New UK-developed test can help predict who will develop type 1 diabetes and unlock treatment
New UK-developed test can help predict who will develop type 1 diabetes and unlock treatment
- New drugs are emerging for type 1 diabetes (T1D), but they can only be given before a person has a clinical diagnosis
- Now countries across the world are looking at introducing the first global screening programmes to identify who is at high risk of developing the disease, to prescribe before it is too late
- A new biochip by Randox, developed with the University of Exeter, is the first in the world to use genetics to quickly identify who is at high risk of developing T1D, filtering who should go forward for further testing and accelerating access to treatment where needed.
A new test that uses genetics to help predict who is at high risk of developing type 1 diabetes is now publicly available for the first time, following research that aims to help people across the globe access new drugs that can modify the disease.
The test could help develop new screening programmes for type 1 diabetes, as new drugs emerge which must be prescribed at early stages to be effective. The new test will also help determine type 1 from type 2 diabetes, further improving clinical decision making and treatment.
The test, developed by UK diagnostics company Randox using research from the University of Exeter, could help introduce public health screening in the UK and across the world, supporting those with a high genetic risk of developing type 1 diabetes. Now, the test has received UK regulatory approval – the first such approval issued globally. This means it will be available to consumers in the UK, through Randox Health clinics, and can be ordered online for sample collection at home and returned to Randox’s laboratories for testing.
Type 1 diabetes has a significant inherited risk. The new test is conducted on a Randox biochip which can simultaneously identify up to 10 genetic variants linked to risk for type 1 diabetes. An algorithm is then applied to assess the risk associated with the identified variants for each individual, to calculate a genetic risk score. Previous trials have shown that genetic risk scores are particularly effective in predicting risk for type 1 diabetes. This score will help identify people who don’t have diabetes but are at high risk of developing the disease in the future and can be referred for autoantibody testing to give a definitive diagnosis. The Randox biochip can also be used after diagnosis, to help identify what type of diabetes a person has, which is crucial to ensuring they get the best possible treatment and care.
Identifying those at high risk is particularly topical, as new drugs emerge that can reduce the impact of type 1 diabetes – and they can only be given at the earliest stages, before a clinical diagnosis is given. In November 2022, the US Food and Drug Administration (FDA) approved the use of teplizumab – the first disease-modifying treatment for type 1 diabetes. It can only be prescribed pre diagnosis, yet there is currently no screening programme anywhere in the world to identify early pre-clinical type 1 diabetes. The drug is not yet approved for use in the UK, however, health services globally are now considering how best to introduce public health screening programmes. Diabetes clinician Professor Richard Oram, of the University of Exeter, developed the genetic risk score based on a decade of research, and has worked with Randox on developing the new biochip. He said: “The world is waking up to the value of screening programmes for type 1 diabetes because of new drugs which must be given at the earliest stages of disease. Our new biochip is a pioneering example of how understanding a person’s background genetic risk can help identify those at highest risk, ensuring they have further antibody screening so we can efficiently identify type 1 diabetes early enough for treatment to be effective. The Randox biochip could aid in speeding up decisions
around who should be monitored and tested further, making public health screening cost effective and improving lives by increasing access to treatment.”
Type 1 diabetes affects more than eight million people worldwide, and numbers are projected to rise significantly. The disease causes the body’s own immune system to attack the beta cells which regulate blood sugar. Although the disease is primarily caused by genetics, only around one in ten people with type 1 diabetes have a family member affected, making the other nine in ten difficult to identify. Currently, they are often referred for autoantibody tests when symptoms start to show – but that can be too late to mean they are eligible for treatment.
The new fingernail-sized biochip works by applying DNA extracted from a patient’s blood sample to the biochip surface, upon which copies of the high-risk type 1 diabetes genetic variants are fixed. If a match occurs, the patient’s DNA will bind to the fixed risk variants and emit light. The pattern of positive genetic variants indicates genetic risk and an algorithm is then applied, factoring the significance of each gene variant. The higher the genetic score, the greater the risk that the individual will develop the disease. Those at high risk can then be monitored and put forward for autoantibody screening, while those at low risk need not be screened, which saves money.
Dr Lucy Chambers, Head of Research Communications at Diabetes UK, said: “We’re delighted to see that research supported by Diabetes UK has informed the development of an innovative new tool to find people at high risk of type 1 diabetes. New treatments to prevent or delay type 1 are on the horizon, and their success hinges on establishing effective screening methods to pinpoint those at higher risk. We are continuing to fund research into type 1 screening and are pleased to see new innovations that have the potential to improve lives.”
Hilary Nathan, Director of Policy and Communications at JDRF UK: “For too long, type 1 diabetes has lain silent and undetected to subsequently devastate lives and cause chaos from the first days of diagnosis. This new biochip from Randox and the University of Exeter is exciting, as the test could provide a new way to predict who is at risk from developing type 1. This knowledge then unlocks the opportunity to provide education and intervene at the earliest stages, enabling us to reduce the number of people being diagnosed with diabetic ketoacidosis, which can have traumatic and potentially fatal consequences. We are also on the cusp of a wave of transformative treatments, which can delay the onset of type 1, offering people invaluable years of life free from its burdens.”
Dr Peter FitzGerald MD of Randox said: “We’re delighted to have worked with the University of Exeter on this project to provide a screening tool to assess the genetic risk of type 1 diabetes which, aligned with autoantibody testing, can greatly improve diagnosis, patient care and access to therapeutics. As a result of our regulatory UKCA approval we will, as a world first, be providing this test through our Randox Health clinics, including within certain John Lewis stores, to private individuals in the UK from7th March. We are also releasing the test via a home-based sample self-collection kit. This test is a game-changer in the diagnosis and treatment of type 1 diabetes and we look forward to deploying the test to support public and private healthcare providers globally.”
2 years on…since the development of the Randox COVID-19 Biochip
Wednesday 02 February 2022: 2 years since the Randox COVID-19 Biochip
February 2022 marks 2 years since the development of the Randox COVID-19 Biochip.
In February 2020, based on almost four decades of experience in diagnostic R&D, including the development of a CE marked panel of tests for fifteen respiratory viruses, as well as tests for SARS and MERS, Randox recognised the threat from COVID-19 and quickly developed a test to accurately identify the virus.
And a lot has happened since then…
Randox’s capability was recognised by the UK government and since March 2020 Randox has been contracted to provide COVID-19 testing support to the UK’s Pillar 2 National Testing Programme. The company immediately pivoted to move from a 9-5 business to a 24|7 operation.
Through the enormous effort and commitment of its staff Randox has (at the time of writing) processed more than 23 million gold-standard PCR tests for the National Testing Programme and for international travel – providing a reliable service to enable COVID-safe travel which facilitates personal, family and business engagements and activities during the pandemic.
Demonstrating its commitment to helping people live their lives as easily and normally as possible, and to enhance accessibility to travel testing, the company partnered with major airlines including British Airways, Easyjet, Ryanair, Wizz Air, Cathay Pacific, and Jet2, travel providers such as TUI, and travel agents including the DNATA Travel Group, to provide discounted travel tests. By investing in testing capacity, logistic capabilities, and the introduction of a dedicated Customer Support team, Randox could make greater efficiencies that allowed it to reduce the price of PCR testing and become the most competitive service in the UK and Ireland.
During the 2020 Olympic Games, Randox got Team GB safely to the starting line in Tokyo by providing the Olympians with its premium COVID-19 testing, a service which it also provided for the ParalympicsGB athletes. A number of other sporting organisations opted to make Randox their COVID-19 testing provider of choice for their players and supporting staff, including the Irish Football Association, the US Men’s National Soccer Team, and Premiership Rugby, to ensure a COVID-safe training environment. Using Randox diagnostic technologies, companies like Norbrook Laboratories and Northern Ireland Screen were able to implement a staff screening programme that demonstrated a high standard of duty of care to their employees.
As and when required, Randox rapidly established new customer-focused services catered to the needs of the ever-changing travel testing guidelines. In May 2021, for example, Randox launched a ‘test to return’ service for UK holidaymakers returning home from Portugal and requiring predeparture tests before their return flight. In a first for the industry, passengers were able to take their PCR kit to Portugal and return their sample to one of Randox’s partner labs in the Algarve, before Randox flew the samples back to its labs in the UK for testing.
The company also provides tests for COVID-19 antibodies, as well as lateral flow testing services, where such tests satisfy international travel requirements, and has developed an innovative phone app to securely process and verify customer identification and results in just 15 minutes.
Randox has amongst the very largest laboratories in Europe and since the start of the pandemic has built, equipped and staffed 80,000 sq ft of PCR testing facilities, in Northern Ireland, Manchester and Greater London, and 50,000 sq ft of supporting logistic and engineering space. Randox has opened a number of mobile testing labs as well as almost 30 travel clinics, for COVID-19 testing appointments and over-the-counter home testing kit purchases. Walk-through and drive-through test centres have opened across a number of key airport locations, some in partnership with renowned travel services provider Collinson.
Randox is the only testing provider in the UK within this reporting period to have reported over 100,000 PCR results in a single day. Turnaround times for test results are rigorously monitored to meet the needs of both Government and private customers.
The company has more than doubled its workforce since 2020 and has developed a robust and comprehensive nationwide logistics network for the timely distribution and return of sample collection kits and samples. In collaboration with reputable partners including Morrisons supermarkets, Wells Pharmacies, Roadchef and PayPoint, Randox has established almost 200 PCR sample dropboxes and over 1500 click and collect sites, with the aim of improving customer accessibility and simplifying the process of COVID-19 testing requirements.
By responding rapidly, dynamically and cost-effectively to an ever-changing environment, with updates to travel testing requirements often being made at short notice, Randox has played an important role in managing the effects of the pandemic in both the UK and Ireland, facilitating safe social and economic activity, including international travel.
For further information on Covid testing services please contact the Randox Covid Customer Support team on 028 9434 3005.
For press enquiries please contact Amy Millar in the Randox PR team: randoxpr@randox.com
Want to know more?
Contact us or visit Randox Health.
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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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Familial Hypercholesterolemia
Familial Hypercholesterolemia
–
Rapid & Reliable Genetic Assessment
Genetic Assessment of Patients with Suspected Familial Hypercholesterolemia (FH)
- Early diagnosis of specific mutations reducing morbidity and mortality from premature CVD ensuring better outcomes & therapeutic intervention
- Saving time & costs by reducing the number of traditional clinical & genetic tests
- Combination of multiplex PCR and Biochip to distinguish between multiple wildtype and mutant DNA regions
- Cascade screening can be performed across both FH arrays to further improve diagnosis
- Provides information on the phenotype and prognosis which cannot be identified through traditional lipid level testing
- Suitable for use on the Evidence Investigator, a semi-automated analyser identifying FH in under 3 hours
The Familial Hypercholesterolemia (FH) Arrays I & II are rapid, simple and accurate diagnostic tests which enable simultaneous detection of 40 FH-causing mutations (20 mutations per array) within the low-density lipoprotein receptor (LDLR), apo‑lipoprotein B (ApoB) and proprotein convertase subtilisin/kexin type 9 (PCSK9) genes. Generally, mutations within the LDLR gene are the most common, with a prevalence of 1 in 500. The ApoB gene has a prevalence of 1 in 1000 and the PCSK9 gene less than 1 in 2500.
FH patients have elevated levels of total cholesterol (TC) and LDL-C from birth and, if untreated, develop coronary heart disease (CHD). FH is characterised by twice normal LDL-C levels in early childhood, and early myocardial infarction. A strong positive family history can imply as much as a 12-fold increased risk of early coronary disease.
Randox Familial Hypercholesterolemia Arrays
| ApoB | |
| Mutation | Protein |
| c.10580G>A | p.(Arg3527Gln) |
| LDLR | |
| Mutation | Protein |
| c.2292delA | p.(Ile764Metfs*2) |
| c.1444G>A | p.(Asp482Asn) |
| c.551G>A | p.(Cys184Tyr) |
| c.1845+11C>G | p.(=) |
| c.693C>A | p.(Cys231*) |
| c.933delA | p.(Glu312Serfs*58) |
| c.301G>A | p.(Glu101Lys) |
| c.313+1G>A | p.(=) |
| c.1706-1G>A | p.(=) |
| c.1706-1G>A | p.(Cys677Arg) |
| c.2029T>C | p.(Pro685Leu) |
| c.2054C>T | p.(Trp483Arg) |
| c.1447T>C | p.(Gly478Arg) |
| c.1447T>C | p.(Asp72Thrfs*134) |
| c.214delG | p.(Trp87Gly) |
| c.259T>G | p.(Arg633Cys) |
| c.1897C>T | p.(Asp227Glu) |
| c.681C>G | p.(Asn688Glnfs*29) |
| PCSK9 | |
| Mutation | Protein |
| c.1120G>T | p.(Asp374Tyr) |
| LDLR | |
| Mutation | Protein |
| c.1285G>A | p.(Val429Met) |
| c.680_681delAC | p.(Asp227Glyfs*12) |
| c.1187-10G>A | p.(=) |
| c.1048C>T | p.(Arg350*) |
| c.118delA | p.(Ile40Serfs*166) |
| c.1168A>T | p.(Lys390*) |
| c.232C>T | p.(Arg78Cys) |
| c.1587-1G>A | p.(=) |
| c.1706-10G>A | p.(=) |
| c.1796T>C | p.(Leu599Ser) |
| c.1436T>C | p.(Leu479Pro) |
| c.1474G>A | p.(Asp492Asn) |
| c.501C>A | p.(Cys167*) |
| c.662A>G | p.(Asp221Giy) |
| c.682G>T | p.(Glu228*) |
| c.1150C>T | p.(Gln384*) |
| c.938G>A | p.(Cys313Tyr) |
| c.136T>G | p.(Cys46Gly) |
| c.2042G>C | p.(Cys681Ser) |
| c.1618G>A | p.(Ala540Thr) |
The Evidence Investigator
Meet the Evidence Investigator
The Randox FH arrays has been developed for the Evidence Investigator, a semi-automated benchtop immunoassay analyser.
The FH arrays would provide an early diagnosis of specific mutations, reduce morbidity and mortality from premature CVD ensuring better patient outcomes & therapeutic intervention.
Want to know more?
Contact us or visit our Investigator Webpage
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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Randox Discovery
Randox Discovery | The Benchtop Lab
Discover The Future Of Molecular & Immunoassay Diagnostics
Why Choose the Discovery?
- The Discovery is an exciting and disruptive analyser capable of molecular and immunoassay testing
- Simultaneous detection of hundreds of targets from a single patient sample via patented biochip technology
- Flexible test menu comprising immunoassay and genetic tests for infectious diseases & oncology
- Rapid turnaround time. Three hours to first batch of results with results for subsequent batches every hour after
- Fully automated platform increasing operator walkaway time. A single operator is all that’s required to run up to 3 Discovery analysers
- Simple and easy to use. Intuitive user interface guides the operator through the entire testing process
Discover The Power Of Automation
Randox Discovery is comprised of three interconnected modules which each operate independently performing different aspects of the diagnostic testing process. Each module is separated by a physical barrier to prevent contamination and is accessible via a door. The workflow process runs from right to left and is compatible with lean working principles.
Nucleic Acid Extraction
Module I is responsible for DNA/RNA extraction. After extraction the sample is automatically transferred to Module II. Before transfer, Module I detects the presence of Module II cartridges using a unique vision system.
Multiplex PCR
Module II is responsible for amplification of the extracted nucleic acid by End-Point PCR. UV light is used to sterilise the module and reduce the risk of crossover contamination.
Biochip Hybridisation & Detection
Module III is used in both immunoassay & molecular workflows and is responsible for hybridisation and subsequent detection using patented biochip technology. The detection camera uniquely moves between sample cartridges to detect biochip chemiluminescence.
Discover the Power of Randox Biochip Technology
The Randox Discovery is an exciting and disruptive molecular & immunoassay diagnostic analyser capable of consolidating the normal workload of multiple laboratories, into one compact benchtop platform. Randox patented Biochip Technology allows simultaneous detection of hundreds of targets from a single patient sample. The benefits of multiplexing in this way are endless; allows complete patient profiling, reduces the amount of time spent on individual tests, identifies co-infections, differentiates between pathogens that exhibit similar symptoms and eliminates the need to run multiple time consuming and sample intensive assays. The biochip detection system is based on a chemiluminescent signal, this is the emission of light, without heat, as a result of a chemical reaction.
Discover Our Comprehensive Test Menu
| VIRUSES | ||
| SARS-CoV-2 (COVID-19) | Sarbecovirus (SARS, SARS like, SARS-CoV-2) |
| Detectable Viruses | ||
|---|---|---|
| SARS-CoV-2 (COVID-19) | Sarbecovirus (SARS, SARS like, SARS-CoV-2) | Influenza A |
| Coronavirus 229E/NL63 | Adenovirus A/B/C/D/E | Influenza B |
| Coronavirus OC43/HKUI | Enterovirus A/B/C/D / Rhinovirus A/B/C | Respiratory Syncytial Virus A/B (RSV) |
| Middle East Respiratory Syndrome Coronavirus (MERS-CoV) | Adenovirus A/B/C/D/E | |
*In Development – Respiratory Tract Infections Array, Chronic Lung Infections Array, Sexually Transmitted Infections Array & Urinary Tract Infections Array, KRAS, BRAF & PIK3CA Array, Familial Hypercholesterolemia Array & Cardiac Risk Array.
*In Development – A number of clinical immunoassay arrays covering a range of disease markers including adhesion molecules, alzheimers, anaemia, bone disease, cancer, cardiac, cytokines, diabetes, endocrines, fibrinolysis, fertility, gastrointestinal, metabolic, renal, stroke, thyroid & tissue damage.
*In Development – A number of clinical toxicology arrays are in development covering a wide range of Drugs of Abuse (DoA) & New Psychoactive Substances (NPS) detecting over 500 drug and drug metabolites using innovative Biochip Technology.
Product availability may vary from country to country. Some product may be for Research use Only. For more information on product application and availability, please contact your local Randox Representative.
Discover Randox’s Molecular Platforms
All In One Point Of Care Molecular Platform
Compact, Semi-Automated Benchtop Analyser
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Evidence Investigator
COVID-19 Testing: PCR (Diagnostic) vs Antibody
18 June 2020
COVID-19 Testing: PCR (Diagnostic) vs Antibody
The advice from the World Health Organisation in relation to the COVID-19 pandemic has been simple; Test. Test. Test.
But what are the different types of COVID-19 tests and what are they used for?
Diagnostic (PCR) Testing
This type of testing detects SARS-CoV-2 (the virus that causes COVID-19) within the body and will tell you if you currently have COVID-19. PCR tests cannot tell you if you have had past infection.
Sample collection for a PCR test can vary, though it is usually in the form of a swab, which will gather an individual’s nasopharyngeal (nose and throat) secretions.
PCR tests for COVID-19 all use methods that detect a specific part of the viral genome – for example Viral RNA or Antigen.
A sample is prepared by extracting the chosen section of the genome, and then PCR (Polyamerase Chain Reaction) techniques are used to amplify (replicate) the genome section, ready for detection.
Viral RNA Tests
This type of test detects the RNA (Ribonucleic acid) contained within the SARS-CoV-2 virus.
It is this type of test, for RNA, that is recommended by The World Health Organisation for COVID-19 diagnosis.
Antigen Tests
Antigens are molecular structures on the surface of viruses that are recognized by the immune system and are capable of triggering an immune response.
Antigen tests detect the presence of the SARS-CoV-2 virus by looking for the antigen on the surface of the virus.
Randox COVID-19 Test
The Randox COVID-19 test, as recommended by the World Health Organisation, detects the RNA contained within the SARS-CoV-2 virus.
After sample extraction and amplification, the virus is detected on our patented Randox Biochip Technology platform.
The Randox Biochip, which can run multiple tests simultaneously, performs two tests for COVID-19 – one specific and one confirmatory – as recommended by the WHO. This delivers extra assurance of the correct diagnosis and avoids the need to repeat the test.
Antibody (Serology) Tests
Antibody (also known as serology) tests, are usually performed on a patient blood sample, and look for antibodies (a type of protein) that may have been developed by the patient’s immune system to fight off disease.
If present, antibodies may provide a degree of immunity for the patient against COVID-19 in the future.
However, there is still much unknown about the body’s antibody response to COVID-19, including;
- Whether all patients who have been infected with SARS-CoV-2 will generate antibodies (recent studies and news reports indicate that this isn’t the case. Click here for an example.)
- Whether those who have had more severe symptoms as a result of COVID-19 will produce more antibodies than those who had mild symptoms, or were asymptomatic.
- If antibodies from other coronaviruses previously experienced by the patient may be enough to fight off the virus, therefore eliminating the need for COVID-19 specific antibodies.
- How long any COVID-19 specific antibody response will last for.
- How much future immunity is provided by COVID-19 antibodies. Will it prevent the patient from being infected, or will future infection just be less severe?
If antibodies for the SARS-CoV-2 virus are present this can give an indication that the patient has been previously infected with COVID-19. Antibody tests do not confirm the real-time presence of the virus in your system.
For example, a negative antibody result does not necessarily mean the body has not been exposed to the SARS-CoV-2 virus. It could in fact, be currently infected, but has not yet generated antibodies. A diagnostic test will confirm current presence of the virus.
Therefore, it is recommended that antibody tests are used in tandem with a diagnostic test to determine a complete overview of the patient’s COVID-19 status.
Randox Health currently offers both diagnostic testing and antibody testing for SARS-CoV-2 (COVID-19).
A combination of diagnostic and antibody testing is available for individual purchase, or as part of our ‘Back to Business’ COVID-19 testing service, for staff screening.
Visit Randox Health to find out more.
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COVID-19 Laboratory Tools for Disease Management
17 June 2020
COVID-19 – Laboratory Tools for Disease Management
In addition to tests for the detection of SARS-CoV-2, the virus that causes COVID-19, laboratory diagnostics play a pivotal role in patient management, risk stratification, monitoring of disease progression, associated complications and response to treatment.
Randox offers a comprehensive range of laboratory solutions including; diagnostics reagents, revolutionary Biochip technology and quality control designed to provide clinicians with valuable insights into disease severity ultimately helping to improve patient care.
Patients with comorbidities such as diabetes mellitus, cardiovascular disease (CVD) and chronic kidney disease (CKD) are particularly susceptible to COVID-19 infection and are at greater risk of developing severe illness. The Randox portfolio may also be used to diagnose and monitor such at risk patients with underlying health concerns.
Biochemistry Reagents
Our extensive test menu comprises 113 assays, including many unique tests and a range of biomarkers designed to assist laboratories when screening for a variety of COVID-19 related health issues.
Randox Reagents are internationally recognised as being of the highest quality; producing accurate and precise results. Applications are available detailing instrument-specific settings for the majority of clinical chemistry analysers.
Elevated markers of inflammation and infection such as CRP may indicate severe viral infection. CRP is elevated in up to 86% of COVID-19 patients who are admitted to hospital. Testing for CRP is useful in assessing prognosis, and when monitoring improvement. It is recommended that CRP is measured at baseline and then at intervals, a sudden increase in levels will prompt surveillance for secondary infection or other cause of deterioration.
As an acute phase reactant, Ferritin levels increase in response to inflammation. High levels have been identified in approximately 60% of individuals hospitalised as a result of COVID-19 infection. In critically ill patients, elevated Ferritin levels may be indicative of a cytokine storm and secondary haemophagocytic lymphohistiocytosis, a hyperinflammatory syndrome associated with organ failure.
Liver Function Tests (Albumin, ALT, AST, Bilirubin)
Patients with COVID-19 may be at higher risk of liver injury or impairment of liver function. Liver function markers such as ALT, AST and Bilirubin are notably higher in more severe infections, decreased albumin levels have also been documented in severe cases. Drug induced liver injury as a result of COVID-19 treatment should not be ignored and should be monitored.
Renal Function Tests (Creatinine, Cystatin C)
Emerging evidence suggests that SARS-CoV-2 may directly affect kidney function, as such COVID-19 patients should be assessed for Acute Kidney Injury (AKI) on admission to hospital and monitored throughout their stay. AKI can lead to worse outcomes for patients.
LDH levels may be a convenient marker for the identification of COVID-19 patients at higher risk of developing severe respiratory failure. It is well documented that high LDH levels are indicative of haematological malignancy and acute lung injury. LDH levels might therefore reflect tissue necrosis related to immune hyperactivity and thus are related to poor clinical outcomes in individuals with COVID-19.
Chloroquine has been investigated as a potential treatment for COVID-19, the anti-malaria drug however could have devastating consequences for those with a G6PDH deficiency. G6PDH deficiency is a genetic disorder affecting the red blood cells, causing them to break down prematurely. The most common complication of deficiency is haemolytic anaemia. An estimated 400 million people globally have G6PDH deficiency, it is most common in certain parts of Africa, Asia, the Mediterranean and Middle East.
Randox Biochip Solutions
Randox Biochip technology is extremely versatile with applications in not only the diagnosis of COVID-19 but also the identification of individuals at risk of developing more severe illness.
Unique to Randox, Biochip technology is capable of simultaneous detection of a panel of related disease markers. An extensive range of Biochip panels are available, each optimised to provide the best performance.
Cytokines play a vital role in the immune system and are known to be involved in the body’s response to a variety of inflammatory and infectious diseases. The over stimulation of these cytokines in response to infection is referred to as a ‘cytokine storm’ and strongly correlates with poor disease outcomes. Cytokine storms are a common complication of SARS-CoV-2 infection triggering viral sepsis, where viral replication and excessive, uncontrolled systemic inflammation may lead to pneumonitis, Acute Respiratory Distress Syndrome (ARDS), respiratory failure, shock, multiple organ failure, secondary bacterial pneumonia, and potentially death. Cytokines such as IL-6 appear to be elevated in patients with more severe illness and may be used to monitor response to treatment as levels decrease as the condition improves.
Quality Control Solutions
Randox offer a range of Quality control and External Quality Assessment (EQA) solutions designed to ensure the accuracy and reliability of patient testing.
Decreased blood counts have been frequently identified in COVID-19 patients and may be indicative of a decreased immunological response to the virus, bacterial infection or consumption.
Blood Gas tests are used to help diagnose and monitor critically ill patients in intensive care units (ICU) and emergency departments. Blood Gas testing continues to play a critical role in the management of COVID-19 patients providing an indication of a patient’s oxygenation levels. Monitoring of these levels will enable healthcare professionals to make ventilator adjustments if required.
Increased levels of cardiac markers including Troponin and CK-MB may be associated with a higher mortality rate in COVID-19 patients.
Patients with severe COVID-19 infection are more likely to have coagulopathy, a condition in which the bloods ability to form clots is impaired. Activation of blood coagulation factors such as Prothrombin Time (PT) and D-dimer are significant predictors of disease severity and mortality.
Procalcitonin is an acute phase reactant released by most tissues during inflammation and is particularly associated with bacterial infection. Although it is not usually elevated in viral infections such as SARS-CoV-2 levels may increase as a result of severe systemic inflammation. It may also be used to help detect secondary infections.
For further information about any of the above Laboratory Tools for COVID-19 Disease Management please email marketing@randox.com
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Cytokine testing for COVID-19 risk stratification and treatment monitoring
11 June 2020
Cytokine testing for COVID-19 risk stratification and treatment monitoring
On Biomedical Science Day 2020, an innovative method of monitoring treatment efficacy and recovery of COVID-19 has been unveiled by global diagnostics company Randox Laboratories.
The test, which looks for the presence of cytokines (a type of small protein) is performed on Randox’s patented Biochip Technology, which can simultaneously detect multiple analytes from a single patient sample.
Cytokines play a vital role in the immune system and are known to be involved in the body’s response to a variety of inflammatory and infectious disease, such as COVID-19.
Lynsey Adams, Randox Marketing Manager, commented;
“Cytokine storms, which are the overstimulation of cytokines in response to infection, are a common complication of severe cases of COVID-19, and can trigger excessive, uncontrolled systemic inflammation.
“The monitoring of cytokine proteins therefore offers a unique opportunity to identify patients who, as a result of this viral sepsis, are at risk of poor disease outcomes including pneumonitis, Acute Respiratory Distress Syndrome, respiratory failure, shock, or even organ failure.
“Treatment for any infection, COVID-19 included, is most effective when administered at an early stage, and so the detection of cytokine storms within COVID-19 patients could provide vitally important information that will direct the appropriate patient care pathway and facilitate improved patient outcomes.”
The comprehensive cytokine testing menu from Randox comprises of 26 different cytokines, across four different biochip panels.
Designed to make cost, time and resource savings for a range of diagnostic laboratories, Randox Cytokine Biochips can detect up to 12 cytokines and growth factors from a single patient sample.
Lynsey continued;
“The multiplex capabilities of the Randox Biochip will provide clinicians with a more comprehensive picture of the patient’s condition.
“Compatible with our Evidence and Evidence Investigator analysers, which are capable of processing 2960 and 2376 tests per hour respectively, Randox Cytokine Biochip panels offer a comprehensive testing method for these proteins which play such a central role in the immune system.”
In addition to COVID-19 risk stratification, cytokine testing has also been linked to monitoring for allergies, vascular diseases, cancer, and a range of autoimmune diseases.
Key Benefits of Randox Cytokine Testing
- Simultaneous detection of up to 12 cytokines and growth factors from a single patient sample
- Fully automated and semi-automated testing platforms available to suit all laboratory throughputs
- Comprehensive test menu comprising 26 cytokines, cytokine receptors and growth factors
- Suitable for use with serum and plasma samples
- Excellent analytical performance
- Availability of complementary quality controls for a complete testing package
For more info please visit www.randox.com/cytokine-testing-solutions/, email marketing@randox.com or phone 028 9442 2413
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