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
Dementia Action Week 2024
Dementia Action Week 2024 (13th – 20th May)
The term Dementia describes the different brain disorders that trigger a loss of brain function. These conditions are all usually progressive and eventually severe. Alzheimer’s Disease is the most common type of dementia, affecting 62 per cent of all those diagnosed.
Dementia is a general term for loss of memory, language, problem-solving and other thinking abilities that are severe enough to interfere with daily life. Common symptoms include memory loss, confusion, and speech problems. Early warning signs may also include finding it difficult to follow conversations, or programs on TV, forgetting names of friends, or everyday objects and feeling confused even in a familiar environment.
Mainly affecting older people, after the age of 65, the likelihood of developing dementia roughly doubles every five years – however, for some dementia can develop earlier, presenting different issues for the person affected, their carer and their family. There is also a considerable economic cost associated with the disease estimated at £23 billion a year, which is predicted to triple by 2040. This is more than the cost of cancer, heart disease, and stroke.
At Randox, we recognise the importance in diagnosing dementia early. Through our Randox Alzheimer’s Disease Array which can be used for Rapid Identification of Alzheimer’s Disease Risk. Randox’s Alzheimer’s Disease Risk Array can be used for the direct determination of ApoE4 status from plasma, eliminating the need for genetic testing, assisting in clinical research and personalised medicine strategies. At Randox, we believe the importance of measuring ApoE4 protein expression in plasma is the way forward to screen those individuals at increased risk of Alzheimer Disease, as new beta amyloid-targeting therapies for this condition are being expected.
Race Against Dementia have been the partner charity for the Randox Grand National Festival over the past two years, working alongside this charity which was founded by three-times Formula One World Champion, Sir Jackie Stewart, with the aim of funding much needed pioneering research into the prevention and cure of dementia.
For further information about the Randox Alzheimer’s Array please email info@randoxbiosciences.com
Randox Biosciences Resource Hub
BioReagents
BioReagents
Randox Biosciences have been a world-leading primary manufacture of high quality antibodies, proteins and conjugates for over 40 years.
With an extensive portfolio of over 900 high quality monoclonal and polyclonal antibodies, antibody fragments including sdAb’s, scFv’s and fAb’s, human recombinant proteins and conjugates, allow us to successfully assist with any new product development, research and partnership needs.
Our team of scientists possess unrivaled expertise which enables us to provide you with a comprehensive suite of products and services dedicated to advancing biopharmaceutical research and diagnostics. A custom development service is also available.
From initial cultivation of raw materials for assay development, through to providing companion diagnostics, custom and molecular based assays across a range of therapeutic areas; Randox BioReagents is a trusted partner supplying quality diagnostic solutions to the clinical, life science, pharmaceutical, research and biopharma industries.
We take pride in our development and quality, which reflect the components used in-house in the product of Randox diagnostics and research. With many unique and novel solutions for a wide range of applications, our standards not only meet unmet market needs but the ability to offer a world-class service meeting all customer requirements including custom developments upon request, in a wide range of pack sizes, producing excellent reproducibility, higher sensitivity and specificity for a multitude of projects.
Our Range of BioReagents
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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Alzheimer’s Disease Month at Randox Biosciences
15 September 2020
Alzheimer’s Risk Array from Randox Biosciences
September 2020 marks the 9th World Alzheimer’s Month
World Alzheimer’s Month is the international campaign every September to raise awareness and challenge the stigma that surrounds dementia. Alzheimer’s Disease is a progressive neurodegenerative disease associated with cognitive decline and is the most common form of dementia. It is defined as an irreversible, progressive brain disorder in which parts of the brain are damaged over time.
According to Alzheimer’s Disease International dementia affects people differently – no two people will experience symptoms in exactly the same way. A person’s personality, general health and social situation are all important factors in determining the impact of dementia on an individual. The most common signs are memory loss, the loss of practical abilities, problems with language, changes in mood and behaviour, and withdrawal from work or social activities.1
Who is affected?
- There are currently around 850,000 people with dementia in the UK. This is projected to rise to 1.6 million by 2040.2
- 209,600 will develop dementia this year, that’s one every three minutes.2
- 1 in 6 people over the age of 80 have dementia.2
- 70% of people in care homes have dementia or severe memory problems.2
- There are over 42,000 people under 65 with dementia in the UK.2
The Randox Alzheimer’s Risk Array is a rapid and highly sensitive blood test facilitating direct Apo E genotyping without the need for molecular testing. Apo E is present in three common isoforms; Apo E2, Apo E3 and Apo E4. Alzheimer’s Disease risk is increased in individuals with the Apo E4 allele.
Apolipoprotein E (ApoE) is a major cholesterol carrier that supports lipid transport and injury repair in the brain. ApoE polymorphic alleles are the main genetic determinants of Alzheimer Disease risk. Presence of ApoE4 allele is associated with increased risk for cerebral amyloid angiopathy and age-related cognitive decline during normal ageing.3
Apo E4 is one of three common isoforms of Apo E and is recognised as a major genetic risk factor the development of Alzheimer’s disease. Apo E4 triggers inflammatory cascades that cause neurovascular dysfunction, including blood-brain barrier breakdown, leakage of blood-derived toxic proteins into the brain and reduction in the length of small vessels.
Utilising revolutionary patented Biochip Technology, the Randox Alzheimer’s Risk Array provides a unique solution for the measurement of both total apoE and the apo E4 isoform levels from a single patient sample, facilitating the fast and accurate classification of Alzheimer’s disease risk in comparison to brain scanning (CT and MRI).
Key Benefits of Alzheimer’s Risk Array
- 2-plex testing from a single sample
- Assist in research and development of potential treatment
- Early risk detection of disease
- Small sample volume
- Fast throughput
Biochip Technology
Biochip Technology is an immunoassay testing platform and is the core of Randox Biosciences. The intelligent chemically activated 9x9mm ceramic biochip acts as a solid phase reaction vessel. Benefits of Biochip Technology include:
- The biochips are pre-fabricated with discrete test regions (DTR’s)
- Highly accurate testing
- Better diagnosis
- Reduced sample volume
- Wide test menu
- Multiple sample types can be used on a Biochip
- Cost consolidation
Evidence Investigator
The Evidence Investigator offers a high throughput even as a compact, semi-automated analyser promoting lab efficiency and cost saving solutions. Utilising Randox’s patented Biochip Technology, this platform facilitates multiplex testing in a rapid, accurate and easy-to-use format providing a comprehensive patient profile from one single sample. This analyser is suitable for medium throughput laboratories and is extremely robust with only one moving part.
For further information on our early risk detection testing for Alzheimer’s Disease, please email info@randoxbiosciences.com
References
- https://www.alz.co.uk/info/early-symptoms
- https://www.alzheimers.org.uk/about-us/news-and-media/facts-media
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3898682/
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Cerebral Array II from Randox Biosciences
13 August 2020
Cerebral Array II from Randox Biosciences
Randox Biosciences’ Cerebral Array II has been designed for the simultaneous measurement of analytes associated with nervous system dysfunctions such as Alzheimer’s disease and multiple sclerosis. The array harnesses multiplex testing measuring up to five biomarkers simultaneously using a single patient sample with a turnaround time of 2.5 hours. It is suitable for human serum, plasma and cerebrospinal fluid (CSF) samples. Our Cerebral Array II offers excellent sensitivity, precision and recovery as well as analytical performance.
Cerebral Array II
- C-Reactive Protein (CRP)
- D-Dimer
- Neuron Specific Enolase (NSE)
- Neutrophil Gelatinase-Associated Lipocalin (NGAL)
- Soluble Tumour Necrosis Factor Receptor I (sTNFRI)
Key Benefits of Cerebral Array II
- Multiplex testing from a single sample
- Suitable for human serum, plasma and cerebrospinal fluid (CSF) samples
- Small sample volume
- Excellent analytical performance
- Fast throughput
- Applicable to fully automated and semi-automated Evidence platforms
Your central nervous system is your body’s control centre which includes the spinal cord and a large network of nerves and neurons. Together, the nervous system controls everything from your senses to the muscles throughout your body. When this is damaged, triggered by an illness or injury it can disturb many functions including memory, sensation and even a person’s personality.1 Up to 1 billion people (1 in 6 of the world’s population) suffer from neurological disorders from Alzheimer and Parkinson Disease, strokes, multiple sclerosis and epilepsy.2
World Health Organisation (WHO) categorizes neurological disorders in two groups which is shown in the table below3. Group one is classified as neurological disorders in neuropsychiatry which are non-communicable diseases (NCD). NCD is a disease that is not transmissible directly from one person to another. Group two are disorders/injuries with neurological sequelae meaning a pathological condition resulting from a prior disease, injury, or attack.
| GROUP ONE | GROUP TWO |
| Epilepsy | Cerebrovascular disease |
| Alzheimer and Other Dementias | Neuroinfectious |
| Parkinson’s Disease | Nutritional deficiencies and neuropathies |
| Multiple Sclerosis | Neurological injuries |
| Migraine |
Randox Biosciences can assist in cerebrovascular research by providing innovative diagnostic technology and tests that will continue to revolutionise the healthcare industry and assist in academic research. This technology includes our Evidence Investigator and our Cerebral Array II which can be used to assist in the discovery and research of Cerebral diseases.
Biochip Technology
Biochip Technology is an immunoassay testing platform and is the core of Randox Biosciences. The intelligent chemically activated 9x9mm ceramic biochip acts as a solid phase reaction vessel. Benefits of Biochip Technology include:
- The biochips are pre-fabricated with discrete test regions (DTR’s)
- Highly accurate testing
- Better diagnosis
- Reduced sample volume
- Wide test menu
- Multiple sample types can be used on a Biochip
- Cost consolidation
Evidence Investigator
The Evidence Investigator offers a high throughput even as a compact, semi-automated analyser promoting lab efficiency and cost saving solutions. Utilising Randox’s patented Biochip Technology, this platform facilitates multiplex testing in a rapid, accurate and easy-to-use format providing a comprehensive patient profile from one single sample. This analyser is suitable for medium throughput laboratories and is extremely robust with only one moving part.
For further information on our Cerebral Array please visit the Randox Biosciences website.
For any other enquiries please email info@randoxbiosciences.com
References:
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Early Detection of Acute Kidney Injury in COVID-19 patients
15 July 2020
The Importance of Early Detection of Acute Kidney Injury in COVID-19 patients
Randox are proud to provide an early detection assay, capable of detecting Acute Kidney Injury in COVID-19 positive patients. AKI is an innovative diagnostic tool with the ability to identify four early and highly sensitive markers of kidney injury.
The National Institute for Health and Care Excellence has highlighted that is important that COVID-19 patients are assessed for AKI on admission to hospital or transfer, monitored for AKI throughout their stay and that AKI is managed appropriately if it develops. (NICE, 2020)
The novel test, which includes biomarkers recommended by the U.S. Food and Drug Administration and the European Medicines Agency detects KIM-I, NGAL, Cystatin C, and Clusterin.
Kidney failure associated with COVID-19 is emerging as a common side effect with further studies underway. Early detection to prevent further renal damage, is vital for an individual’s long-term health, wellbeing and overall survival.
The biomarkers on the Randox AKI Biochip have been identified as more sensitive than traditional testing methods, which, based on urine output and levels of serum creatinine, are grossly insensitive and not specific for the accurate diagnosis and monitoring of AKI.
The Randox AKI assay provides results in 2.5 hours. The new testing panel also facilitates increased lab efficiency and reduced sample prep from the laboratory technician. Using just one urine sample, Randox’s patented Biochip Technology tests for all four AKI biomarkers simultaneously, resulting in time and cost saving benefits, which drive towards an increase in clinical performance.
For further information on our Acute Kidney Injury Array please visit the Randox Biosciences website.
For any other enquiries please email info@randoxbiosciences.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
