Saturday, August 22, 2015

Targeted Next-Generation Sequencing Takes On Growing Role in Pathogen Detection

Earth is now home to some 7.2 billion people, but in and around each individual are an estimated 100 trillion bacteria, viruses and other microorganisms. These variable species are responsible for many human ailments, ranging from mild and asymptomatic, to fatal infections. Re-emergence of the deadly Ebola virus in West Africa early last year is the most recent high-profile example. However, less publicized infections, such as bacterial sepsis, continue to claim hundreds of thousands of lives each year and drain billions of healthcare dollars.

The impact can be partially attributed to the methods historically used to root out these pathogens. In the past, scientists identified bacterial species by isolating and growing them in culture, a sometimes unreliable process. Since most require different environments for optimized growth, only a few microbial species can be detected at one time. Perhaps the greatest limitation to this approach is the time it takes for cultures to generate results. Doctors who are treating patients with a critical infection must wait at least two days or more for information – time that can mean the difference between life and death. This is precisely why many clinicians begin treating their patients with antibiotics before results are available. It’s a hit-or-miss approach, as the prescribed treatment may not have an effect on the bacterial strain present. Furthermore, if results eventually point to a virus, the battery of antibiotics will have been prescribed in vain, as they don’t have any effect on viral infections.

Pathogen detection is an emerging application where targeted, next-generation sequencing (NGS) holds great potential. Not only can it quickly identify all species in a given sample and guide targeted treatments, it can also be useful to track the evolution of microorganisms, allowing public health officials to develop proactive strategies to help them stay ahead of deadly outbreaks.

NGS in the field

The 2014-2015 Ebola outbreak in West Africa served as a sobering reminder of the ongoing threat that viruses pose. The deployment of NGS platforms, complemented by traditional qPCR instruments, by several groups is demonstrative of the valuable data that can be rapidly generated to better understand the molecular nature of a deadly pathogen.

While infection rates have peaked, the virus has persisted in Sierra Leone. To bring much needed assistance and public health vigilance to that region, Thermo Fisher Scientific embarked on a collaborative effort with the University of Cambridge, Wellcome Trust Sanger Institute, Public Health England, International Medical Corps, Ministry of Health and Sanitation Sierra Leone. The goal is to leverage NGS to monitor mutations in the virus and upload that data to the web in real-time. Until now, researchers had to wait for the data to be published in peer-reviewed journals. This approach is designed to expedite research among the global scientific community, potentially delivering solutions faster. The team in Sierra Leone has since released the first data set, enabling researchers to begin developing a deeper understanding of where and how the virus is spreading. With improved surveillance, progress may be made toward preventing future outbreaks.

Speed to results is key in pathogen detection applications and it’s an area where targeted NGS can deliver. However, access to a large body of genomic data that supports bacterial and viral identification is also critical. To date, millions of human genes have been sequenced, which provide a point of reference for scientists to routinely isolate mutations and pinpoint their contribution to disease. Microorganisms, on the other hand, remain elusive. Some have never been sequenced. For those that are, it can be extremely difficult to cross-reference microbe databases to find the species of interest. Until recently, much of this process was performed manually.

Central database key to effective mitigation

Rapid microbial identification is an invaluable tool for public health officials as they track infectious disease outbreaks throughout the world. The challenge has been in building the curated databases that allow identification and real-time microbe monitoring. To address this need, the Centers for Disease Control and Prevention (CDC) have developed MicrobeNet, an online library of known microbial sequences. In 2015, the CDC adopted MicrobeBridge, a software platform designed to seamlessly connect sequencing results to the CDC’s database.

The novel tool enables researchers to more easily access the public health information stored in MicrobeNet. It simultaneously informs laboratory-based surveillance and improves the general understanding of disease outbreaks with the ability to cross-reference data. Through MicrobeNet and similar initiatives, including the Human Microbiome Project, science can now make greater strides applying genomics to pathogen detection and mitigation.

Blood-borne pathogens

Diseases such as lung cancer remain in the crosshairs of research scientists and oncologists alike, and therapeutic advancements are being made. Yet in the United States, more people die each year from a largely unknown condition called sepsis. Triggered by a bacterial or fungal infection of the blood, sepsis mortality can be as high as 30 percent in certain patient demographics. Each hour that passes without treatment increases mortality by 8 percent; yet traditional culture-based methods to identify the causal organism and determine drug susceptibility can take at least two days or longer.

Using targeted NGS technology, researchers can isolate and characterize a pathogen directly from blood, bypassing culture steps and delivering results in less than one working day. Blood-based sequencing definitively identifies microbe species and can provide an indirect phenotype characterization to inform treatment decisions. The presence or absence of virulence factors, for example, can provide information about how easily the virus spreads, and certain genes can also help predict drug susceptibility.

Scientists are beginning to maximize the potential of targeted NGS to scale up and characterize multiple species in tandem. Researchers at the University of Arizona Cancer Center have drawn on this strength to classify unknown bacteria strains swabbed from diabetic foot ulcers. In any particular patient, multiple bacteria communities may be contributing to disease progression, which could explain why some wounds fail to heal. With NGS technology, researchers can clearly distinguish between the populations by uncovering the small snippets of ribonucleic acid (RNA) unique to each microbial species. Once again, the sequencing data can help guide a targeted and more effective treatment.

While targeted NGS has proven to be an effective and still-evolving tool in the field of cancer genomics, science is starting to realize its potential in the field of pathogen detection. Access to real-time sequencing data is currently driving mitigation strategies in even more recent global cases, such as the Middle East respiratory syndrome (MERS) and avian influenza virus (AIV) outbreaks. As in cancer, which has benefited from vast amount of genomic data collated through years of research, the field of pathogen detection will strengthen as central databases continue to build and inform public health labs with critical data to help identify and characterize the microorganisms around us. With an estimated 100 trillion of them in our midst, we have our work cut out for us.

Source: Bioscience Technology

Roche Buys US-based Microbiology Diagnostic Company, GeneWEAVE

Roche, a leader in research-focused healthcare, has signed a definitive agreement to acquire GeneWEAVE BioSciences, Inc. (GeneWEAVE), a privately held company focused on innovative, clinical microbiology diagnostics solutions based in Los Gatos, California, USA.

Under the terms of the agreement, Roche will pay GeneWEAVE shareholders USD 190 million upfront and up to USD 235 million in contingent product related milestones. The transaction is subject to customary closing conditions and, once closed, GeneWEAVE will be integrated into Roche Molecular Diagnostics.

The acquisition provides Roche with GeneWEAVE’s Smarticles technology, an innovative class of molecular diagnostics that quickly identifies multidrug-resistant organisms (MDROs) and assesses antibiotic susceptibility directly from clinical samples, without the need for traditional enrichment, culture or sample preparation processes. GeneWEAVE’s first system in development is the vivoDx—a fully automated, random-access system designed to meet the needs of laboratories addressing MDRO detection and antibiotic therapy guidance. The technology is currently being evaluated in multiple sites across the US.

“With GeneWEAVE, we further strengthen our microbiology diagnostics offerings with cutting-edge technology that will aid in the fight against drug-resistant bacteria. This technology has the potential to provide healthcare professionals access to quick and accurate diagnoses that can lead to rapid, informed treatment decisions,” said Roland Diggelmann, chief operating officer of Roche Diagnostics.

“We welcome GeneWEAVE’s employees, who will continue to focus on the development and manufacturing of diagnostics solutions based on the Smarticles technology.”

“We are very excited to continue developing innovative microbiologic diagnostics solutions as part of the Roche Molecular Diagnostics team,” said Steve Tablak, chief executive officer of GeneWEAVE.

“Roche is the ideal company to deliver on the promise of our Smarticles technology. We are fully committed to the continued success of GeneWEAVE’s employees, products and pipeline.”

New Jersey Beach Act Aims for Faster Results on Bacteria Tests

The public would get speedier water-quality test results under revamped Beach Act legislation touted by federal lawmakers at the gazebo in Pier Village.

Tests results would be made available to the public in a couple hours under the new measure, compared with up to two days under prevailing testing methods.

“Clean, safe and healthy beaches are vital to our state’s economy and give beach goers the peace of mind they need to enjoy this incredible resource,” said U.S. Rep. Frank Pallone Jr., D-N.J.

The Beach Act, established in 2000, set national water-quality standards and provided states with grants to test water quality and notify the public when conditions are unsafe.

The U.S. Environmental Protection Agency has estimated that up to 3.5 million people become sick from contact with raw sewage from sanitary sewer overflows each year.

Pallone and late-Sen. Frank Lautenberg, D-N.J., were the authors of the original bill. Pallone and Sen. Robert Menendez, D- N.J., said Thursday they will introduce the Beach Act of 2015 when Congress returns from recess in September.

Supporters of the law have pushed for same-day testing in the re-authorization, so beach goers can find out about bacteria levels before they go the beach.

Current water-quality monitoring tests take 24 to 48 hours to produce reliable results, during which many beach goers can be unknowingly exposed to harmful pathogens, officials said.

“The Beach Act is one of the most important laws protecting our beaches but it is now 15 years old, and needs to be updated to require faster testing and reporting, tests after storms, and permanent funding,” said Cindy Zipf, executive director of Clean Ocean Action.

The re-authorization legislation mandates the use of rapid testing methods by requiring EPA to approve methods that detect water contamination in two hours or less, so that beaches can be closed shortly thereafter.

Under the Beach Act, the EPA is required to work with states to ensure they use the latest science to sample and test beach waters to protect the public’s health.

If tests come back positive for contaminants the state is then required to close the beach until it is clean. The law also helps states set up and operate comprehensive monitoring and notification programs in order to provide up-to-date information on the condition of all public beaches.

“The Beach Act is really about accepting our responsibilities as stewards of our incredible coastal environment,” said Menendez. “And, it’s about making sure that if you’re spending a day out on the water and bringing your family to the beach, you’ll never have to question whether the water is safe enough for your children to swim.”

Each summer, tourism at New Jersey's beaches produces $36 billion in economic activities and supports nearly 500,000 jobs.

Friday, August 07, 2015

Rapid Diagnostic Testing for Malaria Reduces Overprescribing in Uganda

The introduction of rapid diagnostic tests for malaria in registered drug shops improved treatment of the disease in Uganda, according to the results of a randomized trial.

Rapid diagnostic tests for malaria (mRDTs) were established in 20 geographical clusters of registered drug shops in Uganda’s Mukono district. A cluster was defined as a grouping of one or more registered drug shops within one administrative area.

The researchers randomly assigned 10 clusters to the intervention arm, consisting of the diagnostic confirmation of malaria using mRDT followed by artemisinin-based combination therapy (ACT). In the 10 clusters assigned to the control arm, febrile patients were treated presumptively with ACT.

From January 2011 to December 2011, 15,517 eligible patients with fever sought treatment from one of the 59 registered drug shops enrolled in the study, according to the researchers. Drug shop staff were trained in appropriate malaria diagnosis and treatment, and staff in the control arm were trained how to presumptively diagnose malaria.

Most febrile patients (97.8%) purchased an mRDT from a drug shop; 58.5% had positive test results. The researchers verified that 95% of these readings were accurate.

The majority of drug shop vendors adhered to the test results; only 49 (1.5%) of mRDT-negative patients were referred to ACT, according to the researchers.

Overall, mRDT testing helped substantially reduce antimalarial prescriptions. Of the patients in the mRDT test group, 62.5% received ACT vs. 99.8% in the presumptive diagnosis arm, the researchers wrote. With mRDT, overprescription of malaria drugs was reduced by 72.6%.

“Our findings show that it is feasible to collaborate with the private health sector and introduce malaria rapid diagnostic tests in drug shops,” study researcher Anthony K. Mbonye, PhD, commissioner of health services at the Ugandan Ministry of Health, said in a press release. “The next step is to refine the strategy and understand the cost implications of scaling it up in Uganda. Our long-term aim is to provide evidence to help [WHO] develop guidance to improve malaria treatment in the private sector.”

Source: Healio

Cardiff-based BBI Applies for Emergency use of Rapid Ebola Test

A RAPID test for Ebola believed to have the potential to speed up diagnosis and halt the spread of the killer virus is being manufactured in Dundee.

The BBI Group has applied to the US Food and Drug Administration for Emergency Use Authorisation to allow the assay to be used to screen patients suspected of carrying the infection, and how they are then managed.

The lateral flow assay allows testing to be carried out at the bedside of patients, and does not require to be assembled by medical workers in the field.

This contrasts with the PCR (polymerase chain reaction) or molecular test for Ebola, which tests for the disease at a DNA level and requires laboratory conditions.

Cardiff-based BBI, which has had a site in Scotland since acquiring Dundee’s Alchemy Laboratories in 2006, says that with minimal training local health teams can complete tests at bedside and have a result within 20 minutes.

It believes the test, developed in collaboration with the Defence Science and Technology Laboratory, has the potential to be deployed at borders in the future to monitor and control the spread of the virus.

Fiona Marshall, managing director of BBI Detection, said the development of the kit could bring more jobs to Dundee, where the company currently employs 80 staff. The headcount has already grown by 15 in the last year.

Ms Marshall said: “What it means is we need to increase our assembly capability, so we take on local assembly workers.

“We also have been looking for scientists as well – as soon as you bring more tests on board it means you need to bring more scientists, more assembly workers and, because it is a regulated product, more expertise around regulation as well.”

The test kit currently before the FDA uses an integrated AtomoRapid platform, which reduces the number of components in the kit. This simplifies the process for end users while reducing the risk of user error and cross contaminiation.

BBI, which hopes to launch the product in the third quarter after gaining approval, has held talks with a distributor in Ghana.

The company plans to evaluate a second version of the test in combination with the Novarum DX smartphone reader, which will allow users to read and share test data.

This has the potential for patients and field workers to connect instantly with medical experts, with GPS technology allowing disease hotspots to be tracked and monitored.

Ms Marshall said earlier format of the assay has been trialled in Sierra Leone, where a 100 per cent detection rate was achieved among the 138 patients enrolled in testing. It was also tested in Liberia.

Since the initial outbreak was reported around a year ago, more than 27,000 number of Ebola cases have been reported, leading to 11,000 deaths in West Africa to date.

There was excitement last week about the potential of a vaccine that pharmaceutical giant Merck is developing to protect against the Ebola virus.

But while it was reported several weeks ago that Liberia was free of the disease, the World Health Organisation has subsequently said that 25 new cases are being presented each week.

Ms Marshall said: “They’re worried again there is going to be effectively a new outbreak on the horizon – they have obviously not completely got rid of it.”

Asked if there are comparable products available, Ms Marshall said there are companies operating at a similar stage. But she noted: “The pioneering thing about ours is the actual platform is on. Because it is all integrated in one it makes it so much easier to use.”

Ms Marshall added: “In terms of the performance of the assay compared to other assays, ours is performing better than other assays. In terms of PCR, which is the laboratory-based assay, it’s not performing as well, because that is the nature of lateral flow.

“But the fact you can use it at a bedside or point of care, and you don’t have to go into a laboratory to be tested makes it so much easier to use.”

Ms Marshall believes the test is cost effective, but noted: “Is it a dollar a test? No. It hasn’t become a commodity like malaria tests have at the moment.”

The Ebola test is the first BBI has taken from conception through to market. Until now it has typically manufactured assays for other companies, including ‘flu assays and a test for deep vein thrombosis.

Orasure Technologies Receives FDA Emergency Use Authorization for Ebola Rapid Diagnostic Test

OraSure Technologies, Inc., a leader in point of care diagnostic tests and specimen collection devices, announced today that it has received a U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for its OraQuick® Ebola Rapid Antigen Test for use with fingerstick and venous whole blood.

This test has not been cleared or approved by FDA. This test has been authorized by FDA under an EUA for use by laboratories and facilities adequately equipped, trained, and capable of testing for Ebola infection (including treatment centers and public health clinics).

The OraQuick® Ebola Rapid Antigen Test utilizes the OraQuick technology platform which is the same proven technology used in the Company's rapid HIV and HCV antibody test kits. This authorization allows the use of the OraQuick® Ebola Rapid Antigen Test for the duration of the U.S. Secretary of the Department of Health and Human Services' (HHS) August 5, 2014 declaration that circumstances exist to justify the emergency use of in vitro diagnostic tests for the detection of Ebola virus, unless the EUA is terminated or revoked sooner.

The OraQuick® Ebola Rapid Antigen Test is designed to detect viral antigens in fingerstick and venous whole blood from patients presenting with signs and symptoms of Ebola infection in conjunction with epidemiological risk factors. The test is authorized only for the detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014). Positive (reactive) results may be read as soon as they appear and have been observed as early as 4 minutes. Negative (non-reactive) results have to be read at 30 minutes. The test can be used at ambient temperatures (up to 40°C / 104°F), is easy to use with only two operational steps, a simple visual read, and does not require instrumentation. Additionally, the test is shelf stable in a wide range of storage conditions.

"The OraQuick® Rapid Ebola Antigen Test is an easy to use, rapid test, that we believe will be a critical tool in containing and controlling current outbreaks of the Ebola virus," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "We are grateful to the FDA for working closely with us throughout the EUA process to expedite deployment of our test."

This project has been funded in whole or in part with Federal funds from the U.S. Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201500009C. OraSure has been awarded a contract for $1.8 million, with the potential of $10.4 million in total funding if all options are exercised from BARDA to advance clinical development of its rapid Ebola test. The Company continues to focus its efforts on securing sustainable product purchase commitments from both government and non-government sources.

Critical reagents in the OraQuick® Ebola Rapid Antigen Test are being supplied by the Viral Hemorrhagic Fever Consortium (VHFC; and the Biological Defense Research Directorate at the United States Navy Medical Research Center (NMRC). The VHFC reagents were developed with the support of the National Institute of Allergy and Infectious Diseases of the National Institutes of Health ("NIH/NIAID"). VHFC members, Autoimmune Technologies LLC, and Zalgen Labs LLC manufacture the critical reagents.

Saturday, August 01, 2015

Point-Of-Care Diagnostics For Ebola

In a recent DECODED research profile, Integrated DNA Technologies (IDT), details how IDT scientists Kristin Beltz and Dr Scott Rose are collaborating with Dr Brian Taylor’s research team at Battelle (Aberdeen, MD, USA) to design and validate a RT-qPCR assay that can detect the Ebola virus in the field. The IDT PrimeTime Ebola qPCR Assay detects Zaire ebolavirus, the species involved in the 2013–2015 West African Ebola outbreak. Initial sensitivity and specificity results were presented at the 2015 Chemical and Biological Defense Science and Technology Conference (St. Louis, MO, USA). The researchers noted that the assay has a PCR efficiency of 98.9% and that use of ZEN Double-Quenched Probes (IDT) lowers assay background and increases signal compared to traditional single-quenched probes in qPCR assays.

It can be difficult to distinguish Ebola from other infectious diseases, and current diagnostic tests are time-consuming and complex. They also create challenges related to sample storage and transportation, laboratory biosafety, and staff expertise in performing the assays. Having access to simple, rapid, and accurate viral testing in remote villages would be extremely useful for quelling this and future epidemics. With this goal in mind, Dr Paul Pickering (Ubiquitome Limited, Auckland, New Zealand) is spearheading the project to develop the assay for use with the Ubiquitome Freedom4 device. This portable PCR machine processes 4 reactions (sample plus negative, positive, and extraction controls) in approximately 1 hour, and is easily controlled via an iPhone or laptop. The Freedom4 device eliminates the need for sample preservation and transportation to a laboratory-based testing facility, and can simply be brought to remote locations for use during time-sensitive, public health situations.

The Freedom4 and the PrimeTime Ebola qPCR Assay are now being submitted to the US FDA for Emergency Use Authorization.

Alternative Method for P. aeruginosa Testing in Drinking Water Now Approved by the German Federal Environment Agency (UBA)

IDEXX (USA) recently announced that its Pseudalert test and Quanti-Tray, used for the 24 hour confirmed enumeration of Pseudomonas aeruginosa (P.aeruginosa), has been included as a microbial detection method in the list of alternative methods issued by the UBA (The German Federal Environment Agency). This inclusion has been granted in accordance with the 2001 Enforcement of Drinking Water Regulations (15 Abs.TrinkwV 2001).

In its statement, the Federal Environment Agency accepted Pseudalert and Quanti-Tray in accordance with its rules. The decision to include the new method followed evaluation of comparative tests done in accordance with DIN EN ISO 17994.

The use of Pseudalert and Quanti-Tray was judged to be an acceptable alternative method to the reference method DIN EN ISO 16266 for detection of P. aeruginosa. In addition, the standard for pool water (DIN 19643) refers to the acceptance of approved alternative methods for drinking water and allows those methods to be used for pool water testing. Therefore, Pseudalert is also allowed to be used as an alternative method for pool water testing under DIN 19643.

The IDEXX Pseudalert test is a rapid method for the detection of P.aeruginosa in drinking and recreational water. It was launched in 2012 by IDEXX to complement a growing portfolio of water microbiological testing solutions, to monitor recreational water where elevated levels of the bacteria can give rise to problems such as “hot-tub rash” (folliculitis) and other infections. Pseudalert has also been adopted by utilities and the bottled drinking water industry as a fast, effective quality control test. For vulnerable populations in hospitals P.aeruginosa infections can cause life-threatening conditions including pneumonia, meningitis and septicemia. A confirmed and quantified result can be achieved in 24 hours with Pseudalert, less than half the time taken by standard methods. This allows results to be determined faster and remedial actions to be taken sooner.

“This latest validation of one of our products is testament to the research and development IDEXX has undertaken over the years to provide rapid, efficient and reliable test methods to monitor water quality,” commented Andrew Headland, Senior Business Manager, IDEXX EMEA.

The IDEXX Pseudalert test is based on a bacterial enzyme detection technology that signals the presence of P. aeruginosa through the hydrolysis of a substrate in the Pseudalert reagent. P. aeruginosa cells rapidly grow and reproduce using the rich supply of amino acids, vitamins and other nutrients present in the Pseudalert reagent. Actively growing strains of P. aeruginosa have an enzyme that cleaves the substrate in the reagent to produce blue fluorescence under ultraviolet light.

Pseudalert, which  recently won the prestigious ‘Product Innovation in Healthcare’ Award at the Institute of Healthcare Engineering and Estate Management’s (IHEEM) Annual Exhibition in the UK, detects P. aeruginosa at 1 CFU in standard 100ml water samples and gives a confirmed, quantified result within 24 hours.

Neogen Launches NeoSeek™ Salmonella Serotyping Service

Neogen Corporation has announced the development of a detection and identification technology that provides DNA-specific test results for pathogenic serotypes of Salmonella.

Neogen’s new NeoSeek™ pathogen DNA identification method for Salmonella can provide genomic-based serotypes (e.g., Salmonella enterica Enteritidis and Salmonella enterica Heidelberg) in as little as 72 hours from suspected Salmonella positive isolates. The serotypes identified by the NeoSeek service include all of the “top 30” Salmonella serotypes identified by the Centers for Disease Control and Prevention as being the leading causes of human Salmonella infections since the agency instituted its national surveillance program for Salmonella in 1962.

“The rapid detection and identification of specific strains, or serotypes, of Salmonella can be critical to preventing foodborne illness, or rapidly responding to an existing outbreak,” says Ed Bradley, Neogen’s vice president for food safety. “NeoSeek’s Salmonella serotyping service provides a much quicker, definitive alternative to the conventional biochemical identification of Salmonella serotypes from presumptively positive Salmonella isolates.”

The NeoSeek Salmonella serotyping method was developed through a close collaboration with Dr. Jean Guard of the U.S. Department of Agriculture’s Agricultural Research Service. The process enables seamless identification of Salmonella serotypes from Next Generation DNA sequencing data generated by Neogen’s GeneSeek genomics laboratory in Lincoln, NE.

Rapid Ebola Test Could Play Key Role in Efforts to End Lingering Outbreak

Research presented at the 2015 AACC Annual Meeting & Clinical Lab Expo will expand on the studies that led to a fingerprick Ebola test becoming the first and only rapid diagnostic for this disease to receive approval from the World Health Organization (WHO). This test could prove vital to breaking Ebola's grip on West Africa by identifying suspected Ebola cases within minutes, and enabling healthcare workers to isolate and treat these patients much faster than is currently possible.

More than 11,000 people have died since the Ebola epidemic began in March 2014, and though cases have been declining, the international emergency response that the outbreak prompted has not been able to drive the virus back underground. The fight against the disease achieved a significant victory in May, when Liberia—one of the nations hardest hit by the virus—was declared Ebola-free by WHO. Less than 2 months after this win, however, new cases of the disease were discovered in the country. The first of these was a 17-year-old boy who was misdiagnosed with malaria and who, before passing away, came into contact with at least 102 people who may have caught the disease from him. This case tragically illustrates the need for a fast way to accurately identify Ebola cases so that patients get the care they need and transmission can be halted.

The Viral Hemorrhagic Fever Consortium, which is led by Tulane University and the diagnostic company Corgenix, has developed such a rapid test for Ebola. Called the ReEBOV Antigen Rapid Test Kit, this test uses a few drops of blood and the same technology used in at-home pregnancy tests to provide results in 15 minutes. In comparison, the current gold standard test for Ebola, qRT-PCR, can take up to a day to return a diagnosis.

Matt Boisen, Program Director of Infectious Diseases and Emerging Technologies at Corgenix and Development Director of In Vitro Diagnostics at the Viral Hemorrhagic Fever Consortium, will present the findings of two studies by WHO and Corgenix, respectively, demonstrating ReEBOV's efficacy at the 2015 AACC Annual Meeting. The WHO study, conducted in Ebola-hotspot Sierra Leone, compares ReEBOV's performance with that of qRT-PCR. By testing 292 stored patient samples with both methods, researchers found that ReEBOV performed nearly as well as the gold standard, and agreed with qRT-PCR on 91.8% of infected samples and 84.6% of non-infected samples. ReEBOV's accuracy was also recently confirmed by a third separate study published in The Lancet. This means that ReEBOV could be used as a complement to qRT-PCR, enabling healthcare workers to act immediately on potential Ebola cases without having to wait for the qRT-PCR results to come in.

"All three studies—our internal emergency use authorization study, the WHO study, and The Lancet paper—show that the rapid test can provide a plus 90 percent accuracy when paired with the PCR test," said Boisen. "This really establishes that the rapid test can be used as a triage method to quickly provide patient results that can later be confirmed by PCR. This represents a breakthrough in the detection of Ebola for this and future Ebola virus outbreaks."