Friday, March 3, 2017
"We are excited to welcome the DuPont Diagnostics team to Hygiena and look forward to better serving our global food and beverage customers by offering a wider food safety testing portfolio," said Steven Nason, chief executive officer of Hygiena. "Hygiena now offers testing solutions to cover the full food manufacturing process, from sanitation monitoring to finished product testing. With the growth of our worldwide team, we can now offer even greater service and support for all Hygiena customers around the globe. We are excited to continue investing in new product research and development and further expand our product portfolio through acquisitions."
With the acquisition, Hygiena has expanded its portfolio of food safety diagnostics products to include all of DuPont Diagnostics' business assets, including the BAX® System, RiboPrinter® System, Lateral Flow System, StatMedia™ and Dehydrated Culture Media product lines. The combined product portfolio enables Hygiena to provide a more comprehensive suite of products and solutions for its global food and beverage customers.
Hygiena delivers rapid microbial detection, monitoring, and identification solutions to a wide range of industries, including food and beverage, healthcare, hospitality, pharmaceuticals, and personal care. Utilizing advanced technologies and patented designs, Hygiena provides industry-leading ATP monitoring systems, PCR-based pathogen detection and characterization systems, allergen tests, environmental collection devices, and more. Hygiena is committed to the mission of providing customers with high-quality innovative technologies that are easy-to-use and reliable, backed by excellent customer service and support. Headquartered in in Camarillo, California with offices in Wilmington, Delaware, the United Kingdom and China, and over 80 distributors in more than 100 countries worldwide, Hygiena products span the globe.
To that end, scientists from Florida Atlantic University (FAU) have developed an accurate, rapid, and inexpensive Zika virus diagnostics tool that is as small as a tablet and can detect infection outside of a laboratory.
Current Zika diagnostics tools detect the virus through tests that identify viral antibodies in the bloodstream. Unfortunately, these tests do not always differentiate between Zika antibodies and antibodies of other flaviviruses, such as Dengue, and Chikungunya. According to Waseem Asghar, PhD, lead investigator, assistant professor at the FAU College of Engineering and Computer Science and Charles E. Schmidt College of Science, “Because flavivirus antibodies cross-react with one another current tests cannot distinguish between them.”
To accurately detect Zika, a polymerase chain reaction (PCR) test is needed, which can cost around $20,000 (or more), and requires trained and skillful lab technicians to execute the procedures. It can also take hours to get results back from a PCR test.
Dr. Asghar said in an interview with Contagion®, “It requires trained personnel and high-tech lab to perform the PCR assay which is not suitable for … settings such as airports, community health centers etc. Furthermore, PCR assay takes several hours to test a sample. The device that we are developing can overcome many of these challenges as it will be low-cost [$2], automated (does not require trained personnel) and rapid (test results within 15 minutes)."
The new tool that Dr. Asghar and his team developed can differentiate between Zika, Dengue, and Chikungunya infections. The test requires only a saliva sample, which makes it convenient to use in remote locations that would not normally have access to expensive lab equipment and skilled technicians, such as airports or community health centers.
“The working principle of [the] device is that Zika viruses are first captured and isolated from a few drops of saliva/serum samples using magnetic beads functionalized with specific Anti-Zika Envelop antibodies. The isolated viruses are lysed using detergent, quickly. The virus lysis will change the conductivity of the solution which can be measured rapidly using impedance sensing. All the processing steps are done on a microfluidic device automatically. [The] device is made of plastic and paper, so its low-cost. It will take 15 minutes to do Zika testing using this platform and device,” Dr. Asghar told Contagion®.
This new Zika diagnostics tool draws on technology that the researchers previously developed for HIV detection. The HIV tool uses paper and plastic materials, a “cassette-sized container” that holds up to 12 samples, and a “receptacle about the size of a tablet.”
According to the researchers, this tool is not only cheap, but it can be easily developed, used, and disposed of. According to the University’s press release, the researchers developed this new tool to “reduce the impact of the outbreak until a vaccine is identified.” The team received a seed grant from the FAU Institute for Sensing and Embedded Network Systems Engineering, which “significantly contributed to the development of [the] current device prototype,” according to Dr. Asghar. In addition, the research team recently received a 1-year grant of $199,280 from the Florida Department of Health to commercialize the device.
Looking towards future application of the technology, Dr. Asghar told Contagion®, “The detection platform can be adapted to other pathogens and viruses such as influenza, chikungunya, Dengue, [hepatitis] B and C viruses.”
With new findings suggesting that Zika virus causes a host of complications constantly coming to light, it is important now, more than ever, to be able to detect Zika virus infection rapidly, so as to take necessary precautions.
Dr. Asghar developed this diagnostics tool in collaboration with Massimo Caputi, PhD, co-principal investigator and associate professor of biomedical science at Charles E. Schmidt College of Medicine, and Mariano Gacria-Blanco, MD, PhD, professor and chair of biochemistry and molecular biology at the University of Texas Medical Branch at Galveston.
The report, titled “Evaluation of Immunoassays and General Biological Indicator Tests for Field Screening of Bacilus anthracis and Ricin,” compared fourteen immunoassays from ten different technology providers, including PathSensor’s CANARY biosensor immunoassay and PathSensor’s Zephyr assay sample reader.
A measure of the effectiveness of bio terror and bio threat detection technologies is the technology’s tested “limit of detection,” which indicates the level of sensitivity of the technology and its ability to avoid false positives.
A lower limit of detection indicates a better level of threat detection sensitivity and lower false alarm rate and is more desirable for bio threat detection applications.
In the case of PathSensors’ CANARY® Zephyr technology, the PNNL report found that for detection of bacillus anthracis: “….the CANARY Zephyr achieved an estimated limit of detection of 10^3 spores/mL, which was 4 orders of magnitude lower than any other immunoassay tested.”
For detection of Ricin toxin, the PNNL report found that: “…The CANARY Zephyr achieved the lowest limit of detection (3ng/mL).”
“This new report from PNNL scientists is only the latest in what has been a series of independent validations of PathSensors’ CANARY pathogen detection technology,” commented Ted Olsen, CEO, PathSensors, Inc.
“Anthrax and Ricin are just two of the many pathogens CANARY can detect; now users of CANARY can know that they are using one of the most highly sensitive and cost effective bio threat solutions available.”
PathSensors’ CANARY® (Cellular Analysis and Notification of Antigen Risks and Yields) technology is a biosensor technology that delivers rapid detection of pathogens – including toxins, viruses, and bacteria – at high levels of sensitivity and specificity.
First developed at the MIT-Lincoln Laboratory, CANARY® incorporates pathogen-specific antibodies expressed on the biosensor surface which, in the presence of a pathogen, trigger an intracellular calcium release that in turn activates bioluminescent proteins whose light output can be measured and analyzed.
In independent tests by U.S. government labs, PathSensors’ CANARY® technology was shown to be superior to alternative technologies in terms of sensitivity and speed of detection.
PathSensors has a continually growing library of biosensors for threats such as HLB, Phytophthora, and Ebola.
With a quicker turnaround in test results, clinicians can treat bloodstream infections much sooner, critical in staving off sometimes fatal complications such as septic shock, the agency said in a news release.
Traditional tests to identify sources of bloodstream infection and discern their susceptibility to antibiotics may take 24 to 48 hours to deliver results. In contrast, the PhenoTest BC Kit, performed on the manufacturer’s Pheno system, can identify 14 different species of bacteria or two species of yeast from a positive blood culture in about 90 minutes. In another 6 to 7 hours, it delivers results on antibiotic susceptibility. The test also picks up on two indicators of antibiotic resistance.
The FDA greenlighted the PhenoTest BC Kit based on the manufacturer’s primary clinical study of 1850 positive blood cultures. The test correctly identified bacteria or yeast in the cultures 95% of the time, and proved accurate in assessing antibiotic susceptibility when compared to traditional tests.
The PhenoTest BC Kit comes with the risk of false positives, so results should always be interpreted in light of additional lab tests, according to the agency.
BD Veritor™ System Meets FDA's New Performance Requirements for Rapid Influenza Antigen Detection Tests
BD (Becton, Dickinson and Company), a leading global medical technology company, today announced that its BD Veritor™ System Flu A+B, a digital immunoassay for the rapid detection of influenza, meets the new FDA performance requirements. i
Prompting these changes was the inadequate performance of some point-of-care flu tests available during the 2009 flu pandemic, which raised concerns regarding the accuracy of detecting influenza in patients. With the new FDA requirements,i rapid flu tests, which are used by health care providers and laboratory personnel, must now attain a higher level of performance.
"The change to the new performance standards may help improve the overall quality of testing for influenza," said Dr. Charles Cooper, vice president of medical affairs at BD. "This agency's decision has the potential to improve patient outcomes — ensuring that the tools health care providers use for diagnosing influenza meet new, higher standards for accuracy. As we know, an accurate diagnosis helps to determine appropriate use of antiviral medications, while at the same time reducing inappropriate over-prescription of antibiotics, which can only help in the fight against antimicrobial resistance."
As part of the new reclassification of rapid flu tests from Class I to Class II, the FDA is raising the tests to higher performance standards. This change will help to ensure that health care providers and allied health professionals who use rapid flu tests to detect influenza viruses will have quick access to more accurate information.
In recognizing the need to improve diagnostics, BD developed and launched the BD Veritor System for Rapid Detection of Flu A+B. This was the first Clinical Laboratory Improvement Amendments (CLIA)-waived flu test that provides objective results on an easy-to-read digital display. The now Class II BD Veritor System Flu A+B test became available in 2011, and is the same test used on the new BD Veritor Plus System, a next generation wireless rapid diagnostic system for detection of influenza A and B, respiratory syncytial virus (RSV) and group A strep.
"We are very pleased to receive this award and to offer Vizient's members and their healthcare professionals the benefits of our rapid point of care HIV test," said Robert Mackie, bioLytical's President. "This award is a testament to our strong focus on bringing innovative technologies and products to market and further demonstrates our commitment to improving patient care in the United States and support the CDC guidelines, which recommend HIV screening be a part of routine clinical care in all health-care settings."
"Due to the number of products and services being released and marketed as 'innovative', member hospitals truly value the thorough innovative technology review process in place at Vizient to help them identify products worth further evaluation at their own facilities," said Debbie Archer, Director of Procurement and leader of Vizient's Innovative Technology program for suppliers. "After a full review of the INSTI HIV Test, Vizient's member council agreed this solution offers unique and incremental benefit over other products available on the market today, and recommended it for an Innovative Technology contract. We are pleased to award this new contract to bioLytical."
The INSTI HIV-1/HIV-2 Rapid Antibody Test is a rapid in vitro qualitative test for the detection of antibodies to Human Immunodeficiency Virus Type 1 and Type 2 in human whole blood, fingerstick blood, or plasma. The test is CLIA waived and intended for use by personnel in a variety of settings such as hospitals, clinical laboratories, community health settings and physician offices as a screening assay capable of providing test results in as little as 60 seconds. The INSTI test kit has a unique immunofiltration "flow-through" design that enables detection of HIV in as little as 21 days after infection, leading to accelerated, early and accurate diagnosis. In HIV antibody test devices that do not detect IgM antibodies, it can take as long as two months following infection for those tests to become positive.
Tuesday, February 28, 2017
Biosynth recently launched RUG™, a new substrate for beta-glucuronidase that is based on Resorufin - one of the most intensely fluorescent materials known today. RUG™ (Resorufin-beta-D-glucuronic acid methyl ester) is a highly sensitive chromogenic and fluorogenic indicator for E. coli. After removal of the methyl ester group by unspecific hydrolysis, the product is cleaved by beta-glucuronidase in liquid media and yields an intense pink color. Red fluorescence is obtained upon excitation at 560-570 nm. RUG™ is 5 to 10 times more sensitive than MUG and fluorescence develops in liquid culture media in less than half the time - after only 10 hours. These findings suggest the usage of RUG™ in place of MUG for the development of fast fluorescence E. coli assays.
As RUG™ generates a strong pink coloration that can be detected by the naked eye it further opens possibilities for the use of RUG™ in situations where fluorescence detection is not possible. Field studies are currently being carried out under the auspices of the WHO using RUG™ to test drinking water in hot climates. As RUG™ is chemically stable, prepared dry media containing RUG™ may be stored at ambient temperature for several months.