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.Ā
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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 aurisĀ 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)Ā 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. āConsidering 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,ā 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.
āCandida aurisĀ 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,Ā deputy head of the WĆ¼rzburg 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: āThe 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.ā
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 ā 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. Alzheimerās 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.Ā 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 ā 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 Ā£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. Ā Through our Randox Ā Alzheimer’s Disease Array which can be used for Rapid Identification of Alzheimerās Disease Risk. Randoxās Alzheimerās 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 Alzheimerās Array please emailĀ info@randoxbiosciences.com
Randox Biosciences Resource Hub
BioReagents
BioReagents
Randox Biosciences have been a world-leading primary manufacture of high quality Bioreagents including 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.
Features & Benefits
- Unique and novel products including designer drugs, mycotoxins, and oncology markers.
Highly experienced in developing antibodies to difficult targets (i.e. small molecules and novel biomarkers).
40 years’ experience in raw material manufacture and assay development.
Using sheep as a host species, our antibodies have higher sensitivity and specificity than others in the market.
All products manufactured at our ISO 13485 accredited UK manufacturing plant.
Meeting Your Precise Requirements
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
Randox Clinical Laboratory Services
Randox Clinical Laboratory Services
Randox Clinical Laboratory Services (RCLS) specialises in offering esoteric biomarker testing utilising the expertise and knowledge Randox has built over 40 years producing high quality IVD diagnostics. RCLS strives to provide a clinical laboratory service to meet the time sensitive, bespoke requirements of research and clinical trial projects globally.
By utilising Randox Clinical Laboratory Services you can save your laboratory time and money. Our multiplex panels offer a cost effective, labour saving and time reducing solution for your sample testing. As a result, we provide your laboratory with the best solution for your sample testing.
Clinical laboratories traditionally perform diagnostic testing from a variety of patient samples (whole blood, serum, plasma, saliva, sputum, CSF, swab collections) to determine their health status.
In addition to Diagnostics, Randox Laboratories also perform Biomarker analysis from selected patient cohorts in support of pharma research, aiming at discovering a biological signal related to an NDE’s activity (targeted Biomarker approach) or a novel druggable target (proteomic analysis). Randox Biosciences offer multiple technical solutions to address the above, mostly based on the Randox proprietary Biochip Array Technology.
Why RCLS?
Sample and Data Management
- LIMS system (Labware) utilised and connected throughout the lab
- Customer and project specific folders on an internal secure server
- Ability to transfer data securely through secure email/drop box
Capabilities
Randox Biosciences provide the building blocks of diagnostic development which includes antibodies, corresponding conjugates and proteins. Our immunoassay product offering provides diagnostic solutions covering a variety of disease areas including thyroid, reproduction, cardiovascular and renal.
Biochip Technology from Randox is an innovative assay technology which utilises multiplex testing methodology in a rapid, accurate and easy-to-use format, catering both molecular and immunoassay testing. The technology works by combining a panel of related assays in a single biochip with a single set of reagents, controls and calibrators. Only one single undivided sample is used. The results are read by a CCD-camera and custom image-processing software.
Custom Assay Development
Serving the diagnostic, pharmaceutical, contract research and biotech industries, Randox Biosciences dedicated custom unit develops and manufactures custom assay solutions. This also includes full customised quality control sera and calibrators. A selection of over 320 pre-qualified biomarkers is available for a custom panel design. However, any specific biomarker of interest will be considered for integration into an existing or desired panel, for technical feasibility (concentration range compatibility, potential interferences/cross-reactivities). The number of the required novel biomarkers will help make the feasibility study as a pertinent and complete as possible.
Companion Diagnostics (CDx) are part of the services that Randox Biosciences supply to pharmaceutical companies. With a long-recognized expertise in the development of esoteric assays, and more than 500 IVD products available globally, Randox is a partner of choice to support your CDx needs.
Full Assay Menu
| Acute Kidney Injury | |||
| Clusterin | Cystatin C | Kidney Injury Molecule-I | Lipocalin |
| Adhesion Molecules | |||
| E-Selectin | Intercellular Adhesion Molecule-I | L-selectin | P-selectin |
| Vascular Cell Adhesion Molecule-I | |||
| Anaemia | |||
| Ferritin | |||
| Alzheimers Risk | |||
| ApoE4 | Pan ApoE | ||
| Cerebral | |||
| D-Dimer | Neuron Specific Enolase | Neutrophil Gelatinase-Associated Lipocalin | Soluble Tumour Necrosis Factor Receptor I |
| Chronic Kidney Disease | |||
| C3a Des Arg | C-Reactive Protein | Cystatin C | D-Dimer |
| Epidermal Growth Factor | Fatty Acid-Binding Protein I | Interlukin-8 | Macrophage Inflammatory Protein-1α |
| Neutrophil Gelatinase-Associated Lipocalin | Soluble Tumour Necrosis Factor Receptor I | Soluble Tumour Necrosis Factor Receptor II | |
| Covid-19 | |||
| SARS-CoV-2 Antigen | Receptor Binding Domain | Nucleocapsid | |
| Cytokines | |||
| Granulocyte-Macrophage Colony Stimulating Factor | Interleukin-1α | Interleukin-1ϐ | Interleukin - 2 |
| Interleukin - 3 | Interleukin - 4 | Interleukin - 5 | Interleukin - 6 |
| Interleukin - 7 | Interleukin - 8 | Interleukin - 10 | Interleukin - 12p70 |
| Interleukin - 13 | Interleukin - 15 | Interleukin - 23 | Interferon Gamma |
| Human EGF | Monocyte Chemotactic Protein | Macrophage Inflammatory Protein-1α | Matrix Metalloproteinase-9 |
| Soluble IL-2 Receptor α | Soluble IL-6 Receptor | Soluble Tumour Necrosis Factor Receptor I | Soluble Tumour Necrosis Factor Receptor II |
| Tumour Necrosis Factor Alpha | Vascular Endothelial Growth Factor |
| Epidermal Growth Factor (EGF) | |||
| Amphiregulin (AREG) | Herapin-Binding EGF-like Growth Factor (HBEGF) | Transforming Growth Factor - Alpha (TGF-α) | |
| Gastrointestinal | |||
| Gastrin 17 | Helicobacter Pylori | Pepsinogen I | Pepsinogen II |
| Immunodeficiency | |||
| Interleukin - 17A | Interleukin - 17F | Interleukin - 22 | Interleukin - 17 |
| Metabolic | |||
| Ferritin | Interleukin - 6 | Insulin | Adiponectin |
| C-Reactive Protein | Cystatin C | Leptin | Parathyroid Hormone |
| Plasminogen Activator Inhibitor-I | PTH | Resistin | Tumour Necrosis Factor α |
| Pancreatic Cancer | |||
| Cancer Antigen 19-9 - CA19-9 | Carcinoembryonic Antigen | Alpha-I-Acid Glycoprotein | |
| Stroke | |||
| Brain-Derived Neurotrophic Factor - BDNF | D-Dimer | Glial Fibrillary Acidic Protein - GFAP | Glutathione S - Transferase Pi - GSTPi |
| Heart-Type Fatty Acid-Binding Protein - FABP3 | Interleukin-6 - IL-6 | Nucleoside Diphosphate Kinase - NDKA | Neuron Specific Enolase - NSE |
| Parkinson Protein 7 - PARK-7 | Soluble Tumour Necrosis Factor Receptor I - sTNFRI |
| Thyroid | |||
| Anti-Thyroglobulin (TgAb) | Anti-Thyroid Peroxidase Antibody (TPOAb) | Thyroxine Binding Globulin (TBG) | Total Thyroxine (TT4) |
| Total Tri-Iodothyronine (TT3) | |||
| Tissue Damage | |||
| Adipose Fatty Acid Binding Protein - FABP4 | Brain Fatty Acid Binding Protein - FABP7 | Epidermal Fatty Acid Binding Protein - FABP5 | Heart-Type Fatty Acid-Binding Protein - FABP3 |
| Ileal Fatty Acid Binding Protein - FABP6 | Liver Fatty Acid Binding Protein-I - FABPI | Testis Fatty Acid Binding Protein - FABP9 |
| CARDIAC RISK PREDICTION | |||
| Target | SNP | Target | SNP |
| MIA3* | rs17465637 | LPA* | rs3798220 |
| 9p21 | rs10757274 | LPA* | rs10455872 |
| DAB2IP | rs7025486 | MRAS* | rs9818870 |
| CXCL12 | rs1746048 | LPL* | rs328 |
| ACE | rs4341 | LPL | rs1801177 |
| NOS3 | rs1799983 | SORT1*+ | rs646776+ |
| APOA5 | rs662799 | PCSK9 | rs11591147 |
| SMAD3 | rs17228212 | APOE* | rs429358 |
| APOB* | rs1042031 | APOE* | rs7412 |
| CETP | rs708272 | ||
| CHRONIC LUNG DISEASE (CLD) ARRAY | |||
| Viral | |||
| Adenovirus | Metapneumovirus | Respiratory syncytial virus A | Respiratory syncytial virus B |
| Rhinovirus A/B/C | Influenza virus A | Influenza virus B | |
| Bacterial | |||
| Achromobacter xylosoxidans | Bordetella pertussis | Burkholderia cepacia complex (21spp) | Burkholderia cenocepacia |
| Chlamydia pneumoniae | Haemophilus influenza | Moraxella catarrhalis | Mycoplasma pneumoniae |
| Non-tuberculous mycobacterium (15 spp) | Mycobacterium avium complex (4 spp) | Pandoraea species (5 spp) | Prevotella species (16 spp) |
| Pseudomonas aeruginosa | Staphylococcus aureus | Stenotrophomonas maltophilia | Streptococcus pneumoniae (21 spp) |
| Streptococcus species (19 spp) | Veillonella species (3 spp) | ||
| Fungal | |||
| Aspergillus fumigatus | Candida albicans | Exophialia dermatitidis | Scedosporium species (7 spp) |
| Antibiotic Resistance Markers | |||
| mecA (incl MRSA) |
| FAMILIAL HYPERCHOLESTEROLEMIA | |||
| LDLR 38 mutations | APOB 1 mutation | PCSK9 1 mutation | |
| APOB | PCSK9 | ||
| Mutation | Protein | Mutation | Protein |
| c.10580G>A | p.(Arg3527Gln) | c.1120G>T | p.(Asp374Tyr) |
| LDR | |||
| Mutation | Protein | Mutation | Protein |
| c.2292delA | p.(Ile764Metfs*2) | c.1187-10G>A | p.(=) |
| c.1444G>A | p.(Asp482Asn) | c.1048C>T | p.(Arg350*) |
| c.551G>A | p.(Cys184Tyr) | c.118delA | p.(Ile40Serfs*166) |
| c.1845+11C>G | p.(=) | c.1168A>T | p.(Lys390*) |
| c.693C>A | p.(Cys231*) | c.232C>T | p.(Arg78Cys) |
| c.933delA | p.(Glu312Serfs*58) | c.1587-1G>A | p.(=) |
| c.301G>A | p.(Glu101Lys) | c.1706-10G>A | p.(=) |
| c.313+1G>A | p.(=) | c.1796T>C | p.(Leu599Ser) |
| c.1706-1G>A | p.(=) | c.1436T>C | p.(Leu479Pro) |
| c.1706-1G>A | p.(Cys677Arg) | c.1474G>A | p.(Asp492Asn) |
| c.2029T>C | p.(Pro685Leu) | c.501C>A | p.(Cys167*) |
| c.2054C>T | p.(Trp483Arg) | c.662A>G | p.(Asp221Giy) |
| c.1447T>C | p.(Gly478Arg) | c.682G>T | p.(Glu228*) |
| c.1447T>C | p.(Asp72Thrfs*134) | c.1150C>T | p.(Gln384*) |
| c.214delG | p.(Trp87Gly) | c.938G>A | p.(Cys313Tyr) |
| c.259T>G | p.(Arg633Cys) | c.136T>G | p.(Cys46Gly) |
| c.1897C>T | p.(Asp227Glu) | c.2042G>C | p.(Cys681Ser) |
| c.681C>G | p.(Asn688Glnfs*29) | c.1618G>A | p.(Ala540Thr) |
| c.1285G>A | p.(Val429Met) | c.680_681delAC | p.(Asp227Glyfs*12) |
| KRAS, BRAF, PIK3CA ARRAY | |||
| KRAS Gene Targets | |||
| G12A | G12R | G12D | G12C |
| G12S | G12V | G13D | G13C |
| G13R | Q61K | Q61L | Q61R |
| Q61H(1) | Q61H(2) | A146T | A146P |
| BRAF Gene Targets | |||
| V600EG12R | |||
| PIK3CA Gene Targets | |||
| E542K | E545K | H1047R | |
| RESPIRATORY MULTIPLEX ARRAY II | |||
| Viral | |||
| Influenza A | Influenza B | Adenovirus A/B/C/D/E | Bocavirus 1/2/3 |
| Coronavirus 229E/NL63 | Coronavirus OC43/HKUI | Enterovirus A/B/C | Metapneumovirus |
| Parainfluenza virus 1 | Parainfluenza virus 2 | Parainfluenza virus 3 | Parainfluenza virus 4 |
| Respiratory syncytial virus A/B | Rhinovirus A/B/C | ||
| Bacterial | |||
| Legionella pneumophila | Bordetella pertussis | Chlamydophila pneumoniae | Haemophilus influenzae |
| Moraxella catarrhalis | Mycoplasma pneumoniae | Streptococcus pneumoniae |
| SEXUALLY TRANSMITTED INFECTION (STI) ARRAY | |||
| Pathogens | |||
| Chlamydia trachomatis (CT) | Neisseria gonorrhoea (NG) | Trichomonas vanginalis (TV) | Mycoplasma genitalium (MG) |
| Treponema pallidum (Syphilis) (TP) | Herpes simplex virus 1 (HSV-1) | Herpes simplex virus 2 (HSV-2) | Haemophilus ducreyi (HD) |
| Mycoplasma hominis (MH) | Ureaplasma urealyticum (UU) | ||
| URINARY TRACT INFECTION (UTI) ARRAY | |||
| Bacterial | |||
| Acinetobacter baumannii | Citrobacter freundii | Citrobacter koseri | Klebsiella aerogenes |
| Enterobacter cloacae | Enterococcus faecalis | Enterococcus faecium | Escherichia coli |
| Klebsiella oxytoca | Klebsiella pneumoniae | Morganella morganii | Proteus spp. |
| Pseudomonas aeruginosa | Providencia rettgeri | Providencia stuartii | Serratia marcescens |
| Staphylococcus aureus | Staphylococcus epidermidis | Staphylococcus saprophyticus | Streptococcus agalactiae (GBS) |
| Fungal | |||
| Candida albicans | |||
| Antibiotic Resistance Markers | |||
| mecA (incl MRSA) | Trimethoprim Resistance 1 | Trimethoprim Resistance 2 | Trimethoprim Resistance 3 |
| S mecA (incl MRSA) | Trimethoprim Resistance 4 | Trimethoprim Resistance 5 | Van A (Vancomycin Resistance A) |
| Van B (Vancomycin Resistance B) |
Related Services
CDx & BioPharma Services
CDx & BIOPHARMA SERVICES
Offering a collaborative CDx partnership approach.
As an established IVD company, Randox Biosciences offers tailored development and testing solutions to support faster, more effective and safer development of new drugs.
We have a wide range of in-house capabilities, ranging from the selection and patenting of novel biomarkers; manufacture of bioreagents; production of single and multiplex RUO and IVD grade tests; quality control; provision of clinical laboratory services; regulatory expertise and worldwide distribution.
Why Partner with Randox?
Pharmaceutical and biotech companies are increasingly investing in the research and development of new therapies to address the world’s growing need for earlier and more effective patient treatment.
Randox Biosciences is dedicated to the improvement of personalised diagnostic, prognostic, and predictive assays. We aim to help Pharma Biotechs and CROs move away from a “one treatment fits all” approach and help get a better understanding of the complexity and variability of diseases and increase efficacy of treatment. A key element to realizing the potential for personalized medicine is companion diagnostic (CDx) development. Randox have key expertise in all elements of CDx and diagnostic development and offer a fully flexible partnership to accommodate your needs, providing you with tailored protein & molecular assays.
Randox Biosciences can be your CDx and biomarker assay development partner from early phase trials through to drug launch, addressing all assay requirements in the process, including development of raw materials and assays, verification and validation studies, clinical trial sample analysis, regulatory submissions and co-commercialisation.
Complete CDx Partner Approach
CDx Assay Formats
Randox Biosciences is focused on advancing precision medicine through high quality, flexible assay development. We can offer the full package of Diagnostic and CDx assay development with a range of technologies and platforms for use in clinical trials.
We invite researchers to design their specific multiplex custom array, containing selected biomarkers, ensuring maximum output from a limited sample supply. Our proprietary multiplex biochip array technology can be used in early exploratory biomarker stages and can be brought through to IVD/CDx grade.
CDx Drug and Diagnostic Development Process
Development of Raw Materials
- Extensive portfolio of over 900 products for R&D applications
- Products manufactured under ISO13485 accreditation including mAbs, PAS, HRPs, sdAbs, scFvs
- Capable of custom antibody and protein development
Assay Development
- Randox offer a range of technologies and platforms for use in clinical trials
- Our Biochip technology can be used in early exploratory biomarker stages and brought through to IVD/ CDx grade.
- Comprehensive OEM capabilities for developing assays on any platform.
- Assays developed under full design control and ISO13485 accreditation
Sample Testing
- ISO17025, ISO15189 and GCP accredited laboratories located throughout the UK, Ireland and USA.
- Randox Clinical Laboratory Services (RCLS) can be used to meet bespoke sample analysis needs.
- Strong global network with 3rd party laboratories to ensure clinical trial requirements are met across the world.
Verification & Validation
- Performance of in depth multi lot verifications following CLSI guidelines to ensure full performance requirements are met
- Provide support for regulatory submissions and approvals
- Validation of assay performance and reproducibility across multiple sites
Regulatory Submission
- Experienced in-house regulatory teams provide FULL regulatory support preparing IVD/ CDx submissions and applications for approval.
- Regulatory and Development teams work closely in collaboration with the pharma partner to ensure a timely submission while keeping in line with country specific requirements
- 954 licences across the globe and over 3800 licensed products
Commercialization
- Pre and Post launch support with laboratory, clinician, patient and KOL engagement.
- Strong global laboratory and distribution networks, in house sales and marketing teams, with operations in over 145 countries.
- Capable of manufacturing customised sample collection kits under full design control
Randox Platforms
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
RESEARCH
BIOPHARMA
CLINICAL LAB
BIOREAGENTS
Alzheimerās 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/
RESEARCH
BIOPHARMA
CLINICAL LAB
BIOREAGENTS
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:
RESEARCH
BIOPHARMA
CLINICAL LAB
BIOREAGENTS
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