Swiss Firm, May & Baker Partner on Rapid Genetic Test for Ebola

As Ebola seems to have taken a pandemic toll, a group of Nigerian scientists in Diaspora have been able to validate and adapt a widely published methodology for gene amplification in 30 minutes.

Unlike the current widely used method of detecting Ebola Virus genes called RT-PCR (Reverse Transcription – Polymerase Chain Reaction), which requires about four to six hours of tedious laboratory procedures from sample decontamination to RNA extraction to gene amplification monitored in real time or confirmed from gel-electrophoresis; the Bio-innovation method excludes all those long processes to proceed with gene amplification in just one step at a single temperature.  With the use of a water bath or a dry heating block, the Bio-innovation method for the detection of Ebola viral genes in a sample can be achieved in resource-limited laboratories in Africa.

Nigeria has successfully contained its Ebola outbreak since it began in July 2014 – where a traveler from Liberia arrived the country already symptomatic. It led to a total of twenty cases, eight deaths and twelve discharges – among them were people who survived the disease and are now immune against it. Nigeria has not had any new case since September, 2012 and is now being officially declared Ebola free on 20th October, 2014 by the World Health Organisation (WHO).

However the epidemic still persists in other West African countries including Liberia, Guinea and Sierra-Leone where the death toll has cumulatively risen to more than four thousand. It is being estimated that the death toll due to Ebola Virus Disease may hit a few millions in early 2015 if not contained in time at those hot zones.

Some of the reasons for Nigeria’s success at containing the Ebola Virus Disease Outbreak among others were attributed to strict adherence to public health protocols on contact tracing and monitoring – and readily available diagnostic points coordinated by two reference laboratories which are situated in academic institutions – LUTH (Lagos University Teaching Hospital) and RUN (Redeemers University) respectively. These institutions were able to provide provisional diagnosis by the current gold standard – the RT-PCR method. Though it is such a tedious time-consuming laboratory process, suspected subjects were still being assessed and kept under surveillance through the period of the outbreak in Nigeria.

However, since the outbreak still persists in other West African countries; Nigeria and the rest of Africa may still be at risk - from seemingly innocent asymptomatic subjects that may slip through the ports of entry undetected – just like the case currently being encountered in the USA. The current bio-surveillance measures utilize a questionnaire-based screening tool and a non-contact temperature check to track the onset of symptoms typical for Ebola Virus Disease.    

While the questionnaire-based screening tool is prone to deliberate human errors and a temperature check can only figure out a symptomatic patient at the onset of a high fever; a repeat of the outbreak may be easily replicated at all clear zones in Africa and beyond. But with a rapid genetic test at all ports of entries, all potential – even yet to be symptomatic cases at some points – may be figured out and referred to isolation units for further observation and treatment. Such is the rapid genetic test currently being adapted by some Nigerian scientists.

A group of Nigerian scientists led by Olumide Adenmosun – an alumni of Florida Atlantic University, USA and currently a visiting associate lecturer to Bowen University, Nigeria – is coordinating technical support for the ongoing clinical and research program in Nigeria – together with some other Nigerian scientists and health groups largely involved in the containment of Nigeria’s Ebola outbreak. Olumide has been collaborating with Bioinnovation Solutions, Switzerland – a medical diagnostic company led by Dr. Yemi Adesokan, a Harvard trained scientist – to develop the right testing solution that can be adapted for Nigeria and the rest of West Africa.

In September of this year, Dr. Adesokan jointly with the US Army Medical Research Institute of Infectious Diseases (USAMRIID) also published a study in PLOS One journal – using genetic sequencing based technologies for the detection of Ebola and Marburg viruses.

With a strong technical support team on ground – the Bioinnovation rapid genetic tests are being proposed for use at all ports of entry and equally at secondary and tertiary health care institutions to keep up with biosurveillance especially during this period of the year when cross-border travel peaks.

Each test kit will be able to run 48 samples quite easily with no need for expert training or acquisition of next-gen sequencing or amplification equipment. The access point for the test kits in Nigeria will be through May & Baker – in the coming weeks.   This exciting collaboration involving Nigerian scientists will truly help Nigeria #ToRemainEbolaFree.

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Canadian Company Develops 60-Second Ebola Testing Kit

bioLytical Laboratories, a world leader in rapid infectious disease diagnostic tests, has successfully developed a pre-clinical prototype diagnostic test for the rapid detection of antibodies to the Ebola Zaire strain responsible for the current outbreak in West Africa.

The prototype is based upon the Company's proven, accurate, and highly accepted INSTI rapid test platform, which is capable of providing results in as little as 60 seconds.

"We are very excited about what our research and development team has been able to accomplish in such a short period of time," says bioLytical's Chief Executive Officer Dr. Christopher Shackleton.

"There is clearly a pressing need for a diagnostic test that can rapidly and accurately detect the presence of this potentially deadly infection as early as possible and in diverse testing environments. We also believe that the speed of our INSTI platform will offer considerable advantages as compared to slower point-of-care assays when it comes to the screening of large numbers of subjects in the field as well as in those settings where time is a significant constraint such as travel points of entry."

bioLytical Chairman Robert Mackie adds, "This test is a significant step forward in the battle to contain the current Ebola epidemic, and bioLytical is continuing to work with international authorities to ensure that we're contributing to the containment efforts."

bioLytical Laboratories is a privately owned Canadian biotechnology company engaged in the development and manufacture point-of-care rapid diagnostic tests.  Its flagship product is the 60-second INSTI™ HIV1/HIV2 antibody test - the world's fastest.

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South Bend, IN Company Developing Rapid Ebola Detection

It was just a few days ago that New Jersey Governor Chris Christine made his stance clear on anyone who's traveled to western Africa; quarantine for 21 days. The decision put the governor under fire but a company here in South Bend might be able to come to the rescue. They have a device, called NESDEP IU, which can identify whether a sample has Ebola or not.

"We know we can test for any molecular material," Les Ivey, President and CEO of F³ said. "Ebola is an RNA virus so it has a strand of RNA and we can detect that. The job of our NESDEP device is to extract that RNA from the virus. If it matches with the Ebola then we know we had a successful detection."

The device is encased in a large box that was originally built for military purposes...rocket launchers to be precise. It's pretty big at about 50 pounds, but not huge, making mobility it's greatest asset. That way it could be easily taken to an airport or even in the back of a military vehicle to take to an area of western Africa.

"We designed the unit so, if it had to be, it could be floated out to Lake Michigan for a sample," Ivey said. "It can be battery powered and it's suitable for places like an airport or put it in the back of a Humvee so you can take it to places people could have contracted Ebola and making treatment easier."

NESDEP IU wasn't designed to identify Ebola specifically, but it very well could. The device is a screening tool to test contaminated materials to see if a virus is present. So if you have a sample, the device essentially beats the cellular material until there's nothing left but molecular material in the RNA. It then compares that information to data placed on a bio-chip to see if they match up. If they do, then the sample is identified as a match. F³ has used the device to identify issues in the environment, like contaminated water, or for food safety.

"We have two E. coli tests available for drinking water," Ivey said. "We have three for food safety including listeria, salmonella and E. coli."

They are also conducting clinical trials on the devices ability to identify Methicillin-resistant Staphylococcus aureus (MRSA). The theory is since they can test for any molecular material, identifying an infection like MRSA or a virus like Ebola should be easy.

The beauty of NESDEP is in its speed. The CDC says identifying a contaminated sample of Ebola can take anywhere from 12 to 48 hours. Ivey says NESDEP can identify a contaminated sample in just 90 minutes. However, NESDEP is not approved for diagnosing individuals. It can only take samples from things like a blanket or fluids excreted from a person believed to be affected and test those. This process could save valuable time in the treatment process of a person with Ebola.

"If you were in a transportation hub with many aircraft and two or three of them have possible infected individuals, you want to take those people and get them through the process as quickly as possible," Ivey said. "Otherwise, you have thousands and thousands of people exposed. From a medical point of view, the faster a clinician knows someone is sick, the faster they can act. Twelve hours, especially in an RNA virus like Ebola, could mean the difference between a good outcome and a bad outcome from what we've read."

Also, if NESDEP is taken to areas of western Africa, where sterile conditions may not be available, they can do the test with "dirty" samples. Meaning they don't need to go through the a lengthy process of purifying the sample.

"Imagine a river flowing fast," Shaunasee Kocen, Director of biology and bio-safety officer at F³ said. "Only things that can attach to that rock or that probe are going to stay there. Everything else will wash away. If you look at a human sample, it shouldn't have any bacteria or viruses. But if it does, we want to make sure we wash everything out to get a clean signal. Other technologies like polymerase chain reaction (PCR), you have to get a biologist, someone trained to do this in a clean lab in a clean room. Everything has to be very clean and precise to get what they want. We just put it in our chip and wash away all the impurities."

But in order for F³ to continue their studies, they need more Ebola information. They are not in need of the actual virus to do their studies. They are not equipped to handle a level four bio-hazard like Ebola at their facility in South Bend. So they've reached out to local state representatives and Senator Joe Donnelly's office had this to say:

"Senator Donnelly's office is encouraged that Hoosier companies are using their skills and expertise to try and prevent the spread of the Ebola virus. The senator's office has directed F³ to contact the CDC to see if their technology might be able to help address this epidemic."

And among the other benefits of NESDEP, anyone can use it.

"It's easy enough that anyone can do it," Kocen said. "It's portable and it can go into the field. We've spent so much time shipping our samples to the lab so as long as you can get a car charger and a car, then you can get our sample. If you can use a luer lock than you can use our device."

This technology is relatively new and comes with a price. Each NESDEP device costs $50,000 and each testing kit can cost between $20-$50. However, Ivey doesn't think you can put a price on rapid detection.

"There's no medications or vaccines proven to be effective," Ivey said. "It's important to identify immediately and begin the process of treating the patient as soon as possible. The reason for a rapid test process is to diagnose the presence of the virus and begin the process of treating the patient."

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Chembio and Integrated BioTherapeutics to Develop Ebola Diagnostic Tests

Chembio Diagnostics, Inc. (CEMI) today announced that it has entered into an exclusive agreement with Integrated BioTherapeutics, Inc. (IBT), a biotechnology company focused on the discovery of novel vaccines and therapeutics for emerging infectious diseases. Under the terms of the agreement, Chembio will combine its patented DPP® technology with IBT's proprietary Ebola reagents to develop POC diagnostic tests for Ebola and febrile illness. Chembio will have exclusive rights to any POC product developed through this agreement. Financial terms of the agreement were not disclosed.

While Ebola has caused multiple outbreaks since 1976, the frequency of epidemics in the past 15 years has drastically increased and the current outbreak in West Africa has reached unprecedented dimensions. Over 10,000 people have been infected with Ebola and recent cases outside the African continent are drawing concern from public health officials. Currently, the diagnosis of Ebola hemorrhagic fever can only be performed in specialized laboratories. This limitation significantly delays the identification and isolation of the patients who have Ebola and in turn likely makes it more difficult to control an outbreak or prevent new epidemics.

Javan Esfandiari, Chembio's Chief Science & Technology Officer and the inventor of Chembio's DPP® technology, commented, "We are pleased to partner with IBT, a biotechnology company with extensive experience and a substantial number of reagents for Ebola and other filoviruses, to develop a DPP® Ebola assay. In 2013, we partnered with the U.S. Government to develop a multiplex POC febrile illness assay which, in 20 minutes, can detect antigens from five different viruses, bacteria, and parasites with a single, finger-stick drop of blood. The resulting product, DPP® Febrile Illness Assay, is currently in clinical trials in several countries, including the region of West Africa. Our intent is to develop a stand-alone POC DPP® Ebola test and also include an Ebola test as part of our existing multiplex DPP® Febrile Illness Assay."

John Sperzel, Chembio's Chief Executive Officer, commented, "The partnership with IBT is a significant step in our continued efforts to expand Chembio's POC infectious disease portfolio. Our prior success developing the multiplex DPP® Febrile Illness Assay demonstrates Chembio's ability to create such tests in a short amount of time, and we believe this partnership illustrates the value that our DPP® technology brings to the broader diagnostic market. Through this agreement, Chembio's goal is to further develop innovative, sensitive and specific POC diagnostic tests for detection of febrile illnesses, including Ebola."

M. Javad Aman, President and Chief Scientific Officer of IBT, commented, "We are facing a humanitarian crisis and global public health challenge. Development of a rapid POC test for Ebola will be a critical step towards enabling early detection and quarantine that could help save countless lives. Through this partnership, the capabilities of the two companies will be combined to produce a POC product we believe will meet this serious challenge in a timely manner."

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Roche Seeks Fast-Track for Ebola Diagnostic Test

Roche Holding AG has filed its Ebola virus test for emergency use approval in the United States, in response to the world's worst outbreak of the disease, the drugmaker's head of diagnostics said on Thursday.

Roland Diggelman said Roche has an Ebola test that can run on its polymerase chain reaction (PCR) systems, but said it was currently only labelled for use in research purposes.

"We are in discussions for emergency use application by the FDA (Food and Drug Administration)," Diggelman told an analyst call after the company's third-quarter results.

A spokesman for Roche said the company has also filed for so-called CE mark approval in the European Union. The CE mark is awarded to products that comply with European regulations.

He said it takes approximately two hours for the company's Ebola test to detect the virus. It is possible to run around 480 samples per day on a single Roche LightCycler 480 machine. Only laboratories that fulfil specific safety requirements would be able to handle Ebola samples.

A total of 4,493 people have died from the world's worst Ebola outbreak on record and the situation in Guinea, Liberia and Sierra Leone is deteriorating, the World Health Organization (WHO) said on Wednesday.

Public anxiety about the disease has grown in the United States after a second Texas healthcare worker became infected with the disease after treating Liberian national Thomas Duncan.

The WHO recommends testing for viral ribonucleic acid (RNA) or viral antigen in suspected or probable cases of Ebola.

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U.S. FDA Now Issues Emergency Authorization for Two New Ebola Tests

Federal health regulators granted emergency authorization on Saturday for two new tests made by BioFire Defense that detect Ebola in humans, highlighting new steps by the government to prevent a severe outbreak in the United States.

The U.S. Food and Drug Administration has been working closely with Salt Lake City-based BioFire, a subsidiary of medical diagnostics maker BioMerieux, to obtain the necessary performance data to allow for the authorizations, the federal agency said in a news release.

BioFire's tests can detect Ebola in a blood or urine sample in one hour, compared with the 24 to 48 hours current tests take to deliver results, said Matt Scullion, vice president of sales and marketing for BioFire Defense.

The test can also be performed in a hospital with BioFire lab equipment, whereas current tests need to be sent to specialized labs.

"We have managed to come up with a system that has automated all of the traditional steps that you'd go through to set up a test like this," Scullion said. "All the hospitals already using our systems can begin testing patients."

More than 300 U.S. hospitals have BioFire lab equipment, Scullion said, including Emory Hospital and Bellevue Hospital, where Dr. Craig Spencer, who recently returned from treating Ebola patients in West Africa, is currently being treated for the disease.

"We understand the importance of quickly diagnosing Ebola cases in the U.S. and abroad. FDA is committed to working with companies in the most expedited manner to increase the availability of authorized diagnostic tests for Ebola for emergency use during this epidemic," the agency said.

Under an emergency use authorization, the FDA may allow unapproved medical products to be used to fight life-threatening diseases on an emergency basis when there are no approved or available alternatives.

"Obviously, having more tests authorized for use during this outbreak is a benefit," said Sharon Yao, an FDA spokeswoman. "Hospitals can now test human specimens for Ebola in their facilities and obtain a determination in under two hours."

So far only a handful of people have been diagnosed with Ebola in the United States, most of them medical workers who contracted the disease after treating other patients.

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Diagnostic Tests Key to Helping Swine Producers Fight Porcine Epidemic Diarrhea Virus

One week after the diagnostic lab at Iowa State confirmed that porcine epidemic diarrhea virus had spread to the United States, Animal Disease Research and Diagnostic Lab researchers at South Dakota State University released a diagnostic test to differentiate PEDv genetic material from that of other viruses, according to Jane Christopher-Hennings, ADRDL director and SDSU Veterinary and Biomedical Sciences Department Head.

With the first-generation, gel-based polymerase chain reaction (PCR) test online, the lab’s molecular diagnostics group improved the test’s sensitivity and cut the testing time in half, making it possible to get same-day results, explained ADRDL researcher Eric Nelson, a veterinary and biomedical sciences professor. The second-generation test was commercially available within a few months.

Diagnosing outbreaks quickly

ADRDL’s quick turnaround time for diagnostic testing provides a real value to producers in South Dakota and the region, explained Glenn Muller, executive director of the South Dakota Pork Producers. “The diagnostic lab is the primary source of determining a true, confirmed case of PEDv.”

The PCR-based test can also be used on environmental samples to detect whether items brought onto the farm are contaminated, Hennings explained.

In addition, the test results fulfill the U.S. Department of Agriculture reporting mandate, which also requires producers whose herds test positive to review their biosecurity measures with their veterinarians to pinpoint any changes that may be necessary.

Detecting antibodies

Once an animal is exposed to the virus, it develops antibodies, Nelson explained. ADRDL scientists produced several tests to detect the animal’s immune response to PEDv. These tests are important, not only to identify animals previously exposed to PEDv but also to evaluate an animal’s antibody response to vaccines, according to research associate Travis Clement.

Neutralizing antibodies, in particular, are important indicators of protective immunity to the virus, Clement explained. If pigs with these antibodies have negative PCR results, meaning they have stopped shedding the virus, they might be safely integrated into the operation.

Within four to six months, ADRDL had developed monoclonal antibody reagents used to detect PEDv in tissues from infected animals and to detect viable virus in cell cultures. Though ADRDL does vaccine research, Nelson said, “We’ve had our hands full on the diagnostic side.”

ADRDL does antibody testing on candidate vaccines to determine whether the antibody levels measured are high enough to provide clinical protection against the virus and therefore predict their effectiveness, according to Hennings. ADRDL monoclonal antibodies became commercially available this spring and are used in multiple research laboratories developing vaccines.

“With an emerging disease, research, diagnostics and control measures are critical in limiting the damage and extent of the disease,” added Hennings. Networking among diagnostic labs, especially in the Midwest with regard to swine diseases, helps researchers quickly identify new diseases and develop diagnostic tools.

About the Animal Disease Research and Diagnostic Lab

Since 1887, the South Dakota State University Animal Disease Research and Diagnostic Laboratory has served the public by providing high quality veterinary diagnostic services as a means to promptly and accurately establish causes of animal health problems. Such diagnoses aid attending veterinarians and health officials in the treatment, control, prevention and surveillance of animal diseases, benefiting South Dakota and national livestock industries, other animal owners and public health. Research work involves basic and applied investigations that enhance the understanding of the induction of diseases in animals, the development of diagnostic methods for the detection of diseased animals, products for treatment or prevention of disease and management protocols for the control of disease.

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Paper-based Synthetic Gene Networks Could Enable Rapid Detection of Ebola and Other Viruses

Synthetic gene networks hold great potential for broad biotechnology and medical applications, but so far they have been limited to the lab. A study published by Cell Press October 23rd in the journal Cell reveals a new method for using engineered gene circuits beyond the lab, allowing researchers to safely activate the cell-free, paper-based system by simply adding water. The low-cost, easy-to-use platform could enable the rapid detection of different strains of deadly viruses such as Ebola.

“Our paper-based system could not only make tools currently only available in laboratory readily fieldable, but also improve the development of new tools and the accessibility of these molecular tools to educational programs for the next generation of practitioners," says senior study author James Collins of the Wyss Institute for Biological Inspired Engineering at Harvard University.

The field of synthetic biology aims to re-engineer the molecular components of the cell to harness the power of biology. To accomplish this goal, researchers have designed synthetic gene networks that can control the activity of genes and recognize nucleic acids and small molecules. However, this technology has been restricted to the lab, in part because of biosafety concerns associated with cell-based systems and because the reactions involved have not been practical for field use.

Collins and his team overcame these hurdles by developing a cell-free, paper-based system suitable for use outside the lab. To test the clinical relevance of their method, the researchers developed sensors capable of detecting RNA molecules made from genes that allow bacteria to survive antibiotics, as well as RNA molecules encoding proteins from two different strains of the highly deadly Ebola virus. When freeze-dried onto paper, the sensors quickly detected the presence of these RNA molecules, demonstrating the usefulness of the approach for diagnostic purposes.

"Considering the projected cost, reaction time, ease of use, and no requirement for laboratory infrastructure, we envision paper-based synthetic gene networks significantly expanding the role of synthetic biology in the clinic, global health, industry, research, and education," Collins says.

Journal Reference:

Keith Pardee, Alexander A. Green, Tom Ferrante, D. Ewen Cameron, Ajay DaleyKeyser, Peng Yin, James J. Collins. Paper-Based Synthetic Gene Networks. Cell, October 2014 DOI: 10.1016/j.cell.2014.10.004

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Genalyte Develops 10-Minute Ebola Test

Sprinting into the race to commercialize an Ebola diagnostic, San Diego's Genalyte says it has developed a 10-minute Ebola test.

The company said its test uses one drop of blood from a finger prick, and offers results in as fast as 10 minutes on its diagnostic platform. The test detects Ebola proteins, even at an early stage of infection before the person is showing obvious symptoms.

Genalyte says validation of the test "is only weeks away," and it wants to work with the federal government to make the test available as rapidly as possible.

The test is based on a proprietary silicon chip technology and run on Genalyte's Maverick Detection System testing platform. The platform is being used now to test for immune system rejection of biologic drugs, such as monoclonal antibodies. It's sold to pharmaceutical companies to help in drug development. The system is also used to test for autoimmune reactions.

For the Ebola test, the chip is coated with antibodies that bind to the viral proteins. Blood flows directly over the chip, Gunn said.

The system can be placed at hospitals and airports, as well as in West Africa where the Ebola outbreak is rapidly spreading, said Cary Gunn, Genalyte's CEO.

The Maverick system can process up to 100 tests per hour per instrument. Each instrument costs around $120,000, and the chips will cost about $10 each, Gunn said. The system requires standard electrical power. But the power doesn't have to be on the grid, it can come from a generator, he said.

Ebola researcher Erica Ollmann Saphire said by email that the biggest need in Africa is for rapid tests "that would function well in resource-poor environments."

"There is no electricity in many regions affected by this outbreak, for example,"said Ollmann Saphire, of The Scripps Research Institute. "It would also be good to know specificity and sensitivity - how many false negatives and positive there are and how little viral material can still be detected. These are useful numbers to know for any diagnostic. If testing is still in progress, they may not have those figures."

Gunn said Genalyte will work with government officials and health organizations to provide the needed information. The device comes with a "pretty robust" power converter, he said, allowing it to tap into a variety of sources.

"You can plug it into any kind of current, clean current, 50 hertz, 60 hertz, 120 volts, 240 volts, it doesn't matter," Gunn said. "It will generate the correct voltage internally."

The tests can be run in a standard or high-sensitivity mode, Gunn said. Standard sensitivity tests take 10 minutes, while high-sensitivity tests take 15 minutes.

Gunn said the machine is fairly easy to operate.

"All you need to do is take a fingerprick of blood, put it in a vial or a 96-well tray, put it into the instrument and press go," Gunn said. "Our workflow is simple enough that an untrained technician can do this."

Genalyte is submitting evidence of this ease of use to federal regulators to help get a rapid emergency use authorization for the test.

To validate the test, the company is working with government labs that have access to viral samples, Gunn said. Once that is done, Genalyte can file for an emergency use authorization with the Food and Drug Administration.

Genalyte can make thousands of chips in a run, Gunn said.

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Ebola Detection Using Rapid Tests and ELISA Kits for Humans and Animals

San Antonio, Texas-based Biotech Company Alpha Diagnostic Int'l (ADI) has developed and released several convenient, rapid, and sensitive ELISA test kits for the detection of major Ebola viral protein antibodies (Glycoprotein, GP; Nucleoprotein, NP, and Viral Protein 40 or VP40).  The antibody ELISA kits are available not only for human samples but also for monkey, dog and mouse as some of the Ebola vaccines are first tested in the animal and primate model.

Dr. Kent Brantly, the first American to return to the U.S. from Liberia and then survive Ebola, has donated blood for transfusions to other patients, including Nurse Nina Pham who contracted Ebola while taking care of a Liberian patient who succumbed to Ebola.  ADI’s Ebola virus antibody ELISA kits can be used to determine if Dr. Brantly, or any other potential Ebola survivors, actually has the antibodies prior to giving a blood donation.  “More importantly, a population survey can be done to determine the immunity levels of Ebola in endemic regions,” said Dr. Masarrat Ali, Director of ADI.  The levels of antibodies sufficient enough to provide immunity also need to be established.  ADI has made similar antibody kits for dog and pig to establish if the animals from Ebola endemic regions have any circulating Ebola virus protein antibodies and, therefore, exposed to Ebola virus.  The antibody ELISA kits are highly sensitive and need only a tiny drop of blood or serum to conduct the test within two hours.

The United States, United Kingdom, and Canada have started clinical trials on the most promising candidates for Ebola vaccines.  These vaccines use an adenovirus (chAd3) or vesicular stomatitis virus (VSV) vectors to deliver one of the most antigenic Ebola virus’s Glycoprotein (GP) in order to induce antibodies in humans or primates.  “ADI’s Ebola virus GP antibody ELISA tests along with the chAd3 and VSV protein antibody ELISA kits will allow for immediate assessment of vaccine efficacy,” said Dr. Ali.

Zmapp, an experimental therapeutic cocktail of three humanized GP monoclonal antibodies, has been used in some Ebola patients in order to neutralize the Ebola virus.  The U.S. Department of Health and Human Services has provided $42.3 million to help San Diego-based Mapp Biopharmaceutical accelerate the development and testing of ZMapp.  ADI has developed ELISA kits to not only measure the Zmapp antibody concentration in its purified form but also after infusion to humans or animals.  For example, it is possible to establish the levels of Zmapp in Dr. Brantly’s blood immediately after the first dose and then weeks and months afterwards.  It is also now possible to assess what levels of Zmapp, natural antibodies, or antibodies induced by vaccines are sufficient to prevent an Ebola infection. The Ebola antibodies test is conducted in less than two hours in a laboratory in field setting with minimal instruments or equipment.

Additional rapid tests, similar to pregnancy tests, have been developed to quickly identify and assess the activity of Zmapp in 2-5 minutes.  “These tests will not only help in the manufacturing and quality control of Zmapp but also prevent any fraudulent marketing of the drug,” said Dr Ali.

ADI has also developed the Ebola virus GP antigen and antibody rapid tests to quickly help identify potential exposure to the virus.  The rapid tests, when approved by FDA, can be used in field settings, doctors' offices, pharmacies, airports, or borders.  The tests require no instruments and can be used by any laboratory personnel.  ADI is the first company to develop and release a number of Ebola tests.  ADI is contacting the CDC and health officials in Texas to donate some of these kits.  “The availability of these kits should help diagnose Ebola in humans and animals and allow for rapid testing of various Ebola vaccines,” said Dr. Ali.

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US Army Infectious Disease Unit Supports Ebola Virus Disease Outbreak Response in West Africa

From on-site laboratory support in Liberia, to training of key personnel, to accelerated research efforts on diagnostic, vaccine and treatment approaches, the U.S. Army Medical Research Institute of Infectious Diseases is playing a significant role in assisting the Ebola Virus Disease outbreak response in West Africa.

Ebola virus causes a severe, often fatal hemorrhagic disease in humans and non-human primates. Currently there are no licensed vaccines or drugs to fight the disease, and case fatality rates as high as 90 percent have been reported in past outbreaks. As of Oct. 15, the World Health Organization reported at least 8,997 cases and 4,493 deaths in seven affected countries. These include Guinea, Liberia, Nigeria, Senegal, Sierra Leone and Spain, as well as the first-ever case of Ebola diagnosed in the U.S.

That patient, a man who had recently traveled from Liberia to the U.S., died Oct. 8.

The U.S. Department of Defense is supporting the U.S. Agency for International Development as part of a U.S. whole of government response effort to the Ebola virus outbreak, as announced by President Barack Obama on Sept. 16. U.S. military personnel are deploying to West Africa in support of the effort, called Operation United Assistance. In addition to setting up a regional staging base to facilitate transportation of equipment, supplies and personnel, the U.S. military is establishing additional treatment centers in Liberia and providing medical personnel to train health-care workers in the region.

At the U.S. Army Medical Research Institute of Infectious Diseases, known as USAMRIID, the response effort spans the institute's research and support divisions and there is no sign of the operational tempo slowing any time soon, according to Col. Erin P. Edgar, commander of the institute.

"This is definitely not business as usual," he said.

Late September, USAMRIID was asked to provide training to deploying U.S. forces, according to Lt. Col. Neal E. Woollen, who directs the institute's biosecurity program. Several personnel have volunteered to serve on mobile training teams that travel to deploying units to train and certify troops who will be working in Ebola-affected areas of West Africa. Training is focused on proper wearing of protective equipment, as well as decontamination procedures.

ON-SITE LABORATORY SUPPORT

US Army Supports Ebola Virus Disease Outbreak Response in West Africa

Since April 2014, USAMRIID and the National Institute of Allergy and Infectious Diseases-Integrated Research Facility have provided personnel, training and diagnostic laboratory support to the Liberian Institute for Biomedical Research on a continuous rotational basis, according to Randal J. Schoepp, Ph.D., chief of USAMRIID's Applied Diagnostics branch. He and several others helped to set up an Ebola virus testing laboratory in Liberia and trained local personnel to run diagnostic tests on suspected Ebola hemorrhagic fever clinical samples.

Schoepp said USAMRIID has been working on a collaborative project in West Africa since 2006 (see sidebar article below). Because the team was working on disease identification and diagnostics in the region, he added, "We had people on hand who were already evaluating samples and volunteered to start testing right away when the current Ebola outbreak started."

In addition to providing laboratory testing and training support for the current outbreak, USAMRIID has provided more than 10,000 Ebola laboratory tests, referred to in the medical community as assays, to support laboratory capabilities in Liberia and Sierra Leone. The institute also supplied personal protective equipment to Metabiota Inc., a non-government organization involved in the testing.

Edgar called the project "a great example of medical diplomacy at work."

"This collaboration allows USAMRIID to bring our expertise to bear in responding to an international health crisis," he said. "In addition, it enables us to test the medical diagnostics that we develop in a real-world setting where these diseases naturally occur."

DIAGNOSTIC TOOLS

USAMRIID research led to the only assay currently authorized to diagnose Ebola in U.S. citizens, according to David A. Norwood, Ph.D., chief of USAMRIID's Diagnostic Systems Division. The assay, which detects the Zaire strain of Ebola virus in patient samples, is called the Ebola Zaire Real-Time PCR Assay Test Kit. It was developed, manufactured and tested with help from the U.S. Army Medical Materiel Development Activity.

While the test has not been approved by the U.S. Food and Drug Administration, the FDA has authorized its use under an Emergency Use Authorization, granted in August 2014. According to Norwood, the EUA provides a legal basis for the use of unapproved medical products, including diagnostics, in a declared emergency when there are no alternatives. The test is available at authorized DOD laboratories in the U.S. and overseas, as well as select CDC Laboratory Response Network state public health labs throughout the country for testing U.S citizens.

"This assay is also being used in West Africa for rapid diagnosis of host nation patients," said Norwood. "So there is no disparity between the diagnostic capabilities that are being used in-country and those that are available for testing U.S. citizens. While the labeling and execution is somewhat different for regulatory purposes for testing U.S. citizens, the same capability is available for diagnostic testing for everyone."

Issuance of the EUA was a collaborative effort among several agencies: Medical Countermeasure Systems, U.S. Army Medical Command; Health Affairs, Readiness Division, Health Care Operations Directorate; Joint Program Executive Office Critical Reagents Program; the DOD Clinical Laboratory Improvement Program Office; and the recipient laboratories, including five DOD labs and 15 CDC-LRN state public health laboratories.

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A Handheld Device that Detects Malaria in 30 Minutes

Scientists at the Bangalore-based Indian Institute of Science (IISc) are developing a handheld device that can detect malaria in 30 minutes.

The project, which is in a proof-of-concept stage, is supported by a biotechnology “ignition grant” from the Indian government’s Biotechnology Industry Research Assistance Council (Birac).

The device is being developed by a team of researchers led by Sai Siva Gorthi, an assistant professor at the Department of Instrumention and Applied Physics, IISc and incubated at the institute’s Robert Bosch Centre for Cyber Physical Systems (RBCCPS).

Gorthi’s team is working towards a low-cost diagnostic instrument that takes in a droplet of blood, analyses individual cells, and detects cells that are infected with malaria.

“We are tremendously excited about this simple yet incredible device that can fully automate the complete workflow of clinical microscopy, making accurate diagnosis of malaria far more accessible than it has been before,” said Parama Pal, head of healthcare at RBCCPS.

In 2013, India saw more than 800,000 cases of malaria, with 359 deaths, according to the ministry of health and family welfare. At present, the Indian government recommends the use of microscopy or a rapid diagnostic test, both of which take at least 24 hours to come up with the results.

“Our approach combines various technologies like image processing, microfluidics and microscopy. It’s essentially a pathology lab-on-a-device for malaria diagnosis,” said Gorthi.

When compared with traditional diagnostic methods, the device collects a significantly low amount of blood, about 200 nanolitres, which can contain about one million blood cells. The device analyses each cell in this droplet of blood and gives a visual representation as well as quantitative count of the malaria-affected cells.

The handheld device has a common optical reader into which the user can slide in a new replaceable microfluidic cartridge when a test has to be performed. This cartridge is loaded with a set of compounds to carry out automated on-chip processing of the blood sample. The affected blood cells display structural features that are different from normal cells, which can be seen on the device’s LCD display.

“The algorithms we have developed run on a smartphone-like platform and do this evaluation automatically. It doesn’t require the intervention of a skilled technician. While the qualitative test results can be known instantaneously, quantitative parasitemia levels are assessed and displayed in about 30 minutes,” said Gorthi.

The scientists also believe that this portable handheld device can be modified for diagnosing other diseases as well.

“What we have is a generic platform to automate the diagnostic process. To detect variety of other haematological disorders, such as spherocytosis, sickle cell anaemia, we just need to upgrade the software of the same device to let it run corresponding image processing algorithms that we are developing,” said Gorthi.

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New Test Accelerates Herpes Detection

A new assay for spotting the virus responsible for cold sores has been developed by scientists in Ireland.

It is estimated that between 60–95% of adults worldwide are infected with the herpes simplex virus-1 (HSV-1) and although the symptoms are usually limited to sores or blisters, in rare cases it can infect the central nervous system, which is fatal in 70% of untreated cases. If diagnosed early, antiviral therapy can lead to a positive outcome, thus emphasising the need for rapid diagnostic methods.

At present, the most definitive HSV-1 test involves cell cultures but results can take up to a week to complete. Alternative assays have been proposed but they still remain time-consuming and introduce additional complications, like the need for specialist personnel.

The new test devised by Gil Lee and colleagues at University College Dublin uses beads, composed of iron oxide nanoparticles, coated with peptides that bind to the virus. As the nanoparticles are also superparamagnetic, a simple magnet can accelerate their aggregation and the way in which these aggregations scatter light is measured and used to indicate an infection.

‘We knew that a magnetic bead assay had the potential to be very sensitive based on our previous work with Dengue,’ explains Lee. ‘However, HSV is among the most difficult viruses to detect with this technique because it is a relatively large virus and has a complex and irregular membrane coat.’

Peptide-functionalised beads latch onto the virus and aggregate. These aggregations are easily identified using a flow cytometer.


Peptide receptors are central to the method’s success. While antibody recognition is integral to many diagnostic tests, they require the patient to have had a previous immune response to the virus, so peptides that capture the virus itself therefore offer a convenient and inexpensive alternative. The fact that these beads aggregate increases the sensitivity of this method to 200 copies per ml of sample and enables it to complete within minutes rather than hours.

‘It is interesting that since the assay methodology is rapid and label-free, it may be suitable for point-of-care applications in hospitals or doctors’ offices,’ says Ruben Carbonell of North Carolina State University, US, an expert in using peptides for pathogen detection. ‘While there is still a lot of work to be done to establish this technique as a validated analytical procedure, its advantages hold a great deal of promise for wider application.’

The team are optimistic that their assay will be used to improve point-of-care treatment of HSV, particularly in developing countries, by reducing the cost of diagnosis. They are also keen to expand this research to other viral diseases such as HIV, which requires life-long monitoring.

Source: Royal Society of Chemistry

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IAEA Joins Effort to Stem Ebola Outbreak

Technology for the rapid diagnosis of Ebola will soon be delivered to Sierra Leone by the International Atomic Energy Agency (IAEA). It will also later be supplied to Liberia and Guinea.

In response to a UN Security Council appeal and a request from Sierra Leone, the IAEA said it will deliver "in the coming weeks" diagnostic technology known as Reverse Transcriptase Polymerase Chain Reaction (RT-PCR). The IAEA will provide the west African country with an RT-PCR machine, cooling systems, biosecurity equipment, diagnostic kits and other materials. This technology allows Ebola to be detected within hours, unlike other diagnostic techniques which take several days.

Early diagnosis of Ebola, if combined with appropriate medical care, increases the victims' chance and survival and helps cut the spread of the disease by making it possible to isolate and treat patients earlier.

RT-PCR - instrumental in the global eradication of rinderpest in livestock - initially used radioactive isotopes as markers in the process that determines whether the virus is present in a sample. However, subsequent refining of the method has led to the possibility to use fluorescent, instead of radioactive, markers for screening purposes.

The IAEA said that its support "initiates broader IAEA support to African Member States to strengthen their technological abilities to detect diseases transmitted from animals to humans."

The IAEA plans to extend such support to Liberia and Guinea, which have also been hit by the Ebola outbreak.

IAEA director general Yukiya Amano said: "Transfer of nuclear-related technologies is a key part of the Agency's work, and we have cooperated with Member States for years to develop and strengthen their capacity to use this nuclear-derived technology."

He added, "With this additional support, the Agency makes a small but effective contribution to global efforts to fight the ongoing Ebola outbreak."
According to the World Health Organization, as of 14 October a total of 8914 cases had been reported in the latest outbreak of Ebola. The number of reported deaths is 4447.

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Rapid Diagnostic Tests Performed Poorly in Detecting Chikungunya Virus

Commercially available rapid diagnostic tests for diagnosing chikungunya virus appear to perform poorly in terms of specificity and sensitivity, according to recent findings.

“The increasing threat of [chikungunya virus] emergence in temperate regions and the need to anticipate possible outbreaks of [chikungunya virus] infection are presenting a challenge to the current level of diagnostic preparedness,” researchers wrote in Emerging Infectious Diseases.

In the study, the researchers assessed the utility of four commercially available blood tests approved by the European Commission for the detection of chikungunya virus. Two of these tests were rapid detection tests (RDTs) for chikungunya immunoglobulin M antibodies and included the SD Bioline Chikungunya IgM (Standard Diagnostics Inc.) and the OnSite Chikungunya IgM Combo Rapid Test (CTK Biotech). The remaining two tests were enzyme-linked immunosorbent assays (ELISAs) screening for chikungunya IgM and IgG, and they were manufactured by Euroimmun and IBL International, respectively.

The researchers acquired two sets of serum samples that had been sent to the French Armed Forces Biomedical Research Institute (IRBA) for arbovirus testing between 2005 and 2014. Panel A, which consisted of 23 samples, was assayed in two National Reference Centers for Arboviruses laboratories. The samples were analyzed through two in-house ELISAs and a neutralization test. Panel B was tested via in-house IRBA techniques. Due to limited sample volumes, the researchers used panel A to test the commercial kits, whereas panel B was used only when test results from panel A yielded specificity and sensitivity higher than 70%.

The researchers found that, upon using the two RDTs to test panel A samples plus serum samples infected with Mayaro virus and O’nyong-nyong virus, these tests did not detect either virus. The SD Bioline RDT demonstrated poor sensitivity (30%) and specificity (73%) in the detection of chikungunya in the panel A samples, with a 39% rate of false-negative results and 57% rate of false-positive results. The RDT from CTK Biotech had 93% specificity and 20% sensitivity in the panel A samples, with a 36% rate of false negatives and a 33% rate of false positives. Because the RDTs were determined to be ineffective by the panel A test results, the panel B samples were not tested.

The IgM and IgG ELISAs also were used to assay samples from panel A plus blood samples infected with Mayaro virus and O’nyong-nyong virus. Because the results of these tests had specificity and sensitivity of more than 70%, the researchers also tested panel B.

Both ELISAs detected IgM and IgG antibodies for O’nyong-nyong virus. Additionally, the Euroimmun ELISA detected IgG but not IgM for Mayaro virus, whereas the IBL International ELISA detected neither IgG nor IgM antibodies. The IBL International ELISA yielded a specificity of 88% (IgM) and 96% (IgG), and a sensitivity of 79% (IgM) and 52% (IgG). In the detection of IgM, the IBL International ELISA had a 12% rate of false-positive results and a 21% rate of false negatives.

The Euroimmun ELISA had a specificity rate of 82% (IgM) and 95% (IgG), and a sensitivity of 85% (IgM) and 88% (IgG). In detecting IgM, the Euroimmun ELISA kit had an 18% false-positive rate and a 15% false-negative rate.

According to the researchers, these findings indicate that the RDTs evaluated should not be used in a clinical setting; they added that while the ELISAs performed better, their rates of false-positive and false-negative results are “non-negligible.” They also noted that more effective chikungunya tests are needed.

“If the current outbreak of [chikungunya] infection in the Americas follows the same trend as that seen in the 2005 Réunion Island outbreak, increased circulation of the virus can be expected, and diagnostic laboratories must be prepared,” the researchers wrote. “Our evaluation was a pilot study using a small number of samples, but the findings show the importance of evaluating commercial diagnostic kits and published protocols before using such tools in clinical settings.”

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NanoLogix Technology Being Configured For Rapid Ebola Virus Detection

NanoLogix Inc., an innovative biotechnology company in Northeastern Ohio announces that it is configuring its N-Assay Rapid diagnostic kits for both Ebola Virus and Enterovirus detection and identification. NanoLogix CEO Bret Barnhizer stated, “The Company has been aware of the virus detection capabilities of the technology since the N-Assay development. Viruses viewed as public health concerns prior to Ebola and Enterovirus were Influenza, the common cold, and HIV, none of which have an immediate or near-immediate threat of mortality. Until recently, NanoLogix has been focused solely on the use of their N-Assay kit for bacteria detection and identification. Now, with the recent outbreaks of both Ebola and Enterovirus there is an immediate need for configuration of the N-Assay for viruses. NanoLogix facilities are not designed for work on viruses, for this specific project we are seeking a corporate partner with the facilities necessary to bring the new N-Assay (V) to the market as quickly as possible. We consider this a matter of national security and an emergency priority. We are in discussions with potential partners, positioned with strong ties to the US government, who understand the serious threat these viruses represent.”

The NanoLogix N-Assay (V) ELISA is one of six technologies that may be used for virus detection and identification, the N-Assay (V) has unique qualities that contribute to both its rapid detection capability and long term durability that should be attractive to personnel in both developed and remote locations interested in a screening test that may provide results for Ebola or other viral threats in 30 minutes to a few hours.

Sebastian Faro, MD, PhD, is considered one of the top experts in the world on Infectious diseases of women's reproductive systems. Dr. Faro made the following comments: "N-Assay ELISA technology has been applied to the rapid identification of specific bacteria, e.g. Streptococcus agalactiae (GBS), Neisseria gonorrhoeae, & Enterococcus faecalis. This technology has been used to rapidly identify strains that are resistant to specific antibiotics. This technology significantly reduces the time from specimen submission to identifying these bacteria and resistance to specific antibiotics. This N-Assay ELISA technology can be applied to identifying viruses and is inexpensive. This technology does not require expensive equipment which makes this technology ideal for a variety of laboratory environments.”

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Quidel Receives FDA Clearance for Its Lyra® Molecular PCR Assay for the Detection of Adenovirus

Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market its Lyra Adenovirus Assay, a real-time PCR test for the qualitative detection of human adenovirus (HAdV) viral DNA isolated from nasal swab and nasopharyngeal swab specimens.

Adenovirus outbreaks can occur throughout the year, but are more common from late winter to early summer.[1] Adenovirus infections are seldom life-threatening, however, these viruses can cause several illnesses and symptoms, such as colds, sore throat, bronchitis, pneumonia, diarrhea, pink eye and fever. Severe complications from adenovirus infection can present in infants and people with weakened immune systems. According to the Centers for Disease Control and Prevention (CDC), adenovirus is spread through: 1) close personal contact, such as shaking hands or touching, 2) the air by coughing or sneezing, and 3) touching contaminated objects or surfaces.[2] Some people infected with adenovirus can have ongoing infections without any symptoms, shedding the virus for months or even years.

Quidel's Lyra Adenovirus Assay is part of the exciting new Lyra brand of ready-to-use, molecular PCR reagent kits specifically designed to be compatible with a laboratory's existing thermocycler. The Lyra reagent kits provide attractive features, including a short time to result, ready-to-use master mix, and refrigerated, non-frozen storage of key reagents, as well as other benefits.

The new Lyra Adenovirus Assay augments the growing menu of other FDA-cleared assays on the Lyra platform. The quickly expanding menu of Lyra-based infectious disease products provides healthcare workers with the flexibility needed to meet the specific needs of the clinical laboratory, especially as testing needs shift for specific pathogens with overlapping and variable seasonality. The Lyra assays yield highly sensitive, quantitative PCR results within 75 minutes.
"We are pleased to receive 510(k) clearance for our Lyra Adenovirus Assay," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "This assay adds depth to our molecular respiratory solutions, and when paired with our other Lyra assays, provides customers with the power to customize their testing strategies in response to their unique local or seasonal prevalence demands."

Quidel now offers FDA-cleared Lyra assays for a dozen different infectious agents, including eight molecular tests for respiratory disease (Strep A, Strep C+G, Influenza A, Influenza B, human metapneumovirus (hMPV), respiratory syncytial virus (RSV), and adenovirus (HAdV)) and four other PCR assays for other serious infectious disease pathogens (herpes simplex virus (HSV) types 1 and 2, varicella zoster virus (VZV) and C. difficile).

[1] http://www.cdc.gov/adenovirus/outbreaks.html
[2] http://www.cdc.gov/adenovirus/about/transmission.html

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OraSure Approached About Developing Ebola Test Kit

OraSure Technologies is examining whether technology it developed for its in-home HIV test could be used to screen for Ebola.

The company has been approached by federal agencies and private-sector entities interested in employing the method, which detects antibodies in saliva, to test for Ebola, said President and CEO Douglas A. Michels. He would not specify which government agencies or companies are involved.

"We have been approached by different organizations that have expressed an interest in possibly exploring that with us, and at this point in time we're determining the path forward, as it relates to work that might be involved in developing such a capability," Michels said.

OraSure's testing technology is attractive because it is easy to use, produces a quick result and unlike current Ebola tests, does not require blood to be drawn.

Food and Drug Administration Commissioner Dr. Margaret A. Hamburg said "point-of-care diagnostics" like those produced by OraSure are critical to providing the right treatment and public health response to contain an epidemic.

"The ability to do a rapid diagnostic is key," she said. "I think you are right on the money in terms of the value of that kind of technology being applied in a public health crisis like Ebola."

She and Michels would not speculate where such a test, if developed, could be used, whether to screen patients at hospitals or travelers at airports for the virus.

The Ebola virus has sickened an estimated 8,900 in West Africa, killing more than 4,400. The World Health Organization predicted Tuesday that the rate of infection in Liberia, Guinea and Sierra Leone could hit 10,000 a week by the end of the year.

One person has contracted Ebola in the U.S., a nurse who treated Liberian national Thomas Eric Duncan at a Dallas hospital. Duncan died of the disease last week after returning from Liberia. The 26-year-old nurse, Nina Pham, remains hospitalized.

OraSure's OraQuick rapid in-home HIV test uses a cheek swab to collect saliva. It produces a result in as little as 20 minutes. It works like a conventional pregnancy test, showing a reading on a hand-held indicator.

That's a big plus, Hamburg said, especially in West Africa where many patients are skeptical of or reluctant to engage the public health system. A cheek swab is a lot less intimidating than having your blood taken, Hamburg said. It's also safer than taking blood because it eliminates the risk of needle sticks.

"Clearly the OraSure approach and demonstrated track record makes that kind of technology quite attractive as a possibility, but there are other approaches that also are being studied," she said.

Michels said research has shown that the Ebola virus and antibodies to the virus are detectable in saliva.

"There is an extraordinary level of interest, there is urgency, there has been a high level of activity in recent weeks," Michels said. "It is yet to be proven whether we can develop a product on the platform. We believe we could, but obviously a lot of work has to go into that before we have the empirical data."

Testing and development of an Ebola test will not involve bringing the virus to the company's South Side Bethlehem headquarters. It is restricted to highly controlled Biosafety Level 4 facilities operated by the government and certain research facilities.

"There would certainly have to be validation activities that would require a BL4 facility," Michels said. "That is where relationships with different government entities and research entities have become so critically important."

Besides looking for new diagnostic tools, the FDA is working to accelerate development of vaccines and treatments for Ebola and has transferred resources and staff to those tasks, Hamburg said.

Part of that involves helping to design clinical trials to determine their efficacy and safety.

"My hope is that we will be able to get some meaningful answers in the time frame of this outbreak, which sadly is not going to resolve in the immediate near term," she said. "I think we certainly want to be better equipped for the next outbreak as well."

Since 2002, the FDA and OraSure have worked closely on approval of several first-of-their-kind medical-testing products, including the rapid oral fluid HIV test and in-home HIV test, as well as a rapid test for hepatitis C.

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BioVigilant Introduces Instantaneous Microbial Detection for Pharmaceutical Water Monitoring

Azbil BioVigilant, inventors of Instantaneous Microbial Detection™, today announced the introduction of its new IMD-W™ rapid microbial detection system for real-time water monitoring of pharmaceutical water sources.

“The IMD-W system is one of the first of its kind to respond to a call from the pharmaceutical industry for on-line water bioburden analysis (OWBA),” said JeffreyWeber, PAT project manager at Pfizer and one of the founding members of the OWBA workgroup. He added, “BioVigilant’s IMD-W system is a new complementary tool at our disposal, for trending the state of control of water systems in real time through continuous bioburden monitoring.”

The system targets applications where the instrument can be used immediately to manage and mitigate risks, increase process understanding, save energy through better use of heat sanitization cycles, and drive labor efficiencies.

Using laser-induced fluorescence, the IMD-W system simultaneously measures particle size and determines whether a particle is biologic or inert. This optical design does not require staining or reagents, and incorporates three light scatter signals with advanced software algorithms to detect biologic particles and discriminate non-biologic “interferent” materials which could otherwise be counted as biologics by other systems. The system may be used on-line for continuous monitoring, or at-line, for point-of-use samples and in laboratory settings. Other features include a touch panel for easy-to-use operation, a set of standard reports for data export and analysis, and a flexible communications interface for networking and integration with common industrial control systems.

The IMD-W system augments BioVigilant’s current product offerings focused on rapid microbial monitoring for air in pharmaceutical manufacturing areas and other controlled environments.

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RPS Announces CE Mark of Rapid Point-Of-Care Test to Help Detect the Body's Immune Response to Viral And Bacterial Infections

RPS Diagnostics Inc. (RPS®) announced CE mark of its FebriDx™ test clearing the way for sales in the European Union and all countries recognizing the CE mark.

FebriDx is a rapid disposable in-office test that helps identify and differentiate a clinically significant immune response to viral and/or bacterial acute febrile respiratory infection at the point-of-care. The FebriDx test combines the interpretation of both Myxovirus Resistance Protein A (MxA) – an interferon derivative that becomes elevated in the presence of acute viral infection and C-reactive Protein (CRP) – an acute-phase protein that is elevated in the presence of bacterial infection. This novel and proprietary pattern of results provides an accurate way to identify patients suffering from a clinically significant viral and/or bacterial acute febrile respiratory infection from those patients with a microbiologically unconfirmed respiratory illness (MURI).

Using only a fingerstick blood sample the FebriDx test can be performed by a nurse or technician during a patient's initial workup. Results are available for the clinician in as soon as ten minutes allowing a treatment plan to be established during the patient's initial visit.

"Obtaining the FebriDx CE mark is a significant milestone for RPS" said Robert Sambursky MD chief executive officer and president of RPS. "The FebriDx test will advance our goal to positively impact global healthcare by facilitating an earlier diagnosis helping to reduce the spread of disease and encourage the judicious use of antibiotics."

Acute febrile respiratory infections represent a major source of morbidity mortality and healthcare costs. Identifying a clinically significant respiratory infection and differentiating viral from bacterial etiology during the office visit is challenging because of overlapping symptoms and signs. According to Rattinger et al more than half of all antibiotics are prescribed to outpatients with acute respiratory infection; many of these prescriptions are not needed and lead to avoidable adverse reactions and antibiotic resistance.

Pending distribution arrangements the FebriDx test will soon be commercially available in Europe. The test has not yet been submitted for U.S. Food and Drug Administration (FDA) review.

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PositiveID and ENSCO Awarded Contract for U.S. Department of Homeland Security SenseNet Program

PositiveID Corporation ("PositiveID"), a developer of biological detection and diagnostics solutions, announced that it, in conjunction with its partner, ENSCO, Inc., has been awarded a SenseNet Program contract from the U.S. Department of the Interior on behalf of the U.S. Department of Homeland Security Science & Technology Directorate. The goal of this SenseNet award is to implement faster, less expensive bio-threat detection systems, using existing infrastructure where possible, to provide an added level of security.

As part of this award, PositiveID will offer its Firefly Dx system, which is a point-of-need system designed to deliver molecular diagnostic results using real-time PCR (polymerase chain reaction) chemistry. Firefly is designed to derive results from a sample in less than 20 minutes at the point of sampling, compared to two to four hours for a lab device, which would enable accurate diagnostics leading to more rapid and effective treatment than what is currently available with existing systems, helping to save lives. ENSCO will be responsible for the systems integration and decision support.

"We are pleased to work with ENSCO on this effort for the Department of Homeland Security's SenseNet program," stated William J. Caragol, Chairman and CEO of PositiveID. "We believe our Firefly Dx system, coupled with ENSCO's systems expertise, can provide an ideal solution for the biological detection capabilities that DHS is pursuing."

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BioInnovation Solutions and USAMRIID Develop DNA Sequencing Technology for Rapid Detection and Biosurveillance of Ebola Virus

BioInnovation Solutions SA, a Lausanne based company and pioneer in pathogen sequencing analysis assays and software, has announced with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) the development and testing of a sequence-based platform for rapid detection and surveillance of filoviruses such as Ebola and Marburg. The timely study, carried out under a Cooperative Research and Development Agreement (CRADA), will be published in the prestigious journal PLOS one. USAMRIID’s success using the Bioinnovation multiplex platform highlights the importance of biosurveillance as an early warning system, not only to prevent outbreaks such as the ongoing Ebola outbreak in West Africa, but also to provide an improved response capacity. This study will proceed further to develop sequence-based detection technologies to discover new host biomarkers and biothreats at preclinical levels.

BioInnovations DxSeq™ integrated with the Illumina MIseq next-generation sequencing system (NGS) was used to sequence filoviruses, including Ebola, Reston and Marburg, obtained from endemic areas. The combination of BioInnovation’s platform agnostic technology with any next-generation sequencing platform (including systems from Ion Torrent and Illumina) enables much faster and earlier detection of viral and bacterial pathogens and the discovery of new, previously unidentified strains.

“We are pleased with the success of this study, especially in light of the current Ebola outbreak and the declaration of a Global Emergency by the WHO,” said Pat Beyer, CEO of BioInnovation Solutions. “It is our hope that this technology can be deployed to the endemic areas as an early warning system for future outbreaks.”

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Primerdesign Develops Simple Diagnostic Test Solution to Contain Ebola Outbreak

High-tech British company Primerdesign Ltd, a spin-off company from the University of Southampton, has developed a fast and simple diagnostic test solution specific to the 2014 Ebola outbreak.

With the current epidemic of Ebola virus in West Africa, Primerdesign are racing to provide an easy-to-use, affordable solution for screening suspect Ebola patients.

"Accurate diagnostics is essential in controlling an outbreak like Ebola. There is an urgent need for rapid testing to screen suspected patients and people travelling in and out of the region," explains Dr Jim Wicks, Managing Director of Primerdesign. "Our test is quick, affordable and easy to perform," he adds.

The kit detects the DNA finger print of the Ebola Virus. It means that even minute quantities of the disease can be detected in the early stages allowing for pre-emptive healthcare intervention.

Primerdesign Ltd, which is part of the university business incubator collaboration SETsquared, has finished development work in the last few days and is meeting with the World Health Organisation to discuss plans to possibly put large numbers of these tests in to the front line in West Africa as quickly as possible.

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HHS Pursues Detection Tests for Influenza

Potential tests to help doctors diagnose influenza sooner and more accurately will advance in development under contracts from the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR). The tests could help boost influenza pandemic preparedness by increasing diagnostic capabilities in near-patient care settings such as doctors’ offices, clinics, and hospitals.

One award will advance the development of a simple, low-cost molecular test under a 3.5-year, $12.9 million contract with Alere Inc., headquartered in Waltham, Massachusetts. The other award, to InDevR Inc., of Boulder, Colorado, will allow a biochip test to move forward under a two-year, $7.9 million contract with options to extend the contract up to $14.7 million over four years.

The tests use different technologies to detect influenza viruses and offer different levels of information about the viruses detected. Both tests would use swabs taken from a patient’s nasal passage.

Alere will develop its iNAT Influenza A&B test which could yield results within 15 minutes and show whether a patient has an infection caused by a seasonal influenza virus type A or B infection. The company will conduct studies necessary to submit for U.S. Food and Drug Administration clearance or approval, including a Clinical Laboratory Improvement Amendments waiver for iNAT, which would allow the rapid molecular test to be performed in the near-patient settings.

InDevR will develop its FluChip-8G test to identify seasonal influenza viruses and recognize novel flu viruses within four hours in near-patient settings. Currently, this type of detailed genetic testing is conducted in state, federal, or specialty laboratories, and can take days to complete. If successful during the first two years, InDevR will conduct clinical studies necessary to submit for clearance or approval from the FDA and will develop a fully automated version of the test.

“Administering fast and inexpensive tests at the point of care has tangible benefits to personal and public health, particularly in helping doctors prescribe the right therapy immediately,” said Robin Robinson, Ph.D., director of ASPR’s Biomedical Advanced Research and Development Authority (BARDA) whose office will oversee the development programs. “Prescribing medication or other therapies in a more targeted way is good stewardship and will be critical to reducing the risk of antimicrobial resistance.”

Distinguishing viral influenza infections from bacterial infections could aid doctors and patients in choosing the best treatment, and could reduce unnecessary antibiotic use, as antibiotics are ineffective in treating illness caused by viruses. In addition, testing for influenza viruses in doctors’ offices, clinics, and hospitals could improve use of precautions among patients and health care workers to reduce spread of influenza from person to person.

Improved tests available in more settings can alert doctors and public health authorities to community outbreaks of respiratory illness and signal new viruses causing illness. A new influenza virus to which people do not have immunity could potentially spread quickly and have pandemic potential.

To help prepare the United States for pandemics, BARDA also is supporting development of other diagnostic platforms, including a test to identify drug resistance in influenza, as well as new vaccine technology, antiviral drugs, low-cost, portable ventilators and other medical equipment and supplies.

BARDA is seeking additional proposals for advanced development of new drugs and products to diagnosis and treat illness. Proposals are accepted through the broad agency announcement BAA-BARDA-13-100-SOL-19, available on www.fbo.gov.

These new programs are part of BARDA’s comprehensive integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear agents, pandemic influenza, and emerging infectious diseases.

ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security. HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. To learn more about HHS, visit hhs.gov.

To learn more about ASPR and preparedness, response and recovery from the health impacts of disasters, visit the HHS public health and medical emergency website, phe.gov. Information about influenza is available at flu.gov.

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Entamoeba histolytica Rapid Test Receives CE Mark

Alere Inc., a global leader in rapid diagnostics, announced today that the new E. HISTOLYTICA QUIK CHEK™ test, which identifies the Entamoeba histolytica parasite, has received CE Mark for sale in international markets outside of the United States. The test is developed and manufactured by TECHLAB® Inc.

Entamoeba histolytica is an intestinal parasite that infects an estimated 50 million people worldwide. Infected individuals can develop bloody diarrhea, colitis and liver abscesses, and up to 100,000 deaths from amebiasis are estimated annually.[1] E. histolytica disease has also been diagnosed in 12% of travellers returning from the developing world with acute diarrhea.[2]

"Accurate diagnosis of E. histolytica is very difficult because it is identical in appearance to a non-pathogenic species, Entamoeba dispar," said Dr. James Cottam, Alere Global Product Manager for Gastro-Intestinal Disease. "Currently available tests and microscopy cannot differentiate between the two species, often resulting in inaccurate diagnosis and inappropriate treatment."

Invasive E. histolytica infections can be treated effectively with antibiotics, whereas E. dispar colonization does not require treatment.[3] The current global antibiotic resistance crisis highlights the need for prudent antibiotic use. Inappropriate use of antibiotics can also result in adverse complications for patients, including C. difficile-associated disease.

The E. HISTOLYTICA QUIK CHEK test targets an adhesin unique to E. histolytica and is therefore the first rapid test available that can distinguish between pathogenic E. histolytica and non-pathogenic E. dispar. The test can be used for quick and reliable diagnosis of amebiasis.

"Achieving CE Mark for the new E. histolytica test enhances Alere and TECHLAB's position as  market leaders for gastro-intestinal disease diagnostics and is a testament to our strong partnership with TECHLAB," said Dr. Cottam. "By improving the accuracy of diagnostics for this important parasite, the E. HISTOLYTICA QUIK CHEK promises to be a significant help to clinicians, improving diagnosis and treatment decisions."

1. Buss, S. et al. (2008) Comparison of Two Immunoassays for Detection of Entamoeba histolytica. J. Clin. Micro. Vol 46, No. 8, pp.2778-2779.
2. Freedman, D.O. et al. (2006) Spectrum of Disease and Relation to Place of Exposure among Ill Returned Travellers. N. Engl. J. Med. 354;2.
3. Guerrant. G.L. et al (2011) Tropical Infectious Diseases: Principles, Pathogens and Practice. Vol 1. Enteric Amebiasis. Chapter 67:pp.685-702.

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Neogen Acquires BioLumix

Neogen Corporation announced today that, effective Sept. 30, it has acquired all the outstanding stock of BioLumix, Inc., an Ann Arbor, Mich.-based manufacturer and marketer of automated systems for the detection of microbial contaminants.

The BioLumix business will be consolidated with Neogen's closely related Soleris® technology, which is widely used for the detection of spoilage organisms in several food industries, as well as the nutraceutical market. The Soleris system was the first in the industry used for the detection of microbial contamination based upon an innovative application of well-accepted classical microbiology.

"Combining of the Soleris and BioLumix technologies, market bases, and outstanding technical staffs will greatly enhance both businesses and offer significant labor saving rapid solutions for the food, pharmaceutical, and personal care businesses," said James Herbert, Neogen's chief executive officer and chairman. "The combination also settles litigation of seven years between the two companies, and benefits existing customers of both companies moving forward."

The BioLumix test platform includes an instrument where test vials are incubated and automatically read for results, and an automatic system to alert users to sample results. The basic unit accommodates 32 different test vials at a time and can be combined in modules to accommodate up to 1,000 different samples simultaneously.

Test vials are the consumable portion of the platform and contain growth media and indicators for a number of different microorganisms. A sample is simply added to the vial, and the vial inserted into the instrument. BioLumix currently has 19 different microorganism tests. Specialized software shows test results as soon as detections occur, and avoids the need for involvement from a hands-on operator. The software also creates and maintains all the necessary audit trails to comply with various government regulations.

Terms of the agreement were not disclosed.

Neogen Corporation develops and markets products dedicated to food and animal safety. The company's Food Safety Division markets dehydrated culture media, and diagnostic test kits to detect foodborne bacteria, natural toxins, food allergens, drug residues, plant diseases and sanitation concerns. Neogen's Animal Safety Division is a leader in the development of animal genomics along with the manufacturing and distribution of a variety of animal healthcare products, including diagnostics, pharmaceuticals, veterinary instruments, wound care and disinfectants.

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Auburn University and Keesler Air Force Base Collaborate to Detect Antibiotic-Resistant Bacteria in 10 Minutes

Even as in vitro diagnostics manufacturers are bringing rapid molecular tests to market that can identify infectious diseases within hours, a research collaboration involving a major university and a medical laboratory at an air force base has demonstrated the ability to identify antibiotic-resistant strains of Staphylococcus in just minutes.

This innovative research is being done by Auburn University’s College of Veterinary Medicine and clinical laboratory professionals at Keesler Air Force Base. Funding is by the U.S. Air Force. This research was of particular interest to the military because the risk for Staph infection increases when individuals are subjected to unhygienic conditions in close quarters.

Rapid Detection of Antibiotic-Resistant Bacteria

The project is using microfluidic biosensor technology developed by Vitaly Vodyanoy, Ph.D., Professor of Physiology and Director of the Biosensor Laboratory at Auburn University. His technology can detect antibiotic resistant bacteria within minutes.

The technique specifically targets Staphylococcus (Staph), which was one of the first pathogens to be classified as a “Super Bug”. It becomes deadly in immune-compromised patients or in internal organs, such as lungs or the respiratory tract, noted a report published by Science Daily.

Biosensor Technology Cuts Time to Diagnose ‘Super Bugs’ to Minutes

“In our method, we can determine bacterial antibiotic resistance in 10-12 minutes, while other methods take hours,” explained Vodyanoy, noting that methods traditionally used to detect antibiotic resistance require time-intensive purification steps before multi-hour sequencing protocols.

The hypothesis behind this method is new: it uses stress activation of biochemical pathways—that are targets of antibiotics—to accelerate antibiotic susceptibility testing.

“Our technique is complex and involves many steps and disciplines,” stated Vodyanoy in a press release issued by Journal of Visualized Experiments. This journal published the study about this biosensor technology.

Technology Takes Advantage of Harmless Virus That Kills Bacteria 

As explained by Vodyanoy, the technology involves a rapid microfluidic method for antibiotic susceptibility testing in a stress-based environment. Fluid containing bioteriophages, or phages, and antibody beads is passed at high speeds over bacteria immobilized on the bottom of a microfluidic channel. Phages, and antibody beads can discriminate between methicillin resistant (MRSA) and sensitive Staph bacteria because phages are immobilized by a Langmuir-Blodgett method onto the surface of a quartz crystal microbalance sensor and work as broad range Staph probes. In the presence of stress and an antibiotic, susceptible strains of bacteria die rapidly. Resistant bacteria, however, survive these stressful conditions. The antibody beads recognize MRSA.

The new biosensor technology takes advantage of bacteriophages. These are simple viruses that can target and kill bacteria, but are benign in humans. A bacteriophage, when combined with specific antibodies, produces a color change in a sample that indicates antibiotic resistance.

The standard parts of Vodyanoy’s method include bacterial culture protocols, defining microfluidic channels in polydimethylsiloxane (PDMS), cell viability monitoring with fluorescence, and batch image processing for bacteria counting. Innovative parts of the method are used in culture media flow for mechanical stress application, enzymes to damage but not kill the bacteria, and microarray substrates for bacterial attachment.

Technology Offers Labs Quick, Cost-Effective Method to Diagnose MRSA

This technology, with its promise of a very fast time-to-answer, could provide medical laboratories with a quick and cost-effective way to diagnose Super Bugs in patients. It would be particularly useful in hospital, prison, and military settings.

“We envision a future where clinicians do tests with real blood or saliva samples,” predicted Vodyanoy. “We are interested in someone else reproducing our results [of our research study]. This technology can be used on a larger scale and for antibiotic resistance other than Staphylococcus.”

Vodyanoy also hopes to apply the technology to making antimicrobial surfaces and glassware that kill the bacteria. Of course, this technology is years away from gaining FDA clearance for clinical use. What should interest pathologists, microbiologists, and clinical laboratory managers is how Vodyanov and his collaborators are using multiple technologies in new ways to deliver a lab test result in a short amount of time with acceptable sensitivity and specificity.

Source: Dark Daily

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Alere Awarded U.S. Government Contract to Advance Development of Point-of-Care Molecular Diagnostic for Pandemic Influenza

Alere Inc., a leading global provider of point-of-care rapid diagnostics, today announced that it has entered into a contract with the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) to develop diagnostic countermeasures for pandemic influenza.

Under the terms of the 3.5 year contract, BARDA will provide up to $12.9 million to support the development of a rapid, molecular, low-cost influenza diagnostic device with PCR-like performance at the point-of-care. The project is designed to help support future preparedness and medical response to an influenza pandemic. Funding from BARDA is subject to successful completion of various interim feasibility and development milestones as defined in the agreement. In connection with Alere's development of a rapid, molecular, low-cost influenza diagnostic device, Alere will be responsible for conducting clinical trials to support FDA 510(K) clearance and obtaining CLIA waiver as well as manufacturing and commercializing the resulting molecular influenza test.

Alere will use the funding to develop the next generation of its current Alere(TM) i Influenza A & B test, which improves rapid flu testing by providing highly accurate, molecular results in under 15 minutes. Alere i Influenza A & B was launched in January 2014 in Europe and received clearance from the U.S. Food and Drug Administration (FDA) in June 2014.

The next-generation product platform will be intended for even more widespread use outside of the traditional healthcare system, while not compromising the level of clinical performance.
"Being awarded the BARDA contract is further validation of the significant benefits provided by the Alere i molecular technology," said Avi Pelossof, Alere Global President, Infectious Disease. "We look forward to working with BARDA on the development of a next-generation Alere i Influenza test that will deliver the same high performance at a lower cost, making it even more accessible for use in any environment."

Advanced development of Alere's next-generation molecular influenza test is part of BARDA's comprehensive approach to developing medical countermeasures for pandemic flu preparedness. The program includes developing vaccines, therapeutics, diagnostics and non-pharmaceutical countermeasures for influenza preparedness and building and sustaining facilities for their domestic manufacturing.

According to the U.S. National Strategy for Pandemic Influenza, the influenza virus causes 36,000 deaths and more than 200,000 hospitalizations each year. In addition to this human toll, influenza is annually responsible for a total cost of over $10 billion in the U.S. These numbers have the potential to grow exponentially if a worldwide outbreak, or pandemic, of a new influenza virus occurs.[1] According to the World Health Organization, three pandemics occurred in the 20(th) century. The most severe occurrence (1918-1919) caused the deaths of between 20-40 million people worldwide.[2]

[1] U.S. National Strategy for Pandemic Influenza, http://www.flu.gov/planning-preparedness/federal/pandemic-influenza.pdf, p. 1.
[2] World Health Organization, Pandemic Influenza Risk Management - WHO Interim Guidance, http://www.who.int/influenza/preparedness/pandemic/GIP_PandemicInfluenzaRiskManagementInterimGuidance_Jun2013.pdf?ua=1, Table 3, p. 19.

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