Friday, September 26, 2014

miacom diagnostics Receives Health Canada Approval for hemoFISH Rapid Blood Culture Assay

miacom diagnostics GmbH today announced that their proprietary hemoFISH assay for the identification and differentiation of bacterial pathogens from positive blood culture bottles is now commercially available in Canada. The hemoFISH assays are the first Health Canada approved tests out of miacoms´ diagnostic portfolio.In cooperation with Nova Century Scientific as a distributor Canada is the first country on the North American continent to have this rapid test. Nova Century Scientific is a leader in the manufacture and distribution of diagnostic kits and laboratory supplies for hospitals clinical laboratories and research institutions across Canada.

“We are happy to provide a new reliable tool for the rapid diagnostic of pathogens from blood cultures to our customers here in Canada. At NCS our mission is customer satisfaction” said Walter Schmidt CEO Nova Century Scientific “We are a company committed to meeting customer requirements and enhancing customer satisfaction through continual improvement of its products services and the quality of management.” Nova Century Scientific supports its broad range of quality laboratory products with personalized customer service and responsive technical support.

One of the first hospitals in Canada to use the new rapid test system is the Oakville Trafalgar Memorial Hospital which is part of the Halton Healthcare Services. “Having a relatively simple low capital cost test system that provides multiple pathogen identifications beyond the Gram stain within 30 minutes after a blood culture bottle turns positive may enable earlier directed antibiotic therapy even discontinuation (e.g. coagulase negative Staphylococcus). In conjunction with a local antibiogram the organism ID should facilitate treatment decisions by an antibiotic stewardship team.” highlights Dr. Neil Rau medical microbiologist and infectious diseases specialist.

The miacom assay combines a new way of sample handling with a specific optical marking of the pathogenic agents aiming for an identification and differentiation of various bacteria in 30 minutes. The assay can be easily implemented in nearly every laboratory since it does not require complicated hardware or special environment conditions.

“We´re proud to be able to offer practical solutions for special need by approved tests that are truly unique in the market” said Dr. Mirko Stange CEO of miacom diagnostics. For full diagnostic range the following products will be available: hemoFISH Gram (-) Panel (identification of Gram negative bacteria) hemoFISH Gram (+) Panel (identification of Gram positive bacteria) and hemoFISH Masterpanel (identification of Gram negative bacteria & Gram positive bacteria).

3M Listeria monocytogenes Molecular Detection Assay Earns AOAC PTM Approval

3M Food Safety announced today that its 3M™ Molecular Detection Assay Listeria monocytogenes has been approved by the AOAC® Performance Tested MethodsSM program (Certification #051401). The approval certifies that the test kit, which helps food processors and other parties quickly and accurately detect Listeria monocytogenes, is now considered equivalent or better than standard reference methods for select food matrices by the international organization. The assay provides rapid results in as little as 24 hours of enrichment – days faster than the standard methods.

Select food samples analyzed during the validation study include full fat cottage cheese, chocolate milk, beef hot dogs, deli turkey, cold smoked salmon, bagged raw spinach, romaine lettuce and whole cantaloupe. Testing also covered environmental surfaces including stainless steel and concrete.

In a related development, the 3M™ Molecular Detection Assay Listeria species has received a matrix extension by the AOAC® Performance Tested MethodsSM program (Certification #081203). The test kit has received the PTM extension for the following matrices: full fat cottage cheese, beef hot dogs, deli turkey, cold cooked salmon, bagged raw spinach, whole cantaloupe, as well as environmental surfaces including stainless steel and concrete.

“These latest validations for the 3M Molecular Detection Assays further demonstrate 3M’s commitment to providing fast, reliable, and highly accurate pathogen detection solutions that meet the most stringent requirements,” said John David, Global Marketing Supervisor with 3M Food Safety. “With the 3M™ Molecular Detection System, food processors and testing laboratories can test for multiple pathogens with confidence using a single, easy assay protocol that increases productivity in the lab.”

Achieving AOAC PTM status for these assays required a rigorous, independent laboratory examination of 3M’s unique molecular test method’s ability to accurately detect Listeria monocytogenes and Listeria spp. within a variety of intentionally contaminated food matrices. No statistically significant differences were found in the sample results between the 3M Molecular Detection Assays when compared to conventional reference methods.

The 3M™ Molecular Detection System is based on unique isothermal DNA amplification and bioluminescence detection technologies. It is designed around modern-day food processors’ needs for a real-time pathogen detection approach that’s faster and simpler while also more accurate. The company also has AOAC® Official Method of AnalysisSM (OMA) status for its Salmonella assay and both AOAC PTM and NF VALIDATION by AFNOR Certification for its Salmonella and E.coli O157 (including H7) assays, in addition to certifications from government and regulatory organizations in other countries around the world.

Thursday, September 25, 2014

George Washington U. Research Team Finds Method for More Precise Diagnosis of Pneumonia

A patient survives life-threatening trauma, is intubated in the intensive care unit (ICU) to support his or her affected vital functions, starts to recover, and then develops pneumonia. It’s a scenario well-known to physicians, who understand that the development of ventilator-associated pneumonia in critically ill patients often results in significant morbidity, mortality and additional healthcare costs.

An interdisciplinary team of George Washington University (GW) researchers are investigating more accurate and rapid methods of identification of bacterial pathogens in patients with pulmonary infections, which could lead to more targeted antimicrobial therapy with potentially less adverse effects and lower costs. Next-generation sequencing (NGS) of samples from the sputum of intubated patients, as outlined in their recently published paper in the Journal of Clinical Microbiology, may enable more focused treatment of pneumonia in the critically ill, which has the potential to reduce healthcare spending, as well as improve survival.

“Currently, patients who develop pneumonia after entering the ICU are subjected to broad-spectrum antibiotics, which adds costs, potentially increases the risk of development of antimicrobial resistance, and creates a greater likelihood of an adverse effect attributable to the antibiotics,” says co-author Gary Simon, MD, PhD, the Walter G. Ross Professor of Medicine and director of the Division of Infectious Diseases at the GW School of Medicine and Health Sciences (SMHS). “In our paper, we show these methods could improve if we establish a more precise microbiologic cause.”

NGS, or the process of determining the DNA sequence of a patient’s genome and microbiome, provides the means to establish a more precise microbiologic cause, according to co-author Timothy McCaffrey, PhD, professor of medicine and director of the Division of Genomic Medicine at GW SMHS.

“Through analyzing the data provided by the NGS, we were able to identify bacteria not previously identified through standard microbiological methods,” says McCaffrey.

As technical advances reduce the processing and sequencing times, NGS-based methods may ultimately be able to provide clinicians with rapid, precise, culture-independent identification of bacterial, fungal, and viral pathogens and their antimicrobial sensitivity profiles.

“This will allow for a more precise patient population to be treated for pneumonia,” says co-author Marc Siegel, MD, assistant professor of medicine at GW SMHS. “Using this technology, physicians in the future should be able to make a more accurate diagnosis of the cause of what the pneumonia is and tailor their therapy accordingly.”

Ian Toma, MD, PhD, MSHS, visiting assistant professor in the Division of Genomic Medicine and Department of Physical Therapy and Health Care Sciences at GW SMHS, developed the NGS procedure using the most advanced sequencing methods available. “It was a challenging proof-of-concept study and a truly interdisciplinary translational research effort that will likely be implemented into clinical practice within the near future,” he said.

Keith Crandall, PhD, director of the Computational Biology Institute — a new interdisciplinary research strategic initiative at GW — and his group of researchers contributed to the NGS data analysis with their unique bioinformatics tool “PathoScope,” a promising application for identification of pathogens.

“Our tool provides a powerful statistical approach for sifting through NGS data and quickly identifying and characterizing pathogens from a patient’s sample,” says Crandall. “This is truly ‘personalized medicine’ as we identify specific strains of bacteria infecting individual patients and provide physicians with targeted information for antibiotic treatments for each individual.”

This research was funded in part through a Children’s National Health System and GW Clinical and Translational Science Award grant and by private funding provided by the Abramson Family Foundation, Inc.

Source: George Washington School of Medicine and Health Sciences.

Wednesday, September 24, 2014

Mobidiag Obtains CE-IVD Marking for qPCR Detection of Gastroenteritis-Causing Bacteria

Mobidiag Ltd, a Finnish molecular diagnostics company specialized in the development of innovative diagnostics solutions for infectious diseases, today announced the European launch of Amplidiag™ Bacterial GE, marketed as a CE-IVD product under the Directive 98/79/EC on in vitro diagnostic medical devices. CE marking follows the successful completion of a two-center performance evaluation study. The test optimizes stool sample screening processes by utilizing well-established qPCR technology for rapid qualitative detection of eight gastroenteritis-causing bacteria. In contrast to current routine practices, the test does not require pre-culturing of the sample, bringing both laboratory process benefits by substantially reduced need for cultures, as well as clinical benefits by providing early, clinically relevant information. The test’s rapid and comprehensive results enable timely, evidence-based patient management decisions, contributing to improved healthcare processes.

Amplidiag™ Bacterial GE has been validated with 1235 patient samples and 125 spiked samples in a two-center performance evaluation study. The study was performed at the Clinical Microbiology Laboratory of Karolinska University Hospital Huddinge in Stockholm, Sweden, and UTULab, the clinical microbiology service laboratory of University of Turku, Faculty of Medicine, in Turku, Finland. The results showed an overall sensitivity of 99.0% and specificity of 99.9%, when compared with routine stool culture and independent nucleic acid-based methods. Amplidiag™ Bacterial GE did not give any false negative findings when results were compared with stool culture.

Changing scenery of bacterial gastroenteritis Diarrhea is usually a symptom of gastroenteritis, i.e. infection in the intestinal tract caused by bacterial, viral or parasitic organisms. Every year, there are an estimated 1.7 billion cases of diarrheal disease globally1. Bacterial pathogens are responsible for up to 80% of gastroenteritis cases, especially in traveler’s diarrhea. The most common routine microbiological examination for bacterial gastroenteritis, stool culture, is labor-intensive and usually gives a definitive result only after 1–3 days, but may require up to 7 days. Stool culture is primarily used to identify pathogenic Campylobacter, Salmonella, Shigella and Yersinia species. However, recent studies with modern PCR methods have shown that a majority of enteric infections are caused by certain diarrheagenic E. coli strains. Enteropathogenic E. coli (EPEC), Enteroaggregative E. coli (EAEC) and enterotoxigenic E. coli (ETEC) have been shown to be the most frequent causative agents in traveler’s diarrhea, with a high prevalence of multi-infections2. Enterohemorrhagic E. coli (EHEC) is one of the most important detectable pathogens in terms of patient management decisions.

Amplidiag™ Bacterial GE – Innovation from Finland Amplidiag™ Bacterial GE is an in vitro diagnostic test indicated to aid in the diagnosis of patients suspected of bacterial gastroenteritis. Used as a screening test for stool samples, Amplidiag™ Bacterial GE gives substantial laboratory process benefits and clinical advantages. The test is able to detect eight of the most common and important enteric bacterial pathogens rapidly from the same sample with a single assay and enables reporting same-day results. In addition to Campylobacter, Salmonella, Shigella/EIEC, Yersinia, the test also detects EHEC, EPEC, EAEC and ETEC from DNA extracted from a stool sample. The test results are used in conjunction with other clinical and laboratory findings.

FDA Clears New Rapid Test For Candida Infections Of Bloodstream

Yeast bloodstream infections, which are caused by Candida species, are a type of fungal infection, and if untreated, can result in serious medical complications. People who have a weak immune system, or are hospitalized in intensive care units, or have kidney disease needing dialysis, or have had abdominal surgery are said to be at risk of developing yeast bloodstream infections.

There are over 20 species of Candida yeasts that can cause infection in humans. Of these, the more important pathogenic species include Candida albicans, Candida tropicalis, Candida parapsilosis, Candida glabrata and Candida krusei and Candida lusitaniae.

The traditional approaches to detect yeast pathogens in the bloodstream are tedious and time-consuming. The current gold standard of blood culture requires up to six days, and even more time to identify the specific type of yeast present, according to the FDA. But that's all about to change as a new, rapid diagnostic test for Candida infections of the bloodstream, developed by privately-held T2 Biosystems Inc., has received regulatory clearance.

T2 Biosystems' T2Candida test, which has received FDA clearance, can detect five common yeast pathogens that cause bloodstream infections - Candida albicans and/or Candida tropicalis, Candida parapsilosis, Candida glabrata and/or Candida krusei - directly from an unpurified blood sample as fast as three hours.

According to the company, T2Candida is designed to provide species-specific identification directly from whole blood and without the need for blood culture. However, because of the possibility of false-positive results, physicians should perform blood cultures to confirm T2Candida results, the FDA noted.

Alberto Gutierrez, director of the Office of In-Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health said, "By testing one blood sample for five yeast pathogens and getting results within a few hours, physicians can initiate appropriate anti-fungal treatment earlier, and potentially reduce patient illness and decrease the risk of dying from these infections."

Powerful Salmonella Detection Tools Developed

A funded research project at the US Department of Agriculture’s-Agriculture Research Service Egg Safety and Quality Research Unit, Athens, Ga., in which the researchers developed powerful tools for detecting Salmonella, has been completed, announced USPOULTRY and the USPOULTRY Foundation.

Specifically, the project is titled Project #F043: Rapid Molecular Pathotyping of Major Salmonella enterica Serotypes Based on Single-Nucleotide Polymorphisms (SNPs) in the Adenylate Cyclase (cyaA) Gene (Dr. Michael J. Rothrock, Jr. and Dr. Jean Guard, USDA-ARS Egg Safety and Quality Research Unit, Athens, Ga.)

Detecting Salmonella in various stages of the food production system is complicated by the vast number of Salmonella serotypes and the variation of characteristics even within a serotype, according to the research summary. Simple methods are needed by the poultry industry to track isolates of Salmonella through the production system so that more effective interventions can be implemented.

The recently completed a research project by Dr. Michael Rothrock and Dr. Jean Guard resulted in the researchers developing reagents and protocols to rapidly detect and identify some of the major serotypes of Salmonella and differentiate different isolates within a serotype. Utilizing single nucleotide polymorphisms (SNPs) of two different genes, they could detect 89 to 100 percent of a panel of Salmonella isolates from environmental, poultry production and processing settings.

SNPs are discreet areas in a gene that vary between isolates of similar bacteria and can be used to identify those bacteria. This work demonstrates the power of using SNPs to quickly and accurately distinguish between isolates of Salmonella and can serve as a valuable tool for Salmonella control in the poultry industry.

A complete report may be obtained by going to USPOULTRY’s website,

Tuesday, September 23, 2014

Ifakara Researchers Develop New, Fast Method to Test TB in Babies

Tanzanian researchers have developed a new tuberculosis test known as TAM-TB assay that they describe as ‘the first reliable immunodiagnostic assay to detect active tuberculosis in children’ that is capable of providing results within 24 hours only.

In the statement made available to The Guardian yesterday by the Ifakara Health Institute (IHI) researchers, the new test that is sputum independent provides a fast and accurate tool to diagnose tuberculosis in children.

Commenting on the study a researcher from the Swiss Tropical and Public Health Institute (Swiss TPH) in Switzerland who coordinated the study, Dr Klaus Reither established that the new TAM-TB assay revealed that the study report has already appeared in the journal of Lancet Infectious Diseases earlier this month.

"This rapid and reliable test has the great potential to significantly improve the diagnosis of active tuberculosis in children," said Reither.

According to IHI, the new test was assessed in tuberculosis endemic regions in Tanzania at its centers and NIMR Mbeya Medical Research Center where Dr Reither used to work.

Dr Reither underscored that using standard intracellular cytokine staining procedures and polychromatic flow cytometry, the test result is available within 24 hours after blood sampling.

The test will also improve diagnostics and treatment efficiency, especially in HIV-infected kids, as well as decrease related costs.

The TAM-TB assay was tested in a proof-of concept study carried out between May 2011 and February 2013 in 290 children that presented symptoms of tuberculosis were recruited and followed-up at NIMR (Mbeya) and at Ifakara Bagamoyo health and research centers.

About one million children per year develop tuberculosis (TB) worldwide, but detecting TB in children has been a challenge as the symptoms are often non-specific and similar to those of common pediatric illnesses, including pneumonia and malnutrition.

TB is caused by a bacterium called Mycobacterium tuberculosis and the TB bacteria are spread from person to person through the air making it very contagious.

Cytokines are a category of small proteins important in cell signaling and affect the behaviour of other cells.
Cytometry is a general name for a group of biological methods used to measure various parameters of cells.

 Intracellular Cytokine Staining is a flow cytometry based assay that detects the production and accumulation of cytokines which play an important role in the immune response.

Similalry, mid last year, an international study aimed at identifying new treatment regimens that could shorten the length of TB treatment from six to three months started in Tanzania and South Africa.

The Multi-Arm-Multi-Stage -TB (MAMS-TB) trial uses a combination of established drugs and novel drugs and is funded by the European Developing Country Clinical Trials Partnership (EDCTP) through the Pan African Consortium for the Evaluation of Anti-tuberculosis agents or PanACEA consortium.

The MAMS design enables regimens with unsatisfactory outcomes to be dropped rapidly. It allows the researchers to test multiple potential treatments quickly to select the best regiment to be used in a trial that would allow a new treatment to be approved by licensing authorities.

“The MAMS-TB trial is a unique opportunity to develop a novel TB treatment rapidly that will substantially shorten treatment,” said the Chief Investigator Martin Boeree from the University of Nijmegen.

Michael Hoelscher from Ludwig-Maximilians-University of Munich, who represented the University that sponsors the study, said “…in the MAMS-TB study, we are developing better methods to treat TB for the most disadvantaged in the world community”.

Stephen Gillespie from the University of St Andrews noted that this new development has only been able to occur because of the work of our many collaborators in Africa and the work that the consortium has been doing to develop capacity to test new regimens in an African setting.

One of the principal investigators, Lilian Tina Minja, of the Ifakara Health Institute (IHI), said the PanACEA consortium is an excellent example for bilateral and dynamic collaborations between Southern and Northern partners in TB drug development and evaluation.

According to Dr Klaus Reither, a leading TB researcher from IHI, the PanACEA, MAMS study at Mwananyamala is the largest TB drug trial to involve the institute.

Another principal investigator, Gibson Kibiki, said trial is innovative in terms of design, collaboration and the use of a complete electronic source system.

There are nearly eight million new TB cases every year and more than a million deaths. Conventional market solutions to TB drug development are not expected to provide a solution.

The PanACEA consortium has been able to develop capacity of African centres to tackle TB through building infrastructure and supporting the professional development of African and European scientists. There are 11 collaborating centres in sub-Saharan Africa and a growing group of European collaborators.

Invisible Sentinel Rapid Assay Goes Global with Wine Deal

Invisible Sentinel has signed its first product distribution deal covering the use of its technology outside the United States.

Enartis Vinquiry of Trecate, Italy, a global provider of specialty winemaking products and services, reached an non-exclusive agreement with the Philadelphia life sciences company agreed to distribute Invisible Sentinel’s Veriflow Brett assay.

The assay is used to test wine for the presence of brettanomyces, a yeast that is known the cause spoilage. The microbe produces compounds that, in excess, can foul the taste of wine and give it a “barn-yardy” odor, according to Invisible Sentinel, which specializes in developing rapid molecular diagnostic test kits for use in the food and beverage industry.

Earlier this month, the company formed a partnership with Victory Brewing Co. of Downingtown, Pa., to develop a test to detect a bacteria that can spoil beer.

Enartis, will distribute Veriflow Brett to winemakers in California and other global markets for their in-winery use in quality-assurance testing. The assay detects and measures levels of brettanomyces in wine.

In addition, Enartis’ Windsor, the California-based U.S. subsidiary of Enartis Vinquiry, has adopted Veriflow Brett for use in its Central Coast laboratories — which provide testing services to winemakers in the region.

Financial terms of the deal were not disclosed.

Invisible Sentinel Inc. developed the test for the wine-spoiling microbe in a partnership forged in January with Jackson Family Wines, a family-­owned winery in California’s Sonoma County.

Monday, September 22, 2014

Rare Virus Has Sickened Hundreds More Children, Rapid Test Needed

From mid-August to September 19, 2014, a total of 160 people in 22 states in the U.S. were confirmed to have respiratory illness caused by enterovirus-D68, or EV-D68.  However, hospitals around the country say they are treating hundreds of children who have been sickened by the rare virus.

"We have some of these cases now in our ICU," says Dr. Giovanni Piedimonte, a pediatric pulmonologist and chairman of Cleveland Clinic's pediatric institute. Children with the virus can have serious trouble breathing, he says, enough so that they have to be put on a ventilator or lung bypass machine.

But Ohio isn't on the CDC's list of six states with confirmed cases of enterovirus-D-68 – they are Colorado, Illinois, Iowa, Kansas, Kentucky and Missouri. Official numbers always lag in a fast-moving outbreak, but the gap appears to be particularly big with enterovirus-D68. That may be because it appears to spread easily, because milder cases often look like a cold, and because there's no swift test to identify it.

"It would be great to have a rapid test, because we could identify children more at risk of rapidly developing symptoms," Piedimonte told Shots. He's particularly concerned because children can get worse suddenly and have trouble breathing. They then need immediate medical care.

What the Cleveland Clinic and other hospitals have is a PCR test that can tell if the bug in question is an enterovirus, but not if it's EV-D68. Those samples get sent to the CDC for further testing.

"To be honest, everyone we've tested with the exception of one since Sept. 1 has tested positive with this," Elizabeth Ann Esterl, pediatric nurse manager at National Jewish Health in Denver, a hospital that specializes in asthma and respiratory disease, tells Shots.

Children with asthma appear to be particularly vulnerable to EV-D68, with one-half to two-thirds of cases in children with asthma.

Although the CDC has confirmed 19 cases in Colorado, Esterl says she thinks National Jewish has seen 41 cases. And other children's hospitals in the Denver area say they've seen hundreds more.

"This virus knows no boundaries," Esterl says. "If you think you don't have it in your area, just wait."

Because there's no vaccine or specific medication for enterovirus-D68, the lack of a rapid test doesn't affect treatment. Instead, children are being given fluids, oxygen and other supportive care while they fight the virus. "The good news is that it looks like it's self-limiting, and in a few days they get better," Piedimonte says.

But that doesn't mean that parents should just wait it out if their child seems to be getting worse, he cautions. "When someone has the symptoms of a bad cold that seems to be progressing fast, report as soon as possible to an emergency room," Piedimonte says. "Time is of the essence in case a child requires oxygen and other care."

As more samples make their way to state health departments and the CDC, epidemiologists will have a better idea of why EV-D68 has suddenly morphed from being a rare and rarely dangerous virus to a surprisingly vigorous foe.

"We want to reduce the spread by doing things we know how to do," Esterl says. Number one on her list: Hand washing. Children should cover their coughs, she says, and consider skipping school even if it just seems like a mild cold. "It's a great time to watch movies at home."

The Dire Need For A Rapid Diagnostic Ebola Test In West Africa

The size and spread of this Ebola epidemic is simply unprecedented. The largest previous Ebola outbreak occurred in 1976 in Zaire: 318 confirmed cases and 280 deaths, but the current outbreak in West Africa has exceeded 4,400 cases with 2,300 deaths and growing. According to WHO estimates more than 20,000 more cases will occur before containment is achieved.

I, and many others, have written about the need for more resources and healthcare infrastructure. Hopefully the U.S. commitment of 1700 beds, training of 500 healthcare workers and 400,000 home treatment kits will offer much needed help and reduce the mortality rate from 50%.

But stemming the tide of this epidemic will not happen with only the commitment the President has made. Treating the sick is imperative, but as the number of cases grows exponentially, we have to take a closer look at why – we are failing at contact mapping and containment, and for three very good reasons.

First, there are cultural barriers to containment such as distrust of Western medicine, commitment to local burial practices, and a lingering disbelief that the virus exists. These barriers prevent containment procedures from being implemented and sanitary burials from being practiced.

Second, there is fear of the disease and what identification and isolation means. “Virus hunters,” public health workers skilled in contact mapping of exposures, are having a difficult time finding the sick because of the fear. People hide, change their address, and have even thrown rocks at aid workers. People do not want to be isolated and taken away from their families to wait out the incubation period and possibly die alone in makeshift clinic far from home.

Finally, we do not have a way of rapidly identifying the virus in the field. Current practice for fever in countries like West Africa is to rule out and treat the things that are more common, easily identified and more easily treated with the assumption that if the patient does not improve, a viral hemorrhagic fever is the diagnosis of exclusion. In West Africa, malaria or bacterial infections are the more likely more treatable diseases, so the practice is to rule out malaria and possibly use empiric antibiotics before assuming Ebola.

We have rapid detection tests (RDTs) for malaria that can and are being used in the field. The problem is the sensitivity and specificity are not adequate to definitively diagnose malaria. And even given this practice of diagnostic rule out, the truth remains that a negative test for malaria does not necessarily mean a positive test for Ebola and visa versa. We need diagnostics that are more definitive.

There are many types of tests for Ebola. Isolating the virus provides the most sensitive and specific diagnosis, but requires transport of biohazard material to a BSL-4 lab, of which there are few in the world. Alternatively there are reverse transcription polymerase chain reaction (RT-PCR) and quantitative PCR, which are both very sensitive and specific, but again require a lab. Newer tests include antigen and antibody identification using ELISA, and a nanoparticle microscopy system termed the Single Particle Interferometric Reflectance Imaging Sensor (SP-IRIS), which can digitally identify virons based on size. (ACS Nano. 2014 Jun 24;8(6):6047-55.)

There have been improvements in diagnostic ability in Sierra Leone that have improved care immensely, but all of these tests must be performed in a lab and that lab may not be local. It could take days to get results back. We need a test we can deploy rapidly in the field and have results in under an hour.

A very rapid test would be game-changing for Ebola. Let’s look at triage in a clinic. Everyone comes in the front door together and waits together. Most people have a fever, but they aren’t sure why. Most likely, it’s another endemic infection like malaria, typhoid or shigella. An RDT could quickly identify patients needing quarantine from those who do not. The benefit here is threefold: fast and early quarantine to separate patients at risk for infecting others making the rest of the hospital safer; replacing fear and anticipation with knowledge; and a more efficient use of quarantine resources because they are saved for people with known Ebola infections.

An RDT would also allow healthcare workers to confidently come to work knowing they are not infected. It would also prevent unnecessary quarantine of these most-needed personnel for the 21 day incubation period.

The same would hold true for exposed individuals. Given the lack of clinics and isolation units, public health workers are offering more home-based care. This requires isolation of people in their homes for up to three weeks.  A RDT would allow appropriate use of those resources.

An RTD could also be used at borders and airports for health officials to safely allow or restrict access from a country with a known outbreak, enabling the delivery of much-needed supplies, workers, and resources safely.

Finally, when this outbreak is contained, having an RDT would help more quickly identify new outbreaks in the future, facilitating early containment and guiding the use of prophylactic drugs, like Zmab, if available.

I want to impress upon you this is not conjecture. The reasons above make logical sense, but experts can also use mathematical modeling studies to show the effect of adequate containment versus rapid detection. Containment is certainly effective and has worked during all outbreaks in the past, but diagnostics either on site, off site, for all febrile patients or even just healthcare works can make a significant impact on the size of an outbreak.

An RDT—a new test or an adaptation of what we have—would not only be a massive step towards controlling this outbreak, I think it is the only step that will ultimately prevent this tragic epidemic from becoming a pandemic.


Tuesday, September 09, 2014

Lab-Developed, Commercial Assays Performed Comparably in Norovirus Detection

Four different assays for the detection of norovirus in stool specimens performed comparably, according to data presented at ICAAC 2014.

Researchers from the Mayo Clinic compared the performance of a laboratory-developed real-time polymerase chain reaction (PCR [LDT]) and three commercial molecular assays (Luminex GPP [Waltham, MA], BioFire FilmArray [Salt Lake City, Utah] and Focus Simplexa [Cypress, CA]). Each methodology was used to test 169 stool specimens for norovirus, the results of which were compared to a “consensus result” obtained from at least three of the four PCR assays evaluated.

All of the assays have great sensitivity, Mark J. Espy, MS, division of clinical microbiology, Mayo Clinic, told “Three of them have good specificity: the FilmArray, the Focus [Simplexa] and the ‘home brew assay’ [LDT] that we have. When we initially ran the samples with the Luminex, specificity was very poor; there were a lot of norovirus positives that just were not confirmed by any other assay. When we ran the specimens again with the new lot of reagents, then specificity was comparable to what we have seen with the other assays.”

BioFire, Simplexa and LDT showed similar performance and provided rapid results. Simplexa and LDT showed 100% sensitivity compared with 96% for BioFire and 94% for Luminex. Simplexa and LDT also showed 100% specificity compared with 53% for Luminex. Initially Luminex yielded 55 false positives, but upon retesting it demonstrated 98% specificity.

“They all have good sensitivity, and probably good specificity, but we are a little concerned about the Luminex,” Espy said. “What we in the hospital are going to do in the future is just test in-house patients, and since we do not have a huge volume of them, we are going to go with the BioFire FilmArray. It is very easy to set up, it does multiple targets — close to 20. The only downfall is it is restricted to one specimen at a time, but we don’t see that many in house, so it will work well for us.

“If we open it up to our reference labs, where we have obviously more patients,” he added, “we will have to look at something like Luminex, which can do up to 96 samples at a time.”

Abstract:  Espy MJ. Abstract D-204. Presented at: Interscience Conference on Antimicrobial Agents and Chemotherapy; Sept. 5-9, 2014; Washington, D.C.

Source: Adam Leitenberger at

New Abbott Technology May Uncover the Root of Critical Infections and Cut Health Care Costs

Looks like Abbott’s PLEX-ID rapid detection technology is back in the news.

A new study suggests a pioneering testing technology could reduce hospital stays by up to eight days and lower annual health care costs for people with serious infections by approximately $2.2 million (€1.5 million / £1.2 million). The cost reductions are based on a health economic model from the RApid Diagnosis of Infections in the CriticAlly IlL (RADICAL) study, presented today at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy in Washington, D.C.

The RADICAL study indicates that Abbott's technology (Polymerase chain reaction/Electrospray Ionization Mass Spectrometry or PCR/ESI-MS) has the ability to detect the source of the infection – such as bacteria, fungi or viruses – within hours, even when blood cultures (current standard of care) are negative. This information could help doctors diagnose and initiate appropriate treatments more quickly. Additionally, the Abbott technology may offer the potential for earlier discontinuation of broad-spectrum antibiotics.

"When a critically ill person enters the hospital with a suspected infection, clinicians try to determine the cause using tests that may take days to weeks. This can lead to significant delays in appropriate treatment and extended hospital stays," said David J. Ecker, Ph.D., divisional vice president, R&D for Abbott's Ibis Biosciences business. "Abbott's new technology is designed to identify infections rapidly, without culture, and provide clinicians with information to quickly prescribe the most effective treatment."

An independent, expert panel of physicians reviewed the RADICAL study results from samples obtained from 420 critically ill patients with suspected severe infections from the United Kingdom, France, Belgium, Poland, Switzerland and Germany. After retrospectively comparing Abbott's technology versus culture, the physicians reported they would have prescribed a different course of treatment in 57 percent of the cases evaluated based on the Abbott technology results.

"More than 50 percent of blood culture tests come back negative, even when infections are believed to exist," said study author Jean-Louis Vincent, M.D., Ph.D., Professor of Intensive Care, Université Libre de Bruxelles and the Head of the Department of Intensive Care, Erasme. "The results of the RADICAL study and the economic analysis suggest the Abbott technology will provide actionable information much earlier, allow physicians to improve patient outcomes and may ultimately lower overall health care costs related to these serious infections."

Each year, sepsis affects more than 26 million people worldwide. The fast-moving bloodstream infection is considered the most expensive in-hospital condition, costing more than $20 billion each year in the U.S. and more than £2.5 billion in the UK. Based on results from the RADICAL study, it was determined that by using the Abbott technology, a hospital could reduce intensive care costs for people with blood-related infections by more than 30 percent each year.

Abbott has developed a platform based on PCR/ESI-MS technology with the goal to deliver a broad range of tests that can identify hundreds of bacteria, fungi and viruses directly from a patient specimen within eight hours. The platform, known as IRIDICA (not available in the U.S.), is expected to be available as a CE marked in vitro diagnostic device in European countries within the coming months.

Victory & Tech Firm Team Up to Detect Beer Spoilage Bacteria

The list is long of the perfect accompaniments to beer: hot dogs, pizza, peanuts, and pretzels, to name just a few.

Most definitely not on that list: pediococcus and lactobacillus. Consider them beer buzzkills.

These are types of bacteria that often hitch a ride into breweries aboard grain. If they make their way into the beer itself, they can spoil taste by producing lactic acid, a chemical compound most commonly associated with sore muscles after exertion and first refined in 1780 from sour milk.

Whatever its role, brewers have little use for it. That's why Victory Brewing Co., with headquarters in Downingtown, has entered into a partnership with Invisible Sentinel Inc., a Philadelphia life-sciences company specializing in rapid molecular diagnostics for the food and beverage industry.

"We believe this is really going to be a paradigm shift for the [beer] industry," said Nick Siciliano, CEO and cofounder of Invisible Sentinel, a seven-year-old University City start-up working to speed up detection of pediococcus and lactobacillus. That would reduce spoilage incidents, production costs, and delayed product releases.

Victory, which opened in 1996, sells beer in 34 states and several countries, and is on track to produce 125,000 barrels of suds this year. Zach Miller, quality lab technician, said the significance of the test that Invisible Sentinel is developing for the brewery is "paramount."

"The bottom line is we'll be able to have a lot more confidence in sending out a product that we know is not tainted," Miller said.

Invisible Sentinel's Veriflow brewPAL will provide diagnostic results on a beer sample within four hours, replacing a process currently used in the industry that typically involves a seven-day turnaround.

"By that time, . . . if we find out there is infection in the beer, that beer can be well out the door," Miller said. "It would be a full-blown recall situation, which gets very expensive."

That has never happened at Victory, he said. In his 31/2 years there, the presence of pediococcus and lactobacillus has been detected once, at the end of fermentation. The remedy: 100 barrels of beer dumped down the drain, Miller said.

Running contaminated batches through a sterile filter can get rid of bacteria, but also strips out aroma and flavor compounds, he said.

"That experience was enough to tell us we needed some better results," Miller said of the disposed-of batch.

Victory's president and brewmaster, Bill Covaleski, said he met Invisible Sentinel's Siciliano and cofounder Benjamin Pascal at a brewery open house and concluded that "they really knew their stuff in terms of microbiological detection."

Applying that expertise to beer "was the logical next step," Siciliano said Monday from Sonoma County, Calif., where Invisible Sentinel is partnering with Jackson Family Wines to develop a rapid diagnostic to detect brettanomyces, a yeast considered by some to be a wine taste-spoiler.

Like that yeast, the bacteria Invisible Sentinel is helping Victory detect do not present a serious health hazard.

"These are normal gut bacteria, the same stuff in yogurt - probiotics," Miller said. "They can mess with our gastrointestinal tract and lead to some unpleasantness there."

Sort of like a hangover.

Oregon State Public Health Lab Modifies CRE Test to ID Superbug in Hours

A relatively new test has been developed to identify a dangerous form of antibiotic resistance.

Researchers from Oregon State Public Health Lab have modified the protocol to increase the specificity of the simple and inexpensive test to 100 percent, to provide results in hours.

The research has confirmed the reliability of a test, called Carba NP, which can be conducted in practically any clinical laboratory and allows for rapid identification of carbapenem-resistant Enterobacteriaceae (CRE), often referred to as "super bugs" for their ability to resist most major antibiotics.

Karim Morey of the Oregon State Public Health Lab, and author on the study, said that CRE is currently considered an urgent public health threat by the Centers for Disease Control and Prevention (CDC) as it is rapidly spreading around the globe, and its timely detection is critical to patient care and infection control.

Morey added that the Carba NP test is highly sensitive, specific and reproducible for the detection of carbapenemase production in a diverse group of organisms.

The research was presented at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy, an infectious disease meeting of the American Society for Microbiology.

Uganda Government Launches Rapid Malaria Diagnostic Test Kits

Government has launched the UNITAID private sector Malaria Rapid Diagnostic Test kits (MRDT)to help in the proper treatment of the disease.

The three-year pilot project which was launched at Wakiso district is implemented by Malaria Consortium together with the National Drug Authority, National Malaria Control Programme supported by World Health Organisation and FIND.

The project costing $6.2m (about sh15bn) will be rolled out to other seven districts in mid-western region including; Kibaale, Masindi, Kiboga, Kyankwazi, Hoima and Buliisa.

The state minister for Primary Health Care, Sarah Opendi said the ministry together with other partners have already trained health workers in public health facilities in the use  of MRDT and introduced the tools in all health facilities.

RDT tools can enable health workers at all levels diagnose patients with suspected malaria cases in just 15 minutes.

Opendi said the new national policy calls for mandatory testing of all suspected malaria cases before treatment.

“We realized there are many other common diseases which present with signs and symptoms similar to malaria. Treatment without testing leads to wastage of medicines, misuse and increases the risk of creating parasite resistance to malaria medicines,” she noted.

Opendi said mistreatment of potentially life-threatening non-malaria febrile illnesses can also lead to death. She said the new technology is efficient and easy to use.

“Though emphasis was initially in public health facilities, over 50% Ugandans seek medical care and treatment in the private sector, of which many lack laboratory facilities and we think this is going to help,” she added.

She said the ministry is going to continue with public awareness to promote testing before treatment.

The Malaria Control Programme Manager ministry of health, Dr Alfred Peter Okwir stressed that wrong drug prescription always leads to complications and death.

“This must stop. That is why our people get complications and die at times,” he said.

He said Uganda records 16 milion cases of malaria annually, and 50,000 deaths. Okwir, however, noted that since the introduction of  RDTs in public health facilities, and giving out mosquito nets, the number of malaria cases and deaths has reduced.

He said 22 million nets have been given out countrywide.

Dr W. Alemu, a representative of WHO, noted that Uganda is ranked among the six countries in Africa with the highest burden of malaria, with most cases reported from the public sector, yet 60% of the people seek medication from private sector.

Alemu said the WHO is committed to support the project through giving technical support.

Country director, Malaria Consortium, Dr. Godfrey Magumba said they have already trained 150 health workers from 150 clinics on the use of the kits.

“We have already contracted two manufactures; Standard, and Premier medical diagnostics, whom we have negotiated to reduce the price of the kits below the cost of the anti-malarial drugs. Each kit will cost between sh2000 and sh2500,” he noted.

Wakiso district health officer Dr. Emmanuel Mukisa said since they started using RDTs, stock-outs have reduced at various health facilities.

Patrick Okello, a resident of Kireka B, said MRDT technology will help in giving right drugs to patients after ascertaining the problem.

Agnes Nafula, a teacher at Lweza Primary School, said many people have been taking wrong drugs due to lack of testing equipment in different facilities. “But with MRDT we hope for the best.”

Cepheid Releases New Flu, RSV Rapid Diagnostic Test

California-based diagnostics company Cepheid announced on Tuesday the release of a new test to rapidly confirm and diagnose a respiratory syncytial viral infection and certain types of the flu.

The new test—Xpert Flu/RSV XC—will be marketed as a CE-IVD product, bringing the total number of available tests to 18. The test runs on the company’s GeneXpert System, which has more than 7,000 systems installed to date. It will begin shipping later this month.

“Influenza strains are notoriously unpredictable and the severity of flu outbreaks can vary widely from season to season,” John Bishop, Cepheid’s chairman and CEO, said. “While no one can know exactly which influenza strains will show up in their clinics and emergency rooms, with Xpert Flu/RSV XC hospitals and clinicians can be prepared to reliably diagnose and differentiate influenza strains in real-time.”

David Persing, the chief medical and technology officer at Cepheid, said that in developing the test, researchers attempted to “anticipate emerging novel influenza strains.”

“Though simple to perform, Xpert Flu/RSV XC is a highly multiplexed, state-of-the-art test for rapid and accurate detection and differentiation of Flu A, Flu B, and RSV infection,” Persing said. “This test may also become a valuable asset in efforts toward pandemic preparedness because it was designed from its inception to provide unprecedented coverage of avian influenza strains.”

Scientists Use Magnetic Fields for Rapid Diagnosis of Malaria

A team of researchers from the Singapore-MIT Alliance for Research and Technology ( SMART) have come up with a fast, reliable and possible alternative for malaria diagnosis.

Their study published in the journal Nature Medicine, revealed a new method devised by scientists which uses magnetic resonance relaxometry (MRR), to detect the amount of hemozoin, a waste product of the malaria parasite released after feeding on nutrient-rich hemoglobin carried by the red blood cells.

As the parasite breaks down hemoglobin, iron get released which is used by the parasite to convert it to hemozoin, a weakly paramagnetic crystallite.

Crystals of  hemozoin interfere with the normal magnetic spins of hydrogen atoms. When exposed to a powerful magnetic field, hydrogen atoms align their spins in the same direction.  When a second, smaller field perturbs the atoms, they should all change their spins in synchrony – but if another magnetic particle, such as hemozoin, s present, this synchrony is disrupted through a process called relaxation. The more magnetic particles are present, the more quickly the synchrony is disrupted.

For the study researchers used a 0.5-tesla magnet, much less expensive and powerful than the 2- or 3-tesla magnets typically required for MRI diagnostic imaging.  The current device prototype is small enough to sit on a table or lab bench, but the team is also working on a portable version that is about the size of a small electronic tablet.

This study holds a lot of significance since over the past several decades, malaria diagnosis has changed very little. After taking a blood sample from a patient, a technician smears the blood across a glass slide, stains it with a special dye, and looks under a microscope for the Plasmodium parasite, which causes the disease.  This approach gives an accurate count of how many parasites are in the blood – an important measure of disease severity – but is not ideal because there is potential for human error.

The new technique, however, offers a more reliable way to detect malaria, said Jongyoon Han, a professor of electrical engineering and biological engineering at Massachusetts Institute of Technology (MIT).

There is real potential to make this into a field-deployable system, especially since you don’t need any kind of labels or dye. It’s based on a naturally occurring bio-marker that does not require any biochemical processing of samples, said Han, one of the senior authors of the research.

Scientists Develop Electronic Nose for Rapid Detection of C. difficile

A fast-sensitive "electronic-nose" for sniffing the highly infectious bacteria C. diff, that causes diarrhoea, temperature and stomach cramps, has been developed by a team at the University of Leicester.

Using a mass spectrometer, the research team has demonstrated that it is possible to identify the unique 'smell' of C. diff which would lead to rapid diagnosis of the condition.

What is more, the Leicester team say it could be possible to identify different strains of the disease simply from their smell – a chemical fingerprint - helping medics to target the particular condition. The research is published on-line in the journal Metabolomics.

Professor Paul Monks, from the Department of Chemistry, said: "The rapid detection and identification of the bug Clostridium difficile (often known as C. diff) is a primary concern in healthcare facilities. Rapid and accurate diagnoses are important to reduce Clostridum difficile infections, as well as to provide the right treatment to infected patients.

"Delayed treatment and inappropriate antibiotics not only cause high morbidity and mortality, but also add costs to the healthcare system through lost bed days.

Different strains of C. difficile can cause different symptoms and may need to be treated differently so a test that could determine not only an infection, but what type of infection could lead to new treatment options."

The new published research from the University of Leicester has shown that is possible to 'sniff' the infection for rapid detection of Clostridium difficile. The team have measured the Volatile Organic Compounds (VOCs) given out by different of strains of Clostridium difficile and have shown that many of them have a unique "smell". In particular, different strains show different chemical fingerprints which are detected by a mass spectrometer.

The work was a collaboration between University chemists who developed the "electronic-nose" for sniffing volatiles and a colleague in microbiology who has a large collection of well characterised strains of Clostridium difficile.

The work suggests that the detection of the chemical fingerprint may allow for a rapid means of identifying C. difficile infection, as well as providing markers for the way the different strains grow.

Professor Monks added: "Our approach may lead to a rapid clinical diagnostic test based on the VOCs released from faecal samples of patients infected with C. difficile. We do not underestimate the challenges in sampling and attributing C. difficile VOCs from faecal samples."

Dr Martha Clokie, from the Department of Microbiology and Immunology, added: "Current tests for C. difficile don't generally give strain information - this test could allow doctors to see what strain was causing the illness and allow doctors to tailor their treatment."

Professor Andy Ellis, from the Department of Chemistry, said: "This work shows great promise. The different strains of C. diff have significantly different chemical fingerprints and with further research we would hope to be able to develop a reliable and almost instantaneous tool for detecting a specific strain, even if present in very small quantities."

University of Otago Handheld DNA Diagnostic Device Enables Rapid Virus and Bacterial Detection

A revolutionary handheld and battery-powered DNA diagnostic device invented at the University of Otago is poised to become a commonly used field tool for rapidly detecting suspected viruses or bacteria in samples while also determining the level of infection.

The breakthrough device, dubbed Freedom4, will be unveiled today at the Queenstown Molecular Biology main meeting. It takes advantage of a technology called quantitative PCR to identify target DNA sequences in real-time, without the need for further processing.

As an example, using Freedom4, the presence and extent of norovirus infection in a sample could be confirmed within less than an hour, while the person using the unit was still at the outbreak site.

Dr Jo-Ann Stanton, who led the programme to develop the device, says that as well as enabling ‘anytime, anywhere’ clinical diagnosis of viral infectious diseases in humans and animals, it also has many other potential uses, such as border security, forensics or environmental monitoring.

Developed by Dr Stanton’s multidisciplinary team at Otago’s Department of Anatomy, the sturdy unit weighs the same as a typical laptop and fits on the palm of your hand. Freedom4 boasts a six-hour battery life and can be tethered to a laptop, or connect wirelessly to smart phones or tablets running custom software that analyses and interprets the test results.

“This mobility could provide a great boon for farmers. For instance, vets could drive around a farm analysing samples from various locations, make their diagnoses and treat infected animals—all in one trip,” she says.

A prototype of the device has been independently put through its paces by the New Zealand Institute of Environmental and Scientific Research. After running assays for toxin-producing E. coli, and several gastrointestinal and respiratory viruses—including H1N1—Freedom4 was found to perform on a par with much larger laboratory-based DNA analysis systems.

Dr Stanton says she and her team are delighted that their six-year project to make a handheld point-of-care diagnostic device a reality has come to fruition.

“We are immensely proud that we have created this brilliant device; there is currently no other system in the world that compares in terms of the analytical power we have achieved at this level of mobility and ease of use.”

Dr Stanton’s team includes a physicist, computer programmer, a chemist and biologists. Their project was funded through a New Economy Research Fund (NERF) grant, from what is now the Ministry of Business, Innovation and Employment. NERF objectives include supporting investigator-initiated basic research that has the potential to create the advanced technological platforms that will underpin new and emerging industries.

The University’s commercialisation arm, Otago Innovation, is now working to spin out the technology in partnership with a New Zealand company named Ubiquitome.

Otago Innovation’s Senior Commercialisation Manager David Christensen says that Freedom4’s development exemplifies university research being successfully translated into real-world technology with enormous potential health, economic and environmental benefits.

“Dr Stanton and her colleagues have used their combined multidisciplinary expertise to overcome a number of daunting technical challenges to create a molecular diagnostic device that is truly world-leading,” Mr Christensen says.

It is another great example of technology transfer from the University of Otago, he says.

“We are delighted to be a part of Ubiquitome as it works to realise its dream of connecting the world to meaningful genomic information through handheld, cloud-connected genetic analysis devices.”