Chembio Announces U.S.D.A. Approval of Tests for Detection of Bovine Tuberculosis in Captive Elk and Deer

Chembio Diagnostics, Inc., a leader in point-of-care diagnostic tests for infectious diseases, announces that its U.S. Department of Agriculture (USDA)-licensed products, CervidTB STAT-PAK® and DPP® VetTB, have been approved as primary and secondary tests for bovine tuberculosis by the USDA Animal and Plant Health Inspection Service (APHIS) in order to provide the farmed deer industry with more options for meeting the testing requirements for captive cervids (elk and deer) within the regulations.

Based on published results of independent validation studies conducted by the USDA-APHIS, the Company's tests can reliably detect the presence or absence of antibodies to bovine tuberculosis in several species of captive cervids1). Therefore, the agency has recommended that the captive cervid regulations be amended to recognize these two tests as official tuberculosis tests. This amendment was made effective as of January 9, 2013 without prior notice and opportunity for public comment in order to immediately provide additional testing options to regulated entities that are required to have their captive cervids tested. Public comments may be submitted to APHIS until March 11, 2013.

Commenting on this development, Lawrence A. Siebert, Chembio's Chief Executive Officer, said, "With the increased costs of producing and maintaining healthy livestock, it is vitally important to ensure that herds can be moved and processed, disease-free, in an efficient and timely manner. We welcome the USDA's designation of our CervidTB STAT-PAK® and DPP® VetTB as official primary and secondary tests. We believe that there is substantial potential for veterinary applications of our technology, both in production livestock as well as in companion animals, and we will continue to pursue opportunities in this important market segment."

Farmed deer constitute a significant alternative livestock industry in the U.S., with their numbers exceeding 500,000, according to a published estimate2). The article further indicates there are an estimated two million farmed deer in New Zealand, one million in China, 400,000 in Russia and 100,000 in Canada.

Testing for tuberculosis in cervids is currently performed using tuberculin skin tests. The single cervical test (SCT) is the primary (screening) test, whereas the comparative cervical test (CCT) is the secondary test. Limited and conflicting information is available regarding the accuracy of the skin testing in captive cervids. However, according to a published USDA study, 25/28 confirmed M. bovis-infected elk in Nebraska had false-negative results on the SCT3). In addition, animal handling challenges resulting in high morbidity and mortality are not uncommon, as captive cervids may be required to be captured and restrained for testing up to four different times depending on test results.

Serologic testing offers the advantage over skin testing of limited animal handling, with a reduction in the associated morbidity and mortality. Chembio's tests are rapid (approximately 20 minutes to complete) and simple (one or two steps) animal-side assays that are easy to perform, provide accurate antibody detection results, and do not require laboratory environment, reading equipment, or refrigeration for long-term storage (up to 12 months). An additional advantage is eliminating the subjectivity of interpreting the skin test response at the tuberculin injection site.

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New Handheld Device Performs Rapid HIV Tests

Samuel K. Sia, associate professor of biomedical engineering at Columbia Engineering, has taken his innovative lab-on-a-chip and developed a way to not only check a patient's HIV status anywhere in the world with just a finger prick, but also synchronize the results automatically and instantaneously with central health-care records-10 times faster, the researchers say, than the benchtop ELISA, a broadly used diagnostic technique. The device was field-tested in Rwanda by a collaborative team from the Sia lab and ICAP at Columbia's Mailman School of Public Health.

In the study published online January 18, 2013, in Clinical Chemistry, and in the print April 2013 issue, Sia describes a major advance towards providing people in remote areas of the world with laboratory-quality diagnostic services traditionally available only in centralized health care settings.

"We've built a handheld mobile device that can perform laboratory-quality HIV testing, and do it in just 15 minutes and on finger-pricked whole blood," Sia says. "And, unlike current HIV rapid tests, our device can pick up positive samples normally missed by lateral flow tests, and automatically synchronize the test results with patient health records across the globe using both the cell phone and satellite networks."

Sia collaborated with Claros Diagnostics (a company he co-founded, now called OPKO Diagnostics) to develop a pioneering strategy for an integrated microfluidic-based diagnostic device-the mChip-that can perform complex laboratory assays, and do so with such simplicity that these tests can easily be carried out anywhere, including in resource-limited settings, at a very low cost. This new study builds upon his earlier scientific concepts and incorporates a number of new engineering elements that make the test automated to run with data communication over both cell phone and satellite networks.

"There are a set of core functions that such a mobile device has to deliver," he says. "These include fluid pumping, optical detection, and real-time synchronization of diagnostic results with patient records in the cloud. We've been able to engineer all these functions on a handheld mobile device and all powered by a battery."

This new technology, which combines cell phone and satellite communication technologies with fluid miniaturization techniques for performing all essential ELISA functions, could lead to diagnosis and treatment for HIV-infected people who, because they cannot get to centralized health care centers, do not get tested or treated.

"This is an important step forward for us towards making a real impact on patients," says Jessica Justman, MD, senior technical director at ICAP and associate clinical professor of medicine in epidemiology at the Mailman School of Public Health. "And with the real-time data upload, policymakers and epidemiologists can also monitor disease prevalence across geographical regions more quickly and effectively."

Working with ICAP, OPKO, the Rwandan Ministry of Health, and Rwandan collaborators at Muhima Hospital and two health clinics-Projet San Francisco and Projet Ubuzima, Sia and his team assessed the device's ability to perform HIV testing and then synchronized results in real time with the patients' electronic health records. They successfully tested over 200 serum, plasma, and whole blood samples, all collected in Rwanda.

The mobile device also successfully transmitted all whole-blood test results from a Rwandan clinic to a medical records database stored on the cloud. The device produced results in agreement with a leading ELISA test, including detection of weakly positive samples that were missed by existing rapid tests. The device operated autonomously with minimal user input, produced each result in 15 minutes (compared to 3 hours with the benchtop ELISA), and consumed as little power as a mobile phone.

This latest study builds on previous work from the Sia Lab on building a lab-on-a-chip for personal health diagnosis. For this earlier device, Columbia University was named a Medical Devices runner-up in The Wall Street Journal's prestigious Technology Innovation Awards in 2011.

This research has been funded by a $2-million Saving Lives at Birth transition grant (United States Agency for International Development, the Bill & Melinda Gates Foundation, Government of Norway, Grand Challenges Canada, and the World Bank).

Sia's next step will be to implement an antenatal care panel for diagnosing HIV and sexually transmitted diseases for pregnant women in Rwanda. He is also exploring the use of this technology for improving personal health for consumers in the United States.

"The ability to perform state-of-the-art diagnostics on mobile devices has the potential to revolutionize how patients manage their health," Sia says. "I'm pleased with the progress we have made so far, and we are working hard with our collaborators to bring this technology to clinicians, patients, and consumers."

Source: Columbia University.

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UGA Wins Grant to Study Flu with Lasers

The University of Georgia is researching new ways to combat the flu — with lasers.

This year’s flu outbreak is rampant. As of mid-January, 48 states reported widespread influenza activity and more than 5,200 people had been hospitalized. It isn’t a pandemic, but UGA’s developing technology could help prevent one in the future.

National Institutes of Health granted researchers at UGA $1.1 million to refine a method that allows them to fingerprint the flu virus with laser beams.

“We can tell from that fingerprint whether the flu is a normal/seasonal flu, whether it’s a virulent flu, whether it’s even the flu or not,” said Richard Dluhy, a UGA professor of chemistry.

Virulence is a virus or bacteria’s capacity to defeat the body’s defenses. The more virulent, he said, the more dangerous.

Dluhy and colleagues have been working on the fingerprinting process for about five years and will use the NIH grant to refine the technology over the next four.

Thus far tests have been more than 95 percent accurate, which Dluhy said is much better than the rapid tests available now, which have about a 50/50 chance of a false positive reading. Accurate tests available now take about 24 hours.

If Dluhy and cohorts Stephen Tompkins and Ralph Tripp are successful, it could mean quick and accurate influenza testing on-site at doctors’ offices or clinics. And that, Dluhy said, could be advantageous.

Should a dangerously virulent strain emerge, early identification could prevent mass fatalities. Such early detection would still be too late to provide a vaccine that season — vaccines take six months to develop — but public health officials could order isolation, quarantine or other measures to prevent the disease from spreading.

Easy strain identification could also mean more accurate prescriptions of antiviral drugs like TamiFlu. Doctors are wary of prescribing drugs when they’re not certain a patient has the flu, Tompkins said, but a quick test could eliminate doubt.

Successful development could also lead to similar identification methods for other viruses and bacteria.

“This is what we call a platform technology,” Dluhy said. “Once you have the basics down, it can be applied to a number of pathogens.”

That would allow doctors to easily test patients for strep, mononucleosis and sinus infections and have an answer within minutes.

That’s what Mike Sakalian, the program director who recommended the grant for funding at NIH, is most excited about. His division isn’t focused on researching specific diseases; it’s interested in a useful technology. “We’re interested in things that have broad applicability to a range of diseases and also to basic science,” he said.

It is difficult to predict how long before that technology could become available in offices and clinics, he said.

The method the researchers are using is starkly different from current tests. Currently, Dluhy said, lab workers have to amplify the amount of the test material they have, such as culturing bacteria for a strep test. That takes time.

“We’re trying to … do this without the elaborate chemistry and biochemistry,” Dluhy said.

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Live Pathogens: Rapid Detection Technique Developed

Los Alamos researchers have developed a better technique for quick detection of live pathogens in the field. Identification of viable bacteria in a complex environment is scientifically challenging. Current detection and diagnostic techniques are inadequate in major public health emergencies, such as outbreaks of food-borne illness. Detection of live pathogens in the suspected food supply requires days of laboratory culture.

LANL's new method eliminates the need for laboratory culture and greatly speeds the process. The technique relies on bacteria being critically dependent upon the key nutrient iron. The bacteria synthesize and release sequestering agents, called siderophores, into their environment to bind iron tightly for subsequent uptake. This process occurs only in live, intact bacteria. The LANL team created a simple method to use bacterial siderophores for selective, rapid identification of viable bacteria in their surroundings.

Bacteria secrete siderophores to sequester and incorporate the iron they need. The scientists used bacterial siderophores to identify bacteria selectively and rapidly in complex matrices and to discriminate viable bacteria from their dead counterparts. The team developed surface chemistry strategies to tether siderophores to glass slides. Surface functionalization chemistry, which was developed at LANL for self-assembled monolayers, tethers siderophores and minimizes non-specific interactions associated with complex biological samples, such as culture filtrate, serum and urine. The tethered siderophores captured viable bacteria from a mixture of viable and dead Escherichia coli. The team also used a software analysis tool that was originally developed for satellite imaging to conduct quantitative measurement of fluorescence staining in biological specimens. This tool enables accurate and fast quantitation of the data.

Rapid and selective determination of bacterial viability is critical for food safety. This simple analytical technique has applications for other situations, such as the rapid determination of the efficiency of a decontamination process, efficacy assessment after initial medical intervention to infection, and detection of exposure to a biological threat agent. The siderophore approach could be universally applicable to all bacteria, making it extremely useful for detection in complex backgrounds. The journal Advances in Biological Chemistry published the research:

Determination of bacterial viability by selective capture using surface-bound siderophores. Mark L. Wolfenden, Rama M. Sakamuri, Aaron S. Anderson, Lakshman Prasad, Jurgen G. Schmidt1, Harshini Mukundan. Advances in Biological Chemistry, 2012, 2, 396-402. 

Abstract:

A significant challenge in bacterial detection is the identification of viable bacteria over debris, specifi- cally post decontamination. Of increasing concern are antibiotic resistant strains that require accurate and rapid post decontamination analysis. Current strate- gies are fraught with disadvantages and most of them are not selective for viable bacteria. However, bacte- ria are critically dependent upon iron sequestration, synthesizing and releasing siderophores (SDPs) to tightly bind iron, with the subsequent uptake of iron bound SDPs. This is a highly conserved process that occurs only in intact bacteria. Herein we report a fac- ile method to use bacterial SDPs to selectively and rapidly identify only viable bacteria in complex ma- trices, and discriminate them from their dead coun- terparts. Desferrioxamine B (Desf B) tethered to a glass slide is used to specifically capture viable bacte- ria from a mixture of viable and dead Escherichia coli, as demonstrated by fluorescence microscopy. We re- port both direct conjugation of Desf B on thin-film- coated glass slides as well as biotin-streptavidin con- jugation strategies, both of which are successful in the said goal. We have analyzed the density of images obtained upon fluorescence staining using edge detec- tion with a Canny edge detector. This novel applica- tion of a software analysis tool originally developed for satellite imaging to biological staining allows for accurate quantitation of observed data.

You can download a PDF of the article at http://www.scirp.org/journal/PaperDownload.aspx?paperID=24812.

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IDRI And OrangeLife Register Rapid Diagnostic For Leprosy For Use In Brazil

IDRI (Infectious Disease Research Institute), in conjunction with OrangeLife, a Brazilian diagnostic company, today announces the registration of a rapid diagnostic test for leprosy, offering new hope for early diagnosis and treatment. The test was registered through ANVISA, Brazil's regulatory authority.

Leprosy, an ailment most people associate with biblical times, is a chronic infectious disease caused by the bacterium Mycobacterium leprae. It was reported in 130 countries in the past year and is prevalent in countries throughout Africa, Asia and South America – including Brazil. Symptoms include progressive and permanent damage to the skin, nerves, limbs and eyes that can take several years to appear, making the disease hard to diagnose at an early stage. Nearly 250,000 new cases of leprosy are diagnosed every year, and many more go undetected.

"Currently the method of detection for leprosy is by clinical and/or microscopic assessment," explained Steven Reed, President, Founder and Chief Scientific Officer for IDRI. "There is a great need to more rapidly diagnose the disease, before nerve damage occurs, and we are pleased to have helped develop this technology here at IDRI."

According to Malcolm Duthie, Senior Scientist at IDRI, the diagnostic test is simple and easy to use. "The test requires just a single drop of blood, mixed with a developing reagent," he explained. "From there, a line develops and it's somewhat like a pregnancy test: the appearance of two lines indicates the test is positive and the person has leprosy." He added that scientific publications regarding the rapid diagnostic indicate its ability to diagnose the presence of infection before clinical symptoms appear, in most cases.

OrangeLife coupled IDRI's leprosy diagnostic antigens with a rapid test format that standardize the ability to accurately interpret results and get a quantitative value. "My goal is to eliminate leprosy in Brazil, as well as the rest of the world," said Marco Collovati, OrangeLife CEO. "Being able to easily and rapidly diagnose the disease, even the most remote areas of the country, are the first steps to elimination." According to Collovati, Brazil had 35,000 cases of leprosy reported in its health public system – second only to India. "The problem is that many cases are not known because patients do not have access to a rapid diagnostic and it is difficult to reach the health system. This rapid test, together with our Smart-Reader, will permit an easier interaction for doctors and patients. Many people suffer the stigma of leprosy and are reluctant to seek medical help. We need to improve communication with public campaigns using all channels – this will be of paramount importance to combat the discrimination this disease still has."

While IDRI's work in diagnostics can aid in early detection of leprosy, scientists at the organization are also focused on developing a vaccine. "Although there are drugs to treat leprosy, there hasn't been a focus on prevention," Reed said. "At IDRI, we are developing a defined subunit vaccine to provide long-term protection for those who are most at risk. Once the three components are in place – a test to diagnose, drugs to treat and a vaccine to prevent – we will finally have the tools to bring an end to this devastating disease."

Funding for IDRI's leprosy research and product development program comes from grants from American Leprosy Missions, Renaissance Health Service Corp., the National Institute of Allergy and Infectious Diseases (NIAID), as well as donations from various private foundations and individuals.

IDRI is partnering with American Leprosy Missions to bring attention to World Leprosy Day, observed Jan. 27, 2013. "World Leprosy Day helps focus on the needs of some of the poorest and most marginalized people in the world – those affected by leprosy.  And, it reminds us of the millions of people who suffer from the effects of this terrible disease," said Bill Simmons, American Leprosy Missions President and CEO. "By partnering with IDRI and providing funding for the diagnostic test and vaccine, we hope to bring this disease to an end."

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Rapid Pathogen Screening Expanding Sarasota Footprint

Rapid Pathogen Screening is expanding its footprint in Sarasota with the addition of a new building adjacent to its current headquarters that will double the company’s space.

“International demand for POC diagnostics combined with the supportive local business climate, highly-skilled workforce, and professional associations unique to Sarasota County creates an ideal situation to further pursue our commitment to impact global healthcare by expanding our family of rapid, easy to use tests,” said Robert Sambursky, RPS’s chief executive officer and president.

The company, which is located at 7227 Delainey Court, develops and manufactures rapid point-of-care diagnostic tests for infectious diseases and inflammatory conditions.

RPS spent eight years developing a disposable diagnostic test for pink eye and other inflammatory diseases and is now commercializing the product with a French development firm. The company is marketing the patented test kits to optometrists, ophthalmologists and family physicians across the U.S. and in Europe. The AdenoPlus kit allows clinicians to diagnose the highly contagious viral form of conjunctivitis, or pink-eye, within minutes during a medical office visit. Previously, health care technicians could only confirm pink eye with a culture swab or DNA test, expensive methods that took several hours or days. "These are single use tests," Sambursky said. "We can make the diagnosis before the patient leaves the doctor's office," which prevents spread of the disease and eliminates treatments that aren't needed.

The company recently signed a contract with the U.S. Department of Homeland Security’s Chemical and Biological Defense Division to develop and manufacture a diagnostic test to detect the body’s immune response to viral and bacterial infections.

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Blood Test Speeds Up Infection Detection

An Albuquerque startup may soon gain fame for ending a century-old time warp in medical diagnostics for blood infections.

To detect infections in blood, doctors today must still wait 24 to 72 hours for labs to grow cultures — the same medical process in effect since the 1800s. But nanoMR Inc. has developed technology to detect infections and identify the type of bacteria present in blood in just two hours.

“That’s revolutionary,” said Cathy Petti, an infectious disease specialist and microbiologist who does consulting for the medical diagnostics industry. “Ever since blood cultures were first used to identify infections in the late 1800s, the technology has changed very little. That’s a major barrier to providing effective care to patients.”

Given nanoMR’s radically modernizing potential, the company has attracted $21 million in venture capital from investors since launching in 2006. That includes Dow Venture capital, vSpring Capital, and two prominent, Massachusettes-based life science firms, Excel Venture Management and Healthcare Ventures LLC.

Scientist Thearith Ung with nanoMR extracts a sample of a solution containing nano- sized magnetic beads inside the company’s physical chemistry lab.
Sun Mountain Capital, which manages the New Mexico State Investment Council’s $110 million Co-Investment Fund, has also put money into nanoMR.

“The company’s technology could save many lives and billions of dollars in medical expenses,” said Sun Mountain partner Sally Corning. “It’s potentially game-changing technology.”

The startup originally licensed its technology from the University of New Mexico, and from ABQMR Inc., an Albuquerque firm that specializes in magnetic resonance imaging. UNM and ABQMR researchers jointly developed a process to attach tiny magnetic beads to antibodies that imbed themselves in potentially infected cells. The cells are then run through a device to monitor emissions from the beads, allowing lab technicians to isolate and extract the infected cells from blood samples.

Once extracted, technicians can rapidly identify the bacteria present, allowing doctors to begin antibiotic therapies before an infection invades the bloodstream, said nanoMR President and CEO Victor Esch. That offers a critical advance in patient care, because once the infection has entered the blood stream, a process known as sepsis, it’s much more difficult and expensive to treat, and patients frequently die.

“Our process can capture pathogens from blood extremely fast, and with extremely high efficiency,” Esch said.

The ability to detect infected cells at extremely low concentrations in blood is critical to nanoMR’s technology.

“When sepsis begins, the sick cells circulate in the blood at extremely low concentrations, like one cell per milliliter or less, and even that’s enough to kill you,” Esch said. “Our technology is able to extract cells at that concentration, providing samples for bacteria identification.”

The company has conducted clinical studies since 2010 with assistance from UNM and Tricore Reference Laboratories in Albuquerque. Tricore collects human blood samples from UNM, which nanoMR uses to compare its technology with lab cultures.

“The results are very encouraging,” said Petti, who is providing consulting services to nanoMR.

Chief Science Officer Collin Dykes said the technology has also been effective in detecting rare tumor cells. In addition, apart from blood, it’s been able to identify pathogens in urine samples and food extracts.

“We’re focused on bloodstream infections now, but we’ve been asked to investigate other applications, and in doing so, the system’s universality is becoming apparent,” Dykes said. “We’re even beginning to look at it as a possible method to detect tuberculosis using sputum samples as well as blood.”

The company’s first target markets are hospitals and medical clinics that test for blood infections. Commercial sales are expected to begin in 2014, after nanoMR finishes devising a compact device to extract and identify infections in blood. It’s partnering with Stratos Product Development in Seattle, Wa., to build the device, which Esch said will be ready within six to nine months.

Sales will launch first in Europe, where it’s easier to get regulatory approval for new medical devices than in the U.S. The company has already negotiated agreements for clinical testing at five sites in Germany and France, Esch said.

While pursuing the European market, the company will simultaneously conduct clinical trials in the U.S. to achieve Food and Drug Administration approval, starting in mid-2014.

Once sales begin, nanoMR expects to hire scores of employees in Albuquerque, where it will produce all of the beads, reagents and other inputs used to test blood samples in the company’s device, Esch said. The firm moved from a cramped, 7,000-square-foot complex near the Albuquerque International Sunport last March to a 19,000-square-foot building in the industrial zone by Jefferson Street and Interstate 25. The company currently employs 28 people at the new facility, which includes 5,000 square feet of clean-room space.

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Boulder's InDevR announces spinoff business ViroCyt, LLC

InDevR Inc., a Boulder-based company that develops instruments and assays for microbiological analysis, announced Tuesday that it spun off a business to further expand the commercial market for its Virus Counter technology.

Headquartered in Denver, the spinoff ViroCyt LLC commenced operations with seven employees -- three from InDevR -- and more than $3 million in investment capital in a round led by Boulder-based High Country Venture, said Michael Artinger, a former InDevR executive who now is ViroCyt's vice president of marketing and strategic partnering.

The money will be put toward expanding a North American direct sales force and a network of distributors globally, officials said.

Heading up ViroCyt as its president and chief executive officer is Robert Kline, who founded and led Medivance, the Louisville-based firm that developed products to control core body temperature after trauma. C.R. Bard acquired Medivance in 2011.

"Within the life science research, pharmaceutical and vaccine markets, there is a large and growing need for rapid quantification of viruses, so I am excited to be part of the formation of ViroCyt," Kline said in a statement. "The Virus Counter represents breakthrough technology in this important field and the early customer acceptance has exceeded all expectations."

The Virus Counter is designed to measure the concentration of virus particles -- including viruses such as the flu, rubella and dengue -- in fewer than 10 minutes.

The products current user base includes vaccine companies, government research institutions and universities, officials said.

It wasn't immediately clear what type of ownership stake InDevR has in the spinoff.

Securities and Exchange Commission filings made in November 2012 show that two offerings were made: one consisting of equity and Series A stock for $3.5 million and another consisting of equity and Series B stock for approximately $2.6 million.

Kathy Rowlen, InDevR's CEO and co-founder, was listed as a director of ViroCyt.

When reached by e-mail Tuesday, Rowlen said the spinoff would allow InDevR to direct its attention to developing new technologies.

"We are focused on several additional products that will help make vaccines more affordable and more widely available," she wrote. "Those products include new tools for influenza surveillance around the world and break through technology for ensuring vaccine quality."

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PositiveID Corp. Inks Licensing Deal with Boeing

PositiveID, a developer of airborne bio-threat detection systems for the U.S. homeland defense industry and creator of advanced technologies for rapid medical testing and diabetes management, has signed a license and teaming agreement with The Boeing Company.

Per the agreement, which includes a license fee to PositiveID of $2.5 million, Boeing has the exclusive license to manufacture and sell PositiveID’s M-BAND (Microfluidics-based Bioagent Networked Detector) airborne bio-threat detector for the U.S. Department of Homeland Security’s (DHS) BioWatch Generation 3 opportunity, as well as other opportunities that may arise in the North American market.

PositiveID will retain exclusive rights to serve as the reagent and assay supplier of the M-BAND systems to Boeing in the U.S. market, as well as keep the right to sell M-BAND units, reagents, and assays in international markets.

PositiveID’s M-BAND is a bioaerosol monitor with full capability to collect, process, detect, and analyze air samples for the detection of bacteria, viruses, and toxins. Results from individual M-BAND instruments are reported through a secure wireless network in real time to give an accurate and up to date status. The M-BAND touts significant hardiness, operating from -25 to 125 degrees Fahrenheit, for both indoor and outdoor settings. Toxin analysis takes approximately 40 minutes.

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Duke Researchers Say Gene Studies Can Help Diagnose Flu, Other Infectious Diseases

Duke University researchers have found a way to diagnose infectious diseases such as flu and staph infections more quickly by looking for responses in a patient’s genes.

Genomics, a field of genetics that takes into account the entire gene sequence, can identify diseases more quickly and accurately than typical methods, according to studies published earlier this month in PLOS ONE, a peer-reviewed online journal of science and medicine.

The researchers examined the ribonucleic acid, or RNA, from blood samples taken from patients. They found that the RNA profiles changed in specific ways among patients exposed to infectious viruses or bacteria, according to Geoffrey Ginsburg, director of genomic medicine at Duke’s Institute for Genome Sciences & Policy and an author on both studies.

“Other diagnostic approaches have to be very specific as to what they think the pathogens are,” Ginsburg said. “Our approach doesn’t care, because it takes advantage of the host response,”

To conduct their research, the scientists inoculated 41 people with H1N1 or H3N2 flu before analyzing their blood samples. Specific changes to the RNA profile, called the Influenza Factor, were found in patients exposed to either flu strain. The test was able to distinguish infected from non-infected individuals with 94 percent accuracy.

In a second study, the researchers found a similar factor for diagnosing staph, a common bacterial infection.

The genomic method can reveal an infection before symptoms appear, allowing treatment to begin almost immediately, Ginsburg said.

“If you have been exposed, we can make the prediction on whether you are going to get sick, and consider starting an antiviral medication,” Ginsburg said. “Such early intervention is likely to make the treatment more effective.”

Early treatment could give schools, hospitals and other places where illness spreads quickly a better chance of controlling an outbreak.

“Think back to the SARS epidemic [of 2002-2003], when entire schools were being closed and people were being quarantined because we didn’t know whether they were actually going to be infected and get sick,” Ginsburg said. “A cheap and rapid test would have offered a distinct advantage, from a public health point of view.”

The genomic response approach also could have been useful during the 2009 flu pandemic, which stemmed from a new strain of the virus, said Christopher W. Woods, associate professor of medicine, pathology and global health at Duke and lead author of the flu study.

“The original tests didn’t perform very well in detecting H1N1, because it was something new,” Woods said. “A test like ours would have responded and suggested influenza infection.”

In addition to halting or lessening the severity of an illness, antiviral medication will stop a virus from “shedding,” which is how it is spread from one person to another, the researcher said.

Yet another advantage would be the ability to rapidly distinguish between bacterial and viral infections, Woods said.

Antibiotics are not effective against viruses, but they are sometimes prescribed when the origin of an illness isn’t clear. Overuse of antibiotics causes resistant strains of bacteria to develop, posting a further threat to health, Woods said.

“It’s one of the major issues we are trying to address,” Ginsburg added. “Too many times people are treated for bacterial infections when they have a virus.”

Zach Moore, epidemiologist with the N.C. Division of Public Health, said flu testing is done currently with nasal or throat swabs, typically on patients who are already experiencing symptoms. Results from those tests are usually available within a few hours.

Some doctors use a rapid flu test that produces more immediate results, but those results are less reliable, Moore added.

“The work using genomes sounds interesting,” he said. “I’m looking forward to hearing more about it.”

Research leading to the discovery began in 2007 with $30 million in funding from the U.S. Department of Defense, Ginsburg said.

“The military is interested in maintaining the health of troops,” he said. “If a viral infection is running through a contingent in the field, it can put them in a compromising situation. With our rapid screening diagnostics, military leadership could know almost immediately if there’s a pathogen involved and take action against it.”

More work will be needed before genomic diagnoses can be put into routine use by doctors.

“If we were working with a commercial firm, it could be two or three years before we have something robust, reproducible and ready,” Ginsburg said. “If we were called upon to move fast and had resources from the military or government, it could be quicker – possibly in a few months.”

Eventually, blood tests that measure genomic response may be carried out at home, he said.

“I could imagine a scenario where this could be translated to a simple device, like a home pregnancy test, where you could test a drop of blood to see if you have been exposed,” Ginsburg said. “That would allow you to take action long before you find yourself at the doctor’s office feeling lousy.”

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Bacteria Breakthrough for Safer Food

Chicken meat and other foods will be able to be screened for bacteria even faster and more effectively than ever, thanks to breakthrough nanobiotechnology research.

A team of scientists from The University of Queensland (UQ) and the Department of Agriculture, Fisheries and Forestry (DAFF) will leverage this new technology which enables DNA amplification on “microspheres” to rapidly detect and identify large numbers of different bacteria at once.

Professor Ross Barnard, Director of the Biotechnology Program at the UQ School of Chemistry & Molecular Biosciences, said that authorities have estimated that there are around 5.4 million cases of food-borne gastroenteritis in Australia every year. Of these cases, it is estimated that around 200,000 are associated with the bacteria Campylobacter jejuni and Campylobacter coli.

“We hope to use this new technology to be able to detect and type C. jejuni/coli. These quick identification techniques can underpin relevant and sustainable programs to further improve food safety,” he said.

“The infectious dose for C. jejuni/coli can be very low – around 500 organisms. This means that sensitive, specific and rapid techniques are particularly important for this organism” said Professor Barnard.

He said while testing methods do exist, they had been slow and less effective, so many scientists had turned their focus to leveraging existing “microsphere” technology to a new level.

“After five years, we are now able to extend and develop the platform in ways that haven't been done before,” Professor Barnard said.

“We will now be able to carry out many typing reactions at once by doing a very large number of DNA amplification reactions at the same time on the surface of the microspheres.”

The continuing research will be sponsored by the Poultry CRC (Cooperative Research Centre) and carried out by UQ PhD student Mr Liang Fang, who is working on an International Postgraduate Research/UQ Centenary Scholarship, alongside Dr Pat Blackall (Queensland Alliance for Agriculture and Food Innovation) and Ms Jillian Templeton at DAFF.

The discovery was the result of five years of intensive research and the full scale of the benefits is yet to be known.

“This is just the beginning. Because this testing is based on a platform technology it can be applied in many different ways, such as mutation screening in plant, animal and human genomes, as well as for applications in the realm of infectious diseases,” said Professor Barnard.

The discovery has attracted global interest featuring this month on the front cover of the respected international journal Analytical Biochemistry and has resulted in an invitation to present the work at the Luminex International Diagnostics Forum in Monaco.

This development adds to a growing list of UQ research successes that have the potential to benefit humankind which includes the needle-free injection Nanopatch technology, the development of vaccines to suppress rheumatoid arthritis, and the creation of the cervical cancer vaccine, Gardasil.

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Hyglos Extends its Endotoxin Detection Portfolio and Introduces EndoZyme®

Hyglos is today pleased to announce the commercial launch of EndoZyme® , a homogeneous fluorescence microplate assay using recombinant Factor C derived from horseshoe crab, for measuring endotoxin (Lipopolysaccharides, LPS) in pharmaceuticals, biologics and medical equipment.

Taking up on the pioneering work published by the Japanese scientists around Prof. Sadaaki Iwanaga, the test developers at Hyglos have been able to finalize an improved recombinant Factor C (rFC) assay.

Recombinant factor C, which is the essential part of EndoZyme® , is the endotoxin-specific principal receptor in the LAL enzyme cascade. In the assay recombinant Factor C is activated by any endotoxin present in the sample, recombinant Factor C enzymatically cleaves a synthetic substrate resulting in a fluorescence signal.

EndoZyme® at a glance:

• Improved sensitivity and measurement range 0.005 EU/ml to 50 EU/ml
• Excellent correlation to LAL
• No false-positive glucan reaction due to endotoxin-specific recombinant technology
• Reliability and lot-to-lot consistency
• No animal material, therefore saving the diminishing horseshoe crab population

Lipopolysaccharides (LPS), or endotoxins, are biologically active components (toxins) of the outer cell membrane of all Gram-negative bacteria. Presence of endotoxins in the blood stream causes a triggering of the signaling cascade and may lead to endotoxic shock. In production of parental drugs, infusions and certain medical devices it is mandatory to control endotoxin.

About Hyglos and its Endotoxin Detection products:

Hyglos core competency is to exploit its proprietary phage-ligand technology in developing test solutions for research, manufacturing and clinical applications. With the 2011 introduction of EndoLISA® , the world’s first commercially available solid-phase based method for endotoxin detection, Hyglos paved the way for a new era in endotoxin testing. Thanks to its heterogeneous assay format, EndoLISA®  is particularly suited for complex sample matrices. With the launch of EndoZyme® , Hyglos now also offers a homogeneous test format suitable for all less demanding samples.

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Rapid Tests Diagnose Adenovirus Conjunctivitis

An article published in the January issue of JAMA Ophthalmology (formerly Archives of Ophthalmology) describe a sensitive and specific point-of-care test that can help clinicians quickly and easily reach a diagnosis for adenoviral conjunctivitis.

The test uses direct sampling microfiltration and is based on lateral flow technology, similar to a home pregnancy test. The test producse visual results, with a blue control line and, if positive, a red test line.

The article evaluates the adenovirus test (AdenoPlus, Rapid Pathogen Screening Inc), which detects the most common cause of viral conjunctivitis. Adenovirus-associated conjunctivitis may lead to significant ocular morbidity and is associated with substantial healthcare costs.

Researchers led by Robert Sambursky, MD, a cornea specialist at the Manatee Sarasota Eye Clinic and Laser Center in Sarasota, Florida, compared this recently US Food and Drug Administration–cleared second-generation test with traditional gold standard tests.

"Ophthalmologists and optometrists that have access to a slit lamp biomicroscope and who should be the experts are somewhere between 25% to 60% accurate at making a differentiation between a viral and bacterial disease...and that impacts treatment," Dr. Sambursky told Medscape Medical News.

For the multicenter trial, the researchers recruited 128 patients (76 females, 52 males) with a clinical diagnosis of acute viral conjunctivitis in a prospective, sequential manner within 7 days of developing a red eye. Patients ranged in age from 5 to 90 years, with a mean duration of symptoms among patients from each center of between 2.8 and 3.7 days.

Tear samples were collected with the test device as well as for testing by viral cell culture with confirmatory immunofluorescence assay (CC-IFA) and for polymerase chain reaction (PCR). If either CC-IFA or PCR were positive, the patient was considered definitively positive for adenoviral conjunctivitis. If both were negative, the patient was considered negative for adenoviral infection. The AdenoPlus test, which requires only 10 minutes to develop after sample collection, was read by an independent healthcare professional masked to the clinical examination results.

High Sensitivity and Specificity

Of the 128 patients, 36 were positive by either CC-IFA or PCR. Cell culture has been the traditional definitive test for adenovirus infection. "Compared to [that] gold standard, AdenoPlus has a 90% sensitivity and a 96% specificity," Dr. Sambursky said. "When you actually compare it to PCR, that specificity goes up to about 98% and still maintains a good sensitivity in the mid-80s." Compared with CC-IFA, the test had a positive predictive value of 88% and a negative predictive value of 97%. Compared with PCR, the positive predictive value was 94% and the negative predictive value was 95%.

"[T]he rapidity is a major advantage" of the new test, Dr. Sambursky said. Making a diagnosis early allows withholding inappropriate antibiotics from patients with viral disease instead of treating them empirically, thereby reducing the potential for developing antibiotic resistance, complications, and toxicities. "[N]ot treating is as important as treating effectively," he noted.

Stephanie Marioneaux, MD, a cornea specialist in private practice in Chesapeake, Virginia, and an expert spokesperson from the American Academy of Ophthalmology, commended the trial for comparing AdenoPlus with the gold standard tests, which "are so burdensome, and they are not readily available to your average clinician," she told Medscape Medical News. "[W]hereas this now makes the test much more widely accessible." She noted that the researchers used appropriate patient eligibility criteria, a wide age range of patients, and masked examiners.

Dr. Marioneaux said the test "will add a lot to the clinician's ability to rapidly diagnose something that is extremely contagious and is often very difficult to diagnose." Getting infected patients out of the office quickly is an advantage, she said, because the virus is highly contagious and can persist on surfaces for weeks.

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Dengue Rapid Diagnostic Kit Field Evaluated

Rapid diagnostic tests that detect proteins of and antibodies to the Dengue virus (DENV) are now available to be used in the field. 

Dengue diagnosis is complex and until recently, only specialized laboratories were able to definitively confirm dengue infection, but the rapid tests are now available commercially making biological diagnosis possible in low resource settings. 

Scientists at the Pasteur Institute (Phnom Penh, Cambodia) enrolled 157 patients hospitalized for a suspicion of dengue in a prospective study between June and October 2011. A panel of sera were chosen for positive and negative control and tested with reverse transcriptase polymerase chain reaction (RT-PCR), in-house immunoglobulin M (IgM) capture enzyme-linked immunosorbent assay (MAC-ELISA), and a hemagglutination inhibition assay. 

The rapid diagnostic used was the SD Bioline Dengue Duo kit (Standard Diagnostics (Kyonggi-do, Korea) and for the prospective study, only acute blood samples were tested. The SD Bioline Dengue Duo kit is composed of two tests designed to detect DENV NS1 antigen as a first test and anti-DENV IgM/IgG as a second test in serum, plasma, or whole blood. In the field hospital laboratories, the overall sensitivity was 85.7% and the specificity was 83.9% of the NS1/IgM/IgG combination tests, whereas in the national reference laboratory, the sensitivity was 94.4%, and the specificity was 90.0%. 

The results of the study demonstrated that optimal performances require adequate training and quality assurance. The retrospective study showed that the sensitivity of the combined kit did not vary significantly between the serotypes and was not affected by the immune status or by the interval of time between onset of fever and sample collection. However, in the context of the prospective field study, it was shown that if the SD Bioline Dengue Duo kit is correctly used, a positive result highly suggests a dengue case, but a negative result does not rule out a dengue infection.

The authors concluded that when they assessed the impact of the test results on the clinical management decision, the physicians treated patients according to their clinical diagnosis and did not take negative results into consideration. The combination of NS1 test with antibodies detection improved the performance, though discordances on IgM and IgG results were observed between the hospitals and the national reference laboratories. The study was published online in December 2012 in the journal Public Library of Science Neglected Tropical Diseases.

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Hospitals Speed up Flu Testing for Hectic Season

Laboratory testing for the flu has traditionally taken so long to yield results that most people recovered before finding out if they actually had the virus.

But about half a dozen Chicago-area hospitals can now diagnose influenza in just more than an hour through a federally approved machine that has been working overtime during what is shaping up as a horrendous season for the flu.

"If you don't have this test, then you're just guessing what the best thing to do could be," said Paul Schreckenberger, Loyola University Health System's authority on the FilmArray Respiratory Panel.

A faster and more accurate diagnosis can lead to more effective treatment.

"It is important for the physician to know what they're dealing with," Schreckenberger said. "They can't just look at the patient or read their symptoms."

The screening device — the second of its type to be approved by the U.S. Food and Drug Administration — tests a nasal sample for 17 types of viruses and three kinds of bacteria. Among them are key indicators of the flu that on Friday was classified as an epidemic by the Centers for Disease Control and Prevention.

The automated machine speeds up a diagnostic process that could otherwise take up to a week under different methods. Most hospitals send patient samples to commercial laboratories, where technicians either grow the virus or check for it using their own technology.

In labs without FilmArray, it could be a few days before technicians observe viral growth in test tubes.

"It didn't really lend itself to early diagnosis," said Dr. Xiaotian Zheng, who works with FilmArray at Lurie Children's Hospital of Chicago. "Physicians had to make a decision."

"It's not only time-consuming but labor-intensive," he added.

FilmArray creates millions of copies of RNA strands of influenza in an hour and five minutes. When all is said and done, Loyola says its technicians spend two minutes dealing with the machine.

The Maywood-based health system said it administered nearly 2,500 FilmArray tests in 2012.

Other hospitals that have bought their own panels within the past few years include the University of Chicago Medical Center, Mount Sinai Medical Center and La Rabida Children's Hospital. The technology also can be found at several Chicago-area locations operated by Hammond-based Alverno Clinical Laboratories.

This flu season's early and active start has increased demand, said Sharon Lang, sales manager for BioFire Diagnostics' Great Lakes region. She said she has handled 40 inquiries since the beginning of December.

Local doctors said the device's only drawback is its $36,000 cost. The individual tests cost hospitals more than $100 each.

Many hospitals use less expensive rapid influenza diagnostic tests that cost about $10 per use, but those tests are looked at with skepticism by some in the medical community.

Loyola researchers have found the rapid flu tests, some of which generate results in less than 15 minutes, detect the virus about half of the time.

"You get what you pay for," Schreckenberger said.

Still, FilmArray's necessity is up for debate. Some health officials believe a quick diagnosis is only essential for patients with underlying illness that could be deadly when coupled with influenza.

For others, "they don't really need to know that they have the flu because you treat the flu like any respiratory illness," said Dr. Julie Morita, the medical director of the Chicago Department of Public Health.

An incompetent diagnosis could lead to a patient being prescribed antibiotics, which do nothing to combat viruses. In some cases, the wrong prescription could worsen whatever medical conditions the patient already has.

"You don't want to blanketly give Tamiflu to everyone," Lang said, referring to the antiviral drug that deals with influenza.

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China Health Labs & Diagnostics Ltd. Announces New Food Safety Sales Contract

China Health Labs & Diagnostics Ltd. ("China Health" or the "Company"), is pleased to announce that it has entered into and delivered on a new sales order of RMB 12.4 million ($2.0 million) for 39 food safety rapid test labs, which were installed in large restaurants and hotels in Beijing. The Company's Type B BK Food Safety Rapid Test System ("BK-iRT") was also delivered as part of this food safety rapid test labs installation. The delivery of the food safety rapid test labs and BK-iRT was completed in December 2012.

The Company also delivered in December 2012 on the sales order of RMB 74.0 million ($11.7 million) for food safety products and its BK-iRT, as previously announced by the Company on October 3, 2012. The BK-iRT product and other food safety products are to be used by Beijing's food safety detection units in monitoring the thousands of food preparation and distribution nodes in Beijing.

Subsequent to the Company's delivery on the RMB 74.0 million ($11.7 million) sales order of its food safety and BK-iRT products, a number of Chinese government officials and food safety and health institutions toured the Company's facilities to learn more about the food safety total solutions and products offered by the Company. They provided positive feedback and this resulted in the additional sales order of RMB 12.4 million ($2.0 million), which was delivered in December 2012.

The BK-iRT is a compact and mobile food safety testing solution and can conduct approximately 100 rapid and accurate types of tests, including testing for physicochemical residues, veterinary drug residues, biotoxins, heavy metal residues, prohibited additives, and food additives. The solution also includes an information management module equipped with a 3G telecommunication function to transmit and communicate data with a network of mobile and stationary labs, which allows data sharing, real-time monitoring and dynamic instructions. Other target markets for the BK-iRT include food distribution centres and facilities such as canteens for large organizations, hospitals and universities.

The Company has continued to expand its presence in the food safety industry and has delivered products and food safety labs that could represent revenues of over RMB 86.4 million ($13.7 million) for the fiscal year 2012, representing growth of approximately 52% for the Company's food safety business sector compared to the fiscal year 2011 during which the Company had revenues of $9.0 million. Further, the Company's gross margins in this sector has increased for fiscal year 2012 as the BK-iRT is a proprietary product developed and manufactured in the Company's Beijing facility, whereas sales in prior years consisted of third party products which generated lower gross margins. The Company is actively marketing to other large cities and municipalities in China in growing its food safety sector outside of Beijing based on the Company's past success in delivering to the Chinese government effective solutions to address food safety concerns and also in developing new products to meet future demands.

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Luminex Receives FDA Clearance for First Comprehensive Gastrointestinal Pathogen Infectious Disease Diagnostic in the US

Luminex Corporation announced today that it has received FDA clearance for its xTAG Gastrointestinal Pathogen Panel (GPP), the first comprehensive molecular diagnostic assay that tests for greater than 90% of bacterial, viral, and parasitic causes of infectious gastroenteritis in a single assay. The xTAG GPP assay can be an important clinical tool in the management of gastrointestinal infections, and is now available in the United States.

Diarrheal disease strikes more than two billion times globally each year and is a leading cause of child morbidity and mortality worldwide(1). In the United States alone, 99 million cases of GI infection occur annually, leading to over 250,000 hospitalizations(2) and 17,000 deaths(3), inflicting a significant toll on the healthcare system. Diagnosis of some causes of infectious gastroenteritis has traditionally required multiple tests across the microbiology, virology, and molecular laboratories for which results may not be available for several days.

As the first and most comprehensive multiplexed product of its kind in the United States, xTAG GPP is a nucleic acid-based amplification assay that simultaneously tests for 11 of the most common gastroenteritis causing viruses, bacteria, and parasites.  The panel includes: Campylobacter, Clostridium difficile Toxin A/B, Escherichia coli O157, Enterotoxigenic E. coli (ETEC) LT/ST, Shiga-like toxin producing E. coli (STEC) stx1/stx2, Salmonella, Shigella, Rotavirus A, Norovirus GI/GII, Giardia lamblia and Cryptosporidium.

Depending on the pathogen, currently available technologies and methods can take several days to deliver a single result. xTAG GPP is capable of delivering multiple results within 5 hours. The assay is cleared on the widely available Luminex® 100/200™ system. Additionally, simultaneous molecular testing on a single sample within a single shift provides significant benefit to laboratories in terms of workflow and resource utilization.

"In our experience, simultaneous testing for multiple GI pathogens during routine clinical testing and outbreak investigations enhances both our diagnostic capabilities and public health laboratory efficiency," said Dr. Sanjib Bhattacharyya, Deputy Laboratory Director at City of Milwaukee Health Department. "Routine use of xTAG GPP will allow cost-effective, timely detection of multiple pathogens, optimize use of laboratory resources, and elevate our understanding of pathogen-associated diseases in gastroenteritis."

"CE IVD marked xTAG GPP has provided significant improvement to laboratories and healthcare systems in Europe and other countries and we are pleased to provide this important diagnostic to laboratories and patients in the United States," said Patrick J. Balthrop, president and CEO of Luminex. "xTAG GPP has the potential to enable hospitals to improve patient outcomes while saving money. Our continued innovation is a reflection of the outstanding dedication of our development team and our passion for creating breakthrough solutions to improve health and advance science."

About xTAG GPP

The xTAG Gastrointestinal Pathogen Panel (GPP) is a multiplexed nucleic acid test for the detection of multiple viral, parasitic, and bacterial nucleic acids in human stool specimens from individuals with signs and symptoms of infectious colitis or gastroenteritis.

The detection and identification of specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastroenteritis aids in the diagnosis of gastrointestinal infection and the investigation of acute gastroenteritis outbreaks when used in conjunction with clinical evaluation, laboratory findings, and epidemiological information.  xTAG GPP positive results are presumptive and must be confirmed by FDA-cleared tests or other acceptable reference methods.

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Cepheid Announces Chlamydia And N. Gonorrhoeae Test Categorized ‘Moderate Complexity’ By FDA

Cepheid today announced the U.S. Food & Drug Administration (FDA) has categorized Cepheid’s Xpert® CT/NG test as ‘Moderate Complexity’ under the Clinical Laboratory Improvement Amendments (CLIA). Xpert CT/NG is a qualitative in vitro molecular diagnostic test for the detection and differentiation of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). The test runs on Cepheid’s GeneXpert® Systems and is the first and only molecular CT/NG test to be categorized as Moderately Complex. The Moderately Complex categorization will now allow the accuracy benefits of molecular diagnostics to be realized over a broader testing universe.

“In a recent study of 23 developed countries by the Institute of Medicine and the National Research Council, the U.S. was found to have the highest rates of Sexually Transmitted Diseases among youths,” said John Bishop, Cepheid’s Chief Executive Officer. “Now accessible to more than 20,000 Moderately Complex U.S. labs and 7,000 High Complexity U.S. labs, Xpert CT/NG becomes an important new weapon in reducing STD rates as clinicians can test, consult with, and treat their patients on a more timely basis.”

“The classification of Xpert CT/NG by the FDA as ‘Moderate Complexity’ is a breakthrough for sexual health and STD prevention. The large number of Moderate Complexity point-of-care laboratories that exist in U.S. hospitals and clinics can now offer rapid, highly accurate and private same-day STD testing,” said Jeffrey D. Klausner, MD, MPH, Professor of Medicine, UCLA-David Geffen School of Medicine. “Public health officials need to work with providers to increase the availability of those tests. Faster STD detection and treatment could go a long way in stemming the continued epidemic of STDs in the United States.”

Gonorrhea and Chlamydia are Sexually Transmitted Diseases. Both are easily treated when detected and managed quickly. Chlamydia remains the most common sexually transmitted bacterial infection in the United States. While the CDC recommends annual testing for all sexually active women aged 25 and under, their most recent nationally representative estimate among this population found that only 38 percent of sexually active women were tested for chlamydia during the previous year.

Gonorrhea is the second most commonly reported bacterial infectious disease in the country. The CDC estimates that more than 700,000 Americans become infected with gonorrhea every year, yet fewer than half of these infections are diagnosed and reported to the CDC. Current testing protocols for Neisseria gonorrhoeae are often problematic due to cross-reactivity with other organisms, often requiring an additional confirmatory test. These delays and coordination issues can significantly hamper communication and consultation, leaving both patients and their partners uninformed and untreated.

The categorization of commercially marketed in vitro diagnostic tests under CLIA is the responsibility of the FDA. This categorization includes the process of assigning commercially marketed in vitro diagnostic test systems to one of three CLIA regulatory categories:

• waived tests
• tests of moderate complexity
• tests of high complexity

Cepheid was the first company to receive a ‘Moderate Complexity’ categorization for a nucleic acid test and Xpert CT/NG is the 12th Cepheid test to be categorized as such.
Xpert CT/NG will begin shipping this month.

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Molnlycke Unveils Instant Test for Bacterial Infections

Molnlycke has introduced an innovative new test for detecting bacterial infections such as MRSA that performs faster than any currently available technology.

Developed in association with the University of Edinburgh, the rapid point-of-care testing option uses swabs taken from wounds or sores, which are analysed using a strip with electrical sensors to detect harmful bacteria, reports the Scotsman.

Whereas current methods involve samples being sent off to a centralised or outsourced lab for time-consuming tests, this new solution can deliver results while the patient is still going through the admittance procedure.

It will be trialled at Edinburgh Royal Infirmary and is expected to save valuable time and money for hospitals.

Russell McCraith, managing director of Molnlycke Health Care Scotland, said: "It will improve the efficiency of the hospital with a better patient flow - they will receive care much more quickly without spreading the infections to other patients in the interim."

The collaboration with Scottish Enterprise and Edinburgh University was signed last month and has seen the company set up a new subsidiary in the Edinburgh BioQuarter.

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AdvanDx Adds Enterococcal Bacteremia Assay to U.S. and E.U. Commercial Launch of QuickFISH

AdvanDx, Inc. today announced the commercial launch of Enterococcus QuickFISH BC, a new rapid molecular diagnostic test that identifies potentially life threatening bloodstream infections caused by Enterococcus. This new QuickFISH assay is immediately available and complements the September 2012 launch of Staphylococcus QuickFISH BC for the identification of Staphylococcus aureus and coagulase-negative staphylococci. With these new products, QuickFISH can now be used to identify the causative pathogens of approximately 70% (Ann Clin Microbiol Antimicrob. 2004 May 10;3:7) of hospital acquired infections from blood cultures.

Enterococcus species are the fourth most common cause of hospital-acquired bacteremia in the U.S. and fifth most common in Europe. The vast majority of enteroccocal infections are caused by Enterococcus faecalis and Enterococcus faecium. Treatment decisions are difficult because these species exhibit differing antibiotic resistance profiles. While E. faecalis is generally susceptible to ampicillin, infections caused by other enterococci, mainly E. faecium, are often resistant to ampicillin or vancomycin, or both. Conventional identification methods can take up to 3 days or longer, and patients withE. faecium bloodstream infections often receive inappropriate antimicrobial therapy for days, leading to higher mortality and significant hospital costs. With this new test, clinicians may prescribe earlier and more appropriate therapy for enterococcal infections. QuickFISH marks a significant advance in time-to-result and ease-of-use that will help clinicians, hospital pharmacists and clinical microbiologists optimize antibiotic therapy much earlier for patients with bloodstream infections.

QuickFISH is a new, rapid, molecular diagnostic platform developed by AdvanDx based on its clinically proven proprietary PNA technology. The new platform enables unprecedented (20 minute) species identification of bacteria directly from positive blood cultures allowing the reporting of pathogen identification at the same time as the reporting of Gram stain results.

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Gamechanger In The Fight Against The Flu Is At Loyola

Cold, allergies, the flu or something else? Thanks to advanced technology, physicians at Loyola University Health System receive confirmation of their patient’s respiratory illness within one hour. Loyola is one of only two hospitals in lllinois to use the FDA-approved FilmArray™ Respiratory Panel, which screens for 17 viral and 3 bacterial pathogens in about 60 minutes.

“Loyola continues to push the envelope in infectious disease care, and due to the recent increase in flu cases, all three respiratory panel instruments are operating around the clock,” says Paul Schreckenberger, PhD, director, clinical microbiology laboratory at Loyola University Health System. “This flu season is explosive and the quick, accurate results from the respiratory panel make a real difference to physicians and patients.” Under standard technology, it takes several days for the laboratory to obtain infectious disease test results. “The new system offered at Loyola consists of a single test panel for 20 infectious agents including both bacteria and viruses that can be performed from a single sample,” he said. “Traditional methods of testing require a physician to order a separate test for each suspected pathogen which can be very expensive and often requires days to complete.”

The new system integrates sample preparation, amplification, detection and analysis into one simple system that requires 2 minutes of a technologist’s time and has a run time of about 1 hour. “The improved diagnosis is efficient and accurate,” says Schreckenberger. Faster results can improve patient management, limit the spread of the disease and reduce overall health-care costs. “Laboratory testing with this new technology gives certainty to the physician’s diagnosis and allows tailored specific therapy and improved patient outcomes,” said Schreckenberger.

The panel system also enhances epidemiologic charting and tracking of pathogens, which are shared with clinicians and public health officials. In 2012, 2437 respiratory panels were performed at Loyola with 1187 patients (4%) testing positive for one or more respiratory pathogens. Rhinovirus, which causes the common cold was the number one pathogen detected accounting for 417 cases, followed by Influenza A virus (295 cases) and Respiratory Syncytial Virus (268 cases).

“Loyola is truly a leader in infectious disease care and an early adopter of proven technology, like the respiratory panel, that saves time, saves money and most importantly, improves the health of our patients,” said Jorge Parada, MD, MPH, Professor of Medicine and medical director of the Infection Prevention and Control program at Loyola. Also an early adopter of rapid and reliable diagnostic testing, Loyola chose to use similar DNA detection technology when they became one of the first hospitals to screen all inpatients for MRSA. Screening has enabled Loyola to prevent more than 200 cases of hospital-associated MRSA infections. Loyola is also a leader in the prevention of influenza. Loyola is in its fourth year of mandatory flu vaccine requirement for employees. “We don’t want our staff becoming sick from vaccine preventable illness, nor do we want our staff to pass along infections to our patients,” says Parada. “But when someone is sick, however, we want to know, and want to let the patient know what they have as soon as possible.” For two years, Loyola has offered physicians confirmation and diagnosis of respiratory disease in 60 minutes through useage of the respiratory panel system.

Due to the uptick in seasonal flu cases, Loyola’s immediate care centers are especially busy. “On the first day of 2013, the Ambulatory Care Center at Burr Ridge had seen 47 patients, compared with 87 visits in 2012 in the entire month of January,” said Keith Veselik, MD, internal medicine, Associate Professor of Pediatrics and Medical Director of Primary Care. asto help care for patients, and tools like the respiratory panel are incredibly valuable in the care of our patients.”

Because of their reputation as an early adopter of proven technology, Loyola is participating in clinical trials for other advanced systems and protocols, including new instrumentation for rapid identification of bacteria causing blood stream infections and foodborne illnesses.

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Akonni Pre-Clinical Results on Rapid, Low-cost Array Moves Company Closer to Commercialization for its Infectious Disease Test Portfolio

Akonni Biosystems announced results today from three pre-clinical studies that contribute to the body of clinical evidence that verifies the efficacy of Akonni’s TruDiagnosis molecular diagnostics (MDx) platform. Akonni TruArray® Tests are designed to fulfill market needs for mid-multiplex molecular diagnostics (tens to hundreds of molecular markers) deployed in near point-of-care settings, at a similar cost to conventional culture tests and with the accuracy and speed of gold-standard low-multiplex approaches.

These studies, including those for methicillin-resistant Staphylococcus aureus (MRSA), multi-drug resistant Mycobacterium tuberculosis (MDR-TB), and influenza subtyping, were funded and developed over the past six years by carefully leveraging more than $45M in private and public funding from the National Institutes of Health (NIH), Centers for Disease Control (CDC), National Science Foundation (NSF), and the Department of Defense (DOD).

“The development of highly extensible, mid-multiplex, low-cost diagnostics for use in near-point-of-care settings is critical for mitigating the uncontrolled spread of disease, especially in global health settings,” says Kevin Banks, Ph.D., Vice President Strategic Development at Akonni Biosystems.

Well positioned to take advantage of a $3.0B plus market

The aggregate market opportunity for infectious disease diagnostics exceeds $3B in the United States alone, according to an October, 2012 report by Cowen & Company, LLC. Akonni’s TruDiagnosis platform is positioned to exploit this and broader global health markets with its unique TruArray Tests, which are designed to significantly reduce the complexity and cost of traditional mid-multiplex microarray consumables, equipment, and workflows for laboratory technicians. Mid-level multiplexed molecular assays that can be deployed in the field or in lower-resource settings are particularly useful for infectious disease diagnostics, detecting drug resistance markers, and improving the health of at-risk populations.

“The studies described below demonstrate that we have minimized the technology risks of our platform, and it is time to expand these studies and begin the development and validation processes for regulatory approval," concluded Banks. “This year we expect to find funding partners so we can design and initiate these trials. Once we have gained CE-IVD and FDA clearances, we believe our lower cost MDx tests will facilitate better and more rapid treatment decisions in the clinic.”

Streamlined chemistry simplifies workflow compared to other microarray platforms

Relative to the microarray products provided by Affymetrix (AFFX), Agilent (A), Combimatrix (CBMX), and by Luminex (LMNX), Akonni’s TruArray tests significantly simplify microarray workflows by combining conventional target amplification, fragmentation and labeling processes into a single tube or microfluidic chamber. Preliminary studies also indicate that all amplification, labeling, hybridization, and wash steps can be combined into a single, self-contained amplification microarray consumable, resulting in an entirely closed-amplicon microarray-based test.

“These studies demonstrate the clinical viability of our TruDiagnosis platform and represents a significant advance over conventional mid-multiplexed molecular diagnostic platforms,” explains Banks. Banks continues, “Multi-drug-resistant bacterial strains are evolving quickly, making today’s gold-standard molecular diagnostic tests appear less effective because they fail to capture the diversity within the pathogenic population or have difficulty detecting certain types of genetic variants. For example, several PCR-based tests have difficulty detecting deletion variants such as the methicillin-resistant Staphylococcus aureus (MRSA) mecA dropout strains. Akonni’s recent studies demonstrate that TruArrays can be used to detect known isolates, certain unknown isolates, and those for which traditional PCR alone is difficult to use.”

Methicillin-resistant Staphylococcus aureus program

In collaboration with researchers from Johns Hopkins University, Akonni conducted a retrospective study on 87 clinical isolates and 246 nasal swab samples acquired from a non-random, high‐risk patient population. Of the 87 isolates, the TruArray test accurately classified 86 (98.8%) and correctly identified 14 mecA dropout specimens that were falsely positive in the BD GeneOhm MRSA or BD GeneOhm StaphSR tests. The overall prevalence of MRSA in the clinical sample set was 16.7%. The TruArray test resulted in 80.5% sensitivity and 96.6% specificity, comparable to or better than Cepheid Xpert MRSA or BD GeneOhm tests when applied to similar, high-prevalence patient populations containing a significant number of mecA dropouts. This study was published in 2012 in the Journal of Microbiological Methods.

MDR-TB program

In collaboration with researchers from Johns Hopkins University, Akonni conducted a study with 185 Mycobacterium tuberculosis isolates representing a world-wide distribution of rifampin, isoniazid, streptomycin and ethambutol resistance genotypes. The simplified TruArray Test containing 96 unique probes for 39 drug-resistant mutations in 5 genes enabled a single technician to run up to 24 samples in under 6 hrs using an industry standard thermal cycler and a field-portable, low cost microarray imager. Of 196 mutations in the culture set that were also represented on the microarray, the TruArray test correctly detected 193 (98.4% success rate). This study is scheduled to be submitted for publication in the first quarter of 2013.

Influenza subtyping program

In collaboration with the United States Centers for Disease Control (CDC), New York Department of Health’s Wadsworth Center, and Little Company of Mary Hospital (Chicago), Akonni developed a simplified TruArray Test for influenza detection, sub-typing, and neuramidase resistance detection from nasopharyngeal swabs (in viral transport medium). Limits of detection in clinical nasopharyngeal swab samples were approximately 100 RNA gene copies per test, regardless of influenza subtype. The most sensitive probes were those targeting seasonal and pandemic influenza A H275Y variants. Using a CDC surveillance and reporting guideline, definitive identification was provided for 164 of 178 samples (92%) and 328 of 342 hybridizations (95.9%). No false positives were detected. This study is scheduled to be submitted for publication in the first quarter of 2013.

Additional programs underway

Akonni is also developing a Warfarin pharmacogenetic test that discriminates three single nucleotide polymorphisms (SNPs) within the CYP2C9 and VKORC1 genes. Unique to Akonni’s test for Warfarin, the amplification and hybridization workflow makes use of the ultra-rapid DNA extraction capabilities of Akonni’s TruTip® sample preparation device, making it possible to use less invasive saliva samples. The assay can be completed in less than four hours from sample lysis to result for up to 24 samples at a time by a single technician. This study is scheduled to be submitted for publication in the first quarter of 2013.

Akonni’s environmental testing group has developed and verified an amplification microarray for monitoring microbial community dynamics in groundwater. Analytical limits of detection were between 2 and 200 cell equivalents of purified DNA. Amplification microarray data were well correlated with 16S-targeted qPCR results and accurately detected expected changes in groundwater microbial community structure over time and in response to groundwater perturbations and treatments. The technology has been tested and deployed under various field conditions. The amplification microarray study is in press with Applied and Environmental Microbiology and builds upon a successful field trailer deployment of the TruDiagnosis platform described in a 2010 Environmental Science and Technology publication.

About Akonni Biosystems

Akonni develops highly innovative products and technologies designed to significantly increase productivity in the life science tools/sample preparation market and to dramatically lower the cost of testing in the molecular diagnostics (MDx) market. Akonni Biosystems was founded in 2003 and has more than 48 patents issued or pending. Supported by a series of government grants and contracts from NIH, CDC, DOE, DOD, NIJ, and NSF, the company has built on its founding technology by improving capabilities from sample preparation to final result. Akonni products and near-term pipeline projects include rapid sample preparation methodologies for nucleic acid extraction and mid-multiplex panel assays for detecting multi-drug-resistant tuberculosis (MDR-TB), upper respiratory infections, viral encephalitis, and healthcare-associated infections (MRSA).

Akonni products are currently for research use only. Not for use in diagnostic procedures.

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Bruker and Erasmus Medical Center Sign an Exclusive Licensing Agreement for Adding Rapid Beta-Lactamase Testing Capabilities to the MALDI Biotyper System

Bruker today announces an exclusive licensing agreement with Erasmus Medical Center, Rotterdam, The Netherlands for rapid testing of beta-lactamase activity using MALDI-TOF technology. This new method is fully compatible with the well-established Bruker MALDI Biotyper system, which is used for MALDI-TOF mass spectrometry-based identification of microorganisms in over 700 clinical and non-clinical microbiology laboratories worldwide.

In many laboratories, the MALDI Biotyper has replaced classical biochemical testing for bacterial identification in the past five years due to the accuracy, speed, extensive species coverage, ease of use and cost effectiveness of the system. Classical biochemical techniques depend upon detecting different metabolic properties of microorganisms; however, these techniques can take hours or even days for completion and they lack specificity. The MALDI Biotyper uses a molecular approach based on specific proteomic fingerprints from bacterial and fungal strains and published studies have highlighted the greater accuracy offered, as well as the typically much faster time-to-result (TTR). With an installed base of more than 700 MALDI Biotyper systems at the end of 2012, Bruker estimates that in the year 2012 its customers performed about 20 million microbial identifications on the MALDI Biotyper installed base.

In addition to this paradigm shift for microbial identification, the MALDI Biotyper is increasingly being used for functional resistance mechanism detection. Antibiotic resistance is an ever increasing problem as bacteria acquire new mechanisms of resistance against classes of antibiotics currently being used in clinical care. Data from the WHO European Region shows that resistance of some pathogens now reaches over 50% in some countries, and new resistance mechanisms are emerging and spreading rapidly. In the European Union, Norway and Iceland it is estimated that 400,000 resistant infections are occurring every year, leading to approximately 25,000 deaths.

Gram-negative bacteria are a common source of infections and pose significant challenges due to their ability to rapidly acquire new resistance mechanisms resulting in multi-drug resistant (MDR) strains. One such mechanism of resistance found in gram-negatives is Extended Spectrum Beta-Lactamase (ESBL) in which enzymes produced by bacteria attack and cleave the beta-lactam ring in antibiotics, thus rendering them ineffective. This includes penicillins, and third generation cephalosporins. Another mechanism is resistance to Carbapenems, which frequently are the drugs of last resort for clinicians when other antibiotics have been ineffective due to resistance.

Consumption of carbapenems increased significantly in European countries from 2007-2010 and occurrence of carbapenem-resistant Klebsiella pneumonia is already high and increasing in some European countries. Recent publications in both the scientific and popular press have high-lighted the challenge and outbreaks associated with microorganisms containing ESBL mechanisms including reports on NDM-1, KPC and most recently CRE (Carbapenem-Resistant Enterobacteriaceae). Accurate and rapid detection of resistance is essential for effective infection control measures, as current techniques lack either specificity or rapid turn-around time.

MALDI-TOF mass spectrometry allows for an exact determination of the molecular weight of a broad range of antibiotics. In the presence of an ESBL, the antibiotic is converted to fragments of predictable molecular weight which are also measured using the MALDI Biotyper. As with bacterial identification, the MALDI Biotyper is thus anticipated to provide both improved, shorter time-to-result as well as potentially better specificity.

Dr. Theo Luider, Head of the Laboratories of Neuro-Oncology, Department of Neurology, Erasmus University of Rotterdam, pointed out: "We have been working with MALDI-TOF mass spectrometry for many years originally in the field of clinical proteomics, but more recently the increased usage of the MALDI-TOF approach for microbial identification also became an area of interest for us. We have filed a PCT patent for the characterization of beta-lactamase activity by MALDI-TOF mass spectrometry with the title "Methods and means for characterizing antibiotic resistance in microorganisms". With their outstanding expertise in mass spectrometry and clinical microbiology market presence, we think that Bruker is the right partner to bring such novel assays to the market."

Dr. Stefan Zimmermann, Department of Infectious Disease, Medical Microbiology and Hygiene,at the University Hospital Heidelberg, commented: "We have been using MALDI Biotyper-based functional beta-lactamase assays in our hospital for roughly two years with the main application being epidemiology and hospital hygiene. It is of great importance to know as early as possible, especially in the intensive care unit, if a new patient carries a carbapenem-resistant Klebsiella pneumonia (KPC). In this case we are able to isolate the patient sooner than with older phenotypic methods. MALDI Biotyper-based KPC-testing improves patient health and at the same time improves cost-efficiency of the Intensive Care Unit by limiting the isolation of patients to those cases where it is really necessary."

Dr. Wolfgang Pusch, Executive Vice President - Microbiology Business at Bruker Daltonics, added: "The signing of this exclusive license agreement with the Erasmus Medical Center is another major milestone in our MALDI Biotyper strategy. While MALDI Biotyper-based microbial identification is already established in many countries, we see significant growth potential in MALDI-based beta-lactamase testing. The exclusively licenced IP from Erasmus Medical Center further strengthens our own broad portfolio of intellectual property in the field of mass spectrometry-based microbial analysis ranging from sample preparation, data processing, MALDI-TOF technology, direct analysis from positive blood cultures and beta-lactamase testing, and offers laboratories worldwide another tool in the fight against resistant bacteria."

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Hygiena International Improves on Their ATP Bioluminescence System

Hygiena International Ltd has further developed their highly successful ATP bioluminescence system to specifically measure bacterial contamination, giving results within a working day or shift.

The development involves their low cost but highly sensitive EnSURE hand-held luminometer, combined with their new versatile MicroSnap Total test. This system enumerates bacteria in raw, cooked and liquid foodstuffs as well as on solid surfaces such that results are available in seven hours or less. The system has been successfully launched at the IAFP (International Association of Food Protection) in Europe and USA as well as the Food Safety Management Conference (Chipping Campden, July 2012).

Established laboratory-based procedures to measure bacterial contamination of foodstuffs can prove to be a lengthy and costly process. The common microbiology test for establishing total bacteria (Total Viable Count , or Aerobic Plate Counts) require laboratory incubation for three days in a Petri dish after which colonies are counted to give results expressed at colony forming units (CFU). The optimum number of bacterial colonies to be counted on an agar plate is 30 –300, thus several decimal dilutions are required to find the detectable range. This means that a lot of time, labour and expense is required for sample preparation and testing. The established convention assumes that one colony is desired from a single bacterium which is a gross over-simplification such that the results obtained are imprecise. Automated systems have been developed to process hundreds of samples but these have a high capital cost and those offering rapid detection systems require measurements to be made over 12 - 18 hours such that results are not available until the next day.

The Hygiena MicroSnap Total bioluminogenic test system has a large dynamic range, being able to detect 10 - 10,000 bacteria without the need for serial dilutions, and every viable bacterium in the sample is measured. Accordingly the result is more precise and sample preparation is simpler, thus saving time and labour. MicroSnap requires simple, low cost equipment and being totally mobile, it can be successfully utilised in small remote locations.

MicroSnap Total can be used to test almost any sample and has been used to measure contamination in a wide variety of food types and on solid surfaces. Contamination levels of <10 cfu/g of ground beef were detected in seven hours whereas >10,000 cfu/g were identified within only 4 hours. Similar results were also obtained for a variety of ready-to-eat foods and good correlations were obtained with the plate count.

For the first time, ATP technology has been modified to be independent of ATP in the sample, such that many specific test applications can be developed, and all of which can be performed on the same, low cost, portable instrument (EnSURE).

This multiple test platform includes specific tests to measure bacterial contamination including specific indicator and pathogenic bacteria. The MicroSnap range includes tests for Total Counts, Coliforms and E. coli. Tests for Listeria species, L. monocytogenes, and Staph. aureus as well as its antibiotic resistant forms are also in development. The ZymoSnap range detects enzymes of industrial importance such as phosphatases for dairy and meat products, proteases, lipases and amylase giving results in minutes. SuperSnap is a high-sensitivity surface hygiene test giving results within 15 seconds, that is used as part of an allergen management program together with a high sensitivity protein test (AllerSnap).

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HackensackUMC is the First Hospital in the Nation to Receive State Approval to Report Microbiological Clinical Results for Bacterial and Fungal Identification Using the bioMerieux's MALDI-TOF Technology, VITEK® MS

Hackensack University Medical Center is now the first hospital in the nation to receive state approval to report microbiological clinical results using the bioMerieux VITEK® MS device.

"We are excited to be the first medical center in the nation approved to report such important clinical data obtained through the VITEK MS platform," said Robert C. Garrett, president and chief executive officer of Hackensack University Health Network. "HackensackUMC remains committed to staying at the forefront of new technology and treatment methods to better care for our patients, and the VITEK MS is another example of this commitment."

The VITEK MS is a revolutionary automated identification system for the healthcare industry. Using MALDI-TOF Mass Spectrometry technology and a database developed by bioMerieux for bacterial and fungal identification, the VITEK MS provides rapid and accurate identifications. Although it is used in other facilities across the country for research purposes, HackensackUMC pushed technology further by seeking approval from New Jersey Department of Health to be able to clinically report its lab results.

"The MALDI-TOF methodology incorporated into the VITEK MS platform truly reflects a quantum leap forward in terms of accurate and extremely timely micro-organism identification," said Ciaran Mannion, M.D., chair of the Department of Pathology at HackensackUMC.

"We are proud to house the VITEK MS device in our Microbiology Laboratory," said Tao Hong, Ph.D., chief of Microbiology and Molecular Diagnostics. "The device will not only dramatically cut the necessary time needed to receive results, but will also cut operating costs up to 70% compared to other traditional methods. This technology represents a significant advancement in the clinical management of infectious disease."

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USDA Explores Using Novel Genetic Labs for Faster Detection of E. coli

Pina Fratamico is on the quest to find the easiest and fastest way to test for harmful Escherichia coli in ground beef. In an article published in Frontiers in Microbiology on the 20th of December, she explores using a next-generation real-time polymerase chain reaction (PCR) system to discover specific gene targets that indicate the presence of dangerous foodborne pathogens. The results show that assays performed using this PCR system are rapid, sensitive, and reliable.

"Testing using these types of systems is faster, easier, and more reproducible than previous methods, and this should increase food safety in the long run. I feel that we could confidently move to these new systems for screening ground beef and other foods for E. coli contamination," says Fratamico, researcher at the USDA Agricultural Research Service in Wyndmoor, Pennsylvania (see also Escherichia Coli).

Not all E. coli are dangerous, but certain strains produce a potentially dangerous toxin called Shiga toxin. These Shiga toxin-producing E. coli also known as STEC can be found in raw meat and cause serious food poisoning in humans. According the Food Safety and Inspection Service (FSIS) website, in October of this year over, 2,300 pounds of ground beef were recalled due to contamination with STEC.

"Certain groups of STEC have been declared as adulterants by the USDA FSIS, and the availability of rapid and reliable tests for these pathogens is critical so that testing results are available before meat is shipped to restaurants and consumers," explains Fratamico.

The PCR protocol has already been used for some time in the meat industry. The genetic test detects the presence of specific gene targets that indicate the existence of STEC in meat. The new generation of real-time PCR systems, like the GeneDisc from Pall Technologies in France used in this particular study, employ a self-contained unit that standardizes the procedure and tend to be relatively portable and easy to use - offering obvious advantages for both meat processors and inspectors from the industry and government alike.

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