done to reduce the size we found the binding improved. The mutant aptamer showed 2.5-fold higher binding than the parent aptamer,” says Abhijeet Dhiman from the Department of Biotechnology, AIIMS and first author of the 2018 paper. The optimised aptamer was tested on 87 cerebrospinal fluid samples and found to have nearly 100% sensitivity and about 91% specificity.

New Light Sensor Quickly Spots Deadly Legionella Bacteria

A European group, POSEIDON, has developed a sensor which can spot the Legionella bacteria in minutes, 240 times faster than current methods.

POSEIDON stands for ‘Plasmonic-based automated lab-on-chip sensor for the rapid in-situ detection of Legionella’ and the new biophotonic light sensor can detect the Legionella bacteria in less than an hour, a process which normally take 10 days of cultivation and analysis.

Coordinated in Italy, Poseidon is comprised of several European partners, including those in Italy, Spain, the Netherlands and Sweden. It recently received funding of more than €4 million from the Photonics Public Private Partnership (PPP), via the European Commission’s H2020 programme for a three-year research project.

Equipped with tiny sensors, the device works by using the photonics technique of Surface Plasmon Resonance (SPR), a procedure that reads information from a refracted laser beam, allowing fast, highly sensitive, inexpensive detection from a small sample without the need for ‘labelling’, the process of binding to a protein so that it can be detected.

SPR occurs when polarised beams of light hit a metal film at the interface of two media. A charge density oscillation of free electrons (or “surface plasmons”) at the metal film occurs, reducing the intensity of reflected light. The scale of the reduction depends on the substance on the metal at the interface. Information gathered from the refracted can then be analysed, and a pre-programmed pathogen confirmed, resulting in an unambiguous detection of the bacteria in situ.

Detection and investigation of viruses, bacteria and eukaryotic cells is a rapidly growing field in SPR bio sensing, but the detection has only previously been achieved in laboratory settings.

Legionnaire’s Disease is a respiratory infection that can cause pneumonia, and in severe cases organ failure or septic shock.  Naturally occurring in freshwater lakes and rivers, the Legionella bacterium is harmless in small quantities, but problems start when it multiplies in plumbing systems, air conditioning units, or in a public water supply. Here it can be transmitted to humans when it condenses into droplets of fine mist which are inhaled and then settle in the lungs.

Legionella bacteria survive and flourish at temperatures between 25º to 45º C, and are normally killed off by heating water units above 70º C. However new bacteria can form quickly, and sometimes not all of the pathogens are removed. The Poseidon project aims to remove the uncertainty involved.

Cepheid Receives FDA Clearance and CLIA Waiver for Xpert® Xpress Flu/RSV Test

Cepheid announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for the Xpert® Xpress Flu/RSV test. The test can be performed in near-patient settings, providing rapid and accurate molecular detection of influenza A and B viruses, and RSV RNA from patient specimens in as little as 20 minutes.1

In addition to nasopharyngeal (NP) swab specimens, the Xpert Xpress Flu/RSV test is indicated for use with nasal swabs. Nasal swab collection is less invasive than NP swabs are and allows for a more comfortable specimen collection experience for the patient.

"Reflecting on the enormous impact of the last flu season, we are pleased to announce the launch of Cepheid's third CLIA-waived respiratory test: Xpert Xpress Flu/RSV. Our family of CLIA-waived Xpert Xpress tests allows laboratories to expand their capacity by extending standardized testing for flu, RSV, and Strep A to near-patient and point-of-care settings. Our first-in class multi-module system deals effectively with the surge of tests demanded by a severe flu season and frees up the laboratory to conduct other more complicated tests," said David H. Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer.

According to the World Health Organization, infections of the upper respiratory tract represent the most common reason for antimicrobial use. The vast majority of such infections are of viral origin and do not require treatment with antimicrobials.2 "Xpert Xpress Flu/RSV, Flu, and Strep A tests provide medically actionable and timely information to clinicians to support improved patient management, and antibiotic and antiviral stewardship," continued Dr. Persing.

Xpert Xpress Flu/RSV utilizes automated real-time reverse transcription polymerase chain reaction (RT-PCR) to detect influenza A, influenza B, and RSV RNA. The test's capability to detect multiple segments of RNA improves strain coverage and prevents loss of sensitivity as natural variations (antigenic drift and shift) of the influenza virus occur. The onboard reagents deliver high-performance specifications with no additional confirmation testing required.

A Portable Measurement Device for Rapid Pathogen Food Quality Testing

When microbiological food spoilage occurs, manufacturers and retailers suffer huge losses, consumers are exposed to serious health risks and vast amounts of food are wasted. In the age of the internet and social media, reports of food safety issues can spread like wildfire. Furthermore, slaughter operations and meat processors must comply with strict hygiene guidelines and requirements, by implementing reliable quality control measures stipulated in a wide range of government regulations. Businesses are also under pressure to ensure high product quality and a long shelf life, whilst avoiding excessive food waste.

To satisfy these numerous demands, slaughter operations and meat processors must be able to test the quality of their meat products as rapidly as possible – at every step of the processing chain, but this can be challenging using traditional methods.

To date, retailers and sellers have relied on sensory methods to test meat quality in the receiving area. This includes visual inspections, checking for odours and measuring the temperature. This is then followed by individual random samples that are extracted and sent to a laboratory to be analysed. Retailers typically have to wait several days to obtain the results, thus eliminating the possibility to react while the meat products are being handled. This leaves them with two choices: take proactive measures to dispose of potentially tainted products or accept the risk of low-quality products ending up in the hands of the customer. However, a portable measurement device could present a third possibility.

A need for rapid tests

Given that government-stipulated microbiological tests are too time-consuming and cumbersome, companies need a practical, reliable and cost-effective rapid test that can be utilised anywhere along the value chain. This type of test provides transparency and allows each step of the production process to be analysed and optimised.

The freshdetect BFD-100 portable measurement device satisfies these requirements by determining the quality of meat within a few seconds by means of the total viable count (TVC). This reliable and cost-effective portable measurement device is providing results with accuracy comparable to conventional microbiological tests in the lab. The BFD-100 is therefore, the first device to enable quantitative, comprehensive and preventative quality and process control measures, from the slaughter facility to the meat counter.

Retailers and sellers can now inspect all of the meat products on-site and if necessary, immediately remove any affected batches. The device can furthermore be used to analyse and optimise production flows, benefitting the company through lower production costs, extending the shelf life of the meat products and providing consumers better quality.

About FreshDetect

The BFD-100 portable measurement device was developed and produced by Munich-based FreshDetect GmbH, a developer and marketer of innovative measurement devices and solutions for rapid and tight quality control in the food industry. The people at FreshDetect are experts in the fields of spectrometry measurement technology and microbiology and boast extensive experience in the area of food processing technologies.

Company origins

In response to a series of spoiled meat scandals in Germany over the past decade, a research alliance was formed comprising the Fraunhofer Institute for Reliability and Micro Integration IZM, the Ferdinand Braun Institute, the Leibniz Institute and the Max Rubner Institute. The alliance was tasked with researching rapid test methods designed to avert such scandals in the future. The researchers eventually demonstrated a relative correlation between bacterial burden and the fluorescence signature.

An initial prototype portable measurement device was developed in a follow-up SME project. In 2013, the project resulted in a spin-off company, FreshDetect GmbH, which then developed the same-named de portable measurement device and readied it for production. The capability of the BFD-100 to measure the TVC and temperature of meat samples within three to five seconds with laboratory precision has meanwhile been scientifically validated.

The freshdetect BFD-100

The portable measurement device is a patented mini-lab, which detects the bacteria count by means of fluorescence spectroscopy. It is non-invasive, cost-effective, digital, simple to operate and can be used anywhere. Fluorescence spectroscopy can be used to immediately draw precise conclusions regarding the microbiological quality of food products in every step of the process with minimal effort. This opens up new opportunities for creating a tight network of measurements across the entire manufacturing process. This unprecedented volume of real-time data permits an end-to-end analysis of the manufacturing process for the first time, thus making it possible to optimise quality and costs.

The BFD-100 rapid test is simple to use. The measurement probe is placed on the surface of the meat for five seconds, after which the TVC, which is measured in CFU/cm2 or CFU/g, is immediately displayed and stored in the device. The device also records the temperature, date, time, (sequential) measurement number and other information. The data can be transferred to a PC via USB cable or directly to a management information system using a bluetooth interface. The portable measurement device is easy to operate, clean and calibrate.

The BFD-100 emits an intense blue light on the surface of the meat, which is then captured with a spectrometer. The signal contains fluorescence signatures that correspond to the surface bacteria and the meat matrix, including fluorescent porphyrin, which feature characteristic wave lengths in the ‘green-red’ range. The device then analyses the intensity and wavelengths of the light and determines the TVC, calculated in CFU/cm2 or CFU/g, using special algorithms. Referred to the calibrations sets, these algorithms correspond to a specific type of meat and packaging, two parameters that have a major influence on bacteria growth.

Creation of the calibration sets

The algorithms couple the measured fluorescence spectrum with the lab-based TVC measurement. Calibration thus requires capturing the fluorescence spectrum with the BFD-100 as a first step. The TVC of the same meat sample is then measured using the conventional, DIN 101061-compliant laboratory method. This step is repeated with further samples. The key is to collect a statistically-relevant amount of data – so that a basis is created that closely represents an average value. Prediction models are then developed from this data and are validated with additional samples.

Given that the freshdetect BFD-100 measurements rely on conventional microbiological methods as a reference, in theory, the forecast accuracy of an individual measurement cannot be higher than the error tolerance level of the microbiological reference method and because a significantly higher number of samples can be tested with the BFD-100 portable measurement device at no additional cost, an even more accurate analysis of the actual situation is possible.

Operating the device

If the BFD-100 is ready to be used, the user only needs to power it on and enter a PIN. A reference measurement then has to be performed, after which the start screen appears. This takes around five seconds and must be carried out once a day to calibrate the device. If the device is restarted, the reference measurement is not required.

Once the start screen appears, the user places the measurement probe on the sample and presses the measurement button. After three to five seconds, the TVC, calculated in CFU/cm2 or CFU/g, appears on the screen. The device also displays the sequential measurement number and the calibration setting for the product type, such as minced meat. Relying on experience or a defined threshold value, the user then knows if this measurement value is appropriate for the specific product, whether the meat has to be processed for a different purpose or disposed of.

To support more in-depth analyses or a series of tests, such as for process optimisation or supplier evaluation, the device can store up to 2,000 measurements, which can be exported in a file format like excel or transferred to an ERP system.

BFD-100 fields of application

The cost-effective, rapid and accurate measurement method makes the BFD-100 portable measurement device suitable for any application where detection of the TVC of meat is required. Slaughter operations and meat processors can use the device along the entire processing chain. In slaughter and cutting operations for instance, it can serve as a tool for drawing conclusions about hygiene conditions, or to substantiate hygiene analyses and management decisions. By utilising the BFD-100 in the receiving area, companies can immediately identify poor quality products that have to be rejected or to determine the best way to process the meat. With its minimal on-going costs, the BFD-100 is suitable for testing a large percentage of the delivered products. Apart from monitoring hygiene conditions, the TVC analysis also reveals packaging problems. And in the shipping area, it provides a quality guarantee when handing the product over to the customer. Slaughter and meat processors can thus determine the TVC at every step of the process and optimise their processes accordingly.

Because the BFD-100 is a portable measurement device, retailers have the opportunity to track the quality in the receiving area, as well as at the point of sale on a permanent basis. Waste and losses are minimised as a result. Apart from food retailers, restaurants can also use the BFD-100 to test food products upon delivery and immediately notify the supplier of any issues. Consumers thus enjoy guaranteed quality, in addition to protection against the health risks of contaminated or spoiled meat products.

Even laboratories can utilize the BFD-100, such as for analysing a selection of incoming samples. The rapid test results also allow labs to determine the most suitable dilution step for the microbiological analysis, thus saving time and money.

Food inspectors also benefit since the simple and rapid test method allows them to analyse a much larger number of samples compared to conventional tests. In a survey carried out by the University of Leipzig; food inspectors had a predominately positive stance toward the BFD-100 rapid tests, emphasizing its usefulness as a line of reasoning and for making on-site decisions at companies undergoing inspection.

Slaughtering and cutting

One concrete example that illustrates where the BFD-100 is useful in slaughter and cutting operations is when a production line is retrofitted or replaced. This is because it is difficult to ascertain how reworking a product line impacts product hygiene, costly measurements are required to ensure that the original best before date can be guaranteed. One option is to establish several “test days” quarterly in order to analyse the microbiological status of the products over the course of one production day. This would include a fixed number of measurements per hour. Relying on existing laboratory methods to determine the TVC quickly drives up costs, which can be significantly reduced by utilising the BFD-100.

Because meat can be contaminated by a variety of sources, slaughter operations maintain clear guidelines aimed at minimising the impact. Despite explicit instructions however, employees sometimes fail to observe these guidelines and whilst most contamination is not visible, it still exists. This makes it difficult to detect without microbiological analysis and increases the risk of the contamination spreading to the equipment, surfaces, hands and therefore across the entire production system.

An advantage of a portable measurement device such as the BFD-100 is that it can be used to detect contamination early enough to remove the affected products from the processing chain. If contamination has already spread, it can be used to pinpoint the initial source, thus revealing exactly which products are contaminated and at what step the contamination occurred.


Analysing the overall quality of a palette, such as four sets of eight boxes, requires examining more than one box from the stack. Testing at least three boxes from three different levels of the palette provides a more accurate assessment for instance. The analysis should include an examination of the parameters defined in the specification, such as; fat content, the cut, unusual odours, freshness and adherence to microbiological thresholds.

If each of the boxes has 20 cuts of meat for example, the palette contains a total of 640 cuts (4 X 8 X 20). Three boxes then yield 60 cuts of tested meat, or roughly 10% of the total palette. At a cost of between €5 and €10 to test each sample, this leads to a total cost of between €300 and €600 to analyse one palette. If a truck delivers 15 to 32 palettes, the costs to analyse the microbiological quality of 10% of one shipment can run between €4,500 and €19,000. The vast majority of these costs can be avoided by using the BFD-100.

Storage and cooling

Cooling generates significant costs for companies in the meat industry. The BFD-100 portable measurement device can be used to determine how product quality is impacted when cooling temperatures are modified. Although microbiological tests can be utilised in this case, they come with high costs since multiple measurements are needed to develop a statistically-relevant assessment. By using the device however, the quality manager can perform continuous measurements to assess the impact of changing the temperature in the cooling storage, without delay and without the burden of additional costs. And because the BFD-100 measurements are non-invasive, the tested products maintain their value.

Cutting and processing

Products are taken from the production process several times a day and then analysed. The aim is to determine if the monitoring sensors still react properly to foreign objects or whether the requirements for temperature and packing conditions are being met. Since these samples cannot be returned to the processing chain without determining the bacterial burden, they are frequently collected and then discarded. Using the BFD-100, the company can verify the bacterial quality and continue to process those products deemed to be satisfactory.

Another scenario involves an unplanned expansion of production due to higher demand. The additional production time is taken from the scheduled cleaning window, which could result in bacterial plateaus on surfaces and increased moisture. Both of these factors can lead to an unplanned, higher bacterial burden – a scenario that was not taken into consideration when establishing the best before date. The quality manager must now decide if expanding production at the expense of the cleaning cycle is acceptable with respect to the hygiene conditions and what impact this situation has on the best before date.

Immediate test results using the BFD-100 allow the quality manager to determine the impact on the hygiene conditions in real-time, monitor the extra production shift and confirm adherence to the hygiene standards.


One concrete example in the area of packaging is illustrated by the best before date of minced meat. A minced meat producer is competing for the business of a food retailer, where the best before date is an important aspect of the specification. In the retail food industry, roughly 10% of all food products are discarded because the best before date has expired.

Because there is no further room to adjust the price, management is planning to offer the potential customer a two-day extension of the best before date. The proposal would extend the normal seven-day sales period by 25%. This would have the effect of reducing the retailer’s volume of discarded meat by 7.5%. In the retail food industry, roughly 10% of all food products are discarded because the best before date has expired. A typical supermarket runs through around 750kg of minced meat a month. At a price of €4.50 per kilo, the retailer can then save around €1,000 per store. The only way to extend the best before date is to know the precise bacterial burden of the meat. The BFD-100 offers the opportunity to test all of the products before they are shipped, and to determine if the planned extension of the best before date can be guaranteed.

Optimising the process chain

The freshdetect BFD-100 portable measurement device is the first device to enable rapid detection – within seconds – of the TVC along the entire commercial meat processing chain with accuracy comparable to laboratory-based TVC tests and with nearly no on-going costs for the device.

This combination of immediate results, cost-effective measurements and high degree of accuracy provides companies new opportunities to optimise their workflows at every step of the process whilst creating a wide range of opportunities to reduce costs and ensuring better quality and safer food products.

Alternative methods

Conventional microbiological processes, such as the spatula and pour plate methods, require not only extensive effort, but also trained personnel – to ensure regulation-compliant execution of the tests. Although rapid methods such as impedance, bioluminescence-based ATP measurements and fluorescence-based flow cytometry provide automated measurements for the most part, high procurement costs and the on-going costs for the media and enzymes make these approaches unattractive. Furthermore, they destroy the products since they require extracting samples.

Fluorescence spectroscopy, in contrast, offers a non-invasive way to detect the bacterial density in real-time. In principle, it can measure through packaging films, whereas FT-IR-spectroscopy is not capable of that. Raman spectroscopy offers yet another alternative for testing through film packaging. The downside is that it’s unsuitable for measuring TVC on flat surfaces. With fluorescence spectroscopy and NIR hyperspectral imaging, researchers have demonstrated through a series of correlation models that it’s possible to estimate the amount of surface bacteria under lab conditions. To do that, various information has to be extracted from the spectra and analysed with algorithms.

The added value

Compared to conventional microbiological tests, the BFD-100 offers clear advantages for controlling the quality of meat products. By supplying measurement results within seconds, the device provides reliable information regarding product freshness and hygiene directly on-site, in effect leading to quality control measures that are integrated into the production process. Through this approach, companies conserve natural resources because they have the information they need to decide, during the manufacturing process, whether a product is ready for the retail shelf or more suitable for other uses. In situations such as disruptions to the cooling chain for instance, product returns or rejects no longer occur as a precautionary measure, rather only in cases where they are justified.

Consumers also benefit from access to safer products, this is because, in contrast to conventional tests, the BFD-100 permits a higher sampling rate. And by performing the measurements directly on the product to be sold without using expendable materials, companies contribute to a more sustainable environment and conserve their own resources. The advantages of the non-invasive measurements – even through packaging films – makes the BFD-100 an interesting proposition for health inspectors as well because they can determine the total viable count directly on-site, without waiting for the test results. This leads to a higher sampling rate whilst keeping the laboratory tests to a reasonable number. There are still other positive aspects of utilising the BFD-100. The rapid tests make it possible to objectively determine the best before date and to establish whether the meat is suitable for processing and consumption. This automatically leads to less food waste and other positive influences related to the climate, environment and society.

FreshDetect plans to expand its fields of applications to other food products, from fish and dairy products, to fruits and vegetables. The focus will include not only bacterial contamination, but the detection of pesticides, herbicides, origin, ripeness and other factors. It’s conceivable that a portable measurement device like the BFD-100 will one day replace the Petri dish for detecting the TVC, or even allow the consumer to test the quality of fresh foods directly in the store.

Genetic Signatures Secures Contract for EasyScreen Respiratory Technology

Molecular diagnostics company Genetic Signatures has announced a major new contract with a large Australian pathology service provider and release of two new products.

Genetic Signatures secured the contract with an Australian pathology service provider and expects its new customer to conduct as many as 1,000 tests per day, depending on the severity of the flu season.

The new sales contract means its second generation EasyScreen Respiratory Pathogen Detection Kit will be sold on per test basis to a major pathology service which will also employ Genetic Signatures’ proprietary workflow solution: the GS1-HT System.

The diagnostics company manufactures a range of tests and detection kits for various viruses and “superbugs” that make hospital healthcare more challenging and increasingly difficult as pathogens build resistance to antibiotics.

According to the World Health Organisation (WHO), respiratory viral infections are responsible for the deaths of an estimated 3.9 million people per year, and one of the top five causes of mortality worldwide.

The WHO estimates that in addition to increasing the risk of secondary bacterial infections, respiratory viruses cause an enormous burden to health systems by way of direct medical expenses and indirect productivity losses.

Rapid identification of viral respiratory infection is therefore critical in initiating antiviral treatment and limiting the spread of the infection.

In May, Genetic received Therapeutic Goods Administration (TGA) registration allowing the sale of its novel “Extended Spectrum Beta-Lactamase and Carbapenemase Producing Organisms” (ESBL & CPO) detection kit in Australia.

This follows the company’s receipt of European approval last month which enabled the sale of the ESBL & CPO products across Europe.

Pathogen detection solution

The EasyScreen Respiratory Pathogen Detection Kit leverages the company’s proprietary molecular diagnostic (MDx) 3base platform technology.

The kit can simultaneously detect 14 common respiratory pathogens including Influenza A & B, Rhinovirus and M. pneumoniae. Also, the kit can make accurate diagnoses in approximately 4.5 hours with minimal hands-on time for laboratory technicians.

Meanwhile, the GS1-HT system serves as a supplementary tool that helps technicians to evaluate data obtained by the EasyScreen kit.

The GS1-HT is a high-throughput, proprietary workflow automation system that has been designed to optimise sample processing with EasyScreen assays, as well as other general laboratory processes.

The GS1-HT allows customers to reduce the processing time by approximately 45 minutes with runs of up to 96 samples. This results in an increase in throughput of up to 15% relative to existing instrumentation.

Genetic says that a successful product launch is expected to provide an immediate boost to domestic revenues and help accelerate global sales.

“The new sales contract and the launch of the second-generation EasyScreen Respiratory Pathogen Detection Kit and the GS1-HT marks a major milestone for Genetic Signatures. We are pleased to be positively impacting patient care, having rolled out the products to our customer ahead of the start of the flu season. Although sales of the respiratory tests are dependent on the severity of the flu season, we anticipate sales of approximately 1,000 tests per day during peak flu season for this customer, creating a significant boost to our domestic business,” said Dr John Melki, CEO of Genetic Signatures.

Dr Melki added that “the contract has been achieved via our innovation and development of the 3base platform technology and the supply of our proprietary workflow automation system (GS1-HT), which allows for consistently high levels of throughput to deliver rapid results during peak flu season.”

Keeping tight-lipped about the exact identity of its new customer, Genetic says its new customer creates an opportunity to supply up to 1,000 tests per day during peak flu season and approximately 100-200 outside of the flu season.

The customer is currently consuming approximately 400 tests per day in the lead up to peak flu season, usually occurrent sometime in September-October each year in Australia. Genetic says the timing has been chosen to maximise the value of the deal as flu season approaches.