Thursday, April 30, 2015

Novel Rapid Method for Typing of Clostridium difficile Could Limit Outbreaks

The Public Health Agency of Sweden has developed a method of typing that can allow laboratories to faster establish the presence of hospital outbreaks of the intestinal bacterium Clostridium difficile. The findings are now published in PLOS ONE.

The Clostridium difficile bacteria exist in the intestines of 2-5 per cent of the healthy population, and is rather common among infants. In certain circumstances the bacteria can induce diarrhea in persons treated with antibiotics. The diarrhea is in some cases serious.

The majority of the cases occur at hospitals. This is due to the fact that hospitals and other health facilities accommodate a lot of elderly and sick people, carrying a higher risk of being affected, but it is also a result of a vast prescription of antibiotics in the health care system.

Therefore correct choice of antibiotics is one of the most important means by which health professionals can reduce the risk of patients falling ill being sick due to Clostridium difficile. The infection is usually caused by the patient's own strain of bacteria, however transmission between patients also occurs and when that is the case it is important to take action immediately.

To enable faster identification of outbreaks caused by transmission between patients, the Public Health Agency of Sweden has developed a method that can be used by local laboratories. The method identifies specific proteins on the surface of the bacteria, using a laser pulse (MALDI-TOF). Details about the method, alongside an evaluation of it, is now published in the scientific journal PLOS ONE in an article written by Dr Thomas Akerlund, microbiologist at the Public Health Agency of Sweden and Dr Kristina Rizzardi, molecular biologist at the Agency.

- A unique pattern is shown, making it possible identify bacteria of the same clonal type, says Dr Kristina Rizzardi.

- Within 30 minutes you can tell whether you have strains of the same clonal type, and therefore a probable transmission between patients, or whether a patient has symptoms from his or her own bacteria, says Dr Thomas Akerlund.

Early detection of transmission of Clostridium difficile between patients enables faster action from health facilities to limit the outbreak.

- The most important measures to stop an outbreak are strict adherence to basic hygiene routines. Affected patients should be given care in single rooms only. Proper cleaning of the areas near each patient is also crucial since the bacterial spores are resistant and sometimes difficult to get rid of, says Karin Tegmark Wisell, physician and head of the microbiological department at the Public Health Agency of Sweden.

This unprecedented method was developed in 2013 and tested with satisfying results in 2014.

Reference

Kristina Rizzardi, Thomas Åkerlund. High Molecular Weight Typing with MALDI-TOF MS - A Novel Method for Rapid Typing of Clostridium difficile. PLOS ONE, April 2015.

Bruker Introduces IVD MALDI Sepsityper Solution for Rapid Identification of Over 2,200 Microorganisms Directly from Positive Blood Culture

At the 25th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), Bruker announced the introduction of the new IVD MALDI Sepsityper kit and workflow with standard operating procedures for the rapid identification of microorganisms from positive blood culture bottles. The IVD kit is now labeled according to the European IVD directive EC/98/79, and is developed for use with the IVD MALDI Biotyper (IVD MBT) system for rapid MALDI-TOF mass spectrometry-based microbial identification.

The IVD MALDI Sepsityper kit enables a rapid and easy isolation and identification of microorganisms within minutes from positive blood culture bottles. Harvested microorganisms are processed and then identified using the IVD MALDI Biotyper. The identification assay from positive blood cultures is applicable to Gram-negative and Gram-positive bacteria, as well as to yeast. The IVD MALDI Biotyper reference library covers more than 2,000 different bacteria species and approximately 200 species of yeasts, including candida. This workflow is recommended and optimized for blood culture bottles without any charcoal supplements.

Overall, the IVD MALDI Sepsityper workflow takes approximately 30 minutes after gram-staining and extraction from a positive blood culture bottle to identification. It saves the day normally required for additional agar plate culturing, and it can also save an additional 8-12 hours, when compared to traditional biochemical identification after agar plate culturing.

Sepsis is a life-threatening condition with high mortality rates. Published studies have shown that each hour of delay in initiating effective antibiotic therapy can increase mortality significantly. Due to this high risk, and based on current sepsis guidelines, therapy is typically initiated using broad-spectrum antibiotics to maximize the probability of antibiotic coverage of the potential pathogen, with the goal of either de-escalating therapy to a more narrow antibiotic, or to switch antibiotic or antifungal therapy, based on laboratory findings.

The IVD MALDI Sepsityper workflow reduces the turnaround time provided by traditional workflows by typically 24 to 36 hours after a blood culture bottle becomes positive. The faster results provided by the IVD MALDI Sepsityper workflow aid the clinician in the management of blood stream infections. These earlier identification results, combined with antibiotic stewardship programs, can reduce healthcare costs substantially, and can improve patient outcomes, while also assisting in the fight against antibiotic resistance via reductions in the use of ineffective or expensive antibiotics. In contrast to pure nucleic acid amplification test (NAATs), blood cultures do not amplify biologically non-active DNA or cells, but only the most active and relevant microbial species. Moreover, the IVD MALDI Sepsityper workflow is untargeted and offers very broad microbial coverage of gram-negative and gram-positive bacterial species, as well as clinically relevant yeast species, including candida.

Dr. Cassie Pope, Consultant Clinical Scientist from St. George’s Hospital in London, UK, said: “The introduction of the Bruker MALDI Sepsityper kit into our workflow has proved to be a decision that we are very pleased with, and that has resulted in clear benefits to the laboratory and our users. We implemented it for the identification of organisms in all blood cultures that have flagged as positive in the morning. This has reduced our time to identification by 24 hours, and allows us to provide a better service, and promotes timely prescription of appropriate narrow spectrum antimicrobials. This is valued by clinicians and they are now used to the improved service and earlier identification information. Our scientific staff enjoys using the kit, as it is easy to perform and provides identifications that they have confidence in, typically within 30 minutes.”

Dr. Nils Morgenthaler, Vice President for Medical Affairs for the Bruker Daltonics Division, added: “We and our collaborators now have several years of experience with the research-use-only (RUO) MALDI Sepsityper workflow, and the feedback from our customers and collaborators has been very positive. So far, 21 peer reviewed scientific publications have evaluated this approach, in which the RUO MALDI Sepsityper workflow has been shown to provide approximately 80% correct identification at the species level, with the remaining 20% mostly unidentified, and with essentially no relevant misidentifications at the genus level. With further recent improvements and expansion in the IVD MALDI Biotyper reference library, this already excellent identification performance directly from blood culture is expected to improve even further. The recent CE-labeling of the kit underlines Bruker's strategy to provide more and more workflows for clinical routine use on the IVD MALDI Biotyper platform. We believe that the IVD MALDI Sepsityper kit and workflow has the potential to rapidly become the new gold standard in microorganism identification in clinical microbiology directly out of positive blood cultures, due to its very short TTR and broad bacteria and yeast species coverage.”

Bruker Launches High-Throughput MALDI Biotypersmart System with Lifetime Laser

At the 25th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), Bruker today announced the introduction of the MALDI Biotypersmart (MBTsmart), a new high-throughput option in the MALDI Biotyper product family of bench-top MALDI-TOF mass spectrometry systems for microbiology laboratories. The MBTsmart is IVD-CE labeled according to EU directive EC/98/79, and fully integrated with the new IVD MALDI Sepsityper workflow for rapid microbial identification from positive blood cultures.

The new MALDI Biotypersmart is equipped with Bruker’s proprietary smartbeam solid-state laser, which increases the laser lifetime by an order of magnitude. In practice, this makes the smartbeam laser essentially a ‘lifetime’ laser for most microbiology applications and typical sample throughputs today. Smartbeam is a Bruker-proprietary laser technology which combines the higher speed and lifetime of a solid-state laser with the analytical MALDI performance of a nitrogen laser.

The MALDI Biotypersmart also features a more than three times higher laser repetition rate for even faster Time-to-Result (TTR), which often is crucial in clinical microbiology. It also enables higher throughput during peak demand times in the clinical microbiology laboratory, e.g. in the mornings.

The higher speed and lifetime make the new MBTsmartmorefuture-proof by providing the higher throughput that will be beneficial to implement additional workflows going forward. For example, it facilitates additional research applications, like sub-typing, or the emerging family of Bruker-proprietary Selective Testing of Antibiotic Resistance (MBT-STAR) assays, which use the MALDI Biotyper platform for functional resistance testing of bacteria, initially for beta-lactamase activity. High quality subtyping or MBT-STAR assays, with QC comparisons, are expected to require approximately an order of magnitude more laser shots than identification.

The MALDI Biotypersmartis also equipped with a higher performance vacuum system. This enables flexible and convenient workflows in laboratories where multiple users are working on the same instrument, and have the need to exchange MALDI target plates with a minimum delay. The modified design allows reaching high vacuum faster after preventive maintenance or service, thus even further increasing instrument availability.

Dr. Edwin Boel, Consultant Microbiologist at University Medical Center Utrecht, The Netherlands, explained: “We have been using the MALDI Biotyper system for microbial identification in our routine laboratory for years. But we also envision additional workflows like direct analysis from positive blood cultures, and MALDI Biotyper-based selective testing of antibiotic resistance. Even nucleic acid analysis on MALDI-TOF mass spectrometry might become of interest for the microbiology laboratory in the future. In summary, we are convinced that MALDI-TOF mass spectrometry will have even broader impact on microbiology laboratories in the future. The new MBTsmart provides the hardware improvements to be future-proof for such new workflows.”

Dr. Wolfgang Pusch, Executive Vice President for Clinical MALDI at Bruker Daltonics, added: “Bruker is dedicated to innovation and workflow improvements in clinical microbiology, in order to provide more and better information with dramatically shorter TTRs and higher throughput to infectious disease clinicians. This enables our customers to reduce healthcare costs, improve antibiotic stewardship, and improve patient comfort and outcomes. Since the introduction of the MALDI Biotyper, Bruker has led the MALDI-revolution in microbial identification. With the introduction of the MALDI Biotypersmart, Bruker is now taking MALDI-TOF mass spectrometry to the next level in the microbiology laboratory. The MALDI Biotypersmart system is a new high-end option for those customers who seek further increases in throughput, convenience and flexibility in the laboratory. Higher throughput, speed and laser lifetime facilitate additional workflows for developing the MBT platform more and more into a general microbiology workhorse for multiple diagnostic and analytical tasks.”

Friday, April 24, 2015

MedMira Submits Reveal G4 Whole Blood Rapid HIV Test For U.S. FDA Approval

MedMira Inc. has completed the submission of a supplement to their existing Premarket Approval for the United States Food and Drug Administration (FDA) approval of the next generation of its Reveal rapid HIV test. The supplement requests FDA approval of Reveal® G4 Rapid HIV-1 Antibody Test (Reveal G4), which adds the detection of HIV antibodies in fingerstick and venipuncture whole blood, to the product's current capabilities in testing serum and plasma specimens.

"Reveal G4 represents a significant milestone in our sales and marketing expansion in the United States and this submission marks the first in a series of regulatory submissions we will be making as we introduce new products in this market," said Dr. Kevin Jones, Senior Director, Global Sales & Marketing, MedMira Inc. "Reveal G4 also builds on MedMira's commitment to delivering the most innovative rapid testing solutions to our customers. The whole blood capabilities in Reveal G4 will expand product applications to physician offices, mobile testing vehicles, and convenience care clinics where much of the HIV testing is taking place as healthcare providers implement the latest guidelines for routine screening."

Built on MedMira's patented Rapid Vertical Flow Technology™ (RVF) platform, Reveal G4 offers point-of-care (POC) users a simple 3-step whole blood procedure which is completed in less than three minutes. The product will be sold in three distinct packaging formats, designed to meet the needs of a broad range of customers, including fingerstick whole blood (POC format), venipuncture whole blood/serum/plasma (LAB+ format), and serum/plasma (LAB S/P).

MedMira has successfully served customers in hospitals and laboratories with a serum/plasma version of its Reveal rapid HIV test for the past decade. Reveal is routinely ranked as a top performer in these market sectors with the highest sensitivity and specificity as well as performance comparable to complex laboratory systems.

The submission to the FDA is based on results from multi-center clinical trials conducted across the United States where Reveal G4 showed excellent results with fingerstick and whole blood specimens from a broad range of demographics. The additional whole blood capabilities of Reveal G4 will enable healthcare providers to better serve individuals 15-65 years of age and pregnant women seeking routine screening, helping to reduce the 50,000 new HIV infections in the US each year, including 100 to 200 babies born with HIV.

miacom diagnostics Announces IVD Tools for Direct Testing of Respiratory Samples

miacom diagnostics specializes in the development and commercialization of diagnostics tools for identification and differentiation of bacteria in acute infectious diseases. The company was founded in Duesseldorf, Germany in 2006 with the vision to develop faster and better diagnostic methods than the ones currently available on the market.

With the continuing success of miacom’s hemoFISH® unique multiplex identification system for positive blood cultures, miacom proudly reveals its new line of kits to identify bacteria in pneumonia patients directly from respiratory fluids. With the respiFISH® Masterpanel, clinicians will be able to simultaneously identify the most clinically relevant Gram negative and Gram positive bacteria within 30 min directly from sputum, bronchial or tracheal secretions.

Pneumonia is an inflammation of the lung caused primarily by an infection with bacteria and is the most serious and common infectious disease with a fatal outcome in Western Europe. In many cases pneumonia may spread to sepsis. Especially children, older people, people with a weakened immune system and mechanically ventilated patients are at a higher risk of catching pneumonia. Estimates suggest that roughly three to four million people worldwide die of pneumonia every year. In Germany alone, some 400,000 to 600,000 people catch pneumonia every year. A timely targeted intervention is critical for the treatment of pneumonia patients and prevention of escalating to sepsis. However, traditional IVD methods involve subculturing that can add additional days to identify the bacteria and often show low sensitivities as the viability of the bacteria in the samples has been negatively affected during the transport to the laboratory. Other tests such as multiplex PCR, which do not rely on viable bacteria, are too expensive to be considered as a routine tool for diagnosis or even monitoring of patients and potential shortening hospital stay.

respiFISH Masterpanel covers 14 of the most common bacteria causing healthcare-associated pneumonia and thus provides physicians an indispensable tool for targeted antibiotic therapy in those patients. The test is designed to support routine diagnostics and results can be reported back to the ICU consultant in time together with the results of a Gram stain. Rapid diagnosis can save lives by enabling more effective treatment of the pneumonia infection and by lowering the risk of sepsis. In addition it reduces costs and overall healthcare spending by minimizing the use of broad antibiotics, and shorting hospital stay.

“One of the challenges facing physicians today is the rapid diagnosis of bacterial pneumonia. With respiFISH Masterpanel, we aim to improve patient treatment by providing physicians with the ability to detect the most commonly seen pneumonia bacteria and even mixed infections in just 30 minutes directly from sputum and BAL” said Dr. Mirko Stange, CEO of miacom diagnostics GmbH.

respiFISH® Masterpanel will be officially presented with a miacom own exhibition stand (no. 284) at ECCMID, the 25th European Congress of Clinical Microbiology and Infectious Diseases, which will be held between April 25 – 28, 2015 in Copenhagen, Denmark.

New Gene Sequencing Method Identifies Bacteria Contaminating Oysters

In a major breakthrough in shellfish management and disease prevention, researchers at the University of New Hampshire have discovered a new method to detect a bacterium that has contaminated New England oyster beds and sickened consumers who ate the contaminated shellfish. The new patent-pending detection method - which is available for immediate use to identify contaminated shellfish - is a significant advance in efforts to identify shellfish harboring disease-carrying strains of Vibrio parahaemolyticus.

"Since 2012, the Northeast has been experiencing an ongoing outbreak caused by a non-native strain of V. parahaemolyticus that is endemic to the Pacific Northwest. A significant challenge for managing shellfish harvesting to prevent infections is that we were previously unable to tell the difference between this strain and harmless residents. The new detection platform will provide rapid, and more importantly, specific quantification of the invasive strain, we hope allowing more effective management of harvesting that will protect this important regional industry," said Cheryl Whistler, associate professor of molecular, cellular, and biomedical sciences.

The new detection method was developed by Whistler; Steve Jones, research associate professor of natural resources and the environment; and Vaughn Cooper, associate professor of molecular, cellular, and biomedical sciences. It was developed using genome sequencing and analysis. The research is presented in the forthcoming issue of the Journal of Clinical Microbiology in the article "Use of Whole Genome Phylogeny and Comparisons in the Development of a Multiplex-PCR Assay to Identify Sequence Type 36 Vibrio parahaemolyticus."

V. parahaemolyticus is the most common bacterial infection acquired from seafood in the world. There are an estimated 35,000 cases each year in the United States. In recent years, there has been an increase in the incidence of shellfish contamination, which has caused costly recalls of shellfish and shellfish bed closures in Connecticut and Massachusetts. Some strains of the microbe cause disease and others do not.

Whistler said the new detection method is available for immediate use, and can benefit researchers and managers, food inspectors, wholesalers, and retailers. It could form the basis for a diagnostic test for widespread use in both environmental detection and clinical diagnosis. In addition to enabling the research community, the UNHInnovation office will be seeking a partner to license the patent-pending innovation for commercial applications.

"New ideas that create jobs and healthy communities are among the many advancements that have made the United States the leading economic power in the world. Much of this innovation takes place at top research universities like UNH. This patent and the research that led to it underscores the need for continued federal investments in scientific research that will allow the United States to remain an innovation leader," said Jan Nisbet, senior vice provost for research at UNH.

The new detection method identifies the Atlantic ST36 strain of the bacterium. UNH researchers used genotyping and whole genome DNA sequencing at the UNH Hubbard Center for Genome Studies on 94 clinical isolates collected from 2010 to 2013 in Massachusetts, New Hampshire, and Maine. They determined that it is this particular strain of the bacterium that has been responsible for the bulk of the Vibrio outbreaks in the Northeast in recent years. Researchers were able to identify specific genes found only in the invasive strain.

Details on the regional pathogens used to develop the new detection method are presented in the April issue of Frontiers in Microbiology in the article "Genetic characterization of clinical and environmental Vibrio parahaemolyticus from the Northeast USA reveals emerging resident and non-indigenous pathogen lineages."

Thursday, April 16, 2015

MSU to Develop Mobile App for Malaria Diagnosis

Researchers at the Michigan State University College of Engineering are getting closer to phoning home a rapid-response diagnostic test for malaria.

Peter Lillehoj, assistant professor of mechanical engineering, is heading a team of researchers that will use a $1.8 million grant from the National Institutes of Health to develop the technology to diagnose and monitor cerebral malaria using mobile phones.

The diagnosis and clinical care for patients with cerebral malaria is complicated. “It is difficult to predict which patients are at risk of deteriorating from the disease, and which are not,” said Terrie Taylor, an MSU University Distinguished Professor and internationally recognized expert on malaria.

To tackle this challenge, Lillehoj and his team are working to develop and test a field-ready mobile phone-based biosensor that can perform rapid measurements of malarial biomarkers from human serum and blood samples.

“It will incorporate a miniature detection circuit that plugs directly into a mobile phone, a disposable microfluidic chip and a user-friendly app,” Lillehjoj said.

The app will provide graphical operating instructions to assist the user in performing the test. It also will be capable of wireless data transmission for sending test results to centralized laboratories and public health agencies.

Malaria is one of the world’s most deadly infectious diseases. Most of the world’s 600,000 malaria victims are children.

In addition to Taylor, others working on the project are Andrew Mason, professor of electrical and computer engineering; Karl Seydel, assistant professor of internal medicine; Mat Reeves, professor of epidemiology and biostatistics; Guoliang Xing, associate professor of computer science and engineering; and Don Mathanga, from the University of Malawi College of Medicine.

Source: MSU Today

Lab-on-a-Chip Device Can Detect Cryptosporidium Infection

For a healthy individual, an infection of Cryptosporidium parvum may mean nothing more than a few days of bad diarrhea. For someone with a compromised immune system, it can mean death, following an excruciating, protracted bout of watery diarrhea. Recently, researchers at Fudan University's Institute of Biomedical Sciences in Shanghai developed a lab-on-a-chip device that can rapidly diagnose cryptosporidium infections from just a finger prick -- potentially bringing point-of-care diagnosis to at-risk areas in rural China in order to improve treatment outcomes.

Worldwide, treatment for the parasitic infection consists largely of oral rehydration and managing symptoms until the body clears the infection, something that may take far longer for people with HIV infections. Currently, China has more than 780,000 people living with HIV/AIDS, but there is very little data on how many of them are living with Cryptosporidium infections. This stems from the difficulties of diagnosing an infection in the field -- poor sensitivity and a short window of spore secretion both limit the viability of acid-fast staining, a standard diagnostic assay in use today. More advanced immunoassays, such as ELISA, are difficult to use broadly because they require relatively advanced lab settings and skilled technicians.

To address this need, Xunjia Cheng and Guodong Sui, both professors at Fudan University, sought to develop a device better suited for the field. Cheng's research has involved medical protozoa and opportunistic HIV infections, and Sui's lab focuses on microfluidics. This week in the journal Biomicrofluidics, from AIP Publishing, they describe how they developed and tested the new microfluidic device as the fruit of this collaboration.

The microfluidic chip was designed by AutoCad software and manufactured from a widely used silicon-based organic polymer known as PDMS. It consists of functional valves, pumps and columns, collectively sitting at the heart of a platform of reagent cartridges, an injection pump, a fluorescence microscope and a digital camera. The chip itself is small -- 3 cm by 2 cm -- and only costs about a dollar to manufacture, according to Sui.

The microfluidic device tests for the presence of the parasites' P23 antigen, a major molecular target of host antibody responses against the pathogen's infective stages.

The device is easy to use, allowing just about anybody to operate it, Sui and Cheng say. It can process up to five samples at a time, and the entire detection process can be completed in 10 minutes with only two microliters of blood -- less than the volume of a typical mustard seed.

Sui and Cheng tested their device's efficacy at diagnosing Cryptosporidium infections in 190 HIV-infected patients in Guangxi, China. They found that the device's diagnostic capabilities were on par with those of ELISA - essentially giving you a device that's as effective as the current diagnostic standard, with huge potential reductions in cost, timeframe, size and the amount of training needed to operate.

Future work for Sui and Cheng involves expanding the chip's sample processing capacities to include other infectious diseases, as well as increasing the device's sensitivity and specificity.

The article, "Rapid Microfluidic Immunoassay for Surveillance and Diagnosis of Cryptosporidium Infection in HIV-infected Patients,” is authored by Li Zhang, Yongfeng Fu, Wenwen Jing, Qing Xu, Wang Zhao, Meng Feng, Hiroshi Tachibana, Guodong Sui and Xunjia Cheng. It will appear in the journal Biomicrofluidics on April 14, 2015. The authors of this paper are affiliated with Fudan University and Tokai University School of Medicine.

Source: American Institute of Physics

Atlas Genetics Enters Into Diagnostic Collaboration With a Major Pharmaceutical Company

Atlas Genetics Ltd ("Atlas Genetics" or the "Company"), the ultra-rapid 'test and treat' molecular diagnostics company, today announces that it has entered into a collaboration with a major pharmaceutical company to develop a diagnostic test, expanding capabilities beyond infectious diseases.

The io® system is a highly novel molecular diagnostic system developed initially for the ultra-rapid diagnosis of a broad range of infectious diseases. It is based on a patent-protected electrochemical sensor technology that combines speed, accuracy and low manufacturing costs.

The fully integrated cartridge contains all reagents on board and is designed to receive an unprocessed clinical specimen. The cartridge is then inserted into the reader instrument which then completes the three-stage process of sample preparation, DNA amplification and electrochemical detection. Each cartridge can carry out up to 24 different tests from a single patient sample. This new companion diagnostic collaboration is the first outside of infectious disease.

Dr John Clarkson, Chief Executive Officer of Atlas Genetics, commented: "We are delighted to be exploring this exciting new use of the io® system. Our superior multiplexing capability allows for significant future menu expansion across a range of disease indications. This new collaboration clearly demonstrates this flexibility and the wide ranging applicability of the Atlas Genetics io® system."

International Science Team Paves Way for Fast and Accurate Flu Diagnosis

Statistics indicate that, on average, adults over the age of 30 only contract the influenza virus twice in a decade – but far more frequently (self) misdiagnose a cold virus (commonly rhinovirus or coronavirus) as being the flu.

Accurately diagnosing the flu virus through testing is often considered too slow and cumbersome by many primary-care physicians, with current rapid-diagnosis pathology tests requiring up to 48 hours.

To be effective in reducing the severity of the viral infection, anti-viral medications must be started within 48 hours of symptom onset, which is inhibited by the current diagnostic methods and timelines.

Nuclear scientists at The Australian Nuclear Science and Technology Organisation (ANSTO) are working with an international team of university researchers and companies to help develop a new platform capable of rapid diagnosis.

The team have developed a diagnostic platform that is capable of delivering rapid diagnosis of influenza A, B and C strains, in as little as 5 minutes.

The team is led by Professor Jeremy Lakey from the Newcastle University in the UK, together with Orla Protein Technologies Ltd., OJ Bio Ltd., and ANSTO researchers Dr Anton Le Brun and Dr Stephen Holt.

“What we are working towards is a platform that can be coupled to a portable electronic device, to provide a rapid and accurate diagnosis of influenza,” said Dr Le Brun, Research Fellow at ANSTO’s Bragg Institute.

The rapid diagnosis technology combines specialist protein biomarkers with advanced electronics in the form of a small biochip developed by the UK-based OJ Bio.

When a patient sample is applied to the biochip, the presence of a disease antigen is translated into an electronic signal which is converted into a test result and displayed on a smartphone app or PC.

“If physicians had a tool of this nature available during outbreaks of severe strains, they would have the ability to confidently and quickly prescribe anti-virals to those who need them,” said Dr Le Brun.

“Our lab work, which involves using nuclear research instruments, has so far shown us how to assemble the molecular platforms necessary to create such a device, and in principle how it works.

“Our next steps are to convert our laboratory results into an accessible and reusable way for GPs to quickly test patients for evidence of the influenza virus as part of their treatment process.

“GPs have had access to rapid blood sugar testing devices to help in the management of diabetes for many years. Our aim is to make diagnosis and management of influenza just as simple a process.”

The development of a portable rapid diagnostics device, will significantly improve the treatment outcomes, and decrease complications suffered by those unlucky enough to contract the virus.

About the flu diagnostics device project:
  • Officially titled: ‘Engineered Self-Assembling Monolayers for Label Free Detection of Influenza Nucleoprotein’
  • The project is lead and developed by Professor Jeremy Lakey at the Newcastle University (UK) in collaboration with Dr Deepan Shah at Orla Protein Technologies Ltd and ANSTO scientists Dr Anton Le Brun and Stephen Holt.
  • The protein science and identification technology behind the project was originally developed by Professor Lakey, and has the potential to be used in the diagnosis of a wide array of infectious diseases.
  • The objective of this project is to design a platform that can be coupled to a hand held electronic device, which can provide a rapid and accurate diagnostics for suspected flu suffers. This would enable treating physicians to more easily and accurately diagnose if a patient has contracted influenza, and assess appropriately if anti-virals should be prescribed.
  • This device was designed to be an improvement on an earlier platform. The previous platform only bound a narrow range of different antibodies. This new platform is made more versatile because it binds a wider range of antibodies, expanding the scope of molecules that can potentially be detected.
  • The platform is designed to be versatile so that it can be easily modified to detect different molecules from clinical, veterinary, or environmental situations, but the target chosen for proof of concept was nucleoprotein from the influenza virus.
  • The development of the surface coating technology led to a collaborative development with OJ-Bio Ltd. – a company that develops hand-held electronic biosensors.
  • The current gold standard for diagnosis of influenza includes culturing the virus, and carrying out an immunoassay – which can take up to ten days. Whilst there are methodologies with fast result times (as fast as a couple of hours) these require a specially equipped lab and highly trained technicians.
  • Australian scientists developed the world’s first effective anti-viral influenza treatment, Relenza.
  • A course of anti-viral treatment (with Relenza or with other subsequently developed anti-virals) must be started within 48 hours of the onset of symptoms to be effective in reducing the severity of the viral infection. Prescription of these medications has therefore been limited because of the average time taken to diagnose the virus using current methodologies.

Flexible Polyester-Paper Biosensing Platform Performs Cheap, Rapid Diagnostics

An in vitro diagnostic (IVD) biosensing platform that integrates cellulose paper and flexible polyester film could be used remotely to detect and determine treatment for a range of bacterial conditions without the need for expensive infrastructure or skilled personnel. The device can be used to identify HIV, E. coli, Staphylococcus aureas and other bacteria from a single drop of blood. A compatible app that detects bacteria and disease in the blood using images from a smartphone also has been developed. The technology has the potential to solve pressing healthcare problems in developed as well as developing countries, say the researchers.

In an article published in Nature Scientific Reports, titled "Paper and Flexible Substrates as Materials for Biosensing Platforms to Detect Multiple Biotargets," researchers from Florida Atlantic University (FAU; Boca Raton, FL) and their collaborators explain how the integrated cellulose and flexible polyester film technology can address the limitations of current paper and flexible material–based platforms in diagnostic applications.

Using paper and flexible substrates as materials for biosensors, the researchers have identified a rapid and cost-effective way to diagnose diseases and monitor treatment in point-of-care settings. They have been able to show how their new platforms are uniquely able to isolate and detect multiple biotargets selectively, sensitively and repeatedly from diverse biological media using antibodies.

"There is a dire need for robust, portable, disposable and inexpensive biosensing platforms for clinical care, especially in developing countries with limited resources," said Waseem Asghar, PhD, assistant professor of electrical engineering in the College of Engineering and Computer Science at FAU, one of the authors of the paper.

Existing paper and flexible material-based platforms use colorimetric, fluorometric and electrochemical approaches that require complex labeling steps, are costly to fabricate and require expensive equipment and infrastructure.

Asghar notes that because the materials in their platform are easy to make, easy to use, and can easily and safely be disposed of by burning, they can be used to develop affordable tools with applications in drug development, food safety, environmental monitoring, veterinary medicine and infectious disease diagnostics in developing countries.

"Our paper microchip technologies can potentially have a significant impact on infectious-disease management in low- and middle-income countries where there is limited laboratory infrastructure," added co-first author Hadi Shafiee, PhD, instructor in medicine at the Division of Biomedical Engineering at Brigham and Women's Hospital, Harvard Medical School.

Friday, April 10, 2015

NIH Funds Nine Projects for Rapid Detection of Antimicrobial-Resistant Bacteria

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has awarded more than $11 million in first-year funding for nine research projects supporting enhanced diagnostics to rapidly detect antimicrobial-resistant bacteria. The awardee institutions will develop tools to identify certain pathogens that frequently cause infections in health care settings and, specifically, those that are resistant to most antimicrobials. Advancing the development of rapid and innovative diagnostic tests for identifying and characterizing resistant bacteria is a key goal of the President’s recent National Action Plan for Combating Antibiotic-Resistant Bacteria.

Antimicrobials have been used to successfully treat patients for more than 70 years, but the drugs have become less effective as organisms adapt to the drugs designed to kill them. Each year in the United States, more than 2 million people develop antibiotic-resistant infections and at least 23,000 people die as a result, according to the U.S. Centers for Disease Control and Prevention. Antibiotic-resistant infections also contribute to rising health care costs due to the need for more expensive treatments and prolonged hospital stays.

“Antimicrobial resistance is a serious global health threat that is undermining our ability to effectively detect, treat and prevent infections,” said NIAID Director Anthony S. Fauci, M.D. “One way we can combat drug resistance is by developing enhanced diagnostic tests that rapidly identify the bacteria causing an infection and their susceptibility to various antimicrobials. This will help physicians determine the most effective treatments for infected individuals and thereby reduce the use of broad-spectrum antibiotics that can contribute to the drug resistance problem.”

Each of the institutions receiving the NIAID awards will develop a diagnostic tool that identifies and provides corresponding antibiotic susceptibility information for one or more of the following bacteria: Klebsiella pneumonia; Acinetobacter baumannii; Pseudomonas aeruginosa; Enterobacter species; and Escherichia coli. The current process for diagnosing some bacterial infections can take up to three days and requires patient samples to be sent to labs where the suspected bacteria is cultured, or grown in a special medium. To make this process more rapid and efficient, diagnostic tools developed by these institutions must provide results in three hours or less and be culture-independent (able to directly detect the specified pathogen from typically sterile sites, such as blood, cerebrospinal fluid or the fluid surrounding the lungs).

The NIAID awards were made to three companies and six academic organizations. Each academic organization partnered with an industrial institution with demonstrated experience in product development to be eligible for the award. The list of recipients includes:

BioFire Diagnostics, LLC, Salt Lake City
Project Name: FilmArray Direct: Rapid Diagnosis of Antimicrobial-Resistant Pathogens from Blood
Principal Investigators: Andrew Hemmert, Ph.D., and Wendy Smith, Ph.D., BioFire Diagnostics, LLC
Grant: 1 R01 AI117035-01

Brigham Young University, Provo, Utah
Project Name: Multiplexed, Non-Amplified, Nucleic Acid-Based Identification of Multidrug Resistant Pathogens Using an Integrated Optofluidic Platform
Principal Investigator: Aaron R. Hawkins, Ph.D., Brigham Young University
Co-principal Investigators: William Pitt, Ph.D., Richard Robison, Ph.D., and Adam Woolley, Ph.D., Brigham Young University; Holger Schmidt, Ph.D., University of California, Santa Cruz; Robert Jenison, Great Basin Corporation; and Larry Rea, Great Basin Corporation
Grant: 1 R01 AI116989-01

Denver Health and Hospital Authority
Project Name: Ultrarapid Culture-Independent Detection of High-Priority Carbapenem Resistant Enterobacteriaceae Directly from Blood
Principal Investigator: Connie Savor Price, M.D., Denver Health and Hospital Authority
Co-principal Investigator: Steve Metzger, Accelerate Diagnostics
Grant: 1 R01 AI116993-01

First Light Biosciences, Inc., Bedford, Massachusetts
Project Name: Rapid Detection of Pathogens and Antimicrobial Susceptibility Directly in Patient Samples
Principal Investigators: Don Straus, Ph.D., and Sadanand Gite, Ph.D., First Light Biosciences, Inc.
Grant: 1 R01 AI117058-01

GeneFluidics, Inc., Irwindale, California
Project Name: A Fully Integrated CentriFluidic System for Direct Bloodstream Infection PID/AST
Principal Investigator: Vincent Gau, Ph.D., GeneFluidics
Grant: 1 R01 AI117059-01

Johns Hopkins University, Baltimore
Project Name: A Droplet-Based Single Cell Platform for Pathogen Identification and AST
Principal Investigator: Tza-Huei (Jeff) Wang, Ph.D., Johns Hopkins University
Co-principal Investigator: Joseph C. Liao, M.D., Stanford University School of Medicine
Grant: 1 R01 AI117032-01

The Broad Institute of MIT and Harvard, Cambridge, Massachusetts
Project Name: RNA-Based Diagnostics for Rapid Pathogen Identification and Drug Resistance
Principal Investigator: Deborah T. Hung, M.D., Ph.D., the Broad Institute
Grant: 1 R01 AI117043-01

University of California, Berkeley
Project Name: Consortium for Drug-Resistant Gram-Negative Pathogen Detection
Principal Investigators: Lee W. Riley, M.D., Luke P. Lee, Ph.D., and Niren Murthy, Ph.D., University of California, Berkeley
Grant: 1 R01 AI117064-01

University of California, Irvine
Project Name: Integrated Comprehensive Droplet Digital Detection (IC 3D) System for Rapid Detection of Bacteria and Antimicrobial Resistance
Principal Investigator: Weian Zhao, Ph.D., University of California, Irvine
Grant: 1 R01 AI117061-01

NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available at http://www.niaid.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

Silicon Chip Detects Dangerous Pathogens in Human Blood

Scientists in China have developed a silicon chip doped with silver nanoparticles that can rapidly detect different pathogens in blood samples. The technique may be a rapid and low-cost alternative to current diagnostic tools.

There are growing concerns within the medical community over the emerging threat of resistant pathogens that, if left unchecked, could lead to the premature death of 300 million people by 2050. With only one new potential class of antibiotic discovered in the past 25 years, some research groups are now investing funds into pre-emptive diagnosis strategies in an attempt to prevent a global health crisis.

‘[The] rapid, sensitive and low-cost detection of different pathogenic bacteria in clinical samples [is essential] in preventing … many serious diseases caused by bacterial infections,’ says Yao He from Soochow University in China.

Although there are currently several detection tools available to researchers, the technology cannot keep pace with the community’s need to diagnose patients quickly. He explains that complex biochemical analyses are time-consuming and can suffer from ‘relatively poor sensitivity’.

Surface-enhanced Raman scattering (SERS) may provide a solution to these problems. SERS can distinguish between different molecules by analysing how photons ricochet off them to produce a unique ‘fingerprint’, and the technique has already been successfully applied in clinical studies in the past few years. But it’s been limited in its scope, according to He. ‘SERS methods only focus on the detection of bacteria itself,’ he argues. ‘For the real application of SERS detection of tiny bacteria in clinical samples, it is necessary to develop a highly efficient multifunctional platform.’

He and his colleagues created such a device by embedding silver nanoparticles into a silicon wafer. In order to capture a range of bacteria effectively, the team further modified the chip by anchoring 4-mercaptophenylboronic acid (4-MPBA) – a common bacteria-binding agent – to the surface.

Human blood spiked with Escherichia coli or Staphylococcus aureus was deposited onto the chip to determine whether SERS could distinguish between the harmful pathogens and surrounding blood cells. The researchers found that the SERS chip could detect both pathogens down to concentrations of a few hundred colony-forming units per millilitre. Following detection, the chip killed the bacteria through the slow release of silver anions from the surface.

‘It’s basically discriminating a needle in a haystack – the very low concentration of your target versus the huge amount of interfering molecules,’ says Philip Howes from Imperial College London, UK. Howes comments that demonstrating this technology can work for a ‘complicated biological milieu’ rather than simply a buffer solution is ‘massive’. ‘Work like this [where] they show their chip maintains its high performance [with] human blood is a fantastic demonstration of their technology.’

But he is quick to add that the SERS chip isn’t unrivalled in the field and the technology will need further development before being used in a clinical setting. ‘A really interesting next step is to be able to say:  “Can we apply this to actual clinical samples?” – looking at patients with bacterial infections,’ Howes says.

Reference:  Simultaneous Capture, Detection, and Inactivation of Bacteria as Enabled by a Surface-Enhanced Raman Scattering Multifunctional Chip. H Wang et al, Angew. Chem. Int. Ed., 2015

Thursday, April 09, 2015

Biocartis and Microbiome to Develop Rapid and Sensitive Sepsis Test

Biocartis, an innovative molecular diagnostics company, and Microbiome, a spin-off of the VU University Medical Center Amsterdam, today announced to have entered into a worldwide license and collaboration agreement for the development of an integrated multiplex real-time PCR assay for rapid detection of bloodstream infections.

Under the terms of the collaboration and license agreement, Microbiome’s multiplex PCR assay for identification of sepsis-causing microorganisms will be further developed as an integrated multiplex real-time PCR assay on Biocartis’ Idylla™ platform for use in conjunction with a new platform under development by Biocartis, called Idylla™-Enrich. Financial details of the agreement are not disclosed.

Idylla™-Enrich is a dedicated pre-enrichment platform for bloodstream infections. Rudi Pauwels, Chief Executive Officer of Biocartis, commented: “Molecular diagnostics for bloodstream infections pose a classical needle-in-a-haystack problem; the vast excess of human DNA limits the amount of blood sample that can be used in a pathogen specific molecular analysis. The ability of our Idylla™-Enrich platform to selectively enrich pathogen DNA from 10 ml of whole blood represents an enormous breakthrough in sensitivity as low pathogen concentrations down to 1 colony-forming unit (CFU)/ml can now be detected.”

The Idylla™-Enrich method has extensively been tested as part of the largest sepsis study in Europe to date comprising almost 7,500 clinical samples.[1] Biocartis will further develop the platform and plans to launch it for use in conjunction with the pathogen identification test licensed from Microbiome as a streamlined solution for the diagnosis of bloodstream infections.

Sepsis occurs when the body’s response to an infection spirals out of control and can progress to severe sepsis or septic shock, with a mortality rate of nearly 50% in the event of severe sepsis[2]. Almost 30 million patients per year worldwide encounter a septic episode.[3]

There is evidence that a delay in the treatment of a patient with sepsis increases mortality by 7.6% per hour in the first six hours[4]. These figures call for a faster and more accurate diagnosis. When diagnosing sepsis or bloodstream infections, typically a blood sample of the patient is analyzed for the presence of pathogens. Today’s gold standard approach to detect the pathogens is blood culture which typically takes 24-48 hours for bacteria and even 5 days for fungi, which considerably delays a targeted therapy and contributes to high sepsis mortality.

By combining the enrichment with a multiplex PCR assay on the Idylla™ platform it is possible to identify pathogens in bloodstream infections much faster, reducing current approaches of 24-48 hours to as little as 2 hours.

Paul Savelkoul, Chief Executive Officer of Microbiome, commented: “The combination of rapid and highly sensitive identification of bloodstream pathogens with a panel of key antimicrobial resistance genes will have a major impact on clinical practice. This assay will enable clinicians for the first time to initiate optimal treatment within hours instead of days after admission of a patient. As a spin-off of a medical center, Microbiome builds on extensive clinical experience. Combined with Biocartis’ technology, we feel we are creating the optimal clinical sepsis test.”

Prof. Jean-Louis Vincent, Professor of Intensive Care Medicine (University of Brussels) and a key opinion leader in the field of sepsis management commented, “Early and adequate antimicrobial therapy is of paramount importance in the management of severe infections. There is a real unmet clinical need for tests providing rapid identification of microorganisms so that appropriate antibiotics can be started as soon as possible.”

[1] The Molecular Diagnosis and Risk Stratification of Sepsis (MARS) study was conducted and funded under the framework of the CTMM (Center for Translational Molecular Medicine, The Netherlands) from 2010-2015.
[2] Jawad et al., J Glob Health (2012); 2: 010404
[3] 2015 World Sepsis Day Factsheet by Global Sepsis Alliance
[4] Kumar et al., Crit Care Med. (2006);34:1589-96

Wednesday, April 08, 2015

New Grant Funds MALDI Bacterial Library to Aid Diagnosis

Faculty members from the University of Maryland Schools of Pharmacy and Dentistry have received a $1.1 million grant from the National Institute of General Medical Services  at the National Institutes of Health  to create a bacterial library using mass spectrometry technology. The library, being developed by David Goodlett, PhD, the Isaac E. Emerson Chair of Pharmaceutical Sciences at the School of Pharmacy and Robert Ernst, PhD, an associate professor in the Department of Microbial Pathogenesis at the School of Dentistry, will allow physicians to more quickly and accurately identify a patient’s infection, leading to more accurate and quicker treatment.

“Rapid and accurate pathogen detection and identification is sorely needed in hospitals and clinics to allow physicians to react and respond appropriately to potentially life threatening infections,” says Goodlett, who is also director of the School of Pharmacy’s Mass Spectrometry Center. “So often we hear about patients who were given antibiotics for an infection that wasn’t properly diagnosed because of limitations with the diagnostic process. Antibiotics can be damaging to the kidneys and the bone and can lead to issues with antibiotic resistance, so we want to improve upon existing diagnostic tests in order to improve treatment.”

The current methods for diagnosing bacterial infections that are approved by the Food and Drug Administration include biological culture, nucleic acid amplification, ribosomal protein sequence characterization, and genome sequencing. “Collectively, these methods are slow, require amplification of clinically-obtained material, and are often significantly expensive and burdensome for diagnostic laboratory staff,” says Ernst. “Our study aims to create a library of chemically barcoded bacteria that can be checked to determine which infection a patient has. This will ultimately be faster, cheaper, and more accurate.”

In order to improve the rapid and accurate diagnosis of bacterial infections, Goodlett and Ernst will use a mass spectrometry technique called matrix-assisted laser desorption ionization, or MALDI. “Through this study, we will develop, refine, and use ultra-small scale purification methodologies for the extraction of essential, high abundance lipids from Gram-positive and –negative bacteria, as well as fungi,” says Goodlett. “These lipids are found in all membranes of microbes and are a highly diverse set of molecules. This diversity forms the basis of our hypothesis that essential bacterial and fungal lipids constitute a chemical barcode that can be used to identify pathogens by mass spectrometry profiling.”

Goodlett’s and Ernst’s preliminary data show that these lipid structures are unique and can be used as novel chemical barcodes for the identification of bacterial and fungal infections and resistance patterns to a subset of antibiotic and antimicrobial peptides. “Lipids will be analyzed by mass spectrometry with the results used to generate a mass spectral signature library of lipid ‘fingerprints’ from a wide variety of clinically-relevant pathogens,” says Ernst. “The combined analysis of the protein and the lipid will provide a greater than 99 percent accuracy level in identifying bacteria from a variety of human samples.”

“The methods Drs. Goodlett and Ernst are developing will change how infections are diagnosed in clinics, dropping the time it takes from days to hours,” says Andrew Coop, PhD, professor and chair of the Department of Pharmaceutical Sciences at the School of Pharmacy. “Their collective expertise in infectious diseases and mass spectrometry, combined with the extensive resources of the Mass Spectrometry Center, will translate into improvements in patient care.”

In order to translate the technology fueling the bacterial library concept into commercially available products that benefit patients, Goodlett and Ernst are working with the University of Maryland, Baltimore’s (UMB) Office of Technology Transfer to identify companies interested in developing the needed software for the project and to assist with the development of assays to detect the bacteria.

"Our office is very excited about this technology," said Phil Robilotto, assistant vice president of the Office of Technology Transfer at UMB and chief commercialization officer for UM Ventures. "Drs. Goodlett and Ernst are developing a truly novel point-of-care pathogen identification product. The BacLib detection system's speed and ability to utilize clinical samples without culture makes the system extremely promising from both a patient care and commercial perspective."

T2 Biosystems Candida Panel for Sepsis Demonstrates Significant Cost and Survival Benefits

T2 Biosystems, Inc., a company developing innovative diagnostic products to improve patient health, today announced that results from an analysis on the impact of using the company's T2Candida® Panel were published in Future Microbiology. The study, conducted by IMS Health, found that in a 500-bed hospital with an average of 5,100 symptomatic patients at high risk for developing a Candida infection, early detection with the utilization of T2Candida could provide an annual cost savings of approximately $5.8 million and the prevention of 60 percent of Candida-related deaths.

"We believe these data are extremely compelling and highlight the potentially meaningful benefits of early detection of Candida with our T2Candida Panel – including significantly reducing hospital costs, and more importantly, saving so many patient lives," said John McDonough, chief executive officer of T2 Biosystems. "The findings from this study support our goal of changing the paradigm in sepsis diagnosis, and we look forward to the opportunity to help implement this important change for patients, physicians and hospital administrators."

The study evaluated cost-effectiveness and the impact to hospital budgets using a decision tree model. The model calculated the economic effect of adopting a T2Candida diagnostic strategy over one year in a hospital setting. Key findings included:
  • A typical 500 bed hospital with 5,100 annual high-risk patients could save as much as $5,858,448 annually. This reflects a cost savings of $1,149 per patient tested and a positive return on investment in less than one month.
  • In all scenarios tested, even the most conservative, the T2Candida Panel delivered significant cost savings, with the lowest potential outcome being $4 million in savings.
  • There were cost savings for patients who tested both positive and negative for Candida. Early detection allowed for timely, accurate treatment as necessary, and cost avoidance when not needed.
  • Rapid detection avoided 31.7 patient deaths, or a reduction of 60.6 percent Candida-related deaths per hospital.
"Given the increasing demand for efficiency and improved outcomes in the hospital setting, it is critically important to understand the potential for a new product to both positively impact patient care, as well as budgets," said Julie Munakata, senior principal at IMS Health. "At IMS, we perform many independent analyses and rarely do we see both cost savings and mortality prevention from new products."

FDA Approves Alere's Rapid Strep A Molecular Test

The US Food and Drug Administration (FDA) has granted marketing clearance to Alere Inc's Alere i Strep A test. Alere i Strep A is the first molecular test that detects Group A Streptococcus (GAS) bacteria in throat swab specimens in 8 minutes or less.

Upon receipt of this clearance from the FDA, Alere submitted an application for CLIA (Clinical Laboratory Improvement Amendments) waiver of the Alere i Strep A test. Other assays currently in development on the Alere i platform include respiratory syncytial virus (RSV), C. difficile and chlamydia/gonorrhoea.

"This FDA clearance brings the power of our Alere i molecular platform to the detection of Strep A. The speed and accuracy of the Alere i Strep A test empower healthcare professionals to initiate the right treatment in an actionable timeframe, which is a critical step in reducing unnecessary prescription of antibiotics and enhancing operational efficiency," said Avi Pelossof, global president of infectious disease at Alere.

The Alere i molecular platform was initially cleared for marketing by the FDA for the detection and differentiation of influenza A and B virus in June 2014. In January 2015, Alere i Influenza A & B became the first-ever molecular test to receive CLIA waiver, which allows for broad use by healthcare providers, ranging from hospitals and physician offices to clinics and other healthcare settings. Expanding the menu on the Alere i platform to include Strep A and potentially other assays increases the utility of the platform for a wider range of users. Furthermore, given the less seasonal nature of Strep A, its addition enhances the value of the platform for users on a year-round basis.

Alere i Strep A detects Group A Streptococcus (GAS) bacteria in throat swab specimens using Alere's proprietary Molecular In Minutes (MIM) isothermal nucleic acid amplification technology (iNAT). Unlike polymerase chain reaction (PCR) tests, iNAT does not require lengthy and complex thermocycling or DNA purification and can therefore deliver PCR-caliber results more quickly – and in a broad range of settings.

The clinical performance of Alere i Strep A was established in a multi-center study conducted in the US, in which 481 throat swab specimens were evaluated with Alere i and compared to standard bacterial culture. The overall sensitivity and specificity of the Alere i Strep A was 95.9% (141/147; 95% CI=91.4%, 98.1%) and 94.6% (316/334; 95% CI=91.6%, 96.6%), respectively. All samples generating discordant results between Alere i Strep A and bacterial culture were evaluated by a laboratory developed real-time PCR assay. Of the 6 samples negative by Alere i Strep A and positive by bacterial culture, 4 were also negative for Group A Strep by the real-time PCR assay. Of the 18 samples positive by Alere i Strep A and negative by bacterial culture, 13 were also positive for Group A Strep by the real-time PCR assay.

Group A Streptococcus (Group A Strep, or GAS) bacteria spread through contact with droplets from an infected person's cough or sneeze, and live in a person's nose and throat. Most GAS infections cause relatively mild (noninvasive) illnesses such as strep throat, scarlet fever, and impetigo (a skin infection). More than 10 million non-invasive GAS infections (primarily throat and superficial skin infections) occur annually in the US. Occasionally, these bacteria can cause severe and even life-threatening (invasive) diseases. Cases of invasive GAS infections, such as necrotizing fasciitis and streptococcal toxic shock syndrome, occur less frequently but are associated with higher rates of deaths.

Because Knowing now matters, Alere delivers reliable and actionable information through rapid diagnostic tests, resulting in better clinical and economic healthcare outcomes globally. Headquartered in Waltham, Mass., Alere focuses on rapid diagnostics for infectious disease, cardiometabolic disease and toxicology.

Tuesday, April 07, 2015

Diagnostics Direct Launches CLIA Waived Syphilis Health Check

Diagnostics Direct, LLC., a leading provider of in-office diagnostic tests, is pleased to announce the launch of the first CLIA-Waived rapid treponemal syphilis test: Syphilis Health Check™. The U.S. Food and Drug Administration granted the first-ever waiver, under certain laboratory regulations, for a rapid screening test for syphilis to Diagnostics Direct for their Syphilis Health Check test for use in a greater variety of health care settings.

"The U.S. Centers for Disease Control and Prevention (CDC), estimates that there are approximately 55,000 reported cases in the United States annually; our CLIA approved diagnostic test, Syphilis Health Check, can provide effective screening that should contribute to a higher rate of detection," states Jeff Tobias, VP Sales & Marketing at Diagnostics Direct, LLC. He continues: "Syphilis Health Check is performed by using a sample of whole blood from a finger stick with results available in as little as 12 minutes. The test can be performed while the patient is in the office. If a patient tests positive with Syphilis Health Check, the health care provider can immediately obtain a second sample during the same visit for a confirmatory test using traditional nontreponemal testing."

With the issuance of the CLIA waiver, Syphilis Health Check can be used by more healthcare providers, including untrained health care workers. Each Syphilis Health Check test kit contains everything required to conduct 20 tests including: 20 test devices; 20 fixed volume plastic pipettes; Diluent in a dropper bottle containing saline buffer, detergent and sodium azide (NaN3< 0.1%) - 5 ml; Package Insert Instructions and a Quick Reference Guide.

handyem Introduces HPC-150 Personal Cytometer

handyem Inc., a manufacturer of personal and portable flow cytometers announces the commercial launch of the HPC-150 personal cytometer for life science research, bioprocessing, water quality and many other applications.

The HPC-150 flow cytometer from handyem is portable and rugged. Its reliable fiber-optics flow cell eliminates the need for periodic laser alignment and reduces by an order of magnitude the amount of sheath fluid normally required by conventional flow cytometers. The cytometer has excellent particle counting capabilities and displays scattering resolution suitable for conducting measurement of cells and particles from 0.5 to 40 μm. The product is available in the following configurations: dual-laser red (638 nm) and blue (488 nm), single-laser green (532 nm) or blue (488 nm) and with up to four optical filter colors and six parameters.

“We are proud to offer this new product with enhanced performance and additional modalities compared to its predecessor” says Alain Chandonnet, president and CEO of handyem. “The HPC-150 offers all the flexibility of conventional cytometers, but brings ease-of-use and affordability which contributes directly to our mission to democratize cytometry.”

FiberFlowFluidicsTM, the technology at the core of handyem Personal Cytometry (HPC) platform, uses fiber optics to guide the light beam from the laser to the small interrogation area to ensure consistent excitation of the cells or particles flowing through a microchannel in the collection fiber. The laser beam delivery fiber, the forward scatter (FSC) and side scatter (SSC) collection fibers are bound in a monolithic assembly – the microfluidic flow cell chip– which is impervious to vibrations and misalignment. This allows the user to move or carry the HPC instruments without concern of losing laser beam alignment – hence avoiding a costly and time consuming adjustment often required on traditional flow cytometers.