Wednesday, July 13, 2016

Rapid Result Dengue Test to be Expanded in Taipei

The Ministry of Health and Welfare yesterday said it would expand the use of the NS1 antigen test, a rapid detection test for dengue fever, encouraging physicians to use the test if patients are suspected of having the virus.

Tainan Hospital Division of Infectious Diseases director Hung Yuan-pin (洪元斌) said dengue fever is mainly transmitted by bite from Aedes aegypti and Aedes albopictus mosquitoes, with Aedes aegypti mosquito bites the main cause of the virus’ transmission in Tainan last year.

“The most common symptom of dengue fever is fever. Other common symptoms include headache, eye pain [behind eyes] and muscle pain, but symptoms might not be obvious at first,” he said. “Many people last year suffered gastroenteritis.”

Hung said the diagnosis of dengue fever can be delayed if doctors rely on clinical observations, because about 30 to 50 percent of people develop typical dengue fever symptoms, and people with Chikungunya fever or Zika virus might suffer from similar symptoms.

The rapid screening test allows doctors to confirm whether a person has dengue fever in about 15 to 20 minutes (traditional tests take about an hour), with an accuracy rate of more than 95 percent, he said.

According to current regulations, only medical professionals are allowed to perform the rapid screening test, which requires a blood sample.

Because of the seriousness of the dengue fever outbreak in Tainan last year, many people are going to hospitals asking for a rapid screening test even when they only have a cold, Hung said, adding that the test is only covered by National Health Insurance if a doctor considers it necessary.

Thermo Fisher Scientific and DuPont Nutrition & Health Extend BAX System Q7 Distribution Agreement in Western Europe for an Additional Three Years

Thermo Fisher Scientific and DuPont Nutrition & Health have agreed to renew their Distribution Agreement for Western Europe, allowing Thermo Fisher to maintain exclusive supply of the DuPont BAX System Q7 platform in the region for at least the next three years. Thermo Fisher will also continue to supply the BAX System Q7 on an exclusive basis in Australia and New Zealand and on a non-exclusive basis in Canada under separate agreements.

The original agreement, started 14 years ago, enabled Thermo Fisher to supply the BAX System Q7 in Western Europe and other territories, becoming one of the first companies to offer customers a more rapid way to detect pathogens in foods, enabling them to take faster actions including releasing product to market sooner. Thermo Fisher will continue to offer the DuPont BAX System Q7 platform for foodborne pathogen detection alongside their Thermo Scientific Real-time PCR Solutions, providing customers with the broadest choice of molecular food tests from any single manufacturer.

“We are delighted to continue our current arrangement with DuPont,” says Andy Thomson, president, microbiology, Thermo Fisher Scientific. “Real-time PCR methods provide quick and accurate detection of microbial pathogens in a broad range of foods and associated samples, and at Thermo Fisher we are dedicated to continuous development of validated methods to help our customers protect their brands whilst releasing product to market as soon as possible.”

George McVay, Diagnostics global business and integrated operations leader, DuPont Nutrition & Health, says, “Thermo Fisher’s office-based and in-field specialists have a long history of supporting the BAX System Q7, and the technical expertise and experience they can provide our customers in these regions is unparalleled. We look forward to continuing our current arrangement to serve and support our food manufacturing and contract laboratory customers.”

Cellex, Inc. Receives NIH Grant to Develop Rapid Test for Detection of Carbapenemase Producing Organisms (CPOs)

Avioq, Inc. announced that Cellex, Inc. has received a National Institutes of Health (NIH) grant for developing a rapid test named qCPO for detection of carbapenemase producing organisms (CPO). The grant was jointly awarded to Cellex and Johns Hopkins Medical Institution. The qCPO test uses homogeneous biochemiluminescence assay (HBA) technology developed by Cellex.

“If successfully developed, the test would allow detection of a CPO within 15 minutes using a single culture colony, providing an important tool in fighting CPOs,” said Dr. Chamroen Chetty, CEO of Avioq. Current methods suffer various drawbacks including limited number of assayed carbapenemase targets for molecular assays and long turn-around time for phenotyping assays. qCPO is unique in that it detects enzyme activity.

About Carbapenemase Producing Organisms (CPOs)

Carbapenems are antibiotics of last-resort. These agents are crucial for preventing and treating life-threatening bacterial infections. Carbapenemase enzymes, which degrade carbapenems thereby conferring carbapenem resistance, are harbored on transmissible mobile genetic elements called plasmids that are easily spread from species to species and even among different genera of Gram-negative bacteria. Gram-negative bacteria harboring carbapenemase enzymes, in particular Klebsiella pneumoniae carbapenemases (KPC), have been identified in nearly all States in the U.S. Even more concerning is the increasing reports of the appearance of non-endemic carbapenemase variants in the U.S. such as New Delhi metallo-β-lactamase (NDM)-producing Gram-negative bacilli. Early detection of CPOs in the health care-setting is required as patients with unrecognized colonization with a CPO serve as a reservoir for transmission during health-care associated outbreaks. Therapeutic options for infections caused by a CPO are limited and infections with a CPO have been associated with significant morbidity and mortality. For more information, please refer to the CDC guidance.

New 3M Clean-Trace System Provides Food Safety Data Faster and Easier than Ever Before

3M Food Safety today released its enhanced 3M™ Clean-Trace™ Hygiene Monitoring and Management System. The system is the outcome of years of research, testing and customer feedback, all meant to provide food processors greater confidence and peace of mind.

Food safety managers need rapid testing to quickly and dependably identify potential contamination in their facilities and make the high-risk decision about whether or not to start production. Typical microbial tests take days to deliver a clear result, delaying food production release and shipments. Mere visual inspection is not enough because microorganisms and many soils are invisible to the naked eye. The new 3M Clean-Trace System offers food safety professionals a complete system of products consisting of a luminometer handheld device, compatible tests and a powerful new software platform, to verify that surfaces have been effectively cleaned in seconds, for better decision making and audit preparedness.

To build a system that aligns with industry wants and needs, 3M Food Safety interviewed and observed hundreds of food manufacturing professionals – from technicians on the plant floor to executives in the C-suite – across functions such as sanitation, quality, plant and lab management. The result elevates the capabilities of an already market-leading technology in three key areas:

  • Optical technology – The system was reengineered with photomultiplier detectors, the gold standard in medical devices, medical imaging, aerospace and other fields of science, to improve efficiency;
  • Software – The 3M™ Clean-Trace™ Hygiene Monitoring and Management Software was upgraded for enhanced usability. A new, streamlined dashboard interface presents information where eyes gravitate to, minimizes clicking and allows reports to be quickly generated.
  • Wireless connectivity – The system is now wireless-enabled, capable of transferring data via Wi-Fi or Bluetooth® Technology connections. Information transmits between the handheld luminometer and the software.
  • Industrial design – The 3M™ Clean-Trace™ Luminometer was improved to be more durable, ergonomic and easy to use.

“Certainly there is a heightened public sensitivity for food quality, resulting in more internal and external controls and reporting. There’s been an abundance of new regulations, whether that’s the rollout of the U.S. FDA’s Food Safety Modernization Act or other rules,” said Tom Dewey, 3M Food Safety global marketing manager. “We involved customers throughout the development and design of the entire system to automate and streamline what is in many cases a tedious, manual process of selecting test points, assigning them daily, conducting tests, documenting results, managing sample plans, and developing quality improvement measures.”

When it comes to accuracy, the previous-generation of the 3M Clean-Trace Hygiene Monitoring and Management System was tested by a third-party lab and was shown to produce the most precise, consistent results across time and temperature and between swabs, when compared with several major competing brands. The all-new system builds on the quality of the current system. It represents just one of many innovative solutions from 3M Food Safety that provides food producers trustworthy data and peace of mind when making important product manufacturing and release decisions.

Rapid TB Test Accuracy in West Africa Compromised by Mycobacterium Diversity

World-wide, Mycobacterium tuberculosis (Mtb) is responsible for the vast majority of tuberculosis (TB) cases. However, there are several other closely related mycobacterial species that cause TB, all part of the Mycobacterium tuberculosis complex (Mtbc). One of them, Mycobacterium africanum (Maf), causes up to 40% of TB cases in West Africa. TB diagnosis across Africa relies largely on tests optimized to detect Mtb. A study led by the Medical Research Council Unit The Gambia and the Antwerp Institute of Tropical Medicine, Belgium, published in PLOS Neglected Tropical Diseases now suggests that in West Africa tests to identify Mtbc in culture miss a substantial fraction of cases, with dire consequences for the patients and for TB control efforts.

Concerned about substantial discrepancies in samples from West Africa between the sputum-based results and the results of rapid tests, Florian Gehre, who is affiliated with MRC and ITM, and colleagues undertook a systematic evaluation of two commonly used rapid TB tests. Both tests detect the product of the mycobacterial mpt64 gene.

The researchers started by comparing the abundance of mpt64 gene product in sputum samples of patients with untreated pulmonary TB caused by Maf 2 (the Maf strain common in The Gambia) or Mtb. Samples from five patients with Maf 2 TB, they found, had about 2.5 times less mpt64 gene product than those from six patients whose disease was caused by Mtb.

They then prospectively analyzed culture isolates from 173 patients with one of the rapid tests, the BD MGITTM TBc ID kit. All of the patients had positive sputum microscopy, and cultures were negative for a second test that detects contamination by unrelated bacteria. Based on molecular analysis, the researchers knew that 122 of the samples were from patients with Mtb TB; the remaining 51 samples from patients with Maf 2 TB.

150 of the samples tested positive on Day zero (the day when mycobacterial growth in culture was first recorded), with 23 (13.2%) testing negative at this time point. The accuracy was much higher (over 90%) for the Mtb samples, compared with less than 80% for the Maf 2 samples. The researchers then ran the tests for another 90 days to see whether and when initially negative samples would turn positive (test instructions recommend reading results between Days zero and ten). At Day 10, 84% of Maf 2 samples tested positive compared with 98% of Mtb samples. By Day 90, 98% of both Mtb and Maf 2 samples tested positive.

Based on these results, 22% of Maf 2 patients, and 10% of Mtb patients would have been wrongly classified as having non-TB mycobacteria if the tests had not been repeated after Day zero. At the end of the 10-day window recommended by the BD MGITTM TBc ID manufacturer, 16% of all Maf 2 samples remained negative, compared with only 2% of Mtb samples.

The researchers repeated the same analysis with all samples that had tested negative on Day zero and a random set of those that had tested positive using the SD Bioline Ag MPT64 RapidTM test. They observed no significant difference between the two tests.

Their findings, the researchers say, "indicate that MPT64 tests need to be cautiously used in settings where Maf 2 is common." However, they also recognize that "given the relatively low cost, limited technical expertise and shorter turnaround time associated with using rapid speciation tests compared to alternative speciation methods, MPT64 rapid tests will likely remain one of the preferred options for timely diagnosis of suspected TB despite the possibility of false negative results," and suggest that "a negative MPT64 result would require confirmation by an alternative method."

Overall, they say, their results emphasize "the need to consider strain diversity during TB product development," and demonstrate that "careful evaluation and validation of novel tests before implementation, especially in regions with geographically restricted Mtbc lineages, such as M. africanum in West Africa, is imperative."

Journal Reference:

Boatema Ofori-Anyinam, Fatoumatta Kanuteh, Schadrac C. Agbla, Ifedayo Adetifa, Catherine Okoi, Gregory Dolganov, Gary Schoolnik, Ousman Secka, Martin Antonio, Bouke C. de Jong, Florian Gehre. Impact of the Mycobaterium africanum West Africa 2 Lineage on TB Diagnostics in West Africa: Decreased Sensitivity of Rapid Identification Tests in The Gambia. PLOS Neglected Tropical Diseases, 2016; 10 (7): e0004801 DOI: 10.1371/journal.pntd.0004801

bioMérieux enlarges its pathogen identification capability on VITEK® MS

bioMérieux, a world leader in the field of in vitro diagnostics, announced the launch of the first CE-marked database and reagent kits for the identification of mycobacteria, Nocardia, and moulds in a MALDI-TOF1 Mass Spectrometry System. This innovative solution further enhances the VITEK® MS system’s performance by adding 297 new species including identification of the Mycobacterium tuberculosis (TB) group, 45 species of the most frequent non-tuberculous mycobacteria (NTM), and 48 of the most medically important moulds. The VITEK® MS system’s new database and the reagents kits are now commercially available in countries which recognize CE-marking.

Mycobacteria, Nocardia and moulds are difficult to identify organisms, requiring days or weeks of specific culture conditions for appropriate growth and subsequent advanced methods for reliable identification to species level. The updated VITEK® MS system, however, can now offer simple, rapid and reliable identification of these pathogens, providing clinicians with actionable results to manage the infections which they cause, such as tuberculosis, lung and bone infections, and other serious organ infections.

“For more than fifty years, bioMérieux has introduced pioneering diagnostic innovations to fight against infectious diseases. As a world leader in microbiology, one of our priorities is to develop high medical value solutions which allow rapid and accurate detection of microorganisms,” said François Lacoste, bioMérieux Corporate VP, Clinical Unit. “Introducing the VITEK® MS new features for the rapid identification of these 3 additional groups of important pathogens enhances our diagnostic solutions for the benefit of healthcare providers, with the ultimate goal of improving patient outcomes.”

Based on patented methods, the VITEK® MS Mycobacterium/Nocardia and Mould reagent kits enable easy, rapid, and safe identification of these organisms. The VITEK® MS extended database now enables the identification within minutes of 1,046 species representing 15,172 distinct strains of bacteria, yeasts and moulds. The convenient, user-friendly reagent kits for use with this highly automated mass spectrometry system provide lab professionals with extremely reliable results.

For microbiologists who choose mass spectrometry for microbial identification, bioMérieux offers a fully integrated solution combining identification with VITEK® MS and antibiotic susceptibility testing with VITEK® 2, resulting in enhanced pathogen information, and superior workflow management.

1 MALDI-TOF: Matrix Assisted Laser Desorption Ionization – Time Of Flight

bioMerieux Receives FDA Clearance for Expanded Use of VIDAS® B.R.A.H.M.S PCT™ Test for Managing Sepsis Patients with Elevated Risk of Mortality

bioMérieux, a world leader in the field of in vitro diagnostics, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the use of the VIDAS® B.R.A.H.M.S PCT™ (Procalcitonin) assay using the change in PCT levels over time to aid in the management of sepsis patients after the initial diagnosis. Based on a recent study, monitoring PCT levels over 4 days (96 hours) can help doctors determine which septic patients are at the greatest risk of death, enabling them to adjust or intensify the medical care for those patients.

As a pioneer dedicated to improving patient safety and infection control practices, bioMérieux was the first company to launch an automated test measuring PCT in the U.S.. Today, the VIDAS® B.R.A.H.M.S PCT™ test is the market leader for sepsis prognosis. PCT was originally cleared for use in the first day following admission to an intensive care unit (ICU), and this expanded claim demonstrates the usefulness of PCT levels which are monitored serially over 96 hours.

Monitoring serial PCT levels over 96 hours, along with ongoing clinical assessment and other laboratory tests, will provide additional information to the clinician to help with a more robust prognosis and management of patients with sepsis and septic shock. This combination of tools and data will enable physicians to assess the risk of progression and ultimately the risk of mortality in the septic patient. Armed with this vital prognostic information, physicians can more appropriately manage and aggressively support and treat those with elevated risk.

“In many patients, it can be very difficult to diagnose sepsis up until the moment of obvious shock,” said Devendra Amin, MD, FCCM, intensive care physician and medical director of Critical Care Services at Morton Plant Hospital in Clearwater, FL. “The expanded indication for PCT will allow us to obtain vital information prior to the admission to the ICU and will give us vital information about the patient’s prognosis, risk of mortality, response to treatment and likelihood of survival.”

As part of the FDA filing, bioMérieux submitted equivalence results of the Thermo Fisher Scientific’s Procalcitonin MOnitoring SEpsis Study (MOSES), which tracked PCT levels of patients with severe sepsis or septic shock. Patients whose PCT levels decreased by 80 percent or more during the 96 hour timeframe of the study had a significantly lower risk of 28-day mortality compared to those whose PCT measurements decreased less than 80 percent over 96 hours.

“The study demonstrates that for patients diagnosed with sepsis or septic shock, failure of blood concentrations of PCT to decrease over 96 hours is a strong predictor of mortality over and above clinical indicators,” said Mark Miller, Chief Medical Officer at bioMérieux. “Measuring PCT at clinical presentation and serially over 4 days will provide clinicians with high medical value information to help them identify patients who are at greatest risk of mortality and ultimately can result in improved, more targeted and intensified patient care and better medical outcomes”.