Rheonix and NYU College of Dentistry to Pursue Rapid Zika Virus Diagnostic

Rheonix, Inc., a developer of fully automated molecular testing solutions, in collaboration with New York University College of Dentistry (NYUCD), has received funding to develop a rapid diagnostic for Zika virus infection.

The $656,414 award is an administrative supplement to an existing Small Business Innovation Research (SBIR) Phase I/II Fast-track grant from the National Institute of Dental and Craniofacial Research (NIDCR) of the National Institutes of Health (NIH). The grant will allow the Rheonix/NYUCD team to pursue the development of a fully automated screening and self-confirming assay that will simultaneously detect and confirm the presence of Zika virus in a single, small sample of saliva or blood. The proposed approach will build upon previous success in which the Rheonix/NYUCD team developed a dual assay for the simultaneous detection of HIV antibodies and viral RNA in a single specimen.

The assay will be performed on the Rheonix Chemistry and Reagent Device, or Rheonix CARD® cartridge interfaced with the Encompass Optimum™ workstation. Once a raw sample is placed on the Rheonix CARD cartridge, the automated workstation runs with no user intervention through the process of sample extraction, purification, amplification and detection. This eliminates the need for multiple pieces of existing equipment, helping to make the testing process quicker, more efficient, less expensive and less likely to result in human error.

“As we continue to demonstrate the utility of our novel microfluidic-based technology, we remain committed to deploying the technology to address global health needs,” said Greg Galvin, Ph.D., CEO and chairman at Rheonix. “Addressing the need to test for Zika virus certainly fits the bill given the elevated health alerts issued throughout the world.”

In February 2016, the World Health Organization (WHO) declared Zika virus a public health emergency of international concern. According to the Centers for Disease Control and Prevention (CDC), Zika virus disease is caused by Zika viruses that are spread to people primarily through the bite of an infected Aedes species mosquito; however, transmission from mother to child, through sexual contact and through blood transfusion have also been reported. According to the NIH, there is a tentative link between Zika virus infections in pregnant women and microcephaly, a condition characterized by a small head and brain, in their newborn babies. In addition, a possible connection exists between Zika infection and Guillain-Barré syndrome, a condition in which the immune system attacks parts of the peripheral nervous system.

“We have had a long-standing and very productive collaborative relationship with Dr. Dan Malamud’s laboratory at New York University College of Dentistry, and it has been through those efforts that we successfully developed the dual assay for anti-HIV antibodies and viral RNA,” said Richard Montagna, Ph.D., FACB, senior vice president for scientific and clinical affairs at Rheonix, and the principal investigator on the grant. “It seemed to be a logical extension of those efforts to attempt the same approach for Zika virus.”

“The Zika virus appears to disappear from blood in six to 10 days, but is still detectable in saliva and urine,” explained Daniel Malamud, Ph.D., professor of basic sciences at NYUCD. “Anti-Zika antibodies can be detected several days after infection. A combined RNA and antibody test will enable detection of both early and late Zika virus infections.”

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Diagnostic Kit for Fish Virus Released

The ICAR-Central Marine Fisheries Research Institute has released a virus diagnostic kit specific to betanoda virus that infects marine fish.

The kit was released during a function held at the Central Marine Fisheries Research Institute by Trilochan Mohapatra, secretary, Department of Agricultural Research and Education and director general of the Indian Council of Agricultural Research.

Betanoda virus causes Viral Nervous Necrosis (VNN), also known as viral encephalopathy and retinopathy in larvae and juveniles of marine fin fish for which no effective treatments are available and those fish surviving the infection remain carriers of the virus, facilitating vertical and horizontal transmission.

Preventive steps

Hence, only preventive measures such as vaccination, regular screening of broodstock, eggs, larvae and fingerlings, besides effective disposal of positively diagnosed specimens, are options available to prevent disease outbreaks associated with betanodavirus in hatcheries and aquaculture farms, said a press release here.

Cost-effective

The kit is highly specific and cost-effective. Positive reaction is diagnosed by a green fluorescence that can be perceived by the naked eye under visible or UV light and there is no need for sophisticated equipment like a thermal cycler or trans-UV illuminator as in the case of other molecular diagnostic approaches.

The kit is meant mainly to screen marine brood stock fish to ensure certified specific pathogen-free eggs and larvae in a sensitive and rapid way. It will also help timely identification of betanoda viral infections in fish hatcheries and aquaculture systems during routine screening of eggs, larvae, fingerlings as well as trash fish used as feed during culture operations.

Hatchery production of marine fish seeds is economically important in the context of enhanced marine fish seed requirements arising out of the increasing popularity of marine cage culture along the Indian coast, the press release issued here said.

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Rapid Anthrax Blood Test Being Developed

The first blood test for anthrax that could show results within minutes at a doctor’s office or emergency room will take the final steps in development with support from the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR).

Under an 18-month $2.5 million agreement with ASPR’s Biomedical Advanced Research and Development Authority (BARDA), ,SRI International of Menlo Park, California, will conduct studies necessary to ensure the test accurately detects anthrax infections in blood samples; the studies are needed to apply for clearance to market the device from the U.S. Food and Drug Administration. The contract can be extended for up to a total of three years and $7.8 million.

The test being developed is based partly on a similar version developed at the Centers for Disease Control and Prevention (CDC). Anthrax diagnostic tests available today require sending samples to a laboratory for analysis, with results available in days.

The test SRI is developing uses blood samples on small cartridges; after 15 minutes, the cartridge is placed in a reader, and results are displayed. This compact system fits into the palm of a hand and can be used in locations close to the patient, such as hospital emergency rooms, local health clinics, and potentially at the patient’s bedside or by first responders.

Having the results immediately available will help doctors make fast decisions about the appropriate care and treatment for patients who may have been exposed to anthrax, particularly after an anthrax bioterrorism attack. Anthrax is an acute disease caused by Bacillus anthracis bacteria, and if untreated can be deadly. The inhaled form can cause death in a matter of days.

SRI International will work with DCN Diagnostics of Carlsbad, California, and Web Industries of Holliston, Massachusetts, on regulatory, design, and manufacturing studies of the anthrax diagnostic test.

BARDA, CDC and other federal agencies coordinate as a Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) to prioritize medical countermeasures – drugs, vaccines, and diagnostics – needed in public health emergencies, identify promising medical countermeasures, and transition products from early development to advanced development with the goal of FDA approval.

Protecting health after an anthrax attack requires preventing, detecting, and treating anthrax infections. To meet this national health security need, BARDA’s portfolio includes development of three anthrax antitoxin drugs that have been approved by FDA. BARDA also is supporting advanced development of vaccines to prevent illness after exposure to anthrax as well as improvements on the only vaccine licensed for use prior to exposure so that fewer doses are needed to protect health.

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A Breath Test for Malaria

Diagnosing malaria may soon be as easy taking a simple breath test, according to researchers.

“We really envision this working just like a breathalyzer test when you get pulled over for drunk driving,” said Dr. Audrey Odom, an assistant professor of pediatrics and molecular biology at Washington University in St. Louis.

The device, still in development, would be comparable in cost or less expensive than current diagnostic tools such as a Malaria Rapid Diagnosis Test and wouldn’t require blood samples or trained personnel to use, according to Odom.

The work began in the lab where Odom and her colleagues discovered the parasite produces aromatic organic compounds called terpenes that give off a scent that attracts mosquito’s.

“Those type of compounds when they are in the blood can actually get into the lungs and out in the gas that you exhale,” she said.

The research then moved on to a pilot study in Malawi where the scientists were able to detect and diagnose malaria with 100 percent accuracy in the exhaled breath of children. A second study is scheduled for next fall.

Malaria kills an estimated half a million people every year, most of those children under the age of 5 in Sub Saharan Africa, according to the World Health Organization (WHO).

“We are giving almost 300 million doses of malaria treatment every year and we don’t even know if we are giving them to the right people,” said Odom, adding that over use of antimalarials increases the risk of drug resistance.

“We want to judiciously use antimicrobial and antimalarials only on the people that really need them. So I think a low cost diagnostic test that you could disseminate more widely would allow us to preserve our antimalarials only for the children who need them which would let them work longer.”

Similar research into breathlyzer-type diagnostic tools is underway for diseases such tuberculosis and lung cancer.

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WHO Recommends to Speed Up Detection & improve MDR-TB Treatment Through Rapid Diagnostic Test

WHO's latest recommendations aim to speed up detection and improve treatment outcomes for multidrug resistant tuberculosis (MDR-TB) through use of a novel rapid diagnostic test and a shorter, cheaper treatment regimen.

“This is a critical step forward in tackling the MDR-TB public health crisis,” said Dr Mario Raviglione, Director of WHO’s Global TB Programme. “The new WHO recommendations offer hope to hundreds of thousands of MDR-TB patients who can now benefit from a test that quickly identifies eligibility for the shorter regimen, and then complete treatment in half the time and at nearly half the cost.”

At less than US$ 1000 per patient, the new treatment regimen can be completed in 9–12 months. Not only is it less expensive than current regimens, but it is also expected to improve outcomes and potentially decrease deaths due to better adherence to treatment and reduced loss to follow-up.

The conventional treatment regimens, which take 18–24 months to complete, yield low cure rates: just 50% on average globally. This is largely because patients find it very hard to keep taking second-line drugs, which can be quite toxic, for prolonged periods of time. They therefore often interrupt treatment or are lost to follow-up in health services.

The shorter regimen is recommended for patients diagnosed with uncomplicated MDR-TB, for example those individuals whose MDR-TB is not resistant to the most important drugs used to treat MDR-TB (fluoroquinolones and injectables), known as “second-line drugs”. It is also recommended for individuals who have not yet been treated with second line drugs.

WHO’s recommendations on the shorter regimens are based on initial programmatic studies involving 1200 patients with uncomplicated MDR-TB in 10 countries . WHO is urging researchers to complete ongoing randomised controlled clinical trials in order to strengthen the evidence base for use of this regimen.

The most reliable way to rule out resistance to second-line drugs is a newly recommended diagnostic test for use in national TB reference laboratories. The novel diagnostic test – called MTBDRsl – is a DNA-based test that identifies genetic mutations in MDR-TB strains, making them resistant to fluoroquinolones and injectable second-line TB drugs.

This test yields results in just 24-48 hours, down from the 3 months or longer currently required. The much faster turnaround time means that MDR-TB patients with additional resistance are not only diagnosed more quickly, but can quickly be placed on appropriate second-line regimens. WHO reports that fewer than 20% of the estimated 480 000 MDR-TB patients globally are currently being properly treated.

The MTBDRsl test is also a critical prerequisite for identifying MDR-TB patients who are eligible for the newly recommended shorter regimen, while avoiding placing patients who have resistance to second-line drugs on this regimen (which could fuel the development of extensively drug-resistant TB or XDR-TB).

“We hope that the faster diagnosis and shorter treatment will accelerate the much-needed global MDR-TB response,” said Dr Karin Weyer, Coordinator of Laboratories, Diagnostics and Drug Resistance, WHO Global TB Programme. “Anticipated cost-savings from the roll out of this regimen could be re-invested in MDR-TB services to enable more patients to be tested and retained on treatment.”

WHO is working closely with technical and funding partners to ensure adequate resources and support for the uptake of the rapid test and shorter, cheaper regimen in countries.

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Stellenbosch University Scientists Develop a TB Rapid Screening Test

A point-of-care rapid diagnostic test for tuberculosis (TB) has been developed by a multinational team of scientists led by researchers at Stellenbosch University in South Africa.

“This low-cost screening test has the potential to significantly speed up TB diagnosis in resource-limited setting,” says co-inventor, Professor Gerhard Walzl of Stellenbosch University’s faculty of medicine and health sciences. The test comprises a finger-prick blood test and can make a TB diagnosis in less than an hour.

The diagnostic test is a hand-held, battery-operated instrument that will measure chemicals in the blood of people with possible TB. The device is currently in developmental phase and its accuracy and efficacy will be tested in five African countries over the next three years by the ScreenTB consortium, a team of TB experts from eight African and European partnering institutions.

“Healthcare workers with minimal training will be able use the test at grass-roots level and get immediate access to screening test results,” says Walzl.

Other recent advances in TB diagnostics have radically improved diagnostic times, but high costs and the sophisticated equipment required have made this technology inaccessible to many.

“People in remote areas with high TB incidence still do not benefit from the newer developments and face long diagnostic delays and often multiple return visits to clinics before they are diagnosed,” says Walzl.

The new test will be able to provide near-immediate results that will enable a person with TB to be diagnosed and started on treatment during a single visit to a healthcare facility.

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York U Invention Promises Rapid Detection of E. coli in Water

Tragedies like the E. coli outbreak in Ontario's Walkerton in May 2000 could be averted today with a new invention by researchers at York University that can detect the deadly contaminant in drinking water early.

"We have developed a hydrogel based rapid E. coli detection system that will turn red when E. coli is present," says Professor Sushanta Mitra, Lassonde School of Engineering. "It will detect the bacteria right at the water source before people start drinking contaminated water."

The new technology has cut down the time taken to detect E. coli from a few days to just a couple of hours. It is also an inexpensive way to test drinking water (C$3 per test estimated), which is a boon for many developing countries, as much as it is for remote areas of Canada's North.

"This is a significant improvement over the earlier version of the device, the Mobile Water Kit, that required more steps, handling of liquid chemicals and so on," says Mitra, Associate Vice-President of Research at York U. "The entire system is developed using a readily available plunger-tube assembly. It's so user-friendly that even an untrained person can do the test using this kit."

Traditional methods of testing for E. coli contamination involves collecting water samples to send to an appropriate microbiological lab where the bacteria is cultured before a plate count is done to detect E. coli presence.

The testing device uses the porous hydrogel matrix, developed by Mitra's team at his Micro & Nano-scale Transport Laboratory that cages specific enzymatic substrates that release certain enzymes in E. coli cells. These enzymes then chemically react with the substrates to change colour. If there is no E. coli, the colour of the hydrogel won't change, as there is no chemical reaction.

The results of the water test can be instantly broadcast using a mobile app already developed by the team.

The breakthrough invention has resulted in forming of Glacierclean Technologies Inc, an Innovation York spinoff company, in partnership with York U. "We have received a significant number of queries from related industries. We strongly believe that the product is in a unique position as the only one available in the market for rapid detection of E. coli," says Naga Siva Gunda, president and CTO of Glacierclean, talking of the commercialization plan for affordable rapid E. coli detection tool, adding that the company has recently hired a CEO.

This innovation is the cover feature titled "A hydrogel based rapid test method for detection of Escherichia coli (E. coli) in contaminated water samples" in the current issue of Analyst. The journal, published by the Royal Society of Chemistry, explores fundamental discoveries, inventions and applications in the analytical and bioanalytical sciences.

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Crystal Diagnostics Awarded AOAC-PTM Accreditation for the Rapid Detection of Salmonella in Foods

Crystal Diagnostics (CDx) Xpress System, a rapid and sensitive detection platform, announced today that it has received AOAC-PTM Certifications for Salmonella on whole uncut tomatoes and whole chicken rinsate when present at levels of 1 colony-forming unit per sample.

The CDx Xpress System combines proprietary liquid crystal technology with antibody-coated paramagnetic microspheres to selectively capture and detect Salmonella from food matrixes, faster than other commercial systems.

CDx previously announced that it had been accredited by AOAC for detection of E. coli O157 and and the “Big 6” STECs. According to CDx President and CEO Jim Bruce, “The Company is quickly expanding our portfolio of target pathogens and food types with our rapid and accurate liquid crystal biosensors. We expect to have AOAC accreditation for Listeria in June and other accreditations by year end.”

Jay Hardy, Founder of Hardy Diagnostics, the national distributor of Crystal Diagnostics’ products said, “A 15-hour sample-to-result Salmonella test was unimaginable just a year ago. To be able to offer this unique detection system incorporating such speed and accuracy keeps our customers on the leading edge of food safety technology.”

The Company expects an AOAC certified 12-hour Salmonella test by yearend, covering a wide range of food types.

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New 3M Microbial Luminescence System Kit Fast-Tracks UHT and ESL Beverage Testing

Global demand for commercially sterile beverages is growing more than 9 percent annually, according to a market research report by Reportlinker, fueled by supply chain cost benefits and consumer demand for more convenient beverages that retain both flavor and nutrients. With the growing trends around these beverages, 3M announced today the launch of the 3M™ Microbial Luminescence System UHT Beverage Screen Kit, a new rapid test for Ultra High Temperature (UHT) and Extended Shelf Life (ESL) beverages.

This new rapid test expands the application of the 3M Microbial Luminescence System (MLS) from UHT dairy products to a wide variety of UHT and ESL beverages such as fruit juices, caffeinated drinks, coconut waters, smoothies, dairy, dairy substitutes, and dairy/juice mixtures. The system provides a rapid method for quality release testing, reducing the time-to-result by two to three days or more, compared to traditional methods like agar plates and pH measurement.

Using bioluminescence technology, the 3M Microbial Luminescence System detects ATP (adenosine triphosphate), an energy molecule universally present in all living organisms, no matter how small. This technology allows the 3M MLS to have faster time-to-result than traditional pH or agar tests, and more reliably detect a broad range of microorganisms than traditional methods.

Following a 2-3 day sample pre-incubation time, the 3M MLS technology provides a rapid result in less than 30 minutes, eliminating the need for further plating and incubating of agar dishes. This expedited time-to-result enables beverage producers to release product quicker, reduce inventory and storage space as well as increase their flexibility and lab productivity.

“UHT and ESL beverages and their processing techniques are becoming more sophisticated and diverse. Yet the historical test methods continue to lag behind and are time-consuming and limiting,” said Eric Amann, 3M Food Safety global marketing manager. “This new and improved 3M technology provides a quicker and more reliable way to detect microorganisms in a wide variety of beverages.”

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ID Genomics Wins $3M NIH Grant to Develop UTI Diagnostic

ID Genomics announced that it has received a three-year, $3 million grant from the National Institutes of Health to continue development of a rapid genetic test for the diagnosis of urinary tract infections (UTIs) and prediction of antibiotic resistance.

The test, called CloNeT, involves barcoding infecting bacteria in urine by detecting the presence or absence of a small number of single nucleotide polymorphisms via PCR. These barcodes are associated with various bacterial strains and linked to antibiotic resistance profiles.

Analysis can be completed within 45 minutes, according to ID Genomics, and provides a physician with information on which antibiotic is best suited for a patient's particular infection.

With the NIH grant, ID Genomics aims to refine and validate CloNeT for the diagnosis of UTIs caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter spp, and Proteus mirabilis using clinical isolates from different geographic regions across the US.

It previously received a $3 million grant from the NIH to build a prototype of the test.

The company said it envisions the technology eventually being applied to other infectious diseases including sepsis and pneumonia, and that it aims to identify and monitor most antibiotic-resistant pathogens in a global epidemiological surveillance network.

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OraSure Developing Rapid Zika Test

OraSure Technologies' scientists have trained their research sights on the latest global health threat, the Zika virus.

The Bethlehem company, which developed a rapid test for the deadly Ebola virus in 2015 based on its OraQuick HIV and hepatitis testing platform, is working on a similar diagnostic tool that would allow health practitioners to quickly determine if a patient has been exposed to Zika.

"We are developing Zika tests on the OraQuick platform and are also pursuing development funding for those activities through multiple sources and we will continue to pursue that," said CEO Douglas A. Michels. "Health officials have expressed an urgent need for highly sensitive rapid diagnostics, not just here in the U.S. but in other affected regions."

The virus, which is spread primarily by a particular species of mosquito, can cause severe birth defects if contracted by a pregnant woman. Most people who contract the virus experience mild symptoms such as fever, rash and conjunctivitis, and may not even know they are infected.

Endemic to Africa, Zika was first detected in South America last year and has spread through much of Central America and the Caribbean.

The virus is expected to eventually gain a foothold in parts of the southern U.S., but so far all domestically reported Zika cases have involved travelers infected in parts of the world where the virus is being transmitted by mosquitoes.

OraSure's Ebola test was developed during a major outbreak in West Africa in late 2014 and early 2015. It was funded primarily by a commitment of up to $10.4 million from the Biomedical Advanced Research Development Authority of the U.S. Department of Health and Human Services. The Centers for Disease Control and Prevention also agreed to purchase $1.5 million worth of the tests.

The market for the Ebola test has been limited primarily to West Africa, where the outbreak was centered. Zika is more widespread, posing a broader threat to public health and a wider potential market for a rapid diagnostic test, if it can be successfully developed.

"The team is excited about it," Michels said. "We've got a road map we have created with the Ebola test so we are pursuing it aggressively."

OraSure is already getting "good support from potential partners" in federal government and academia, and has invested some of its own money to obtain materials it needs to begin development, Michels said. "We think we are in a great position to develop and provide a tool to deal with this serious issue."

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Rapid Diagnostic Test for Mycoplasma pneumoniae Receives EU Mark of Approval

Meridian Bioscience, Inc. announced that it has received the CE Mark for a new molecular diagnostic test for Mycoplasma pneumonia (M. pneumoniae). The new and improved illumigene Mycoplasma Direct assay features a simplified procedure compared to the existing illumigene Mycoplasma product. The new procedure will significantly expand Meridian’s customer base by eliminating the need for specialized techniques and training, as well as providing definitive results in less than one hour.

The launch of illumigene Mycoplasma Direct adds to the already robust illumigene menu that includes molecular tests for Group A Streptococcus, Pertussis, C. difficile, Chlamydia, Gonorrhea, HSV 1&2, Group B Streptococcus, and Malaria. All illumigene products are distributed in the EMEA regions by Meridian Bioscience Europe and in additional international markets by the Company’s global distribution network.

Mike Shaughnessy, Executive Vice President and President of Meridian Global Diagnostics stated, “We are excited to improve upon the only CE-marked and FDA-cleared stand-alone molecular assay for Mycoplasma pneumoniae (illumigene Mycoplasma). By simplifying the procedure we are able to provide more customers with a superior diagnostic tool that will improve patient care. Due to the lack of cell wall in Mycoplasma, typical antibiotics like penicillin and cephalosporin are not effective, making rapid, targeted detection for appropriate treatment of the utmost importance.”

Often referred to as “walking pneumonia”, M. pneumoniae is associated with up to 40% of community-acquired pneumonias and has been increasingly prevalent in the majority of data-reporting European countries. Infection occurs in both children and adults without geographical, gender or climate-related restrictions. M. pneumoniae is most often associated with atypical pneumonia, presenting with symptoms that include headache, malaise, fever and sore throat accompanied by dry, paroxysmal cough.

illumigene Mycoplasma Direct is effective immediately as symptoms appear, by amplifying the specific DNA for the detection of active Mycoplasma pneumoniae infection. This represents a significant advancement in improving healthcare diagnoses and outcomes by providing a fast and definitive result, thus helping to ensure that patients receive the appropriate antibiotic therapy in a timely manner. M. pneumoniae bacterial culture lacks sensitivity and is often impractical for patient management as the organism may take as long as up to six weeks to culture. The ability to avoid treating patients empirically will reduce the administration of broad spectrum antibiotics and the likelihood of antimicrobial resistance.

The illumigene Mycoplasma test utilizes throat swabs and provides highly sensitive and specific results. It requires no expensive capital equipment or service contract. The test relies upon a simple procedure that takes less than two minutes of hands on time. The simplicity of this technology, along with its cost efficiency and small footprint, makes this innovative test ideal for enabling a more rapid diagnosis; providing earlier identification of outbreaks and prevention of secondary cases though implementation of control measures.

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Mass. General Device May Provide Rapid Diagnosis of Bacterial Infections

A team of Massachusetts General Hospital (MGH) investigators has developed a device with the potential of shortening the time required to rapidly diagnose pathogens responsible for health-care-associated infections from a couple of days to a matter of hours. The system described in the journal Science Advances also would allow point-of-care diagnosis, as it does not require the facilities and expertise available only in hospital laboratories.

"Health-care-associated infections are a major problem that affects more than 600,000 patients each year, more than 10 percent of whom will die, and incurs more $100 billion in related costs," says Ralph Weissleder, MD, PhD, director of the MGH Center for Systems Biology, Thrall Family Professor of Radiology at Harvard Medical School (HMS) and co-senior author of the report. "Rapid and efficient diagnosis of the pathogen is a critical first step in choosing the appropriate antibiotic regimen, and this system could provide that information in a physician's office in less than two hours."

While considered the gold standard for diagnosing bacterial infections, traditional culture-based diagnosis can take several days and requires specialized equipment, trained laboratory personnel and procedures that vary depending on the particular pathogen. Emerging genetic approaches that identify bacterial species by their nucleic acid sequences are powerful but still require complex equipment and workflows, restricting such testing to specialized hospital laboratories.

The system developed by the MGH team, dubbed PAD for Polarization Anisotropy Diagnostics, allows for accurate genetic testing in a simple device. Bacterial RNA is extracted from a sample in a small, disposable plastic cartridge. Following polymerase chain reaction amplification of the RNA, the material is loaded into a 2-cm plastic cube containing optical components that detect target RNAs based on the response to a light signal of sequence-specific detection probes. These optical cubes are placed on an electronic base station that transmits data to a smartphone or computer where the results can be displayed.

In this proof-of-principle study, the team used a prototype PAD system containing four optical cubes to test clinical samples from nine patients and compared the results with those acquired by conventional microbiology cultures. Testing for the presence of five important bacterial species -- E. coli, Klebsiella, Acinetobacter, Pseudomonas, and Staph aureus -- and for factors indicating the virulence and antibiotic resistance of specific strains produced identical results with both procedures. But while PAD provided results in less than two hours, the bacterial culture process took three to five days. The team has now designed probes for more than 35 bacterial species and virulence factors, and the overall cost of running the PAD assay should not exceed $2.00.

"This prototype still needs several improvements, including building a self-contained system housing all functions, further reducing the current assay time to less than one hour and expanding the panel of probes to even more pathogens and resistance factors," says Hakho Lee, PhD, of MGH Center for Systems Biology (CSB), co-senior author of the report and an associate professor of Radiology at HMS. "But we can see three immediate applications for a system that can provide such rapid and accurate results - quickly diagnosing a patient's infection, determining whether antibiotic-resistant bacteria are present in a group of patients, and detecting bacterial contamination of medical devices or patient environments."

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