PCR rapid tests for Candida auris for Vivalytic by Bosch now available
PCR rapid tests for Candida auris for Vivalytic by Bosch now available
World’s first fully automated PCR test for detection of the multidrug-resistant fungus at the point of care.
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Vivalytic test detects Candida auris in under an hour at the point of care, making it the world’s first test suitable for screenings.
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Candida auris infection rates are on the rise in Germany and can cause severe infections, for example in the bloodstream (sepsis).
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Hospitals can use the new screening test to detect colonization, allowing them to implement measures to contain outbreaks.
Bosch Healthcare solutions has developed a PCR test for detecting Candida auris (C. auris) and on the Vivalytic platform. The test is a global innovation now available for order from distribution partners including Randox Laboratories Ltd. and R-Biopharm. This test enables the fully automated detection of the frequently multi-resistant fungus in less than an hour at the point of care. The rapid testing capability also makes it suitable for carrying out screenings when necessary. In contrast, traditional culture tests in centralized laboratories require one to three days, delaying diagnosis and the initiation of targeted treatment. “Considering the heightened risk of severe progression in individuals with pre-existing conditions, we have developed a new test that enables clinics to respond more swiftly,” states Marc Meier, managing director of Bosch Healthcare Solutions. Patients with compromised immune systems, such as those in intensive care, individuals with serious underlying conditions such as diabetes, or those who are immunosuppressed due to cancer or HIV, as well as patients about to undergo invasive surgery, face a heightened risk of active infection with C. auris. The mortality rate for C. auris infections ranges from 30 to 72 percent.
“Candida auris can be transmitted from person to person through contact and contaminated surfaces. When this fungus presents, rapid detection is therefore rapid detection is therefore paramount to enable implementation of effective control and prevention strategies,” says Dr. med. Alexander Maximillian Aldejohann, deputy head of the Würzburg Laboratory at the National Reference Center for Invasive Fungal Infections (NRZMyk.) Since July 2023, Germany has implemented a limited statutory reporting requirement under the Infection Protection Act. Aldejohann is in favor of extending this reporting obligation: “The fungus has the capacity to rapidly develop resistance to many common antifungal agents coupled with the ability to survive for a relatively long time on surfaces. This high so-called tenacity also increases the risk of outbreaks that are difficult to contain.”
Increasing spread of Candida auris
C. auris is spreading globally. In some states in the U.S, the annual incidence rate has been shown to increase by a factor of 2 to 3. The Robert Koch Institute (RKI) also drew attention to a rise in cases within Germany during the past year in the Epidemiological Bulletin at the at the beginning of May. The RKI points out that in specific areas screening could be beneficial. In the U.S, the annual case count has in the meantime reached the thousands. The Centres for Disease Control and Prevention (CDC) already consider the screening of patients, visitors, and staff for C. auris as a crucial strategy to curb its spread in healthcare settings. While the fungus is harmless for healthy individuals, it can it can lead to severe nosocomial infections, i.e. infections acquired in hospitals or other healthcare environments, in patients at high risk and, if the fungus enters the bloodstream, can trigger sepsis.
Easy handling, rapid detection The Vivalytic Analyser enables effortless testing directly at the point of care: The sample is placed into the test cartridge, which already contains all necessary reagents. The cartridge is then inserted into the Vivalytic Analyser for automated processing. Healthcare professionals require only minimal training to use the system, and the fully automated process significantly lowers the risk of infection. The Vivalytic Analyser thus facilitates rapid and precise diagnostics in PCR quality, bypassing the frequently lengthy process through a central laboratory. Bosch Healthcare Solutions is expecting CE certification for the Vivalytic C. auris test soon.
For More Information Please Contact:
Martin Conway, Phone: +44 (0) 28 9442 2413
E-mail: martin.conway@randox.co
Growth through medical technology: Randox and Bosch invest heavily in the Vivalytic analysis platform
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New partnership for Vivalytic analysis platform: Bosch and Randox
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Laboratories Ltd. to invest 150 million euros in research, development, and
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distribution
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Strategic growth field: point-of-care molecular diagnostics expected to
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become a future market worth billions
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Growth with fully automated laboratory diagnostics: the two companies aim to
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achieve sales in the nine-figure range by 2030.
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Smartphone-sized laboratory: sepsis IVD grade test based on cutting-edge
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BioMEMS technology is a joint development objective.
With many diseases, every minute counts, and determining whether a patient is presenting the symptoms of a simple cold, the flu, or something as severe as life-threatening meningitis is usually only possible after time-consuming and expensive
laboratory diagnostics. With its Vivalytic analysis platform, Bosch has set itself the goal of making fast and highly precise diagnostics accessible at the point of care – and aims to use molecular diagnostics to become a leading provider in the
market by 2030. To achieve this, Bosch has now agreed on a strategic partnership with Randox Laboratories Ltd., a leading diagnostic and medical technology company. The two companies will invest around 150 million euros in joint research, development, and sales activities for new tests for the Vivalytic analysis platform provided by Bosch Healthcare. One goal is the development of a sepsis IVD1 grade test that will be the first to feature highly innovative and novel BioMEMS technology.
Bosch has defined medical technology as a strategic growth field. Point-of-care molecular diagnostics is expected to become a future market worth billions. And with its Vivalytic analysis platform, Bosch aims to achieve a leading position in this market. “With cutting-edge technology from our own labs and our own production lines, we want to grow long-term together with partners in the field of precision diagnostics,” says Stefan Hartung, chairman of the Bosch board of management. “Here, our medical technology can draw considerable benefit from our diversification, from our expertise, from the groundwork we have done in automation, miniaturization, molecular diagnostics, and from our experience in microchip development and manufacturing,” Hartung adds. “We are investing long-term in an exciting high-tech growth field and continuously developing it together with partners. With technology ‘Invented for life’, we can relieve the burden on medical professionals and help make the diagnose and treatment of disease faster”.
Shared growth: decentralized diagnostics at the point of care
Bosch Healthcare Solutions and Randox are now joining forces in an attempt to accelerate the development and market launch of new tests and to make distribution channels more efficient. The partnership is set to run for more than ten years. With Vivalytic, the two companies aim to achieve sales in the medium nine-figure range by 2030. “Globally, healthcare is moving toward decentralized and personalized diagnostics, that enable rapid interventions and individual treatment plans,” says Marc Meier, managing director of Bosch Healthcare
Solutions GmbH. “With our partner Randox, we want to further expand the test portfolio of our Vivalytic analysis device. Our fully automated molecular diagnostics PCR tests provide clarity directly at the site of sample collection,
shorten waiting times, and take the strain off the healthcare system,” Meier adds. The two partners are a good fit: Bosch can contribute its technology and manufacturing expertise across the fields of molecular diagnostics, microchip
development and manufacturing, and miniaturization. The universal Vivalytic platform for molecular diagnostics was developed in over ten years by Bosch researchers and brought to market maturity by Bosch Healthcare Solutions. Randox has 40 years of experience in the design and development of highly sensitive IVD tests performed on a variety of technologies, including microfluidic platforms. In combination with the company’s extensive market knowledge and global sales and distribution network, this adds up to considerable opportunities for growth. “Randox has always been committed to improving health worldwide and sees the need to invest in research and development initiatives that will support clinical decision making across a variety of disease areas. Diagnostics has always been an indispensable component of healthcare, and the alignment of both science and technology makes for the perfect fit in an area for high potential impact, especially in pressure-driven environments,” says Dr. Peter Fitzgerald, Managing Director of Randox Laboratories Ltd. Bosch Healthcare Solutions and Randox already collaborated during the Covid-19 pandemic. In spring 2020, Bosch launched one of the world’s first fully automated PCR tests for the SARS-CoV-2 coronavirus. Together with Randox, the rapid test for use in doctor’s offices, nursing homes, testing stations, and hospitals was made ready for the Vivalytic analysis device within the space of just a few weeks.
Development goal: sepsis test based on BioMEMS technology
One focus of the development partnership with Randox is the implementation of a highly sensitive multiplex2test for sepsis on the Vivalytic analysis platform.Sepsis, also known as “blood poisoning,” is a potentially life-threatening complication3 that can occur in conjunction with various infectious diseases. A medical emergency that can lead to multiple organ failure, it requires immediate medical treatment. The planned IVD grade sepsis test is to be based for the first time on the highly innovative and novel BioMEMS technology developed by teams from Bosch corporate research in Renningen and Bosch Healthcare Solutions in Waiblingen. “We have set ourselves the ambitious goal
of adding the functions of a high-performance silicon chip based on microsystems technology to our test cartridges for the Vivalytic platform. In doing so, we will combine Bosch’s unique expertise in the areas of MEMS chips, molecular diagnostics, and microfluidics,” Marc Meier says. “Clinical outcomes in sepsis depend on timely diagnosis and appropriate early therapeutic intervention. Current methods of sepsis diagnosis are insufficient and time-consuming. With over 10 years of experience in the field of infectious diseases diagnostics, we aim to develop a state-of-the-art sepsis test using the highly multiplexing BioMEMS technology. Such a test could revolutionize sepsis diagnosis, ultimately leading to improved treatment outcomes and lower mortality rates from this life-threatening condition,” says Dr. Peter Fitzgerald.
Smaller and faster: from microfluidics to nanofluidics – thanks to BioMEMS
The powerful BioMEMS chip adds a further innovative analysis method to the Vivalytic test cartridge, enabling it to test simultaneously and significantly faster for a large number of different pathogens. It is called BioMEMS because it combines microelectromechanical systems (MEMS) with microfluidics for applications in the field of medical technology. In microfluidics, very small amounts of fluid in the microliter range are moved in a very small space. Miniaturization allows qualitative biochemical polymerase chain reactions (PCR) to run in parallel in real-time on a single BioMEMS chip. “Compared to previous PCR reactions, the volumes of liquids are reduced by a factor of 1,000 to the nanoliter range. The analysis of liquids is left to a small microchip,” Marc Meier explains. With the new BioMEMS technology, fully automatic testing up to 250 genetic characteristics4 (e.g. pathogens) in one cartridge is possible in less
than 15 minutes. The test cartridge is a highly complex laboratory the size of a smartphone, so to speak. Another future advantage of BioMEMS will be simpler and faster adaptation of new tests or existing tests on the chip itself. For example, existing tests can easily be expanded to include additional features. “The BioMEMS technology paves the way for us to move into nanofluidics, where each pathogen will be examined in a reaction vessel the thickness of a hair,” Meier says. To achieve this, Bosch wants to create more capacity on a MEMS chip and expand it what are known as “nanocavities”. Thanks to t
hese very small cavities, even more biochemical processes will be able to run in parallel on a
chip. With increasing miniaturization, the technology has potential to be used in oncology as well over the long term. The BioMEMS chips are to be manufactured at the Bosch semiconductor plant in Reutlingen, with bio-integration and cartridge
assembly to be carried out at Bosch Healthcare Solutions in Waiblingen.
Vivalytic platform: easy application at the point of sample collection
The advantages of carrying out PCR tests on the Bosch Vivalytic platform lie not only in speedy a
nalysis, but also in the ease of use: Once the sample has been taken, it is placed in the test cartridge. The cartridge, which contains all the necessary reagents for the respective test, is then inserted into the Vivalytic analyser for automated evaluation. Medical staff require only brief training on how to operate it. This enables fast and targeted diagnostics directly at the point of sample collection – either at the doctor’s office or in the hospital – without the often long and time-consuming detour via a central laboratory. Bosch Healthcare Solutions already distributes various tests for diseases of the upper and lower respiratory tract, such as SARS-CoV-2 – also a pooling variant and as a saliva test – or a test to differentiate between SARS-CoV-2, RSV virus and influenza. There are also tests for pathogens that cause sexually transmitted infections (STI) and MRSA / SA (“hospital germ”). Starting in summer, it is planned to expand the portfolio with tests for whooping cough (Bordetella holmesii, Bordetella parapertus
sis, and Bordetella bronchiseptica), urinary tract infections (UTI), bacterial meningitis, the two most common sexually transmitted diseases (Chlamydia trachomatis; CT and Neisseria gonorrhoeae; (NG), fungal infections (Candida auris), and three tests for diarrheal diseases
(norovirus, Clostridioides difficile, HSP)
Contact persons for press inquiries:
Robert Bosch GmbH
Dörthe Warnk, Phone: +49 711 811-55508
E-mail: doerthe.warnk@bosch.com
Randox Laboratories Ltd.
Martin Conway, Phone: +44 (0) 28 9442 2413
E-mail: martin.conway@randox.com
Vivalytic | Extensive SARS-CoV-2 Pooling
Vivalytic | Extensive SARS-CoV-2 Pooling Test
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15 Samples, 1 Cartridge
Simultaneous SARS-CoV-2 detection from up to 15 pooled samples
- Detection from real-time PCR using saliva lollipop swab collection.
- Up to 15 patient samples may be pooled and added to a single cartridge targeting the E gene sequence
- The SARS-CoV-2 pooling test has recently received CE marking.
- Simple and easy to use POC analyser with a small footprint making it suitable for use in laboratory and non-laboratory settings
- Rapid turnaround time of less than 45 minutes for results.
- Convenient 4 step process from sample entry to results. No laboratory training required
Extensive SARS-CoV-2 Pooling is a rapid real-time PCR test cartridge, providing clear and concise results in a timely manner, direct at the point of care on the Vivalytic. The SARS-CoV-2 pooling test with lollipop swab allows for the screening of up to 15 patient samples. One of the first rapid pooling PCR tests on the market, the Vivalytic produces results in less than 45 minutes delivering high accuracy for extensive and faster testing ideal for rapid and confirmatory SARS-CoV-2 screening in any environment.
Ideal for mass testing, the pooling could be done at the level of a ward, medical speciality, social bubble, or group of colleagues. It has potential for use in other settings, such as pre-operative screening, schools and universities, prisons, nursing homes, primary care, and large workplaces. Sample pooling allows more people to be tested quickly using fewer testing resources.
“AWARD-WINNING DESIGN DELIVERS
AN UNCOMPLICATED USER EXPERIENCE”
Vivalytic Workflow
Intuitive engineering of Vivalytic ensures the analyser is user friendly. The process of patient sample to result comprises a very simple 4 step workflow.
To begin the test, the user scans or enters sample information. The cartridge code is then scanned into the embedded Vivalytic software. The user then adds sample into the dedicated cartridge slot, closes the lid and inserts the cartridge into the Vivalytic.
The touchscreen display will countdown the time remaining to test completion. Results will be displayed on the screen. Multiple Vivalytics can be wirelessly connected allowing the user to control multiple tests at one time all reporting to a master Vivalytic platform.
Want to know more?
Contact us or visit our COVID-19 Monitoring & Management page
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Vivalytic’s rapid coronavirus test delivers results for positive samples in less than 30 minutes
18th December 2020
Cloud-based software update means a faster PCR test for SARS-CoV-2
We are happy to announce that due to improved software for the Vivalytic analysis device, the CE marked Vivalytic SARS-CoV-2 rapid coronavirus test, which uses polymerase chain reactions (PCR), now delivers its results even faster. By applying optimized evaluation strategies, the Vivalytic analysis device can detect a positive SARS-CoV-2 sample through its high viral load in less than 30 minutes, right where the sample is collected.
This modified product is part of a research and development project relating specifically to COVID-19, funded by the German Federal Ministry of Education and Research (BMBF) to the tune of 4.97 million euros. The project’s aim is to expand the options for detecting acute infections of the coronavirus, looking particularly at on-the-spot testing in which the sample is analyzed in a fully automatic PCR process, as this offers rapid yet reliable results.
- Improved software for Vivalytic: turnaround time for positive SARS-CoV-2 samples reduced to under 30 minutes.
- Update from the cloud: Vivalytic analysis devices are updated over the internet.
Dr. Volkmar Denner, chairman of the board of management of Robert Bosch GmbH said;
“In the fight to contain the coronavirus pandemic, speed is of the essence. With Vivalytic, we are delivering cutting-edge medical technology. Our IT and software expertise have helped to make the Bosch Corona test for positive samples even faster – all within a short period of time.”
The new update is available for the SARS-CoV-2 singleplex test and the SARS-CoV-2 pooled test. Updating the Vivalytic testing devices is simple and straightforward – all that is required is an internet connection to access the Bosch cloud platform Vivasuite. Developed in-house at Bosch, the Vivasuite cloud platform allows users to digitally manage and update all their Bosch Healthcare Solutions devices. This is also an advantage when Vivalytic devices are in use in the field. The platform meets the strictest security standards and data privacy is guaranteed at all times: for example, there is no remote access to Vivalytic devices, and no possibility of accessing patient data.
The turnaround time for samples negative for SARS-CoV-2 is still 39 minutes. PCR tests are considered the gold standard, and Bosch’s rapid coronavirus tests have a sensitivity of 98 percent and a specificity of 100 percent.
Contact marketing@randox.com for further information on the latest vivalytic software update for SARS-CoV-2 testing.
Randox in the media
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Randox & Bosch Healthcare – Collaboratively Combating COVID-19
29th October 2020
Randox & Bosch Healthcare – Collaboratively Combating COVID-19
A game-changing partnership between Randox Laboratories and Bosch Healthcare Solutions continues to change the testing landscape and capabilities of both laboratory and non-laboratory settings in rapidly detecting COVID-19.
Providing clear and concise results, direct at the point of care, the Randox and Bosch Healthcare Solutions collaborative approach not only allows patients to take the recommended safety precautions without delay, but also provides a solution to both analyse and differentiate COVID-19 from other viral respiratory diseases. Multiple testing approaches with the same aim – to overcome COVID-19!
Combining science & technology, timing is of the essence in the fight against coronavirus. Together, we have combined efforts in successfully launching the Vivalytic – the all in one solution for molecular diagnostics consolidating nucleic acid extraction, polymerase chain reaction (PCR) and detection onto one small platform.
These efforts reflect a global partnership of both cooperation’s working together to deliver world-class diagnostic solutions, harnessing the power of innovation to improve health worldwide, providing an all in one approach minimising the spread of COVID-19 globally.
Launched after just six weeks at the beginning of the COVID-19 pandemic back in March 2020, the Viral Respiratory Infection array (VRI) set the benchmark for rapidly detecting SARS-CoV-2 (COVID-19) whilst simultaneously differentiating between nine other respiratory diseases, in under two and a half hours.
Proactively working together to combat the spread of COVID-19, Randox, Bosch Healthcare Solutions and R-Biopharm are proud to offer variable analysis strategies to detect SARS-CoV-2 (COVID-19). Capable of providing reliable results in just 39 minutes, with a sensitivity of 98% and specificity of 100%, the Vivalytic SARS-CoV-2 rapid test is currently among one of the fastest PCR tests worldwide.
Since the outbreak of COVID-19, we have significantly combined our efforts to provide a diverse range of testing solutions and approaches to meet the need of the rise in global cases. Our approaches have been utilised at all possible levels and together we open up a range of different testing strategies, with developments still underway with the upcoming release of the SARS-CoV-2 Pooling test.
The SARS-CoV-2 Pooling test is a rapid solution for the detection of SARS-CoV-2 (COVID-19) offering an accelerated decentral testing approach to effectively and efficiently monitor and detect viral infection from the offset. Capable of detecting SARS-CoV-2 (COVID-19) from up to five pooled samples simultaneously with a capacity to process more than 160 patient samples a day. The pooling could be done at the level of a ward, medical specialty, social bubble, or group of colleagues. It has potential for use in other settings, such as pre-operative screening, schools & universities, prisons, nursing homes, primary care, and large workplaces. Sample pooling allows more people to be tested quickly using fewer testing resources.
Partnering together, we continue to increase our testing capacity, enabling fully automated processing of patient samples to rapidly combat COVID-19.
Please contact marketing@randox.com for further information.
Randox in the media
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New 39-minute COVID test available on Randox-Bosch Vivalytic
02 October 2020
New 39-minute COVID test available on Randox-Bosch Vivalytic
- The world’s fastest PCR based SARS-CoV-2 test for the point of care delivers reliable results in 39 minutes.
- Has a sensitivity of 98 percent and a specificity of 100 percent.
- Simultaneous testing of five people with one cartridge by pooling will be available from early October.
- Work is in progress to further reduce time to result.
A rapid new coronavirus test, which provides results for Covid-19 in just 39 minutes, is now available on the Vivalytic, a point of care platform brought to market by Randox Laboratories and Bosch.
The test for detection of the SARS-CoV-2 pathogen, is currently the fastest PCR test (the gold standard of test methods) worldwide, and is predestined for decentralized use in mobile test centres at service stations or in airports, so that people who take the test can obtain a reliable result while at the testing site.
Available now in Europe, the CE-approved test, which has a sensitivity of 98 percent and a specificity of 100 percent, helps avoid time in quarantine, relieve laboratories, and make travel and work safer again.
“Rapid and accurate testing plays a crucial role in identifying cases of Covid-19 – to contain any outbreaks and limit the spread of the virus,” says Dr. Heather McMillan, Molecular R&D Manager at Randox Biosciences.
“This new rapid test will be a game-changer in the coronavirus testing landscape by allowing patients to receive their results at the point of care faster than ever before.”
Randox and Bosch launched the first rapid test for the Vivalytic analyser at the end of March, after just six weeks’ development.
As a multiplex test, it simultaneously checks samples for the SARS-CoV-2 virus as well as nine other respiratory diseases in two and a half hours, whereas the new accelerated test is exclusively for SARS-CoV-2.
“With our different coronavirus tests and variable analysis strategies, we open up a range of testing scenarios with a Vivalytic device – from screening all the way to supporting differential diagnosis for similar symptoms,” says Marc Meier, president of Bosch Healthcare Solutions GmbH.
And development work for Covid tests on the Vivalytic is ongoing: as of early October 2020, by pooling samples together it will be possible to simultaneously evaluate five samples in one test cartridge and at a comparable speed – a world first.
This will increase available testing capacity, by enabling fully automated processing of more than 160 samples a day using a Vivalytic device.
Key Benefits of SARS-CoV-2 test on Vivalytic point of care platform
The advantages of the rapid SARS-CoV-2 test on Vivalytic lie not only in speedy analysis, but also in ease of use. A sample is taken from the nose or throat using a swab, and placed in the test cartridge. Then the cartridge, which contains all the reagents required for the test, is inserted into the Vivalytic device for automated analysis.
- Turnaround time of 39 mins from sample entry to result.
- The SARS-CoV-2 rapid test has recently received CE marking.
- The SARS-CoV-2 pooling test can run up to 5 samples on-board one single cartridge.
- Easy 4-step user-friendly process from sample entry to result. Minimal training required.
- Detection from real-time PCR from Nasopharyngeal and/or Oropharyngeal swab.
- Suitable for use in any laboratory and non-laboratory settings.
The development of the new Vivalytic PCR singleplex test is part of a research and development project funded by the German Federal Ministry of Education and Research (BMBF).
For more information please contact marketing@randox.com
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Point of care coronavirus test from Randox and Bosch will launch in April 2020
26 March 2020
Vivalytic Viral Respiratory Tract Infection Array Detecting SARS-CoV-2 (COVID-19)
A game-changing point of care coronavirus test from global diagnostics company Randox Laboratories and leading technology manufacturer Bosch Healthcare Solutions will launch in April 2020.
The Vivalytic Viral Respiratory Tract Infection (VRI) Array can identify SARS-CoV-2 (COVID-19) and differentiate it from nine other respiratory infections with similar symptoms, including influenza and all known coronaviruses.
This provides a more comprehensive respiratory screening which enables precise and informed treatment decisions to be made.
Dr. Heather McMillan, Molecular R&D Manager at Randox Biosciences, commented;
“This array focuses not only on the identification of the novel coronavirus strain that causes COVID-19, but also nine other respiratory infection targets simultaneously, including Influenza A and B, Sarbecovirus and MERS. The aim is to diagnose patients fast and accurately from a single genetic sample, maximising containment of the virus whilst minimising the spread. With the development of this array onto a fully automated platform, patients can be diagnosed rapidly at point of care locations globally such as pharmacies and doctor surgeries.”
The Viral Respiratory Tract Infection Array is one of the world’s first multiplex molecular diagnostic tests meeting the COVID-19 testing recommendations of the World Health Organisation (WHO) and the Centres for Disease Control (CDC).
The target genes for COVID-19 being used on the VRI array represent conserved regions of the genome which have been chosen for their high sensitivity and specificity.
Marc Meier, Managing Director of Bosch Healthcare Solutions, a subsidiary of Bosch Group, said:
“We are enthusiastic about partnering with Randox to offer their assay technology on the Vivalytic platform. The core competencies of Bosch in automation, miniaturization, sensor technology and connectivity are complemented by Randox’s expertise in developing excellent biocontent for a wide range of assays and commercializing innovative diagnostic solutions.”
The new VRI test will be conducted on Vivalytic a point of care platform brought to the market by Randox Laboratories and Bosch. The Vivalytic system is a fully-automated, cartridge-based platform capable of both Hi-Plex and Lo-Plex testing. The cartridges are fully-sealed which minimises the risk of contamination, require room temperature storage (space-saving), contain all the reagents on-board the cartridge and utilises end point PCR. The test only requires a single nasal swab from the patient and an easy four step process to be carried out by the user to run the patient sample.
Key Benefits of Vivalytic | Point of Care Platform
- Fully-automated
- User friendly
- No laboratory training required
- 4 step work flow
- Minimal contamination risk – fully contained system
- No peripherals required – hygienic
- Touchscreen
- Connects to LIMS (Laboratory Information Management System)
- Sample Type: Nasopharyngeal Swab
- Sample Volume: 300µl clinical sample
For more information or to arrange interviews, please contact info@randoxbiosciences.com
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Multiplex STI assay for 10 sexually transmitted infections receives CE marking
02 March 2020
Multiplex assay for 10 sexually transmitted infections receives CE marking
CE marking has been granted to one of the most comprehensive cartridge-based STI tests.
The test, developed by the UK’s largest health diagnostics company, Randox Laboratories, tests simultaneously for 10 of the most common sexually transmitted infections, on the firm’s patented Biochip Technology.
Quickly and efficiently testing for multiple STIs, which often have mild symptoms if any at all, ensures early diagnosis at a stage when treatment is most successful, supports the targeted use of antibiotics, and ultimately reduces their mishandling.
Dr Peter FitzGerald, Managing Director of Randox Laboratories, commented;
“Antibiotic stewardship is a critical issue which we all have a responsibility to embrace and drive forward. The CE marking of the STI assay, which incorporates Randox Biochip Technology, will be a game-changer for clinicians and patients across Europe, by facilitating early, accurate and comprehensive diagnoses of STIs that allows for the best possible patient outcome. Never before has there been this level of accessibility and speed with regards to STI testing.”
The Randox STI assay is performed on the Vivalytic system, an intuitive point-of-care platform, developed in partnership with German technology company Bosch that provides the broadest range of test options ever seen for an analyser of its size.
Harnessing the application of multiplex assays to provide greater information from a single patient sample, the Vivalytic simplifies the testing process for otherwise complex laboratory testing procedures.
Marc Meier, Managing Director of Bosch Healthcare Solutions, a subsidiary of Bosch Group, said:
“We are enthusiastic about partnering with Randox to offer their assay technology on the Vivalytic platform. The core competencies of Bosch in automation, miniaturization, sensor technology and connectivity are complemented by Randox’s expertise in developing excellent biocontent for a wide range of assays and commercializing innovative diagnostic solutions.”
Benefits of the Randox STI assay technology on the Vivalytic system
- Fully automated, cartridge-based molecular diagnostics.
- Multiplex technology detects multiple STIs, including co-infections, from a single patient sample.
- Full molecular workflow of extraction, PCR amplification and detection.
- A hygiene and space-saving all-in-one solution that does not require additional peripherals such as laptop, keyboard, barcode scanner or filling stations.
- Ultimate protection of data and valuable sample material thanks to integration of software with instrument that ensures a safe and reliable run.
- Test results can be presented either in summary or in detailed raw data form.
- Instantly available results due to easy integration with popular standard IT systems.
The assay tests simultaneously, from one patient sample, for the STIs below;
- Chlamydia trachomatis (CT)
- Neisseria Gonorrhoeae (NG)
- Trichomonas vaginalis (TV)
- Mycoplasma genitalium (MG)
- Treponema pallidum (syphilis) (TP)
- Herpes simplex virus 1 (HSV-1)
- Herpes simplex virus 2 (HSV-2)
- Haemophilus ducreyl (HD)
- Mycoplasma hominis (MH)
- Ureaplasma urealyticum (UU)
For further information please contact the Randox PR team on 028 9442 2413 or email randoxpr@randox.com
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Cystic Fibrosis Awareness Month at Randox Biosciences
May is National Cystic Fibrosis (CF) Awareness Month. The purpose of having the awareness month is to educate and raise additional awareness to the public about the horrible disease and how it affects those who suffer. According to the Cystic Fibrosis Foundation, more than 30,000 people are living with cystic fibrosis. More than 75% of these people are diagnosed in their early childhood 1.
What is CF?
Cystic Fibrosis is a genetic, life-threatening disease which affects the respiratory and digestive system. A person with CF is born with the condition and therefore it is not possible to catch it from someone else. The gene affected by CF controls the movement of salt and water in and out of cells, which results in a build-up of thick sticky mucus in the lungs, digestive system and other organs. This causes a wide range of challenging symptoms affecting the entire body.2
Symptoms of CF:
There are many symptoms to Cystic Fibrosis which can make life for someone who suffers with CF challenging. The build-up of sticky mucus in the lungs can make breathing difficult and clog up the pancreas which as a result can increase the risk of developing a lung infection or worse, death. This can make it difficult for those who have CF to absorb nutrients from food properly and therefore they must eat more calories to avoid malnutrition. Other symptoms include the following:3
- recurring chest infections
- wheezing, coughing, shortness of breath and damage to the airways (bronchiectasis)
- difficulty putting on weight and growing
- jaundice
- diarrhoea, constipation, or large, smelly poo
- a bowel obstruction in new-born babies (meconium ileus) – surgery may be needed
Complications of CF:
3People with CF also have a higher risk of developing other conditions. These include:
- weak and brittle bones (osteoporosis)– medicines called bisphosphonates can sometimes help
- diabetes– insulin and a special diet may be needed to control blood sugar levels
- nasal polyps and sinus infections – steroids, antihistamines, antibiotics or sinus flushes can help
- liver problems
- fertility problems – it’s possible for women with CF to have children, but men won’t be able to father a child without help from fertility specialists (see a doctor or fertility specialist for more advice)
4There is no cure for CF, but with improved treatment and management people with Cystic Fibrosis are living longer. It’s thought that children born with CF nowadays are likely to live to an average age of over 50 years old.
How we can help:
Randox Biosciences offer the Vivalytic with the Chronic Lung Disease cartridge, in combination with our intelligent Biochip Array Technology which detects 132 pathogens. The 132 species are simultaneously detected across this 320 Array including bacterial, viral, fungal targets and an antibiotic resistance marker from a single sputum sample!
For more information at info@randoxbiosciences.com or visit us at: wwww.randoxbiosciences.com
- https://www.cff.org/What-is-CF/About-Cystic-Fibrosis/
- https://www.blf.org.uk/support-for-you/cystic-fibrosis/what-is-it
- https://www.nhs.uk/conditions/cystic-fibrosis/
- https://www.nhsinform.scot/illnesses-and-conditions/lungs-and-airways/cystic-fibrosis
Randox / Bosch partnership delivers game-changing device in fight against antibiotic resistance
A partnership between Randox Laboratories, the UK’s largest manufacturer of in-vitro diagnostics, and the German technology giant Bosch is changing the way doctors will treat patients with antibiotics, with the launch of a revolutionary product – the Vivalytic.
It’s estimated that 20% of antibiotics currently prescribed are unnecessary, and fuel the growing threat of global antibiotic resistance. This threatens the ability to treat common infectious diseases, and a growing number are becoming harder, and in some cases impossible, to treat. The World Health Organisation warns that without action, we are heading towards a post-antibiotic era.
This problem is being addressed by the Vivalytic. The result of a decade of R&D, it is an intuitive point-of-care analyser that, depending on the complexity of the test, will deliver results from 30 minutes: enabling doctors to select the right course of therapy faster than before. In some cases, this will be life-saving.
The first tests available on the Vivalytic are Randox’s panels for respiratory and sexually-transmitted infections*.
Using Randox’s patented Biochip Array Technology, the Respiratory Multiplex Array simultaneously reports on 22 viral and bacterial pathogens including Bordetella pertussis and parapertussis which causes whooping cough – without the need for secondary or confirmatory testing to inform clinical treatment decisions. The STI array enables the detection of 10 STIs from a single sample. Every day more than 1 million STIs are acquired, and many have mild if any symptoms at all. Identifying these infections correctly first time reduces the misuse of antibiotics and supports their targeted use.
The Managing Director of Randox Dr Peter FitzGerald commented:
“Antibiotic stewardship is a critical issue which we all have a responsibility to embrace and drive forward. This partnership is ideal, combining our expertise in molecular laboratory diagnostics with Bosch’s cutting-edge engineering. The Vivalytic is a game-changer for clinicians and patients: never before has there been this level of accessibility to this range of molecular diagnostics.”
Marc Meier, General Manager of Bosch Healthcare Solutions, a wholly owned subsidiary of Bosch Group, said:
“We are enthusiastic about having gained Randox as the first partner on our platform with two initial panels available from the start. It´s the beginning of jointly expanding the Vivalytic test portfolio for our clients. In this partnership the core competencies of Bosch in automation, miniaturization, and networking are complemented by Randox’s expertise in developing and commercializing innovative diagnostic solutions.”
Vivalytic and the panels will be presented to industry professionals for the first time at the ECCMID 2018 Congress in Madrid, Spain, in hall 10, booth 55A between 21st – 24th April.
*CE pending and FDA planned.
For further information about the Vivalytic, please contact randoxpr@randox.com
