New 39-minute COVID test available on Randox-Bosch Vivalytic
02 October 2020
New 39-minute COVID test available on Randox-Bosch Vivalytic
- The world’s fastest PCR based SARS-CoV-2 test for the point of care delivers reliable results in 39 minutes.
- Has a sensitivity of 98 percent and a specificity of 100 percent.
- Simultaneous testing of five people with one cartridge by pooling will be available from early October.
- Work is in progress to further reduce time to result.
A rapid new coronavirus test, which provides results for Covid-19 in just 39 minutes, is now available on the Vivalytic, a point of care platform brought to market by Randox Laboratories and Bosch.
The test for detection of the SARS-CoV-2 pathogen, is currently the fastest PCR test (the gold standard of test methods) worldwide, and is predestined for decentralized use in mobile test centres at service stations or in airports, so that people who take the test can obtain a reliable result while at the testing site.
Available now in Europe, the CE-approved test, which has a sensitivity of 98 percent and a specificity of 100 percent, helps avoid time in quarantine, relieve laboratories, and make travel and work safer again.
“Rapid and accurate testing plays a crucial role in identifying cases of Covid-19 – to contain any outbreaks and limit the spread of the virus,” says Dr. Heather McMillan, Molecular R&D Manager at Randox Biosciences.
“This new rapid test will be a game-changer in the coronavirus testing landscape by allowing patients to receive their results at the point of care faster than ever before.”
Randox and Bosch launched the first rapid test for the Vivalytic analyser at the end of March, after just six weeks’ development.
As a multiplex test, it simultaneously checks samples for the SARS-CoV-2 virus as well as nine other respiratory diseases in two and a half hours, whereas the new accelerated test is exclusively for SARS-CoV-2.
“With our different coronavirus tests and variable analysis strategies, we open up a range of testing scenarios with a Vivalytic device – from screening all the way to supporting differential diagnosis for similar symptoms,” says Marc Meier, president of Bosch Healthcare Solutions GmbH.
And development work for Covid tests on the Vivalytic is ongoing: as of early October 2020, by pooling samples together it will be possible to simultaneously evaluate five samples in one test cartridge and at a comparable speed – a world first.
This will increase available testing capacity, by enabling fully automated processing of more than 160 samples a day using a Vivalytic device.
Key Benefits of SARS-CoV-2 test on Vivalytic point of care platform
The advantages of the rapid SARS-CoV-2 test on Vivalytic lie not only in speedy analysis, but also in ease of use. A sample is taken from the nose or throat using a swab, and placed in the test cartridge. Then the cartridge, which contains all the reagents required for the test, is inserted into the Vivalytic device for automated analysis.
- Turnaround time of 39 mins from sample entry to result.
- The SARS-CoV-2 rapid test has recently received CE marking.
- The SARS-CoV-2 pooling test can run up to 5 samples on-board one single cartridge.
- Easy 4-step user-friendly process from sample entry to result. Minimal training required.
- Detection from real-time PCR from Nasopharyngeal and/or Oropharyngeal swab.
- Suitable for use in any laboratory and non-laboratory settings.
The development of the new Vivalytic PCR singleplex test is part of a research and development project funded by the German Federal Ministry of Education and Research (BMBF).
For more information please contact marketing@randox.com
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Vivalytic | Test Cartridges
Vivalytic | Cartridges
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Powered by Biochip Technology
Simple & Accurate POC Molecular Diagnostics
- Unique test menu covering a diverse range of respiratory, genitourinary and hospital acquired infections including SARS-CoV-2 (COVID-19)
- Multiplex technology allows for the detection of multiple targets from a single patient sample
- All reagents are on-board vivalytic cartridges
- Vivalytic cartridges are capable of target detection from multiple sample types Urine, Nasopharyngeal or Oropharyngeal Swab & Sputum
- Vivalytic cartridges are suitable for use at room temperature
- Vivalytic cartridges provide users with minimal risk contamination
Vivalytic cartridges are compact, technologically advanced Molecular Diagnostic tests utilising micro-fluidics to enable simple and accurate diagnostic testing. Vivalytic cartridges are powered by a variety of technologies, dependent upon the test application. High-Plex and Low-Plex tests can be analysed on the Vivalytic. High-Plex tests utilise Randox patented Biochip Array Technology, enabling end-point qualitative PCR and providing multiple test results from each sample. Low-Plex tests are based on a variety of detection methods including real-time qualitative PCR and melting curve analysis.
Randox patented Biochip Technology allows simultaneous detection of multiple targets from a single patient sample. 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. Each biochip is prefabricated with spatially discrete testing regions (DTR’s).
Each DTR represents an individual test. Each DTR can be occupied with oligonucleotides specific to a pathogen or target of interest. The High-Plex capabilities of Biochip Technology eliminates the need to run multiple time consuming and sample intensive assays.
An enzyme is used to catalyse the chemical reaction of the biochip which generates the chemiluminescent signal. The light emitted from the chemiluminescent reaction that takes place in each DTR is simultaneously detected and quantified using a Charge – Coupled Device (CCD) Camera. This CCD Camera simultaneously records the light emission from all the DTRs on each biochip. The Vivalytic automatically generates a result report for all targets.
Want to know more?
Contact us or visit our COVID-19 Monitoring & Management page
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Vivalytic | SARS-CoV-2 Rapid 39 Minute Test
Vivalytic | SARS-CoV-2 Rapid 39 Minute Test
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Detecting SARS-CoV-2 (COVID-19)
Rapidly Detecting SARS-CoV-2 (COVID-19)
- Detection from real-time PCR via Nasopharyngeal and/or Oropharyngeal swab
- The SARS-CoV-2 rapid test targets the E gene sequence for COVID-19 detection
- The SARS-CoV-2 rapid test has recently received CE marking
- Simple and easy to use analyser with a small footprint making it suitable for use in laboratory and non-laboratory settings
- Rapid turnaround time of just 39 mins from sample entry to result
- Convenient 4 step process from sample entry to results. No laboratory training required
Clinical Significance
SARS-CoV-2 (COVID-19) is a rapid real time PCR test cartridge, providing clear and concise results in a timely manner, direct at the point of care. This enables the patient to take the recommended safety precautions without delay.
In collaboration with Bosch, we are proud to release not only a rapid testing solution for the detection of SARS-CoV-2 (COVID-19) but an accelerated mass testing solution to effectively and efficiently monitor and detect viral infection from the offset with an aim of minimising the rise in infections globally. The new SARS-CoV-2 pooling test will allow users to test up to 160 samples a day and has sensitivity of 98% and a specificity of 100% – a world’s first!*
* Detailed information on the determination of analytical performance can be found in instructions for use provided with SARS-CoV-2 kit.
Features
Sample Type: Nasopharyngeal or Oropharyngeal Swab (eNAT)
Sample Volume: 300 μl
Detection Method: Real-Time PCR
Time to result: 39 minutes
| Detectable Virus |
|---|
| SARS-CoV-2 (E gene sequence) |
“AWARD-WINNING DESIGN DELIVERS
AN UNCOMPLICATED USER EXPERIENCE”
Vivalytic Workflow
Intuitive engineering of Vivalytic ensures the analyser is user friendly. The process of patient sample to result comprises a very simple 4 step workflow.
To begin the test, the user scans or enters sample information. The cartridge code is then scanned into the embedded Vivalytic software. The user then adds sample into the dedicated cartridge slot, closes the lid and inserts the cartridge into the Vivalytic.
The touchscreen display will countdown the time remaining to test completion. Results will be displayed on the screen. Multiple Vivalytics can be wirelessly connected allowing the user to control multiple tests at one time all reporting to a master Vivalytic platform.
Want to know more?
Contact us or visit our COVID-19 Monitoring & Management page
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Viral Respiratory Infection Array
SARS-CoV-2 Pooling Test
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Prime Minister Boris Johnson congratulates Randox
Prime Minister Boris Johnson congratulates Randox in House of Commons 22 Sep 2020
On Tuesday 22nd September 2020, in the House of Commons, Prime Minster Boris Johnson congratulated Randox for our vital role at national level in helping to deliver the Government’s testing programme.
The statement from the Prime Minister came in response to Sir Jeffrey Donaldson MP, who asked the Prime Minister if he would commend Randox for the work we have done. Sir Jeffrey Donaldson MP said;
Randox has committed 99% of its Covid testing capacity to that programme and on 19th September they successfully reported almost 10,000 samples beyond the recommended daily rate.
The Prime Minister responded by saying;
I do indeed congratulate Randox and all the other businesses involved and we are massively expanding testing the whole time.
Many thanks again for your ongoing support.
Our staff are our best asset and we salute your hard work and commitment.
For further information please email randoxpr@randox.com
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Matt Hancock pays tribute to Randox staff in House of Commons
Matt Hancock thanks Randox staff in House of Commons 21 September 2020
On Monday 21st September 2020, in the House of Commons, Secretary of State for Health and Social Care, the Rt Hon Matt Hancock MP, personally thanked Randox staff for the role we play within the National Testing Programme.
He said;
Randox deliver a very significant number of tests every single day – a growing number – in fact, they are currently outperforming the allocation we have asked them to deliver and I pay tribute to every single person who works at Randox for the work that they have done and the part that they have played in keeping people safe.
Because everyone who gets a Randox test result, like every other test result, gets more information with which they can keep themselves safe and we have more information with which we can try to keep the whole of society safe.
Our work has greatly expanded the capacity for testing in the UK and we will continue to ramp up our capabilities, to both save lives and promote a timely return to a more normal society.
We thank our staff for their ongoing support, and for their commitment to the work that we do, which is making a real and positive difference.
For further information please email randoxpr@randox.com
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Randox response to Sunday Times Article 20 September 2020
STATEMENT FROM RANDOX: 20 September 2020
Key Points:
- Randox has committed 99% of its Covid-19 testing capacity to the national testing programme.
- Randox are fully committed to the national testing programme and robustly refute accusations within today’s Sunday Times.
- On 19th September Randox successfully reported to the national programme almost 10,000 samples beyond its committed daily rate.
- The majority of samples which are voided at Randox are down to logistical reasons outside Randox’s control. Samples voided at Randox’s laboratories are comparable to other laboratories across the programme. Every voided sample is properly accounted for.
- Randox does not prioritise private samples over comparable samples within the testing programme.
- Randox staff have performed extraordinarily well and are our strongest asset.
- All Randox investment in rapidly increasing capacity to the national testing programme has been through its own private resources.
Randox are fully committed to supporting the national Covid-19 testing programme and fully recognise the importance of this work to the economic and social well-being of the nation. We have made significant private investment to increase capacity and drive process improvements. We work very closely with all partners within the programme to ensure the most effective possible testing.
Randox robustly refutes accusations in today’s Sunday Times (Sunday 20th September 2020) that private samples are prioritised over comparable samples within the national testing programme.
This is a gross mis-representation of the facts on the ground with regard to its processes.
We reiterate that Randox does not prioritise private samples over comparable samples from the national testing programme.
Once processed into Randox’s laboratories the vast majority of all samples are reported on within 24 hours. It is inaccurate and unreliable to claim that Randox has completed fewer than one in 10 tests on time. In fact Randox is successfully meeting and exceeding the capacity requirements agreed with Government and fulfilling its contractual obligations. Moreover Randox is successfully reporting above our commitment to Government for the national testing programme.
On average the Randox void rate is comparable across the programme. It is important to note that whilst all laboratories conduct the voiding of samples, the reason for the voiding most frequently lies outside the laboratory – normally user or logistic type issues. It is extremely inaccurate and misleading to claim that Randox, or indeed any laboratory, voids samples without explanation.
Every sample is receipted in accordance with stipulated, formal procedures and processed accordingly. This includes cross-referencing every sample barcode electronically with the national registration database. Every sample is appropriately accounted for and samples will only be voided if, due to the quality of the sample, the results could not be guaranteed as reliable. Every sample is fully assessed and if voided is allocated a formal reason for void, and all void statistics are reported daily to Government for further analysis.
It is important to note that Randox is not responsible for the sample logistics of the national programme and, as requested by the national programme, often receives samples in excess of daily capacity to report on within the following days. This is manageable given the time that samples remain valid.
Randox is a private sector diagnostics company, has been in operation since 1982 and operates in 145 countries across the globe. As such Randox have experience of a wide range of public and private sector responsibilities. Randox takes great care in meeting all of its contractual obligations and fully recognises the critical importance of meeting those obligations with regard to the national testing programme.
Randox does not prioritise commercial work ahead of other work streams.
As stated to the Sunday Times, staffing levels are not an issue and holidays have not impacted on throughput – Randox is currently successfully above our commitment to government.
We reiterate that Owen Paterson MP has played no role in securing any Randox contract with DHSC.
Randox staff have been extraordinary in their commitment and dedication in meeting unparalleled need at a time of national crisis, often in the face of ill-informed and misplaced criticism. We salute our staff.
Press enquiries should be emailed to randox@newcenturymedia.co.uk
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Vacancies available in support of the COVID-19 National Testing Programme
17 September 2020
Vacancies available in support of the COVID-19 National Testing Programme
Vacancies available in support of the COVID-19 National Testing Programme
There’s no doubt that coronavirus is having a devastating effect across the globe.
But here in Northern Ireland there’s a company making a real impact in the fight against COVID-19. And you can be part of it.
Randox Laboratories, in County Antrim, has partnered with the government on its programme for coronavirus testing across Northern Ireland, England, Scotland and Wales.
The programme, which in its first few weeks was focused primarily on staff working within the NHS, and then on key workers, is now available to anyone living across the UK who has symptoms of coronavirus.
Randox are providing high volume laboratory testing of potential COVID-19 samples in its laboratories at the Randox Science Park in Antrim.
It’s an enormous task, but one that Randox is well-equipped to handle. In 2019, Randox manufactured over 3 billion tests and exported to 145 countries. Its new headquarters, the result of a £161 million investment, houses state-of-the-art laboratories and the latest innovations in health diagnostic technology.
The company stepped up to support the government’s testing programme without hesitation.
Across the COVID-19 testing process, a multi-disciplinary team work collaboratively and assiduously to provide optimal support to the national response to COVID-19.
It begins with the production of Randox’s Biochip, a patented testing technology which can run multiple diagnostic tests simultaneously.
Upon identifying the latest strain of coronavirus as a significant global threat, and by drawing on almost 40 years of experience as a world-leading diagnostics company, Randox developed a new Biochip for the diagnosis of COVID-19 in a greatly accelerated time frame of just two weeks. The new Randox Biochip processes two coronavirus tests simultaneously – one specific and one confirmatory – as recommended by the World Health Organisation.
The firm’s team of talented scientists continue to develop these COVID-19 Biochips on an unparalleled scale, in preparation for testing of samples from across the UK.
Meanwhile, specialist engineers design and build the coronavirus testing platforms used to conduct the tests when they arrive at the laboratory.
Randox recently announced it was hiring 160 mechanical, electrical and manufacturing engineers to work on the fast-tracked development of newly designed molecular analysers used to detect the presence of COVID-19.
And the company is also recruiting for positions in Manufacturing and Science, and in particular scientists who have experience in a diagnostic laboratory, in support of Randox’s role within the government testing programme for COVID-19.
These scientists will be exposed to molecular testing techniques including DNA extraction, PCR techniques and Biochip technology, in order to process samples that arrive at the laboratory for testing.
Everyone at Randox has a vital role to play in the practical application of COVID-19 testing. For Scientists, Engineers and those with experience in Manufacturing, Randox’s recruitment drive is a unique opportunity to make a positive impact in the fight against COVID-19. Successful applicants will contribute directly both to saving lives and assisting the national recovery from the COVID-19 pandemic.
To find out more about the positions available for Randox’s COVID-19 testing project, visit https://randox.getgotjobs.co.uk/
Want to know more about Randox?
Contact us or visit our homepage to view more.
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Randox response to Sunday Times Article 13 September 2020
STATEMENT FROM RANDOX: 13 September 2020
Randox analyse samples and provide Covid-19 test results through the national portal as efficiently as possible, and those tested will receive their results by text and email. The vast majority of those tested will receive negative or positive results.
Otherwise, a small minority of samples may be voided for reasons such as leaking or damaged tubes, or have time expired. Those being tested are made aware that samples only remain valid for a limited period once collected, and those periods of validity are fully understood across the planning and logistic process. Randox have no responsibility for the logistics of sample delivery to laboratories.
Should samples enter the laboratory outside that period the results could not be relied upon; the sample could give a false result and would be voided. In all void circumstances individuals are advised by the national program to seek a retest. Randox, and the Government planners, take every precaution possible to minimise voids, understanding that each sample is of critical importance.
A test can only be voided once it is processed and reviewed within our laboratory system, including cross referencing each barcode electronically with the national registration database.
Randox Laboratories are committed to supporting the Government’s response to the Covid-19 pandemic and play an important role in national network of Pillar 2 (outside the NHS) laboratories testing those who may be currently infected with Covid-19. Such testing is critical to the timely identification and containment of Covid-19 outbreaks and to reduce further spread. It is acknowledged that the success of the testing program is essential to the social and economic well-being of the nation.
To support our operations Randox liaise very closely with Government planners responsible for the national collection and distribution of samples, and have built an additional 30,000 square feet of laboratory space and employed many more staff in order to increase capacity. At the time of writing further increases in capacity are being implemented and planned. Decisions on sample distribution across the Pillar 2 laboratory network are made at a national level.
Randox remain committed to effective and timely Covid-19 testing at scale – this is work of national importance.
Press enquiries should be emailed to randox@newcenturymedia.co.uk
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Vivalytic | The All in One Molecular Solution
Vivalytic | All In One Molecular Solution
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Making a Point to Care
Molecular Diagnostics at the Point of Care
- Fully automated, sample to answer point of care diagnostics
- Full molecular workflow consolidated into one small benchtop platform
- Unique test menu covering a diverse range of respiratory, genitourinary and hospital acquired infections including SARS-CoV-2 (COVID-19)
- High-Plex & Low-Plex Capabilities. Powered by Randox Biochip Technology enabling multiple results from one patient sample
- Wireless connectivity, no peripherals required making Vivalytic a unique space-saving & hygienic solution
- Easy 4 step process from sample entry to results. No laboratory training required
Consolidate the Full Molecular Workflow
Supporting Team GB through the Paris Olympics
The Vivalytic has supported Team GB by providing comprehensive testing for a wide range of respiratory infections from a single sample. This allows for targeted management of athletes’ health, ensuring precise treatment and quick recovery.
Regular and rapid testing with the Vivalytic helped maintain athletes in peak physical and mental condition by ensuring infection was detected and treated at the earliest opportunity. Check out the video to the right to learn more about how Vivalytic helped prepare and support Team GB.
“It’s important we know the pathogen driving the disease process to be able to target management appropriately“
“AWARD-WINNING DESIGN DELIVERS
AN UNCOMPLICATED USER EXPERIENCE”
Vivalytic Workflow
Intuitive engineering of Vivalytic ensures the analyser is user friendly. The process of patient sample to result comprises a very simple 4 step workflow.
To begin the test, the user scans or enters sample information. The cartridge code is then scanned into the embedded Vivalytic software. The user then adds sample into the dedicated cartridge slot, closes the lid and inserts the cartridge into the Vivalytic.
The touchscreen display will countdown the time remaining to test completion. Results will be displayed on the screen. Multiple Vivalytics can be wirelessly connected allowing the user to control multiple tests at one time all reporting to a master Vivalytic platform.
Want to know more?
Contact us or visit our COVID-19 Monitoring & Management page
Related Products
VRI Array
SARS-CoV-2 Rapid Test
SARS-CoV-2 Pooling Test
Vivalytic Test Menu
Randox selected to screen travellers to the UAE for Covid-19
02 September 2020
Randox selected to screen travellers to the UAE for Covid-19
Randox Laboratories selected to screen travellers to the UAE for Covid-19, with six sample collection centres across the United Kingdom and Ireland
Randox Laboratories has been selected by Pure Health, the largest laboratory network in the UAE, to test airline passengers flying into the United Arab Emirates, in accordance with the UAE’s requirement for travellers to prove they are not infected with Covid-19. Pure Health has been appointed by the UAE’s government to launch this pioneering project to promote safe travel.
“We are delighted to support Pure Health in their efforts to control the Covid-19 pandemic and facilitate safe travels for passengers flying into the UAE,” said David Adamson, Randox Laboratories, Business Development Manager.
“As one of the largest diagnostic facilities in UK, we are ideally placed to successfully deliver this ambitious initiative, and we are grateful for the trust placed in us.”
Randox Laboratories has already set up six collection centres across United Kingdom and Ireland. The programme is already up and running in London, Liverpool, Glasgow, Belfast, Antrim and Dublin.
“The UAE has trusted Pure Health with safeguarding it against any incoming Covid-19 threats, worldwide, this responsibility requires us to ensure we only partner with verified and accredited facilities around the world, thus why we have partnered with Randox Laboratories, to ensure that the screening process is of the highest quality and to ensure an excellent customer service for the travellers.” said Maria El Houari, International Passenger Screening Project Manager at Pure Health.
The UAE issued regulations that require all travellers flying into the UAE to provide proof of a negative Covid-19 test. Travellers without such a certificate are refused entry into the flight.
The system is similar to the ESTA process in the United States. The traveller visits screening.purehealth.ae, chooses a testing location, selects a time slot, and completes the test at the agreed time and place. Test results are then transmitted to the UAE authorities, who use the data to cross-check arriving travellers against the border control database.
For further information please email randoxpr@randox.com
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