Wednesday, April 25, 2018

New Salmonella Multiplex PCR Solution for Simultaneous Detection of Three Salmonella Targets in One Rapid Test is Now Certified by AFNOR

Laboratories performing tests for poultry producers can simultaneously screen samples for Salmonella species, Typhimurium and Enteritidis using the first independently validated PCR test of its kind.

Thermo Fisher Scientific, a market leader in culture media, microbiology, molecular and mass spectrometry systems, was recently awarded the NF VALIDATION mark by AFNOR Certification for the Thermo Scientific RapidFinder Salmonella Multiplex PCR Workflow which features simple sample preparation and results in as few as 16 hours from raw, ready-to-eat and ready to reheat poultry and pork, as well as production environment samples. This is the latest approval in an on-going validation program designed to address all stages of the poultry production process. In 2017 the test received AOAC-RI PTMSM certification for the same types of samples.

"The poultry industry invests heavily to ensure compliance with European food safety regulations designed to reduce the risk of foodborne illnesses caused by Salmonella and other organisms," says Bernd Hofmann, vice president, global marketing, microbiology, Thermo Fisher Scientific. "This unique tool provides valuable information in a short timeframe which can bring substantial economic benefits to producers, while enabling them to continue meeting the relevant safety criteria. To be able to identify Salmonella Typhimurium and Enteritidis in Salmonella species-positive samples in as few as 16 hours means faster actions may be taken compared to other validated methods, which take a minimum of 36 hours to provide the same level of information."

Many rapid methods, including other PCR tests, are available to indicate when Salmonella is present but not many are capable of providing serovar identification at the same time. To get that information the laboratory must either run additional rapid tests, which can prove very expensive, or use traditional identification techniques that take several days to complete, thereby delaying the point at which product can be released or other actions taken.

The RapidFinder Salmonella Multiplex PCR Solution offers:
  • Simple sample enrichment and PCR preparation protocols – fast & scalable for small to higher-throughput laboratories
  • Multiplexed, simultaneous detection of Salmonella species, Typhimurium and Enteritidis facilitating one-well screening and identification for maximum efficiency
  • Excellent sensitivity, specificity and reliability as evidenced through the AOAC-RI PTMSM and NF VALIDATION studies
  • Confidence in results – AOAC-RI PTM and AFNOR Certification as part of an extensive validation program to address salmonella testing needs at all stages of the poultry production process
In addition to the RapidFinder Salmonella Multiplex PCR Solution, Thermo Fisher Scientific provides real-time PCR-based workflow solutions and other methods to test for a broad range of food safety and quality indicators, as well as an expanding range of custom developed assays. All of our PCR solutions are designed to run on the Applied Biosystems 7500 Fast Real-Time PCR System which provides expansive molecular capability and streamlined testing processes which may reduce overall costs.

iGenetic's New Molecular Diagnostic Approach to Detect Dengue in First 24 Hours

Molecular diagnostic approach, a path-breaking method adopted by leading diagnostics company iGenetic, can accurately and rapidly diagnose viral infections including dengue.

Doctors have so far been confronted with the problem of managing a patient’s condition who have all the symptoms of dengue but the laboratory test results are yet to confirm the patient is suffering from the vector borne disease.

Doctors used to find them in a fix for days whether to start dengue medicines or not since it used to take 3-4 days for test results to determine that. However, with a change in the technique of diagnostic tests, it can now be found out within 24 hours whether a patient has been affected with dengue or not.

According to data from the National Vector Borne Disease Control Programme, DGHS, there were 1,57,220 cases of Dengue last year- over a 5.5-fold increase from 2010 to 2017. Deaths due to dengue infection have more than doubled over the same period

Missed or even delayed diagnosis can lead to severe complications due to dengue. Two-thirds of deaths from dengue are due to missed diagnosis necessitating use of a quick, reliable method for detection. Routine testing for dengue is done using ELISA to detect Nonstructural protein 1 (NS1), IgM and IgG. NS1 can be used for detection in the 1st 5 days after infection while IgM is detected only after 3-5 days of illness in cases of primary infection and persists for two or three months. IgG may appear in the same time-frame but persists life-long. However, IgM/IgG detection is not very specific for dengue and may cause false positives due to cross-reactivity with other Flaviviruses.

Additionally, none of these assays can be used for serotyping.

“Dengue and other viral infections are difficult to diagnose using conventional microbiological methods. Viral cultures are not commonly done by routine diagnostic labs and serological methods have low sensitivity and specificity. We have successfully employed molecular diagnostic approaches to accurately and rapidly diagnose viral infections. Even other complex conditions like Septicemia and CNS infections are diagnosed in 24 hours at iGenetic. Speed and accuracy of diagnosis are vital in critical care. Besides, our innovations help us keep prices affordable so that these services can be used even in smaller cities and villages.” says Arunima Patel, Founder and CEO, iGenetic Diagnostics.

With its innovative molecular assays, iGenetic Diagnostics can detect dengue virus in blood samples of patients at a very early stage of infection. This ensures timely treatment resulting inbetter outcomes for the patient. The company headquartered in Mumbai applies advanced PCR-based technologies to look for the genetic material of the pathogen in the patient’s sample. Dengue virus and hence, its RNA, is detectable in the blood from Day 1 to about Day 7. The highly sensitive method developed at iGenetic enables detection of dengue from Day 1.

Dengue virus has 4 serotypes- DENV1, DENV2, DENV3 and DENV4. All serotypes are found in India. Of these, DENV2 and DENV3 are frequently associated with severe disease accompanying secondary dengue infections. Once a person has been infected with one serotype, they have lifelong immunity from infection by that serotype. However, if an individual gets a Dengue infection again with a different serotype, disease progression is accelerated and severe, thereby proving deadly. So iGenetic has also developed a rapid Molecular Diagnostic test that can identify the serotype of the virus.

iGenetic specialises in molecular diagnostics, which applies molecular biology to medical testing to provide quicker and more accurate results. ? iGenetic has the capability to develop many in-house tests and products which are not available in the market today with several "first in the market" tests already commercialized.

Hepatitis C: A Novel Point-of-Care Assay

One of the major challenges identified by the WHO in efforts to eradicate the hepatitis C virus (HCV) is the diagnosis of chronic cases that are generally asymptomatic. Major progress is required for new diagnostic techniques that can be "decentralized", in other words accessed by populations and countries with limited resources. Scientists from the Institut Pasteur and Inserm, in collaboration with the company genedrive, have developed and validated a rapid, reliable, point-of-care HCV assay. This new screening assay means that patients can begin treatment for the disease as soon as they are diagnosed. The results have been published in the journal Gut on April 4th, 2018.

Hepatitis C is a liver disease caused by the hepatitis C virus (HCV). The virus can result in chronic infection, which may lead to severe complications such as cirrhosis and liver cancer many years later. Chronic infection with the hepatitis C virus affects approximately 1% of the global population (71 million people) and claims 400,000 lives every year when it develops into severe disease.

New direct-acting antivirals can successfully treat more than 95% of patients with chronic HCV infection if they are taken in time. In 2016, the WHO therefore published a plan to eliminate this major threat for public health by 2030. But the main challenge in meeting this ambitious target remains the diagnosis of asymptomatic patients, especially in low- or middle-income countries, where access to traditional screening assays is limited.

The current method for HCV diagnosis involves two stages. The first is to screen for specific HCV antibodies, but this does not reveal whether patients were infected in the past (and experienced spontaneous HCV clearance) or are still chronically infected. So the second stage requires a PCR1 assay to detect HCV RNA in the blood to confirm or rule out chronic infection.

There are rapid serological assays for HCV antibodies, but PCR screening requires dedicated infrastructure and qualified staff. In countries with limited resources, this type of assay is only available in centralized laboratories, which means that less than 1% of infected individuals in these regions actually know that they are infected. PCR screening may also involve several visits, and the time required between each result increases the risk of losing patients before the final diagnosis. To improve patient care from diagnosis to treatment, a screening assay for HCV RNA that can be "decentralized" and used in rural or low-income areas is urgently needed.

The team of scientists led by Darragh Duffy (Immunobiology of Dendritic Cells Unit, Institut Pasteur / Inserm) developed an assay in collaboration with the company genedrive that detects HCV RNA as reliably as existing assays but is faster and can be utilized at the point of care. PCR can be performed with the miniaturized device that enables the necessary succession of 40 reaction cycles to be carried out more quickly than in a conventional platform. The analysis can be performed in approximately an hour. This type of device is ultimately less costly than the current assays, which require significant laboratory infrastructure and maintenance.

The scientists began by clinically validating the assay on cohorts from the Institut Pasteur in France and the National Health Service in Nottingham, UK, then with data from Johannesburg-based Lancet Laboratories using samples from South Africa, Kenya, Ghana, Nigeria and Uganda.

The study demonstrated that the assay had a specificity of 100% – in other words there were no false positives – and a sensitivity of 98.6%, thereby meeting WHO requirements for this type of assay.

The kit has obtained CE certification for distribution in Europe and will be available for sale in the Middle East, Africa, South-East Asia and India once local regulatory clearance is obtained.

This study was funded by the organizations listed above and by the EU FP7 project POC-HCV.

1 PCR : Réaction enzymatique qui permet de sélectionner puis d’amplifier un fragment d’ARN en une très grande quantité. La PCR est une suite de cycles, qui se répètent en boucle, comportant chacun trois paliers de température. En moyenne une PCR comporte entre 20 et 40 cycles.


Development and clinical validation of the Genedrive point-of-care test for qualitative detection of hepatitis C virus, Gut, April 4th, 2018.

FDA Approves Roche's Cobas CT/NG for Cobas 6800/8800 Systems to Detect Chlamydia trachomatis & Neisseria gonorrhoeae DNA

Roche, a global pioneer in pharmaceuticals and diagnostics company, announced that the US Food and Drug Administration (FDA) has provided 510(k) clearance for cobas CT/NG for use on the cobas 6800/8800 Systems for the direct detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in both symptomatic and asymptomatic individuals.

“cobas CT/NG on the cobas 6800/8800 Systems provides clinicians with results in which they can have high confidence given the excellent sensitivity and specificity of the assay for all relevant sample types,” said Barbara Van der Pol, international expert on STIs and Associate Professor of Medicine, School of Medicine, University of Alabama at Birmingham. “For the laboratory, the platform provides a tech friendly solution that minimizes hands-on time while maximizing the flexibility of incorporating sexually transmitted infection screening with other assays that are currently available on the system.”

cobas CT/NG is the first assay available in the US for the testing of sexually transmitted infections on the cobas 6800/8800 Systems. It is cleared for use with male and female urine specimens, clinician-instructed self-collected vaginal swab specimens (collected in a clinical setting), clinician-collected vaginal swab specimens, endocervical swab specimens (all collected in cobas PCR media) and cervical specimens collected in PreservCyt Solution.

“Sexually transmitted infection rates are rising worldwide and the cobas CT/NG helps labs meet increasing testing volumes with highest throughput solution on the market today,” said Uwe Oberlaender, Head of Roche Molecular Diagnostics.  “With exceptional performance, exemplary workflow and a flexible testing solution, the CT/NG helps labs free up staff to perform other tasks while still ensuring clinicians receive accurate and rapid results to aid in patient management.”

Other STI assays are in development and will further allow laboratories to consolidate high volume STI testing on a single platform. In addition to cobas CT/NG, cobas 6800/8800 Systems menu in the US includes viral load monitoring tests for HIV, HBV, HCV and CMV, as well as MPX, WNV, DPX and Zika for use in screening blood donations. Since its introduction in 2015, the fully automated cobas 6800/8800 Systems have offered labs the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms.

Chlamydia trachomatis is the most common bacterial Sexually Transmitted Disease (STD), with the highest prevalence among youth. Routine screening for chlamydial infection in young women has been demonstrated to reduce infection rates and the long-term consequences of untreated disease, as well as lowering the financial burden on the healthcare system. The Centers for Disease Control and Prevention (CDC) recommends annual Chlamydia trachomatis screening for all sexually active females under 25 years old and additional testing for pregnant women and those with risk factors.1

Neisseria gonorrhoeae is the second most commonly reported bacterial STD in the United States. Infections in males are generally symptomatic, motivating infected patients to seek evaluation by a clinician for identification and treatment before the onset of serious complications. Gonococcal infections in women are often asymptomatic and may not be immediately recognized, which can progress to pelvic inflammatory disease, tubal scarring, infertility and ectopic pregnancy. Screening of sexually active women under the age of 25 and those at high risk for infection is the focus of successful detection programs in the United States.

Since 2014, the cobas 6800 and cobas 8800 Systems have established the new standard for routine molecular testing by delivering fully integrated, automated solutions that serve the areas of viral load monitoring, donor screening, sexual health and microbiology. Based on Nobel prize-winning PCR technology, the systems deliver proven performance with full automation, increased throughput, fast turnaround time and complete track connectivity, providing users with greater flexibility to consolidate their testing to a single system while increasing overall workflow efficiencies.

The systems provide up to 96 results in about 3 hours and a total of 864 results for the cobas 6800 System and 1,824 results for the cobas 8800 System from an eight-hour shift. Both make it possible for labs to perform up to three tests in the same run with no pre-sorting required. The systems also enable up to eight hours (cobas 6800 System) and four hours (cobas 8800 System) of walk-away time with minimal user interaction.

Phigenics Launches Its Next Day Legionella PCR Validation Test

Building on its patented Phigenics Validation Test® (PVT) TimeZero™ method, which is the fastest and most accurate Legionella and total heterotrophic aerobic bacteria (THAB) testing service, the Phigenics Research and Innovation Lab is excited to announce its most recent innovation, the Next Day Legionella PCR.

This new testing service offered by Phigenics detects Legionella DNA by the Polymerase Chain Reaction (PCR), which is the exponential amplification of a target sequence of DNA. Facility managers and building owners rely on the detection of Legionella sp. DNA for fast, preliminary results to indicate whether or not building water systems are well-managed. The use of PCR in water validation testing  was instrumental in allowing New York City health officials to rapidly identify the source of a Legionnaires' disease outbreak in 2015.

The provision of the defensible, guaranteed Next Day Legionella PCR result is due to Phigenics' Ultra-Rapid DNA Extraction (P.U.R.E.)™ protocol. "The new, innovative and advanced P.U.R.E.™ protocol provides superior results sooner," says Dr. WillIam McCoy, Phigenics Co-Founder and Chief Technology Officer. "When compared to traditional Legionella ISO 11731 culture results, the negative predictive value of this test is ≥ 99%." A limitation of the detection method, as with currently marketed PCR products, is that it cannot differentiate between viable and non-viable Legionella. Therefore, the new protocol is primarily useful as a negative screen to predict culture-negative results in building water systems.

The Next Day Legionella PCR is an enhancement to the industry-leading PVT PREMIUM product line, which delivers the fastest, most accurate and most comprehensive Legionella testing service. The PVT PREMIUM Potable and PVT PREMIUM Utility testing services apply both the TimeZero™ test method and P.U.R.E.™ protocol. Results from these tests are useful for the validation of biological hazard control in water systems such as those in healthcare facilities, hotels, commercial buildings, cooling towers, pools, spas, and from any other water systems in the built environment.

Mesa Biotech Demonstrated New Molecular POC Testing Platform at ECCMID

Mesa Biotech Inc., a privately-held, molecular diagnostic company that has developed an affordable PCR (polymerase chain reaction) testing platform designed specifically for point-of-care (POC) infectious disease diagnosis, demonstrated its novel Accula™ Flu A/Flu B test at the 28th Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).  The System obtained CE Mark in the European Union (EU), as well as 501(k) clearance and CLIA Waiver from the U.S. Food and Drug Administration (FDA) earlier this year.

Diagnosis of influenza is difficult because initial symptoms can be similar to other upper respiratory virus infections. The patented Accula system enables healthcare professionals to access actionable, laboratory-quality results at the POC with greater sensitivity and specificity than current infectious disease rapid immunodiagnostic tests. Further, because antiviral medications for influenza are only effective when taken within 48 hours of symptom onset, rapid diagnostics are required to direct therapy for these viral infections.

The Accula System, a palm-sized, reusable dock with disposable test cassettes, offers the simplicity, convenience and procedural familiarity of traditional POC rapid immunoassays, while providing the superior sensitivity, specificity and information content of laboratory-based PCR testing. Test results are available in approximately 30 minutes to guide same day treatment decisions. The Accula Flu A/Flu B test is indicated for use with nasal swab collection that is less invasive than nasopharyngeal swabs and allows for a more comfortable specimen collection experience for the patient.

"We are wrapping up a devastating flu season in both Europe and the U.S., reinforcing the need for a rapid and accurate POC diagnostic that enables doctors to begin the appropriate treatment as soon as possible," said Hong Cai, Co-founder and Chief Executive Officer, Mesa Biotech, Inc. "With distributors identified in key EU markets, we are continuing to expand our distribution network for our initial Accula Flu A/Flu B test, as well as for follow-on POC diagnostics on our expandable PCR platform."

BD Unveils Suite of Diagnostic Informatics and Automation Innovations

BD (Becton, Dickinson and Company), a leading global medical technology company, today introduced several new informatics and automation solutions for clinical laboratories, which may play a critical role in the fight against infectious diseases and antimicrobial resistance. The new molecular, microbiology and software solutions were showcased at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Madrid, Spain.

The company announced the plan for the commercial availability of BD Synapsys™ microbiology informatics solution, which provides laboratories with secure connectivity across instruments and locations. The new easy-to-use, browser-based application will help streamline workflows, automate manual processes, and facilitate on-demand actionable insights. Together these capabilities will enable laboratories to improve productivity, simplify compliance, and ultimately get results to clinicians more efficiently.

The BD Synapsys solution will enable on-demand access to data and actionable insights, initially supporting BD BACTEC™ FX systems, BD Kiestra™ solutions, and in the United States BD VeritorTM Plus systems, with plans to include other BD clinical microbiology instruments in the future. This solution helps laboratories and hospitals meet cybersecurity and data privacy standards. The BD Synapsys solution will soon be available in the United States and will be offered in Western Europe and Canada.

"BD understands our lab needs an advanced informatics solution that supports integrated workflow across lab instruments, with access to data across all systems to better utilize our resources, reduce turnaround times and error rates, and show efficiency data in order to maximize the usage of our instrumentation to ultimately allow us to better serve our physicians and patients," said Alanna Emrick, Microbiology Manager at UMC Health System.

Also to be unveiled at the BD booth at ECCMID:
  • BD COR™ system is an all new high-throughput molecular platform designed to support a menu of clinically differentiated assays for women's health, sexually transmitted infections and gastrointestinal (GI) applications. The automated system integrates the pre-analytical and analytical steps needed to process samples and provide actionable results, while reducing hands on time for laboratory staff and reducing the potential for manual errors. The BD COR system will be offered in Western Europe beginning in mid-2019 following required regulatory authorization.
  • BD Kiestra ID/AST modules will be new additions to the BD Kiestra solution that automate the processing steps for bacterial identification and antibiotic susceptibility testing using the BD Bruker MALDI and BD Phoenix™ systems. These unique laboratory automation solutions use a single organism to ensure that the same bacteria is used in both tests. As with other BD Kiestra modules, the ID/AST modules will drive efficiency in the lab, reduce hands-on time, eliminate errors, and ultimately help clinicians make timely patient management decisions. Upon receiving applicable regulatory authorizations, the BD Kiestra ID module will be offered in early 2019 and the ID/AST module will be available in mid-2019, initially in Europe and Canada. Availability in the U.S. and other regions will follow after regulatory authorizations are secured.
The company also highlighted recently launched CE-IVD marked panels for the BD MAX™ system. The panels are not available in the United States.  These include:
  • BD MAX enteric viral panel, available in two configurations. The panels can identify norovirus, rotavirus, adenovirus, sapovirus and human astrovirus, all of which are central to the diagnosis of infectious diarrhea.
  • BD MAX Check-Points CPO assay, was developed in conjunction with Check-Points Health B.V. This test provides detection of the five most common carbapenemase genes in approximately 2.5 hours, allowing for the rapid identification of patients colonized with these organisms so that proper infection control measures can be implemented.
"We aim to bring our customers the most comprehensive portfolio of high-quality diagnostic tools, because we understand that important medical decisions about patient management and treatment rely on our products," said Dave Hickey, president, Diagnostic Systems at BD. "These innovative new solutions will enable more robust processing of clinical samples, and faster, more comprehensive reporting of results back to clinicians."

Bruker Introduces Bologna Workflow for Rapid and Cost-Effective Clinical Microbiology Diagnosis of Bloodstream Infections with Broad Species Coverage

At the 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2018), Bruker introduces new diagnostic workflow solutions for rapid and cost-effective microbial identification and antibiotic resistance testing from positive blood cultures – called the integrated Bologna Workflow.  Bruker also launches additional molecular assays for comprehensive and fast invasive fungal disease (IFD) testing in blood, without the need for any culturing step.

Rapid and cost-effective positive blood culture (PBC) testing, including broad species identification (ID) and testing for the most important antibiotic resistance mechanisms, are urgent priorities in clinical microbiology, which require routine adoption for optimized patient benefits. The integrated Bologna Workflow for bloodstream infections has recently been introduced at the S. Orsola-Malpighi University Hospital in Bologna, Italy. The spread of resistance against third-generation Cephalosporins and Carbapenems among Gram-negative bacteria poses a high burden on the Italian healthcare system, and this problem is also rapidly increasing elsewhere in Europe. Starting from a PBC in hospital testing for bloodstream infections, Bruker's new, simplified Fast Sepsityper solution for the MALDI Biotyper (MBT) platform further reduces hands-on time and decreases time-to-result.

The Bologna Workflow combines rapid ID with broad species coverage with the MBT STAR-Carba assay for fast carbapenem-resistance testing, all within 60-90 minutes. An automated warning for carbapenem-resistant Klebsiella pneumoniae (KPC), associated with the blaKPC gene, is performed with an optional MBT subtyping module. For the S. Orsola-Malpighi University Hospital this makes up the majority of KPC cases. KPC-subtyping occurs simultaneously with microbial ID, and a warning is displayed in the research-use-only version (RUO) of the MBT software, which has been validated by the hospital for internal use.

The Bologna Workflow is now further enhanced by the addition of the new MBT STAR-Cepha kit (CE-IVD) for a MALDI-MS-based functional resistance test against third generation cephalosporins.

Due to the continuous expansion and refinements of the MALDI Biotyper reference library (CE-IVD), the Bologna Workflow can now also detect very rare species in a positive blood culture. Bruker is introducing a MBT reference library update at ECCMID, which adds another 239 species across 24 microbial genera. The library update also improves the coverage of biological diversity for many species. For example, it further improves the identification of Candida auris, which is increasingly causing fungal infections in critically ill hospital patients. Candida auris is resistant against a number of antifungal agents and can cause blood stream infections, urinary tract infections and wound infections. Bruker is also introducing the MBT Filamentous Fungi Library 2.0 as a RUO-version with 26 new species.

Miriam Cordovana, in the department of Bacteriology and Mycobacteriology of the S. Orsola-Malpighi University Hospital in Bologna, Italy, stated: "Using the MALDI Biotyper Positive Blood Culture (PBC) workflow, it is now possible to get fast and accurate microorganism identification and resistance detection within 60-90 minutes after a PBC alert, enabling a significantly shorter reporting time in comparison with current routine methods."

In addition, Bruker is launching the new RUO Fungiplex Universal kit for broad-coverage, real-time PCR testing covering 23 filamentous fungi genera, which complements the existing more specific CE-IVD Fungiplex Candida species ID kit.  As a complement to the existing CE-IVD Fungiplex Aspergillus species ID kit, the new Fungiplex Aspergillus Azole-R (CE-IVD) kit now also detects Azole-resistance. All Fungiplex assays are done directly on blood and without any need for cultures, which often grow very slowly, if at all.

This unique and powerful combination of four Fungiplex kits with fast time-to-result within 2-4 hours can now provide infectious disease doctors with a phased, comprehensive workflow for Invasive Fungal Disease (IFD) testing of critically ill patients in the hospital.

Wolfgang Pusch, Executive Vice President for Microbiology & Diagnostics at Bruker Daltonics, commented: "We now offer a very fast, compelling and cost-effective workflow for identification with extremely broad species coverage from positive blood cultures, integrated with rapid functional testing for resistance against carbapenems and cephalosporins, all on the established MALDI Biotyper platform.  In contrast to competing syndromic panels for BSI, the Bologna Workflow is cost-effective and suitable for broad clinical adoption. It covers identification of more than 2,700 microbial species, and two of the most important resistance mechanisms for Gram-negative bacteria, all in only 60-90 minutes after the blood culture has been flagged as positive.  Optional RUO KPC-subtyping, simultaneous with ID and without additional cost, can provide resistance gene alerts that need to be validated by other methods."

About the Bruker MALDI Biotyper (MBT) Platform

The MALDI Biotyper enables molecular identification of bacteria, yeasts and fungi.  Classification and identification of microorganisms is achieved reliably and quickly using proteomic fingerprinting by high-throughput MALDI-TOF mass spectrometry.  The MALDI Biotyper uses a molecular approach based on specific proteomic fingerprints from bacterial strains.  Many published studies have highlighted the greater accuracy and lower cost, as well as the typically much faster time-to-result (TTR).

Applications of various MALDI Biotyper solutions include clinical routine microbial identification, environmental and pharmaceutical analysis, taxonomical research, food and consumer product safety and quality control, as well as marine microbiology.  In many European and international laboratories the MALDI Biotyper has replaced classical biochemical testing for bacterial identification in the past few years due to the accuracy, speed, extensive species coverage, ease of use and cost effectiveness of the system.  Traditional biochemical techniques detect different metabolic properties of microorganisms, can take many hours or even days for completion, and they often lack specificity.

The robust MALDI Biotyper requires minimal sample preparation and offers low consumables cost.  The products of the MALDI Biotyper family are available in a research-use-only (RUO) version, as the U.S. FDA-cleared MALDI Biotyper CA System, or in an IVD-CE version according to EU directive EC/98/79.  The MALDI Biotyper also has medical device registrations in numerous other countries.

RUO versions of the MALDI Biotyper software allow selected, high-value antimicrobial resistance tests.  The CE-IVD MBT STAR®-Cepha kit now allows rapid, functional antibiotic resistance testing against Cephalosporins, and the CE-IVD MBT STAR-Carba kit is for fast Carbapenem-resistance testing.

New Method Developed for Faster Typhoid Diagnosis

Indian scientists have developed a rapid and accurate method for diagnosis of Salmonella typhi bacteria which causes enteric fever and typhoid.

The new test, developed by scientists at the Indian Institute of Technology, Delhi, requires minimal blood quantity, besides being accurate and potentially cost-effective. Blood-culture based diagnosis of enteric fever, used at present, is time-consuming and requires skilled practitioners and costly instruments. Besides, these methods sometimes even fail to detect and identify the bacteria correctly.

In blood culture tests for diagnosis of enteric fever, once the bacteria are separated, identification depends on various biochemical and serological tests. Most serological methods, which look for antibodies in the body, are unable to pick up an infection in the early stages as the numbers are low. The lack of specific, rapid and affordable diagnostic tests leads to inappropriate use of antibiotics in all fevers cases.

The new method uses magnetic nanoparticles coupled with antibodies. In tests, it was found that over 65 per cent bacteria cells got bound to nanoparticles within 30 minutes. The bacteria were separated from nanoparticles using magnets by heating it at 65°C for 45 minutes. The cells were reheated at 100°C for 5 minutes to breakdown the covering of bacteria to recover the genetic material. Then the liquid was collected and put through the loop-mediated isothermal amplification (LAMP) process to increase in availability of genetic material required for identification of the bacteria.

This method is quick as there is no need for multiple cycles of rapid heating and cooling as required in traditional methods. The minimum time taken for conventional methods to confirm the presence of disease-causing bacteria is 72 hours while the new method confirmed it in 6 hours, according to results of the study published in journal PLOS One.

The method, according to the study, has the potential for clinical use due to its high detection levels and ability to identify cells which can cause disease in a quicker turnaround time. In future, it can be developed into a handheld and portable device.

The research team included Dinesh Kalyanasundaram, Avinash Kaur and Ravikrishnan Elangovan (IIT, Delhi); Arti Kapil and Sandeep Jha (AIIMS, New Delhi). The study was funded by the Naval Research Board, Department of Science and Technology (DST) and Indo-German Science and Technology.

NHS Fife Microbiologists Receive Award for 30 Minute Flu Test

Fife microbiologists have been recognised with a prestigious award after cutting the wait to diagnose flu from 24 hours to 30 minutes.

The NHS Fife team scooped the Scottish Government’s Award for Driving Improvement, Delivering Results at the Advancing Healthcare Awards.

Health board chief executive Paul Hawkins said: “This winter was especially challenging, with a spike in respiratory illnesses coupled with particularly difficult weather conditions.

“The successful implementation of the rapid flu system allowed us to initiate effective treatment quickly and improved the care we could provide at the time when demand for our services was at its height.

“Over the course of recent months our microbiology service has consistently stepped up to the plate, going above and beyond to ensure that vital services could continue, and the standards of care maintained.

“They are truly a credit to the organisation and I can think of no more deserving recipients of such an award.”

Confirming a diagnosis of flu generally takes up to 24 hours from the point where a patient is initially tested in hospital.

With the pressures on services at their peak, the board’s microbiology service was tasked with speeding up the process of identifying those patients with the flu virus. Within a matter of days, the microbiology service implemented a rapid flu testing system and had trained staff in how to use it.

This meant nursing staff could confirm whether a patient was positive for flu within 30 minutes, ensuring prompt and appropriate treatment while also preventing unnecessary hospital admissions.

GeneCapture Inc. Announces Novel Platform for Portable Rapid Infection Diagnosis

GeneCapture Inc. has demonstrated a new process for rapidly determining the genetic signature of a pathogen – a germ-causing infection. In less than an hour, this new, patented technique analyzes a human or animal sample – whether it is blood, urine, saliva or swab – to detect the presence of a broad range of specific bacteria, viruses or fungi.

The disposable test cartridge is about the size of a smartphone. Signature probes for newly discovered or mutated pathogens can be added to the cartridge in just a few days, providing fast intelligence for new epidemics.

“Our team of biochemists and engineers has combined several cutting-edge technologies into an innovative and rugged solution for a very critical problem we face today – the diagnostic delay in identifying the source of an infection,” said CEO and co-founder Peggy Sammon. “During that one- to three-day turnaround, contagion spreads and the microbes mutate, making conditions for epidemics and antibiotic resistance highly concerning. We want the patient to get a diagnosis within an hour and get on the right medicine right away.”

GeneCapture is based at the HudsonAlpha Institute for Biotechnology, a leading nonprofit research institute that brings together genomic researchers and for-profit businesses under one roof to create an environment for the rapid deployment of solutions. The institute is close to the University of Alabama in Huntsville (UAH) campus, where the original idea was conceived and patented. GeneCapture’s chief technology officer, Krishnan Chittur, Ph.D., has been working on rapid infection diagnosis since he endured a suspenseful three-day wait to see if his premature baby had pneumonia.

“It turns out she did not have an infection, but we didn’t learn that until after three days of strong antibiotics had coursed through her tiny body. A few years later, in my lab at UAH, we worked out a fast way to see if an infection was present right away. We knew it was a game-changer,” Chittur said.

Chittur met with entrepreneur Sammon, and together they formed the company, licensed the patent and assembled a team to turn the idea into a product. The original process took several hours, but after Harvard biochemist Paula Koelle refined the steps and perfected the recipe, the company’s prototype now gives reliable results in 45 minutes.

The technology is based on unique genetic probes that capture the genetic material of the pathogen if it is present. Hundreds of probes are arranged on a microarray, allowing them to make a direct match to a broad selection of pathogens. An optical scan identifies which probes were activated, resulting in a rapid on-site or wirelessly reported diagnosis.

“From the start, we knew we wanted a simple, rugged, inexpensive product that could be used in remote applications. Our goal is to keep the entire test cost under $20, and we are on a good path to accomplishing that,” said Koelle, vice president of program management. “Our initial work with patient samples shows that the technology is living up to its potential.”

Koelle met Sammon on the sidelines of a soccer field where their daughters were teammates.

“We have received funding through Alabama Launchpad and a group of visionary angel investors, and we have benefited from the help of several local clinics and the collaborative entrepreneurial environment in Huntsville,” Sammon said.

“Breaking the one-hour barrier, the $20 barrier and the portability barrier makes this a great market creation opportunity,” Sammon said. “We want to get this product in use at doctors’ offices, nursing homes, clinics, field hospitals, airports and cruise ships – all the places that can react quickly to infectious outbreaks.”

The company is now developing the pre-manufacturing model for clinical studies and submittal to the U.S. Food and Drug Administration for an expected clearance.

Rheonix Launches Enhanced Technology That Detects More Than 60 Organisms Responsible for Beer Spoilage

Rheonix Inc., a developer of fully automated molecular testing solutions, has expanded its Beer SpoilerAlert ™ assay to detect more organisms that may cause spoilage in beer. The Beer SpoilerAlert assay now detects over 60 bacterial and yeast spoilage organisms plus four hop resistance genes, all in a single test, making it the most comprehensive beer spoilage panel available. Rheonix will showcase this new technology for use on the Encompass Optimum ™ workstation at the Craft Brewers Conference, April 30 to May 3 in Nashville, at booth 3200.

“The expanded SpoilerAlert assay is the simplest, but also the most comprehensive beer spoilage assay in the market,” said Kenny Salky, executive vice president of sales at Rheonix. “Combined with our new pricing on the workstation and kits, it is now the most cost-effective molecular method in helping brewmasters maintain the quality of their beer.”

The Encompass Optimum   workstation and the Beer SpoilerAlert assay enable:
  • Comprehensive coverage: The highly multiplexing system simultaneously detects critical spoilage organisms and the genes that enable these organisms to grow in and spoil beer.
  • Reduced labor and laboratory costs: The automated system requires no technical expertise to run and only 10 minutes of hands-on time. Users can place 24 samples on the workstation, press “start” and walk away.
  • Faster results: The technology provides next-day results, versus four to seven days for conventional methods, enabling rapid detection of spoilage indicators.
The expanded Beer SpoilerAlert assay features the ability to detect at least 60 different bacteria and yeast species that may spoil beer:
  • Saccharomyces cerevisiae var. diastaticus
  • Brettanomyces; expanded detection of five species
  • Lactobacilli; expanded detection of 39 species
  • Pediococcus; eight species detected
  • Megasphaera; added detection of four species
  • Pectinatus; added detection of three speciesHop resistance genes; horA, horC, bsrA, bsrB
The SpoilerAlert assay now has the broadest coverage of any commercially available assay. Even when using three distinct assays, other spoilage testing solutions detect only between 26-34 different species of yeast and bacteria and two or fewer hop resistance genes. The Rheonix solution not only provides broader coverage in a single test, but requires minimal hands-on time, reducing laboratory costs and saving brewers time and effort.

In an increasingly competitive brewing landscape, quality control and product consistency are critical. Even with regular cleaning of facilities and equipment, it can be difficult to completely eliminate all of the microorganisms that have the potential to cause spoilage in beer. The complete sample-to-answer Rheonix system can help breweries large and small, enabling them to quickly identify and eliminate organisms that could negatively affect flavor, appearance and aroma of their beer.

About Rheonix

Through experienced leadership and creative vision, Rheonix has developed the Encompass Optimum ™ workstation, a highly customizable sample-to-answer system, for use in research and applied testing laboratories. The workstation performs fully automated, complex molecular assays in an easy-to-use and economical format on the Rheonix CARD ®  cartridge. With both the Rheonix CARD cartridge and Encompass Optimum workstation family of products, Rheonix is well positioned to penetrate key molecular testing market sectors. In 2016, Rheonix introduced the Encompass Optimum workstation for rapid, fully automated multiplexed detection of pathogens in food samples and for beer spoilage

FDA Approves Rapid Diagnostic Test for Candida auris

The US Food and Drug Administration (FDA) has authorized the first rapid test to identify the emerging multidrug-resistant fungal pathogen Candida auris.

On Apr 20 the FDA announced that it was permitting the Bruker MALDI Biotyper CA System to be marketed for the identification of C. auris, which first appeared in the United States in 2016 and to date has been detected in 287 US patients, with 257 cases confirmed, according to the Centers for Disease Control and Prevention (CDC).

The yeast causes severe infections in hospitalized patients, is associated with high mortality, and is difficult to identify with standard laboratory methods. Misidentification can lead to inappropriate management of infections and allow the pathogen to spread.

Results in under an hour

The test, first approved by the FDA in 2013, uses a technology known as matrix-assisted laser desorption/ionization-time of flight (MALDI-TOF) mass spectrometry to determine the unique protein fingerprint of a microorganism cultured from a patient, then matches those fingerprints to a reference organism database to identify 424 clinically relevant bacteria and yeast species. MALDI-TOF can provide results in less than an hour, while conventional methods of species identification usually take 24 to 48 hours.

"The FDA has confidence in this technology and recognizes the need to rapidly address outbreaks both for C. auris and for other pathogenic microorganisms to help protect Americans through the recognition and identification of emerging infectious pathogens," Donald St. Pierre, acting director of the FDA's Office of In Vitro Diagnostics and Radiological Health, said in a news release.

The approval was based on performance data for 28 C. auris isolates and other supporting analytical studies, according to the release. The findings indicated that the system can reliably identify C. auris 100% of the time.

C. auris was first identified in the ear of a Japanese patient in 2009 and since then has spread to several other countries and emerged as a global health threat. Most of the strains in the United States have been linked to patients who had recently received healthcare in a country where C. auris has been reported.

The fungus has shown varying levels of resistance to all three major classes of antifungal medications used to treat Candida infections (azoles, echinocandins, and polyenes), making it extremely difficult to treat, and it can spread within hospital settings.

Rapid Detection of Pathogen and Antibiotic Resistance with DNAe’s LiDia® Bloodstream Infection (BSI) Technology

DNAe, the inventor of semiconductor-based genomic analysis technologies, and the developer of a new game-changing test for bloodstream infections (BSI) that can lead to sepsis, announces new data generated with its LiDia® Bloodstream Infection (BSI) technology, currently in development. The LiDia® BSI method was demonstrated to detect pathogen and antibiotic resistance in samples collected from patients after receiving antibiotic therapy. Time to detection by the LiDia® BSI method was significantly shorter (hours vs. days) compared to standard-of-care blood culture testing.

Early treatment with broad-spectrum antibiotics is critical for patients with BSIs. However, antibiotics can affect the growth of any bacteria present in a sample and can therefore lead to false negatives if blood culture is used for diagnosis once a patient has begun antibiotic treatment. The technology used by LiDia® BSI can detect the presence of pathogens without interference by antimicrobial therapy.

Pathogens and antibiotic resistance detected by the LiDia® BSI method in samples collected from patients with suspected or confirmed BSI showed concordance with blood culture results in 31 patients pre-treated with antibiotics. The LiDia® BSI method also detected pathogens in a further nine samples, where blood culture collected concurrently produced a negative result.  The LiDia® BSI results in these samples matched earlier blood culture results from the same patients. Time to result for the LiDia® BSI method was just a few hours, whereas blood culture results were available 2-5 days after specimen collection.

Clinical specimens were collected with consent from two sites, the Mayo Clinic (Rochester, MN, USA) and the University of New Mexico Health Sciences Center (Albuquerque, NM, USA). The largest numbers of patients with positive blood cultures in the DNAe study came from the Medical Intensive Care Unit (MICU) (25%), surgical wards (20%) and general medical wards (17.5%), followed by Emergency Departments (ED) (12.5%). The most frequently encountered microorganisms were Escherichia coli, Staphylococcus aureus and Klebsiella pneumoniae.

Once a specific diagnosis is confirmed, patients can be treated with a more targeted antibiotic. Rapid and accurate identification of the pathogen would enable physicians to prescribe targeted treatment faster, potentially improving the patient’s prognosis and reducing healthcare costs. It could also help to reduce the spread of antimicrobial resistance by preventing the over-use of broad spectrum antibiotics.

David Davidson, Chief Scientific Officer at DNAe and author on the poster said, “The study demonstrates the real-world potential of LiDia® BSI, and its ability to rapidly identify infectious agents even in patients who are already being treated with antibiotics. The test could help clinicians determine if patients already being treated with antibiotics are on the correct drug and may enable treatment with targeted antibiotics to begin immediately. Faster and more tailored treatment with this test could have huge implications for patient care.”

The data were presented as a poster (#P1960) at the 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), in Madrid, Spain, 21-24th April, 2018. Whilst the data presented at ECCMID combined LiDia®’s core methodologies, prototype systems were on show at ECCMID, demonstrating the simple, rapid utility of the test, at the point-of-need.

About DNAe

DNAe is developing its pioneering semiconductor DNA sequencing technology for healthcare applications where rapid near-patient live diagnostics is needed to provide actionable information to clinicians, saving lives by enabling the right treatment at the right time.

In January 2015 DNAe acquired nanoMR, Inc. (now DNA Electronics Inc.), a developer of a novel system for rapid isolation of rare cells in the bloodstream. DNAe is developing LiDia®, its sample-to-result genomic analysis platform, combining DNA Electronics Inc.’s Pathogen Capture System with its own portfolio of semiconductor-based genomic technologies, trademarked Genalysis®. The LiDia® range of tests will enable DNA analysis directly on a microchip, providing rapid and accurate results from a user-friendly system.

DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific information can make the difference between life and death. LiDia® will launch with the LiDia® Bloodstream Infection (BSI) test, a groundbreaking rapid direct-from-specimen test for bloodstream infections that lead to sepsis. Built into a compact device for use at the point of need, the system will diagnose accurately and rapidly what infection a patient has, providing the clinician with actionable information to help select the appropriate antibiotics to treat the disease.

OpGen Highlights Acuitas® Analytical Validation Data for Rapidly Predicting Antibiotic Resistance Using Drug Resistance Gene Profiles at ECCMID

OpGen, Inc. announced that it has presented analytical validation results for the Acuitas® AMR Gene Panel u5.47 (RUO) for detection of multi-drug resistant pathogens and antibiotic resistance genes and the use of test results to predict antibiotic resistance using the bioinformatics capabilities of the Acuitas Lighthouse® Software. The results were presented at the 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Madrid, Spain.

The poster, titled “Analytical Validation of a Rapid Molecular Test for Semi-Quantitative Detection of Bacterial Pathogens and Antibiotic Resistance Genes in Urine,” demonstrated the semi-quantitative detection of five pathogens and 47 antibiotic resistance genes from primary urine specimens and bacterial isolates. Results from the Acuitas AMR Gene Panel u5.47 (RUO) were used with the Acuitas Lighthouse Software to predict phenotypic resistance for 35 isolates from the CDC & FDA Antibiotic Resistance (AR) Isolate Bank. For the ten E. coli isolates tested, the Acuitas Lighthouse Software predicted antibiotic resistance to thirteen antibiotics with 94% sensitivity, 93% specificity, and 94% agreement with traditional testing methods.  Results for the ten K. pneumoniae isolates were 85% sensitivity, 100% specificity, and 88% agreement.  For the ten P. aeruginosa isolates, the predictions were at 100% sensitivity and agreement. The AR Isolate Bank is provided by the U.S. Centers for Disease Control and the U.S. Food and Drug Administration to help industry with development of new diagnostic devices, tests, assays and therapeutics. The study demonstrated a lower limit of detection for each pathogen of approximately 1,000 organisms per milliliter of urine, accurate detection of pathogens with semi-quantitation over 10^3 to 10^6 organisms per milliliter of urine, and no species cross-reactivity with 39 pathogens commonly associated with urinary tract infections.

Terry Walker, PhD, OpGen’s Senior Vice President R&D, commented, “In the validation study, the Research-Use-Only Acuitas AMR Gene Panel u5.47 accurately semi-quantitated the organisms and resistance genes in our test. The Acuitas Lighthouse Software demonstrated accurate prediction of phenotypic resistance to thirteen antibiotics commonly prescribed for these pathogens.”  Dr. Walker concluded, “Development of our Acuitas products continues to progress. We recently reduced time to result to two hours and the preliminary performance continues to meet our expectations.”

A second poster, titled “Comprehensive analysis of fluoroquinolone resistance in Pseudomonas aeruginosa,” demonstrated an example of OpGen’s whole genome sequencing analysis and prediction pipelines. In the study of 616 isolates, sensitivity and specificity for prediction of resistance to two fluoroquinolone antibiotics ranged between 91% and 95%.

The Imperial College Healthcare NHS Trust, London, United Kingdom, presented “Evaluation of a gene-resistance profile testing platform (OpGen) with traditional typing methods as a potential for more accurate and quicker identification of carbapenem-resistant Enterobacteriaceae (CRE) outbreaks.” The study demonstrated 100% agreement with the Cepheid Carba-R FDA cleared test for carbapenem resistance genes and capabilities of the Acuitas Resistome Test for detection of 46 antibiotic resistance genes for infection control of drug-resistant pathogens in a National Health Service Hospital.