Randox unveils whole pathogen molecular controls for SARS-CoV-2 (COVID-19)
Randox unveils whole pathogen molecular controls for SARS-CoV-2 (COVID-19)
16 April 2020
Randox unveils whole pathogen molecular controls for SARS-CoV-2 (COVID-19)
Whole pathogen quality controls to support accurate coronavirus testing have been developed by scientists in the UK.
The molecular controls, available from global diagnostics company Randox Laboratories, are currently being used as part of a nationwide testing programme for frontline NHS workers.
Alongside its pioneering COVID-19 tests, performed on its proprietary Biochip, Randox is using these third-party quality controls to ensure accurate coronavirus test and system performance, and ultimately, guarantee laboratory quality assurance.
Lynsey Adams, Randox Quality Control Manager, explained;
“Accurate and reliable laboratory testing is an essential aspect of COVID-19 disease management and outbreak control.
“Designed specifically for laboratories currently managing COVID-19 testing, Randox SARS-CoV-2 controls help ensure the accuracy and reliability of molecular assays used in the testing of suspected coronavirus samples, and importantly, give clinicians absolute confidence in any COVID-19 diagnoses they may make.”
Available under the brand name Qnostics, the new SARS-CoV-2 controls are manufactured using whole pathogens. They therefore mimic the patient sample, providing the best sample matrix for laboratories.
Lynsey continued;
“The Randox Qnostics SARS-CoV-2 controls are clinically relevant for full-process validation. Liquid frozen for user convenience and ease of use, the development of the controls using whole pathogen material ensures clinical relevance from extraction to amplification and detection.”
The new coronavirus controls from Randox, which contain the entire SARS-CoV-2 genome, including the conserved regions recommended by CDC and WHO, are compatible for use with both commercial and in-house testing methods, and are quantified by digital PCR to ensure batch to batch reproducibility.
Lynsey added;
“We are proud to be able to support the high demand for coronavirus testing by delivering a full COVID-19 testing package – not only our COVID-19 tests on the Randox Biochip, but now also the corresponding molecular control material that will ensure the delivery of accurate, and reliable results.
“The World Health Organization (WHO) has been very clear about the importance of testing in the global efforts to contain and delay COVID-19 and we are pleased that our new controls comply with guidelines not only from the WHO but also from the Centres for Disease Control and Prevention.”
Randox Qnostics SARS-CoV-2 Controls are heat-inactivated to be non-infectious and are manufactured to ISO 13485 standards.
Key Features and Benefits of Randox SARS-CoV-2 Qnostics Controls:
- Whole pathogen controls – the controls contain the entire SARS-CoV-2 genome meaning they are compatible with the majority of commercial and in-house assays, and target the CDC and WHO consensus sequences
- Monitor the entire testing process – whole pathogen controls are the ideal clinically relevant material for full-process validation, from extraction to amplification and detection, to ensure ultimate quality assurance in laboratories.
- Non-infectious – the controls are heat-inactivated and gamma-irradiation enabling safe handling of material.
- Highly characterised – the controls are quantified by digital PCR to ensure batch to batch reproducibility.
- Clinically relevant – performance data is available to support the clinical relevance and the compatibility with molecular assays currently in use in clinical laboratories.
- High Quality – the controls are manufactured under ISO 13485 guidelines and are therefore suitable for a broad range of usage.
- Liquid for Ease-of-Use – the controls are conveniently supplied in a liquid frozen format meaning there is no additional preparation or handling required.
- Negative controls available – delivering a complete testing package.
For more information visit www.randox.com/coronavirus-randox
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Official statement from Randox on Covid-19 testing
03 April 2020
OFFICIAL STATEMENT FROM RANDOX
On the emergence of the Covid-19 threat Randox utilised their years of regulated diagnostic experience to quickly develop and robustly validate a test for the Covid-19 virus. Randox had significant confidence in this test and presented them to Public Health England (PHE) for evaluation. PHE were managing this validation process for each of England, Wales, Scotland and Northern Ireland.
The UK Government showed significant confidence in Randox’s capability and conducted full engagement and planning subject to PHE acceptance of the Randox test. When PHE acceptance was granted, the Randox part in the national plan had been prepared and was quickly initiated.
We understand that the national plan for the testing of key workers is exactly that, a national plan, inclusive of Northern Ireland. Initially relatively small numbers of tests were sent to the areas of significant national threat in London.
The planning for the national distribution of test kits is being managed by the various relevant statutory agencies however Randox has made the case that tests should be made available locally. Following that engagement, tests have now been made directly available within Northern Ireland and Randox will continue to support Northern Ireland within the UK national plan.
Randox have acted with speed and initiative throughout this crisis and will continue to ramp up our testing capability to support the national testing plan for key workers in Northern Ireland.
Every part of Randox’s business is focused on doing everything we can to support the Covid-19 testing programme, to both save lives and ensure the speediest possible return to a more normal society.
For more information please contact the Randox PR team by emailing randoxpr@randox.com
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Randox joins government drive on COVID-19 tests for frontline NHS staff
27 March 2020
Randox Laboratories is partnering with the government to develop a new coronavirus testing programme in which NHS staff will be first in line.
The new service, which will be free, will help to end the uncertainty of whether NHS staff need to stay at home. Those who test negative for coronavirus will be able to return to work – enhancing the capacity of the NHS and social care to treat patients and care for those in community settings, with plans for a full roll-out for health, social care and other frontline workers.
Randox are providing high volume home sample collection kits and laboratory testing.
Randox CEO Dr Peter FitzGerald, said:
“We have an excellent Covid-19 assay and we are committed to supporting the government and this important initiative to test key workers and support vital public services.
“Randox Laboratories is now operational for COVID-19 testing and will be ramping up extensively in the coming weeks. This will provide extensive employment opportunities for laboratory and support staff.
“Our first tests have gone to the London Ambulance Service and we look forward to playing our role in ensuring that this critical capability continues to operate.”
To offer its coronavirus testing capabilities to the new programme, Randox’s COVID-19 test recently underwent evaluation from, and has been accepted by, Public Health England.
In its evaluation of the Randox COVID-19 test, Public Health England’s report noted that the assay correctly identified all positive and negative samples without exception.
As a result the government are proceeding to utilise the Randox COVID-19 test in the new testing programme for NHS staff, with an exceptionally high degree of confidence.
Two simultaneous tests are carried out on the proprietary Randox Biochip, in line with guidelines from the Centres for Disease Control and Prevention, and the World Health Organisation.
Health Secretary Matt Hancock said:
“We want to save lives, protect the most vulnerable, and relieve pressure on our NHS.
“Healthcare staff are key in our fight against the virus and I want to ensure that any frontline NHS or care worker who has symptoms of coronavirus or who has a family member with symptoms can be tested quickly and reliably.
“I pay tribute to the generosity and public spirit of Britain’s universities, research institutes and companies who have lent us their equipment without hesitation.”
Dr Jenny Harries, Deputy Chief Medical Officer, said:
“Laboratory-based testing on this scale is a little like building the medical equivalent of a car factory. We are assembling many different parts, some of them quite specialised and hard to find, then getting them to work accurately together in a highly co-ordinated process. There are bound to be teething problems, so we cannot switch on hundreds of thousands of lab tests overnight. But we hope that soon these hub laboratories will be operating round the clock, allowing us to significantly scale up our testing.”
For more information or to arrange interviews, please contact the Randox PR team by emailing randoxpr@randox.com
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Point of care coronavirus test from Randox and Bosch will launch in April 2020
26 March 2020
Vivalytic Viral Respiratory Tract Infection Array Detecting SARS-CoV-2 (COVID-19)
A game-changing point of care coronavirus test from global diagnostics company Randox Laboratories and leading technology manufacturer Bosch Healthcare Solutions will launch in April 2020.
The Vivalytic Viral Respiratory Tract Infection (VRI) Array can identify SARS-CoV-2 (COVID-19) and differentiate it from nine other respiratory infections with similar symptoms, including influenza and all known coronaviruses.
This provides a more comprehensive respiratory screening which enables precise and informed treatment decisions to be made.
Dr. Heather McMillan, Molecular R&D Manager at Randox Biosciences, commented;
“This array focuses not only on the identification of the novel coronavirus strain that causes COVID-19, but also nine other respiratory infection targets simultaneously, including Influenza A and B, Sarbecovirus and MERS. The aim is to diagnose patients fast and accurately from a single genetic sample, maximising containment of the virus whilst minimising the spread. With the development of this array onto a fully automated platform, patients can be diagnosed rapidly at point of care locations globally such as pharmacies and doctor surgeries.”
The Viral Respiratory Tract Infection Array is one of the world’s first multiplex molecular diagnostic tests meeting the COVID-19 testing recommendations of the World Health Organisation (WHO) and the Centres for Disease Control (CDC).
The target genes for COVID-19 being used on the VRI array represent conserved regions of the genome which have been chosen for their high sensitivity and specificity.
Marc Meier, Managing Director of Bosch Healthcare Solutions, a subsidiary of Bosch Group, said:
“We are enthusiastic about partnering with Randox to offer their assay technology on the Vivalytic platform. The core competencies of Bosch in automation, miniaturization, sensor technology and connectivity are complemented by Randox’s expertise in developing excellent biocontent for a wide range of assays and commercializing innovative diagnostic solutions.”
The new VRI test will be conducted on Vivalytic a point of care platform brought to the market by Randox Laboratories and Bosch. The Vivalytic system is a fully-automated, cartridge-based platform capable of both Hi-Plex and Lo-Plex testing. The cartridges are fully-sealed which minimises the risk of contamination, require room temperature storage (space-saving), contain all the reagents on-board the cartridge and utilises end point PCR. The test only requires a single nasal swab from the patient and an easy four step process to be carried out by the user to run the patient sample.
Key Benefits of Vivalytic | Point of Care Platform
- Fully-automated
- User friendly
- No laboratory training required
- 4 step work flow
- Minimal contamination risk – fully contained system
- No peripherals required – hygienic
- Touchscreen
- Connects to LIMS (Laboratory Information Management System)
- Sample Type: Nasopharyngeal Swab
- Sample Volume: 300µl clinical sample
For more information or to arrange interviews, please contact info@randoxbiosciences.com
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Hospitals in Wuhan and Guangzhou roll out new coronavirus test developed by Randox scientists
02 March 2020
Hospitals in Wuhan and Guangzhou roll out new coronavirus test developed by Randox scientists
Randox’s pioneering new test for coronavirus, which identifies COVID-19 and differentiates it from nine other respiratory infections, is to be used in Chinese hospitals.
The comprehensive test, which is being shipped this week to hospitals in Wuhan and Guangzhou, has been developed on Randox’s unique technology platform, the Biochip. This allows for each patient to be simultaneously tested for a range of respiratory infections inclusive of all known coronaviruses.
The Coronavirus Biochip tests each single patient sample for the SARS-CoV-2 virus that causes COVID-19, as well as nine other respiratory viruses, including SARS, MERS, and Influenza A and B. This enables clinicians to quickly and efficiently differentiate between potentially lethal and non-lethal infections, prioritise patients and administer appropriate and timely treatment.
Dr Peter FitzGerald, Managing Director of Randox Laboratories, commented;
“Current technologies being used to diagnose COVID-19 are focused on simply detecting the presence or lack of this singular strain and therefore neglect to differentiate it from other respiratory infections. At Randox we have developed a multiplex Viral Respiratory Infection Array that tests for COVID-19 and nine other infections simultaneously, and are delighted that this new technology will be deployed in Wuhan and other cities across China.
“The Coronavirus Biochip will eliminate the need for multiple back-and-forth tests before the root cause of symptoms is found, thereby empowering clinicians to make faster and better-informed decisions.”
Due to be used in hospitals in Wuhan, the epicentre of the coronavirus outbreak, as well as in The First Affiliated Hospital of Guangzhou Medical University, the new testing technology is capable of processing 324 patient samples, generating 3240 reportable results, in just 8 hours.
The panel includes two tests for COVID-19, a specific test (SARS-CoV-2) and a confirmatory test (Sarbecoviris) on the same panel, as recommended by the World Health Organisation. This avoids the need to repeat the test, and importantly, reduces the likelihood of incorrect diagnosis, ensuring appropriate containment and reducing the risk of further contamination. This faster and more comprehensive testing will ultimately support the health service in China by facilitating the efficient use of valuable healthcare resources.
Byron Wang, CEO of Beijing Promed, Randox’s partner in providing the new coronavirus test in China, commented;
“We welcome the support of the global community in assisting us combat COVID-19 at this time. Randox is a highly regarded In Vitro Diagnostic company in China and has supported our market with high quality products for many years. We look forward to supplying this test to hospitals located within the area of greatest need and believe it will make a real difference.”
Dr FitzGerald concluded;
“Randox is committed to saving and improving lives on a global scale and we know that this new COVID-19 test will make a significant contribution to the global coronavirus containment effort.”
The Coronavirus Biochip tests simultaneously for Coronavirus SARS-CoV-2 (COVID-19), Sarbecoviris (SARS, SARS like, COVID-19), Coronavirus 229E/NL63, Coronavirus OC43/HKUI, Middle East Respiratory Syndrome Coronavirus (MERS-CoV), Adenovirus A/B/C/D/E, Enterovirus A/B/C, Influenza A, Influenza B and Rhinovirus A/B.
The Randox Coronavirus Biochip complies with guidelines from the Centres for Disease Control and Prevention and the World Health Organisation.
For more information or to arrange interviews, please contact the Randox PR team on 028 9442 2413 or email randoxpr@randox.com
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Randox Extended Coronavirus Array: Bringing the Best Science to the Forefront
COVID-19 (2019-nCoV) was declared a global emergency of international concern. The WHO’s director-general’s greatest concern is the potential for COVID-19 to spread to countries with weaker health systems. The biggest catch with containing the epidemic of COVD-19 is the detection. It has been recognised that faulty kits have been shipped around America by the Centers for Disease Control and Prevention (CDC) and there simply aren’t enough kits in China 1. Randox can aid in overcoming these challenges.
What is COVID-19?
The COVID-19 is a new strain of coronavirus that has not been previously identified in humans. Consequently, research on this new strain is lacking. Symptoms are similar to that of the common cold or flu, including: fever, cough, difficultly breathing, muscle pain and fatigue. Like other respiratory infections, transmission occurs through respiratory droplets from coughing and sneezing, with an estimated incubation period of 2 to 14 days 2.
Current Situation
Globally, there are 46, 997 confirmed cases of COVID-19, with 46, 550 of these confirmed cases attributed to China. Only 447 of the total number of cases are outside of China, across 24 countries. The total number of deaths attributed to COVID-19 sits at 1, 369 of which all have been observed in China, except one. These statistics are laboratory-confirmed cases only 3. These statistics were reported by WHO on 13 February and is the situation of number, total and new cases, within the past 24hrs from being recorded. Whilst China is at a very high risk, the global risk level is high. These statistics indicate the necessity for COVID-19 diagnosis, especially as the above are only laboratory-confirmed cases combined with the faulty tests distributed in America and the lack of diagnostic tests in China.
The Randox Extended Coronavirus Array
Randox have developed a fast and accurate test for the detection of COVID-19, the new strain of coronavirus. The Randox Extended Coronavirus Array is the only test in the world that can identify the potentially lethal strain and differentiate between other respiratory pathogens with similar symptoms.
The new test utilises the Randox Biochip Technology, with results within 5 hours on the Randox Evidence Investigator, a semi-automated analyser capable of processing 54 patient samples simultaneously.
The Randox Coronavirus Array comprises five coronaviruses strains, including the COVID-19 (2019-nCoV) strain. The table below provides a breakdown of the viruses included in the Randox Extended Coronavirus Array:
Dr Peter FitzGerald, Managing Director of Randox Laboratories, commented;
“Current technologies for the diagnosis of coronavirus are designed simply to detect the presence or lack of COVID-19, and therefore neglect to differentiate between this strain and other respiratory infections. We have therefore developed an extended Viral Respiratory Infection Array that tests simultaneously for COVID-19 and nine other viruses. This will eliminate the need for multiple back-and-forth tests before the root cause of symptoms is found, and empower clinicians to make fast and informed decisions.”
Want to know more?
Contact us or download our coronavirus flyer
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Randox actively testing samples for Coronavirus COVID-19
12 February 2020
Introducing the COVID-19 Coronavirus Test from Randox
A ground-breaking test for the potentially fatal COVID-19 strain of coronavirus, is available at global health diagnostics company Randox Laboratories.
The test, developed on Randox’s patented Biochip Technology, is as an enhanced multiplex array which includes tests for COVID-19 and nine other respiratory viruses which can display the same symptoms.
The new enhanced Biochip therefore allows clinicians to quickly and efficiently differentiate between potentially lethal and non-lethal infections.
Dr Peter FitzGerald, Managing Director of Randox Laboratories, commented;
“Current technologies for the diagnosis of coronavirus are designed simply to detect the presence or lack of COVID-19, and therefore neglect to differentiate between this strain and other respiratory infections.
“We have therefore developed an extended Viral Respiratory Infection Array that tests simultaneously for COVID-19 and nine other viruses. This will eliminate the need for multiple back-and-forth tests before the root cause of symptoms is found, and empower clinicians to make fast and informed decisions.”
The test is available on the Randox Evidence Investigator with a turnaround time of 5 hours.
Benefits of the new Randox COVID-19 test
- Quick Turnaround Times (5 hours on Evidence Investigator)
- Multiplex array differentiates between mild and serious infection
- Automated and Semi-Automated options available
- Medium to high throughput (54 samples in 5 hours)
For further information please visit www.randox.com/coronavirus-randox
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Coronavirus: A Global Health Emergency of International Concern
There is still a lot unknown about the 2019 novel coronavirus (2019-nCoV), however, current knowledge is mostly based on the intel of existing coronaviruses including Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV) 1. Last week, the World Health Organization (WHO) declared the 2019-nCoV a global health emergency of international concern. The WHO’s director-general, Tedros Adhanom Ghebreyesus stated: “The main reason for this declaration is not because of what is happening in China but because of what is happening in other countries. Our greatest concern is the potential for this virus to spread to countries with weaker health systems, which are ill-prepared to deal with it” 2.
WHO recommend educating all and increasing knowledge of the 2019-nCoV. The aim of this article is to provide further information on the 2019-nCoV to aid in combatting the mass hysteria through education.
About the 2019-nCoV
The 2019-nCoV belongs to a large family of respiratory viruses with illnesses ranging from the common cold to more severe diseases such as MERS-CoV and SARS-CoV. 2019-nCoV is a new strain that has not been previously identified in humans 3. Coronaviruses are common in a variety of animal species including: bats, cats, cattle and camels 1. Coronaviruses are zoonotic which means the virus can be transmitted between animals and humans. SARS-CoV was transmitted from civet cats and MERS-CoV was transmitted from dromedary camels 3. Zoonotic viruses are commonplace with approximately 60% of current infectious diseases and 75% of all emerging infectious diseases in humans being zoonotic according to the UNEP Frontiers 2019 Report: Emerging Issues of Environmental Concern, with approximately one new infectious disease emerging in humans every four months 4.
2019-nCoV Transmission & Prevention
The exact origin of the 2019-nCoV is unknown and the analysis of the genetic trees of this virus is ongoing, however ‘it is important to note that person-to-person spread can happen on continuum’. Currently, it is unclear on how contagious the 2019-nCoV is 5. It is believed that the spread of the 2019-nCoV virus is similar to that of other respiratory pathogens (influenza). It is believed that the spread occurs via respiratory droplets produced when an infected person sneezes or coughs and lands in the mouth or noses or possibly inhaled into the lunch of people nearby (about 6 feet). It is unclear at this time if the 2019-nCoV can be caught via touching surfaces or objects that have the virus and then touching their nose, mouth and possibly eyes.
It is important to understand that the transmissibility and severity of viruses vary and there is still much to learn about the 2019-nCoV 6. Whilst there is no vaccine to prevent the transmissibility of the 2019-nCoV, daily steps can be taken to aid in the prevention of the spread, similar to that of respiratory infections in general 7:
1. Wash hands with soap and water for 20 seconds, especially after using the toilet, before eating, after blowing your nose, sneezing and coughing.
2. If soap and/or water is not readily available, alcohol-based (minimum 60% alcohol) hand sanitisers can be used.
3. Avoid toughing mouth, nose and eyes with unwashed hands.
4. Avoid close contact with those who are sick.
5. Stay at home when you are sick.
6. Always cover coughs and sneezing with a tissue and discard in a bin.
7. Clean and disinfect frequently touched objects and surfaces using a regular household cleaning wipe or spray.
It is vitally important to get tested if you believe you have the 2019-nCoV which can aid in preventing the further transmissibility of the virus.
Randox Coronavirus Arrays
Randox are developing a rapid test for the 2019-nCoV which will utilise the Randox Biochip Technology, with results available within 3 hours on the Vivalytic and with 5 hours on the Randox Evidence Investigator.
The Randox Novel Coronavirus Array detects the 2019-nCoV strain quickly and accurately, enabling effective and accurate medical protocols to be actioned.
The Randox Extended Coronavirus Array encompasses multiple strains of the coronaviruses including: 2019-nCoV, 229E, NL63, OC43 and HKUI. The wider panel provides a comprehensive coronavirus screening panel, enabling effective and accurate medical protocols to be actioned.
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Coronavirus test available at Randox
26 January 2020
Introducing the COVID-19 Coronavirus Test from Randox
A ground-breaking test for the potentially fatal COVID-19 strain of coronavirus, is in the final stages of development at global health diagnostics company Randox Laboratories.
The soon-to-be-launched test, developed on Randox’s patented Biochip Technology, will be available for immediate COVID-19 testing, but an additional enhanced multiplex array will also include tests for other respiratory viruses which can display the same symptoms.
The new enhanced Biochip will therefore allow clinicians to quickly and efficiently differentiate between potentially lethal and non-lethal infections.
Dr Peter FitzGerald, Managing Director of Randox Laboratories, commented;
“Current technologies for the diagnosis of coronavirus are designed simply to detect the presence or lack of COVID-19, and therefore neglect to differentiate between this strain and other respiratory infections.
“Whilst we’re very quickly developing an efficient novel test for this new strain of coronavirus, we are therefore also working on an extended Viral Respiratory Infection Array that will test simultaneously for COVID-19 and a range of other viruses. This will eliminate the need for multiple back-and-forth tests before the root cause of symptoms is found, and empower clinicians to make fast and informed decisions.”
The test will be available for the Point of Care analyser, the Vivalytic, within 3 hours, and within 5 hours on the Randox Evidence Investigator.
Benefits of the new Randox COVID-19 test
- Quick Turnaround Times (3 hours on Vivalytic and 5 hours on Evidence Investigator)
- Multiplex array differentiates between mild and serious infection
- Automated and Semi-Automated options available
Randox also currently has available a Respiratory Tract Infection Array, which can test for 22 viral and bacterial respiratory infections simultaneously. The test therefore determines the exact cause of your symptoms and differentiates between mild and serious infections, such as coronavirus. This is also available from Randox Health as a Cold, Cough and Flu test.
For further information please visit www.randox.com/coronavirus-randox
For enquiries email marketing@randox.com or to book your Randox Health Cough, Cold and Flu test please ring 0800 2545 130.
Randox is committed to saving and improving lives on a global scale, and will bring you updates on developments on our test for COVID-19 as and when they happen.