New 30-Minute Microarray Blood Test to Reduce Sepsis Deaths

A new detector using photonics to identify E. coli bacteria from a tiny drop of blood in less than 30 minutes could help reduce the mortality rate from sepsis by more than 70%.

Programmed to detect proteins and E. coli, one of the deadly bacteria that can cause the human body to go into septic shock, the detector uses light to look for specific biomarkers (the tell-tale signs or indicators of a disease) that are as small as a few nanometers in size, or 1/1,000,000th of the thickness of a single human hair.

The rapid microarray detector looks at a small blood sample taken from a thumb or forefinger. The patient’s blood sample is then separated in a centrifuge so that a clinician can examine the plasma, the part of the blood sample where all the proteins are contained.

The sepsis detector uses photonic technology to make a clear and accurate diagnosis. The plasma sample flows over a microarray, a collection of tiny spots containing specific antibodies on a nanostructured gold slide. Two light beams are then shone through the full microarray, with one of them passing through the sample, while the other one goes through the clear part of the slide, acting as a reference. The beams passing through the biomarker and the clear regions on the slide are then checked for any changes in intensity.

“Depending on the amount and type of biomarker attached to each antibody, we obtain a unique image, a signature pattern if you like,” said Roland Terborg, project coordinator. “The image patterns tell us what is present in the plasma sample, which we then record with a CMOS sensor, the same technology used in a digital camera that converts light into electrons.”

Preclinical trials have already begun at the Vall d'Hebron University Hospital where the device has been in operation since 2018. Clinical trials are expected to take place at the end of 2019.

Current techniques for detecting sepsis, a condition that kills more than 20,000 people per day worldwide, can take hours or even days to produce the results and diagnosis. While bacteria need to reproduce in large quantities before an accurate determination can be made, a patient can often be waiting more than a day before a course of treatment can be determined. If caught early enough, patients can be treated for sepsis with simple antibiotics.

The detector could also possibly be extended to perform other types of disease screenings or multiple simultaneous diagnoses, especially those requiring a rapid detection of large numbers of biochemical targets (more than one million) on a single microarray.

Developed by the RAIS project (or scalable point-of-care and label-free microarray platform for rapid detection of sepsis), the project was coordinated by ICFO in Barcelona and is a success story for the Photonics Public Private Partnership.

The RAIS consortium received a grant of €2,988,572 ($3,333,528) from the EU via the H2020 program and was made up of partners from Spain, Switzerland, Germany, Belgium, the U.K., and Italy. RAIS was coordinated by ICFO, and oversaw the collaboration of the Ecole Polytechnique Federale de Lausanne, iXscient, Diesse, the Catalan Institute of Nanoscience and Nanotechnology, microTEC, Trinean, Hospital Vall d’Hebron, and Thermo Fischer Brahms.

Additional information may be found on the RAIS Project website.

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3M Salmonella Molecular Test Validated for Animal Feed and Pet Food

3M Food Safety announced that the 3M Molecular Detection Assay 2 – Salmonella has earned matrix extensions from AFNOR Certification for its NF VALIDATION.

In February 2017, the test was first certified by AFNOR (Certificate reference number: 3M 01/16-11/16) for detection of Salmonella spp. in all human foods as well as in samples from the food processing environment, excluding primary production samples. The pathogen test’s validation now encompasses samples taken from primary production as well as from animal feed and pet food.

The Salmonella pathogen test kit is part of the 3M Molecular Detection System platform, award-winning technology that combines isothermal DNA amplification and bioluminescence detection to produce rapid, accurate results with fewer steps, reducing costs and technician time. Enhanced with a proprietary 3M nanotechnology, the test gives processors a streamlined workflow that enables same-day or next-day pathogen test results and faster, more confident food safety decisions. Comparative research shows that the 3M Molecular Detection Assay 2 – Salmonella will process a batch of 96 samples 1.7 times faster than the closest competitive technology. Last year, the 3M Molecular Detection System became a primary method of the USDA Food Safety and Inspection Service for the detection of both Salmonella and Listeria.

“We are committed to providing a wide range of customers with pathogen tests that have been rigorously and relevantly validated,” said Lisa Monteroso, 3M Food Safety regulatory affairs specialist. “Salmonella is an organism that can persist in a variety of foods – including those that are low-moisture – so we are pleased to share additional scientific support for our assay’s performance and use in these important categories.”

The NF VALIDATION certification process begins with a scientific comparison of testing methods; a single, expert lab thoroughly tests the technology’s effectiveness versus the NF EN ISO 6579 reference method. Subsequent to that, multiple laboratories coordinate to compare the efficacy of both the new test method and reference method under reproducible and repeatable conditions.

3M Food Safety is a leader of innovative solutions that help the food and beverage industries optimize the quality and safety of their products to enable consumer protection. It provides solutions that mitigate risk, improve operational efficiencies and impact bottom lines.

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Chembio Diagnostics Announces Approval of Zika, Dengue and Chikungunya Point-of-Care Multiplex Test by Brazil’s Health Regulatory Agency

Chembio Diagnostics, Inc., a leading point-of-care diagnostics company focused on infectious diseases, today announced the approval of its DPP Zika/Dengue/Chikungunya System by Agência Nacional de Vigilância Sanitária (ANVISA), Brazil’s health regulatory agency, in collaboration with Bio-Manguinhos/Fiocruz.

Chembio’s DPP Zika/Dengue/Chikungunya multiplex test allows simultaneous and discrete detection of antibodies for both active (IgM) and prior exposure (IgG) to the Zika, dengue, and chikungunya viruses, which is important for both treatment and surveillance. The test is performed using a small (10µL) drop of fingertip blood and provides quantitative results in approximately 15 minutes when used with the company’s handheld DPP Micro Reader. An evaluation of the multiplex test by Brazil’s Instituto Nacional de Controle de Qualidade em Saúde (INCQS) demonstrated outstanding analytical performance using patient samples in this highly endemic region, with all six results yielding sensitivity between 95.2% - 100% and specificity between 96.6% - 100%.

“Brazil faces a complex epidemiological scenario, characterized by simultaneous circulation of three arboviruses - Zika, dengue, and chikungunya - all transmitted by the Aedes aegypti mosquito,” stated John Sperzel, Chembio’s Chief Executive Officer. “Co-circulation hampers clinical differential diagnoses, as those arboviruses share common signs and symptoms. This ANVISA approval paves the way for commercialization in Brazil, and we believe our multiplex test will be an important tool in combating these serious diseases.”

This ANVISA approval advances Chembio’s previously announced commercial agreement with Bio-Manguinhos, a Brazilian government agency and supplier of diagnostic products to Brazil’s Ministry of Health, to develop and supply high-quality, rapid diagnostic tests for Zika, dengue, and chikungunya using Chembio’s DPP technology platform.

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GenePOC Obtains CE Marked for its GenePOC™ Carba Test

GenePOC Inc., member of the Debiopharm Group, announces its third test to be CE marked, the GenePOC Carba assay, to be used with the revogene™ device.

About carbapenem-producing organisms (CPO)

CPO are considered a serious global public health threat and are associated with significant morbidity, mortality and hospital costs.[1] In 2015, 13 of the 38 countries of the European Union and European Economic Area (EU-EEA) reported interregional spread or an endemic situation.2 High mortality rates, ranging from 30% to 75%, have been reported for patients with severe CPO infections.[3]

About the GenePOC Carba assay

The GenePOC Carba assay is a qualitative, in vitro diagnostic test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48-like, and blaIMP gene sequences associated with carbapenem-non-susceptibility.  The assay can provide results from one up to eight samples in approximately 70 minutes using characterized carbapenem-non-susceptible isolated colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa.

"The fight against carbapenemase-producing Enterobacteriaceae (CPE), a rising threat in healthcare facilities, requires rapid and efficient detection and differentiation," mentioned Professor Thierry Naas, MD, from the bacteriology services at Hôpital de Bicêtre, France.

It is important to note that CPO are adapted to spread in healthcare settings as well as in the community. To prevent transmission from CPO-positive patients, hospitals should consider enhanced infection control measures such as contact precautions, isolation and dedicated nurses for patients who are confirmed CPO-positive.[2]

"We are proud to receive the CE marked for our GenePOC Carba assay," said Patrice Allibert, PhD, CEO of GenePOC. "A test which offers rapid and accurate results will contribute to the identification of colonized patients, therefore limit the spread of these organisms in healthcare settings and save on hospital costs. Our GenePOC Carba assay also demonstrates the power of our technology to be compatible with panel detection," concluded Patrice Allibert.

About revogene

The revogene is an automated and stand-alone device, enabling testing of single-use proprietary microfluidic cartridges with fluorescence-based real-time polymerase chain reaction technology to deliver an accurate diagnosis.

About GenePOC

GenePOC, a member of the Debiopharm group, specializes in the development of diagnostic devices which enable the prevention and detection of infectious diseases.

References

1. Borer A et al. Infect Control Hosp Epidemiol. 2009;30(10) :972-6
2. https://ecdc.europa.eu/sites/portal/files/media/en/publications/Publications/carbapenem-resistant-enterobacteriaceae-risk-assessment-april-2016.pdf 
3. Tischendorf J. et al. Am J Infect Control. Epub 2016 Feb 15.

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New Biological Detection System Predicted to Provide Faster Less Expensive Results for Veterinarians

Veterinarians and agricultural inspectors who seek to detect and contain the spread of animal diseases can now turn to a newer, faster and less expensive biological detection system.

Known as the Axiom Microbiome Array, or AMA, the new biological detection system is the most comprehensive microorganism detection platform built to date and the first high-throughput microarray.

The AMA is the commercialized successor to Lawrence Livermore National Laboratory’s earlier microarray, called the Lawrence Livermore Microbial Detection Array (LLMDA).

The LLMDA was licensed in 2016 to Waltham, Massachusetts-based Thermo Fisher Scientific and went on sale later that year as Applied Biosystems AMA.

In a yearlong evaluation, published earlier this month in the online scientific journal PLOS ONE, a team of researchers from LLNL, Kansas State University and Thermo Fisher Scientific concluded that the microbiome array “is an efficient tool to rapidly analyze large numbers of clinical and environmental samples for the presence of multiple viral and bacterial pathogens.”

“Two of the array’s advantages are that it’s faster and cheaper,” said Raymond “Bob” Rowland, professor of diagnostic medicine and pathobiology at Kansas State’s College of Veterinary Medicine. “I live in the world of veterinary medicine and cost is critical.

“If we were to do a test using the LLMDA, it would have cost us about $250 just for the reagents; now with the AMA we can do the same tests for $40.”

When LLNL biologists and computer scientists first unveiled the versatile LLMDA in 2010, it could analyze samples for nearly 3,000 bacteria and viruses, all within 24 hours. But it could only analyze four samples a day.

With the 96-well AMA, the new detection system can analyze 96 samples in three days. Additionally, each of the 96 wells contain about 1.4 million probes, so samples are analyzed by about 132 million probes.

“One of the most important conclusions of our study is that this is the first high-throughput microarray that has been developed,” said LLNL biologist Crystal Jaing, who heads the LLMDA/AMA efforts. “It increases the throughput by 10- to 20-fold and decreases the cost by five-fold.”

As LLNL and Thermo Fisher Scientific researchers moved to a higher throughput microarray, one of the team’s prime goals has been to maintain a high-resolution and sensitivity of detection.

In their PLOS ONE paper, researchers from the three institutions note that with the new array, they were able to detect both Shigella, a food-borne bacterial pathogen, and Aspergillus, a fungal pathogen, at 100 genome copies, as well as vaccinia virus DNA, a genetic relation to smallpox, at 1,000 genome copies.

In veterinary tests with pigs, the microbiome array detected two viruses – porcine reproductive and respiratory syndrome virus and porcine circovirus type 2 – as well as other common viral and bacterial microbiome species.

During their evaluation, the researchers conducted tests with 14 veterinary samples and 30 environmental samples, finding that the AMA performed at a resolution similar to the LLMDA, according to Jaing.

Because of the microbiome array, veterinarians can now conduct multiple tests on a single animal in Rowland’s view.

“This is a technology that is meant for the veterinary technician to use. It’s the everything test for everything.

“We base our testing on pathology. When we see a change in the tissue of an organ, that’s where your pathogen can usually be found. If we see changes in multiple organs and multiple tissues, now we can sample them all,” Rowland said.

According to the PLOS ONE paper authors, “Rapid detection and characterization of bacterial and viral pathogens is important for clinical microbiological diagnostics, public health, veterinary diagnostics, drug and food safety, environmental monitoring and biodefense.”

The current version of the AMA has the capability to detect more than 12,000 microorganisms and can identify 6,901 bacteria, 4,770 viruses and a combined total of 842 archaea, fungi and protozoa.

The new arrays, which come in 24- and 96-well formats, can analyze a variety of different sample types and can be used for nutrigenomics, agrigenomics, plus animal research and modeling.

In addition to Rowland and Jaing, the paper’s lead author, other paper co-authors are LLNL biologists James Thissen and Nicholas Be, LLNL bioinformaticists Kevin McLoughlin and Shea Gardner (deceased), retired LLNL computer scientist Tom Slezak and Thermo Fisher Scientific biologists Paul Rack and Michael Shapero.

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Texas State Researcher Develops a Simple Test to Diagnose Deadly Global Illnesses

Here is a glimpse into the future of global public health: a credit-card sized piece of paper is dunked into a liquid sample at a health clinic in a developing nation, quickly telling a doctor or nurse whether a malnourished child with diarrhea is infected with a virus, a bacteria, or a parasitic protozoan.

Gastrointestinal ailments may sound like a small matter in the industrialized world, but in millions of remote villages in developing nations, food, and waterborne illnesses are potentially deadly matters. According to the World Health Organization, diarrheal diseases are among the top 10 causes of death; and they are the second biggest killer of children under the age of 5.

Rapid diagnosis can mean fast, appropriate treatment. This is the quest of Shannon Weigum, an associate professor of biology at Texas State University. Her laboratory is merging principles of biochemistry and materials science to create a miniature, highly portable, rapid-detection tool for diarrheal illnesses. Her hope is that this tool could someday make a major impact on global health.

“In healthy people, diarrheal illnesses often resolve themselves without treatment,” she said. “When a person is malnourished, immune compromised, or suffering from chronic illness, the consequences can become very serious. This is especially true in malnourished children.”

Weigum’s first diagnostic targets are noroviruses, which cause more than half of the foodborne illnesses in the United States. Health data show that noroviruses are the most common cause of diarrhea in adults and the second most common cause in children. The tests have been expanded to detect bacteria and protozoan parasites.

The overall goal is to make diagnostic testing available where it previously was not. To be practical for remote clinics in undeveloped areas, though, laboratory tools have to be inexpensive as well as highly portable. Poor countries lack medical infrastructure and skilled personnel to operate the sophisticated diagnostic tools found in large urban medical centers.

Imbued with nanoparticles and using microfluidics, the paper cards interact with specific bacteria or viruses to quickly, accurately identify diseases. A faster diagnosis means healthcare workers can move beyond treating symptoms and attack the disease.

“We’ve teamed up with Paratus Diagnostics, a biotech startup company located in Texas

State’s Science, Technology and Advanced Research (STAR) Park. By working and teaming up with a biotech company, we are able to progress the technology to the point of commercial viability,” Weigum said.

Additional funding for the project has come from the U.S. Department of Defense and a Small Business Innovation Research (SBIR) grant. “We had a successfully funded phase one and phase two. SBIR supports research and development and potential commercialization,” she said.

The ‘sample to answer’ test provides results in about 20 minutes. It utilizes smartphone technology as an analytical instrument. Now, instead of reading the sample with the naked eye the phone acts as an optical instrument to read the light-based signal. “We can detect signals from many different pathogens at the same time. Our goal is to detect six to eight pathogens that most commonly cause illnesses.”

Weigum began her science career as a high school teacher in San Antonio, and then returned to the classroom as a student to pursue advanced degrees at The University of Texas at Austin. After earning master’s and doctoral degrees in biochemistry, she moved to a postdoctoral fellowship in bioengineering at Rice University, where her love of biology began to merge with materials science and opened the door to cutting-edge engineering innovations in developing diagnostics.

Next up is pre-clinical and clinical testing. Working with Dell Children’s Medical Center in Austin, Weigum expects pre-clinical trials to begin in six months to one year.

“The whole process is moving from the lab to the marketplace so that eventually it can get into the hands of medical personnel in the field.”

Source: Texas State University

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Bluejay Diagnostics, Inc. and U.S. Navy Enter Co-Operative Research and Development Agreement to Develop Non-Invasive Point-of-Care Tests for Lyme Disease

Bluejay Diagnostics, Inc. (Bluejay) is pleased to announce a new Cooperative Research & Development Agreement (CRADA) with the U.S. Naval Medical Research Center (NMRC), Silver Spring, Md. The project, which will take place in Maryland, will investigate and develop a non-invasive point-of-care test for Lyme disease with the goal of improving detection of Lyme disease at an early stage.

This collaboration will focus on the study of antigens from various pathogens, and successful identification of the most immunoreactive antigen. This information will then be used to develop a rapid test for the efficient detection of pathogen-antigens in biofluids (such as serum, urine or other biofluids) using Bluejay’s FDA-Cleared platform technology, which combines immunochromatography and laminar flow using proprietary materials and design.

“We are confident this collaboration will allow the Navy and Bluejay to pursue not only the development of Lyme disease tests, but also for other infectious diseases,” said Neil Dey, Chief Executive Officer for Bluejay Diagnostics. “We look forward to working with the Navy on this project.

The two-year agreement between the Navy and Bluejay Diagnostics will be completed in four phases to identify the most pertinent antigen, confirm sensitivity and specificity, generate specific high-efficient antibodies, and provide a proof-of-concept test on the platform technology.

About Bluejay Diagnostics, Inc.

Bluejay Diagnostics, Inc. develops, manufactures and markets easy-to-use, point-of-care medical diagnostics tests. The company offers multiple FDA-Cleared non-invasive, affordable products, including the Allereye® Tear Total IgE Test used to aid in the diagnosis of allergic conjunctivitis, and a urine-based HIV-1 screening test and a HIV-1 confirmatory test. Bluejay, headquartered in Acton, Massachusetts, continues to leverage its innovate, proprietary platform to develop new products for underserved diagnostic markets.

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