Update on Sample Kits
Update on Sample Kits
STATEMENT FROM RANDOX: 07 August 2020
Randox Laboratories have today taken the decision to recall Covid-19 sample collection kits, following the identification of incomplete EC certification. On 15th July DHSC placed these kits on hold due to the absence of swab certification from an external supplier. To date, Randox have not been provided with evidence to satisfactorily support the CE marking for these swabs. So, noting the lack of CE certification by the supplier and that some kits remain in the field at this time Randox has, as a regulatory measure, initiated the recall of those kits used within the National Testing Programme.
Randox Laboratories will continue to provide high volume Covid-19 testing to the National Testing Programme from their laboratories, based on sample collection kits from other providers.
DHSC have stated the risk to safety is low and test results from Randox kits are not affected.
This recall applies only to sample collection kits within the UK National Test and Trace Programme. Randox private customers or kits are not affected.
Press enquiries should be emailed to randox@newcenturymedia.co.uk
Randox in the media
Latest News
FAQs
Protected: Analysis of results from the QCMD Coronavirus Preparedness EQA Pilot Study
COVID-19 Testing Service Testimonial: The Irish Football Association
COVID-19 Testing Service Testimonial: The Irish Football Association
As we move towards a new ‘normal’ and sporting organisations begin the process of restarting their games, many teams will be wondering how to ensure a safe and reassuring training environment for their players and their staff.
Thanks to our COVID-19 testing service, The Irish Football Association was able to facilitate a timely and efficient return to play by confirming their players as ‘COVID-safe.’
Our ‘Back to Business’ programme has enabled the IFA to demonstrate their commitment to their players, their staff, and their fans, as well as get back to business by ensuring the highest level of safety.
Corinne Lannie, Risk Manager at the Irish Football Association, commented;
“The test kits were very straightforward to use. The instructions were clear as was the YouTube guidance video. The recording onto the Randox system was easy and the speed of results was exceptional.
“The support provided by Paul (Randox Business Development Executive) was amazing – he was extremely helpful and supportive and really went above and beyond.”
At Randox, we offer two types of testing;
PCR (diagnostic) testing, and antibody testing, which can give an indication that an individual has been previously infected with COVID-19.
Sample collection services are available.
David Hallendorff, Business Relations Manager at Randox Health commented;
“Collectively we are all working towards a timely return to a more normal society, which will see companies reopening and people returning to work.
“To facilitate this recovery of the economy, without compromising the health of workers or of the wider general public, workplaces have a responsibility to provide a safe working environment.
“It is great to see so many companies putting the health of their staff as a priority and taking a proactive approach to testing.”
To find out more about our Back to Business COVID-19 Testing Service, please email info@randoxhealth.com or phone 0800 2545 130
Want to find out more?
Click one of the links below.
COVID-19 Products and Services
HOME TEST
ANTIBODY TEST
TESTING SERVICE
LABORATORY TOOLS
Temporary Precautionary Measure
STATEMENT FROM RANDOX: TEMPORARY PRECAUTIONARY MEASURE
16 July 2020
As an immediate precautionary measure we have temporarily suspended distribution of sample collection kits using one particular batch / supplier of swabs. This is a temporary measure and does not apply to our private business which uses a different supplier of swabs.
Test results from Randox kits are not affected.
For more information please contact the Randox PR team by emailing randoxpr@randox.com
Randox in the media
Latest News
FAQs
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
RESEARCH
BIOPHARMA
CLINICAL LAB
BIOREAGENTS
RX modena and Randox Reagents used in COVID-19 hospital in India
RX modena and Randox Reagents used in COVID-19 hospital in India
Randox Laboratories has installed an RX modena into a COVID-19 hospital in India; the Netaji Subhash Chandra Bose Medical College in Madhya Pradesh state.
The installation, which marks the first RX modena to be used in an Indian Government Medical College, replaces existing instrumentation in the Medical College laboratory, an initiative which was driven by College Dean Dr. Pradeep Kumar Kasar and Head of Department Dr. Ashok Kumar Sahu.
The RX modena will cater for an additional 38 samples compared to the previous instrumentation, and is running a range of biochemistry tests that play a pivotal role in COVID-19 patient management, including C-Reactive Protein (CRP), Ferritin, and Lactate Dehydrogenase (LDH).
Dr. Ashok Kumar Sahu, Head of Biochemistry at Netaji Subhash Chandra Bose Medical College, commented;
“We are very pleased with the performance of the RX modena, and in particular with its wide menu of tests that can be utilized for COVID-19 patient management. Its high throughput and versatility have been a great support for the clinicians working in our COVID-19 hospital, in determining risk stratification, disease progression, and response to treatment.”
The RX modena is a high volume, floor standing, fully automated clinical chemistry analyser with a world leading test menu which covers specific proteins, lipids, therapeutic drugs, antioxidants, diabetes and veterinary testing. The versatile analyser offers advanced methodologies with excellent correlation to the gold standard, and excellent reagent CV ranges.
Shail Dholabhai, Randox India Sales Manager, commented;
“We are delighted that the team at Netaji Subhash Chandra Bose Medical College have chosen the RX modena to fulfil the testing requirements of this COVID-19 hospital. Offering an unrivalled test menu of routine and specialized chemistries, the RX modena provides laboratories with the superior precision, reliability and accuracy that the Randox RX series is renowned for.
“Capable of performing a total of 1200 tests per hour including ISE, the RX modena presents a new class of efficiency which will result in faster and more accurate diagnoses, and ultimately, lead to better patient outcomes.”
Benefits of the RX modena
- Capable of performing 800 photometric and a total of 1200 tests per hour including ISE.
- World-leading extensive test menu covering routine chemistries, specific proteins, lipids, antioxidants, cardiac, diabetes and veterinary testing, offering cost savings through consolidation of routine and novel tests on a single platform.
- Economic platform with low water consumption of less than 20 litres per hour saving on consumable costs. The RX modena also requires less than 5 minutes minimal maintenance.
- Interactive touch-screen technology with integrated barcode readers for reagent and sample identification. Increased functionality with 13 wavelengths generated via diffraction grating (340-800nm) ensuring a multitude of chemistries are possible on one system.
- Easy-to-use advanced Microsoft 10 software with a built-in Inventory Management System calculating the number of tests remaining, providing alerts of shortages and expired reagents and calibrators. The RX modena also features automatic test re-run function and sample dilution.
- Dedicated reagent and sample pipettes to minimise the risk of errors and contamination. The RX modena also features a continuous loading hatch to allow for samples to be analysed quickly and easily during a run.
- Advanced QC capabilities with daily, monthly and batch QC with data archiving, Levey-Jennings charts and automatic QC and calibration. There are also 7 different calibration options available.
For further information about the RX modena click here.
For information about laboratory tools for COVID-19 patient management please click here.
For other enquiries please contact marketing@randox.com
Want to know more about Randox?
Contact us or visit our homepage to view more.
Our Randox Products and Services
REAGENTS
RX SERIES
ACUSERA
BIOCHIP
Matt Hancock and Lord Bethell support Randox in call for future focus on diagnostics
Matt Hancock and Lord Bethell support Randox in call for future focus on diagnostics
In a recent Opinion Piece in The Daily Telegraph, our Managing Director Dr Peter FitzGerald stressed the value of diagnostics, the important role it plays in public health, and the contribution it has made specifically during the COVID-19 pandemic.
Whilst regrettable that it has taken a pandemic to bring the health diagnostics sector into focus, it is a positive step forward for healthcare that the huge national and international scope of our sector is now rightly acknowledged.
Indeed, Dr FitzGerald’s commentary was acknowledged by both the Secretary of State for Health, Matt Hancock, and the Minister for Innovation, Jim Bethell.
The Secretary of State noted that “Randox have played a vital role in building our global-scale diagnostics capacity.”
It is clear that the diagnostics industry, inclusive of the work Randox has done in the field, has had a positive impact in the fight against COVID-19. We know that testing at scale is the most effective way to both save lives, and ensure a timely return to a more normal society.
We are very proud of our staff, for their ongoing support, and for their commitment to the work that we do, which is making a real and positive difference.
You can read Dr FitzGerald’s full Opinion Piece for The Daily Telegraph, on our own website, by clicking here.
For further information please contact randoxpr@randox.com or phone 028 9442 2413
Want to know more about Randox?
Contact us or visit our homepage to view more.
Our Randox Products and Services
REAGENTS
RX SERIES
ACUSERA
BIOCHIP
COVID-19 has shown UK leadership on diagnostics; we can now become a world leader
COVID-19 has shown UK leadership on diagnostics; we can now become a world leader
An Opinion Piece by Dr Peter FitzGerald, Managing Director of Randox Laboratories, in The Daily Telegraph
When I founded Randox Laboratories in 1982 in Antrim, Northern Ireland, I could not have envisaged that today we would be manufacturing more clinical diagnostic products than any other company in the UK. Whilst I am incredibly proud that Randox is taking a leading role in the national Covid-19 testing effort, it is deeply regrettable that it has taken this pandemic to bring the UK’s health diagnostics sector into focus.
The pandemic represents the biggest diagnostics and health infrastructure challenge of modern times. It has forced and necessitated a herculean collaborative effort from Government, the NHS and the private sector. This partnership has delivered a new trust and information sharing network which bodes well for the future.
Ministers now know what we can do and rightly acknowledge the huge national and international scope of our sector and for global UK leadership and new skilled jobs. The Government is right to highlight and reflect that too many of these critical sectors and supplies have been allowed to be offshored in recent years. This has consequently had implications for patient care and the support available for health workers.
In March, the World Health Organisation’s Director General, Tedros Adhanom Ghebreyesus, said that he had a simple message to countries on how to deal with the COVID-19 outbreak that was sweeping the globe, this message was ‘Test, test, test.’ In the UK, mass testing was, at that time, simply not possible. Indeed, the Health Secretary, Matthew Hancock, acknowledged that it was the lack of a significant domestic diagnostic industry that had impeded the Government’s initial efforts on testing, which is why we were behind Germany and other states. He was right and much has already been done to re-shore capacity and re-set this policy alongside understanding the importance for future British sector leadership.
Going forward, we can and must deliver a new and much tighter partnership between the NHS and private sector across diagnostics and preventative healthcare. Improved communication, co-operation and partnerships will grow British sector expertise, jobs and skills. The potential for British leadership and success here is huge.
Earlier this month, I had the pleasure of welcoming Northern Ireland Secretary, Brandon Lewis MP to see our new £30m specialist Covid-19 testing hub at the Randox Science Park in Northern Ireland. This investment will create 200 new science, engineering and manufacturing jobs at the facility on top of our existing workforce. It was fast-tracked over the space of four weeks and is the first step in a wider diagnostics investment programme as part of Randox’s efforts to enhance our national Covid testing capacity.
A wider appreciation of the value and resource support for diagnostics testing and preventative health policy is now overdue and timely especially when you consider that seventy per cent of all medical decisions are based on the results of lab tests. This testing must now account for more than the two per cent of the national healthcare budget. Alongside our major focus on R&D, our scientists work on pioneering research into a range of common illnesses such as cancer, cardiovascular disease and Alzheimer’s disease. With around twenty five percent of turnover reinvested in R&D, Randox has more new tests in development than any other diagnostic company. Our products are used across hospitals and veterinary laboratories, food testing, forensic toxicology and life sciences.
Randox labs have spent over £305 million researching the thousands of biomarkers present in our bodies and have identified the gold standard in testing. Our patented Biochip Array Technology has revolutionized the diagnostics industry by offering a unique testing platform which allows multiple tests to be carried out from a single patient sample. On Covid, we have been able to include two tests on the same biochip; one specific and one confirmatory as recommended by the World Health Organisation.
The ambition and determination to build a world-beating British diagnostics sector is overdue and right. It offers so many advantages ranging from a healthier and happier population which lives longer to more skilled jobs in a sector which works hand in glove with our world beating academia and NHS. The pandemic has rightly brought the UK’s diagnostics capability into sharp focus, and it is paramount that when we move to a post-Covid world, we take what we have learned from this crisis and build a self-reliant sector fit for the future.
For further information please email randoxpr@randox.com
Want to know more about Randox?
Contact us or visit our homepage to view more.
Our Randox Products and Services
REAGENTS
RX SERIES
ACUSERA
BIOCHIP
We Are Randox | How Kelly Mon became Deputy Testing Coordinator for COVID-19
We Are Randox | How Kelly Mon became Deputy Testing Coordinator for COVID-19
In support of our new £30m COVID-19 laboratories, we are hiring 200 new staff across Engineering, Manufacturing and Science.
For an idea of what it’s like to be part of the COVID-19 testing programme at Randox, we spoke to Deputy Coordinator Manager Kelly Mon.
Kelly spoke to us about what a typical day in COVID-19 testing looks like, the career path she took to her current role, and her advice for a successful job search.
Name: Kelly Mon
Job Title: Deputy Co-Ordinator Manager
Department: COVID-19 Testing
Kelly, what did you study and where?
After secondary school, I studied a BTEC National Diploma in Applied Science (Medical) in Belfast Met in Castlereagh, and then moved on to study Biomedical Science at Ulster University in Coleraine. I later studied part time for an MSc in Stratified Medicine.
Give a brief outline of your career to date
I trained as a Biomedical Scientist in Antrim Area Hospital for one year to gain a recognized certification from the Institute of Biomedical Science. When I graduated I started as a Laboratory Analyst at Randox Clinical Laboratory Services, where I ran health tests on our patented Biochip Technology. After a short time, I became a Clinical Team Leader managing a number of clinical trials for companies and universities. Recently I have been promoted to Deputy Co-Ordinator Manager for our COVID-19 testing programme.
Are there alternative routes into the job?
For a job in Clinical Research you would ideally have a BSc in Biomedical Science, Biochemistry or Life Sciences, and a Diploma in Professional Practice. Alternatively, if you have a degree in another area we have a scheme at Randox that allows graduates the chance to rotate throughout departments, and many good candidates are offered positions at the end. There are also apprenticeships and student placements available.
What does a typical day look like for you?
A typical day in clinical trials usually involves running patient blood or urine samples on Randox Biochips that have been custom-made to suit that particular project. We work to tight deadlines, have regular updates with internal staff and customers, and conduct data analysis and reports. A typical day working on COVID-19 testing involves lots of PPE, and constant communication between a wide range of staff and departments. In my role I oversee our quality control, create and communicate important procedures, and visit the lab to make sure my staff are doing well.
Is this what you always wanted to do?
Whilst I knew that I liked science, I wasn’t sure what job I wanted to do. No one in my circle had ever gone on to study at university so I hadn’t considered it an option. I couldn’t even imagine that I could become a scientist.
What are the best and most challenging aspects of the job?
For me, the best aspect of any job is the people and at Randox I work with a great bunch. I also like the fact that there is career progression for people who put in the work to get it, and that you are trained to perform all tasks, not just one part of the work flow. The most challenging aspect of the job at times is the intensity of the workload, which is why organizational skills and the ability to keep calm under pressure are key in this job.
Why is what you do important?
There is that old saying that your health is your wealth and I’m proud to work for a healthcare company providing high quality health diagnostics. These products are used every day to assist in the detection of a wide range of diseases to provide the earliest possible diagnosis and improved patient outcomes. In my department the clinical trials we manage help to detect biomarkers of disease and determine treatment efficacy, which is important to identify less invasive methods of diagnosis, and more tailored ways to treat each patient.
What advice would you give anyone looking to follow a similar career path?
It’s important in any career to work hard and stick at it. I dropped out of two courses before I started the BTEC Diploma. I could have given up when times were hard, but I stuck with it and here I am sharing what I’ve learnt throughout my career. If you are planning specifically to study Biomedical Science, the advice I would give is to choose a course with a placement. My own course had a one-year placement in an NHS hospital, and the experience in a professional environment that gave me key laboratory skills was invaluable. It also gets you contacts in the industry which is always helpful.
If you weren’t doing this what would you like to do?
I love my job, I love my career and I love the people I work with so honestly, I wouldn’t choose any other career path!
Describe your ideal day off.
My ideal day off work involves pyjamas, junk food and good old Netflix.
And finally, what’s the key to any successful job search?
Sometimes job searching can be tiresome and after a while you start to apply without properly researching, but the key to any successful job search is preparation. Start by giving your CV an update and get someone – perhaps your university careers team, or a friend or family member – to proof-read it. Or, if you don’t have any other help, you can begin by searching CV templates on the internet. Personally I would advise that you include some interesting hobbies to make your application stand out. You would be surprised how things seemingly unrelated to a particular job will keep you in the recruiter’s mind. Then come up with some possible questions and think of the answers you might give before you go for interview.
We are delighted to have Kelly with us at Randox as part of our COVID-19 testing programme.
For current vacancies at Randox please visit careers.randox.com
For more We Are Randox stories about our amazing colleagues, make sure to follow us on Facebook, Instagram and Twitter and follow the hashtag #WeAreRandox.
For further information please email recruitment@randox.com or phone 028 9442 2413.
Want to know more?
Contact us or visit our Randox Careers
Find out more about Randox Careers
Careers News
Vacancies
Our People
Careers Website
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.
Want to know more about Randox?
Contact us or visit our homepage to view more.
