SARS-CoV-2 Antigen Test EI & MultiSTAT

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SARS-CoV-2 Antigen Test EI & MultiSTAT

SARS-CoV-2 Antigen Test

Quantitative measurement of SARS-CoV-2 nucleocapsid protein in nasopharyngeal swab

Simultaneous detection of SARS-CoV-2 nucleocapsid protein

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    Simultaneous detection of SARS-CoV-2 in up to 54 patient samples in 2.5 hours

     

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    Nucleocapsid protein has been confirmed an ideal target for early detection in SARS-CoV-2 infection
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    Early identification of SARS-CoV-2 in asymptomatic high-risk exposure individuals
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    Rapid results allow for better timely therapeutic intervention to limit virus /community spread
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    Antigen detection of SARS-CoV-2 Omicron variant with 97% clinical sensitivity

     

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    Antigen tests can be used in a variety of testing strategies to respond to the SARS-CoV-2 pandemic

Randox have developed an Antigen test for SARS-CoV-2 for the quantitative measurement of SARS-CoV-2 nucleocapsid protein in nasopharyngeal swab samples. Designed to aid in the identification of individuals with SARS-CoV-2, the Randox antigen test provides a timely and accurate diagnosis imperative to limit virus spread and to provide appropriate treatment to patients.

Viral antigens are only expressed when the virus is actively replicating, thus making antigen tests such as the Evidence Investigator SARS-CoV-2 antigen test clinically valuable for identification of acute/early infection.

Ordering Information

DescriptionCat Code
54 Biochip Investigator Kit for SARS-CoV-2 AntigenEV4451/A
Control Kit for SARS-CoV-2 Antigen TestEV4451/B

Available Platforms

Evidence Investigator

Estimated turnaround time: 2.5 hours

Medium throughput (54 samples)

Batch testing

Suitable for laboratory setting

Comprehensive immunoassay and molecular test menu available

Evidence Investigator

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Response to release of specified minutes, notes and correspondence relating to Government contracts awarded to Randox

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4th February 2022: Response to release of specified minutes, notes and correspondence relating to Government contracts awarded to Randox

A spokesperson for Randox said:

“It is clear from these papers that Randox contracts were awarded in full compliance with government procedures and protocols in place at a time of the emerging pandemic.

“The awarding of the contracts reflected Randox’s extensive diagnostics capabilities within the UK and 40 years of experience in that field. As Secretary of State, Sajid Javid says in his statement, the service Randox provided was integral to the rapid building, from scratch, of the largest ever testing industry in UK history.

“Randox’s laboratories expanded rapidly in order to operate at scale and were the first laboratory to report over 100,000 PCR results in a day. It is clear from these papers that the company has delivered a vital and core part of the UK’s testing capacity.

“Randox remains proud of its performance and delivery of Covid 19 testing throughout the pandemic. To date Randox has reported almost 24 million PCR results and has played a key role in both keeping people safe and sustaining vital national infrastructure.

“Unlike other laboratories Randox was able from the outset to provide whole-system capabilities to deliver the tests. Both the World Health Organisation and the UK government agreed this capability was crucial to combating the pandemic.”

For all media enquiries, please contact Ian Monk on ian@ianmonk.com or  +44 7970 026072 / + 44 203 011 1933

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2 years on…since the development of the Randox COVID-19 Biochip

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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.

2 years on

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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Randox provides Team GB’s COVID testing for Beijing Winter Olympic Games

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Tuesday 01 February 2022

Gold standard testing for Great Britain’s Olympians: Randox provides Team GB’s COVID-19 testing for Beijing Winter Olympic Games

As part of the two-year partnership between Randox and The British Olympic Association,  the Team GB Olympians competing in the Olympic Winter Games 2022 have used Randox COVID-19 tests to ensure they touch down in Beijing free of COVID and have the best possibility opportunity to compete without the fear of being ruled out on health grounds.

The ‘stop the virus’ logistics drive mirrors a similar and highly successful regime which ensured that Team GB landed in Japan for the 2020 Olympic Games COVID-free, and that no athlete was forced to withdraw in Tokyo because of infection or close contact with someone who had tested positive.

Despite fears that the virus could impact Team GB’s Olympic hopes, the rigorous testing programme put in place helped UK sporting stars to rack up 54 medals – their best-ever performance at an overseas Games bar the 67 medals won in Rio in 2016.

To provide its gold-standard PCR testing services, Randox created a bespoke dashboard for Team GB to register its samples, which will be taken by the Team GB Clinical Team and then transported to the company’s laboratories which are located in Manchester, Greater London and Northern Ireland.

Randox is testing a delegation of 200 Olympians, coaches and support staff in order to meet China’s testing requirements and thereby minimising possible transmission of the virus in Beijing. Randox is providing each member of Team GB with four rounds of pre-departure tests and can offer rapid same-day testing on the day of flying as an extra precaution.

At the time of the announcement of the partnership between Randox and the British Olympic Association, in June 2021, Randox Managing Director, Dr Peter FitzGerald, said:

“We are delighted to be supporting Team GB by helping them get safely to the starting line in Tokyo with our premium Covid-19 testing services, the provision of which has been a major focus of ours since the outbreak of the pandemic. Over the last year, we have been investing significantly in our customer service and testing capacity, which means Randox can now process over 500,000 tests per day, making it the largest laboratory in Europe, and to date has processed over 13 (now 23) million tests. For this reason, our Olympians and anyone else who needs to travel internationally can rest assured that they will receive timely results.”

British Olympic Association CEO, Andy Anson, said:

“This is a fantastic and vital partnership for Team GB ahead of Tokyo 2020 and Beijing 2022. We have committed to our hosts in Japan and the IOC to ensure that our delegation is fully vaccinated and are also ensuring we have enhanced Covid testing in place. Randox’s pedigree in this area gives us great confidence that we are providing athletes with the best possible medical support around Covid testing and that they get to the start line safely ready to compete successfully for the biggest moment of their sporting careers.”

Randox, with almost 40 years of international diagnostics experience, has been at the forefront of COVID-19 testing since the outset of the pandemic. With proven testing capability and well-established logistics and customer support services, Randox are strongly placed to allow international travellers to travel with confidence.

Beijing Winter Olympic Games 2022

Pictured with a Randox COVID-19 Predeparture Test is English freestyle skier Katie Summerhayes

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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Evaluation of Omicron Variant to Ensure Test Effectiveness

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7th December 2021

Evaluating Omicron and Other SARS-CoV-2 Variants to Ensure Test Effectiveness

SARS-CoV-2, like all viruses, evolves over time through mutations, as it spreads and replicates. Since the beginning of the COVID-19 pandemic, many variants of the SARS-CoV-2 virus, with different sets of mutations, have been observed worldwide. Most changes have little impact on the virus’ properties. However, some may cause increased transmissibility, severity of disease or the ability to evade the host immune response. Surveillance of genetic variations is therefore crucial to identify those variants which pose a higher risk to human health.

Variants may impact the performance of current diagnostic approaches. This is why Randox continuously review public genomic databases to assess whether any emerging mutations overlap with the assay design and monitor assay performance as part of post-market surveillance efforts to ensure the coronavirus assays continue to meet the highest quality standards.

In light of the emergence of the new variant of concern detected in South Africa, Omicron (B.1.1.529), Randox have analysed all publicly available sequences of the variant to predict any impact of defining mutations on assay designs.

As the COVID-19 assays from Randox Laboratories Ltd. are designed using a dual-target approach (ORf1ab, E gene) to reduce the impact of genetic variation in the SARS-CoV-2 genome, detection of SARS-CoV-2 is not predicted to be affected by the currently known variants.

Detection of SARS-CoV-2 using the Vivalytic rapid RT-PCR tests, targeting the E gene sequence are not affected by the identified mutations. Assay performance is not predicted to be impaired by the current known variants.

Randox Laboratories Ltd., in collaboration with leading technology manufacturer Bosch Healthcare Solutions, have developed a range of COVID-19 testing solutions, providing clear and concise results in a timely manner, directly at the point of care. Randox is a distributor for Vivalytic platform and cartridges.

For all enquiries regarding our COVID-19 assays performance , please contact marketing@randox.com

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Randox welcomes CMA moves to safeguard consumer interests around PCR testing

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3rd December 2021

Randox Statement: Randox welcomes CMA moves to safeguard consumer interests around PCR testing

Responding to today’s announcement by the Competition and Markets Authority (CMA), a spokesman for Randox said:

“We welcome the role played by the CMA, with our full co-operation, in ensuring that consumers continue to get a fair deal during the Covid emergency.

“Randox has been happy to engage fully with the CMA from the outset to ensure in the interests of its customers while the company delivers millions of Covid-19 PCR tests to facilitate vital international travel against the changing requirements of governments.

“As the industry leader, Randox has been in the ideal position to both review the services required to support the international traveller and provide a consumer-industry standard of Terms and Conditions. These have, of necessity, evolved over time.

“In working with the CMA, Randox’s aim has been to ensure absolute fairness whilst building and providing critical services in a highly volatile and demanding environment.”

Additional Information

Randox has today welcomed engagement with the CMA to optimise Covid-19 PCR testing support for international travel whilst ensuring the sustainability of critical national services.

As the industry leader Randox has been in the ideal position to both review the services required to support the international traveller, and provide a consumer-industry standard of Terms and Conditions, which have evolved over time. In working with the CMA Randox’s aim has been to ensure absolute fairness whilst building and providing critical services in a highly volatile and demanding environment.

“Both industry and the travelling public have faced significant pressures in enabling international travel,” said a spokesperson. “From an industry perspective Government required immediate and large scale investment to establish validated end-to-end testing services, supported by nationwide logistics, with fully secure reporting to both individuals and Government. Yet there were no contracts, no expected duration for services and the requirement was based on a single product – Covid-19 PCR testing. It was also evident that Government would remove the requirement for such testing as soon as practicable and would not provide any further support.”

The spokesperson went on; “At the same time as requiring significant investment and a rapid response from industry, Government retained the right to alter demand on an almost daily basis and did so frequently by moving countries between the green, amber and red lists with no notice. Government subsequently removed the country lists entirely and effectively closed the requirements for international travel PCRs by moving to lateral flow devices in October – only months after establishing services.” The decision by the Prime Minister to reintroduce PCR testing at very short notice this week, without prior notice to industry, further illustrates the challenges faced.

It had also been clear that the public were faced with highly variable pricing by a number of suppliers – some advertising low prices, but which were only available in very limited circumstances – something Grant Shapps asked the CMA to review. “From the very start Randox committed to highly competitive and transparent pricing which was available across the nation,” said the spokesperson. “Our home testing kits are available at an all inclusive price of £43 with a click and collect service at £34.99 – we know that these represent excellent value for money.”

Randox’s engagement with the CMA has provided the ability to review consumer-industry terms and conditions in the light of very hard won experience. “We do hope that other providers will consider our terms and conditions,” said the spokesperson, “and we know that the CMA will provide further guidance where required.”

The spokesperson went on; “We at Randox are very proud of what we have achieved in very demanding and volatile circumstances. We have built and sustained a reliable and cost effective service to enable international travel – meeting critical business needs and ensuring friends and families can continue to meet. We are committed to providing this service for as long as Government requires.”

 

For all media enquiries, please contact Ian Monk on ian@ianmonk.com or  +44 7970 026072 / + 44 203 011 1933

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Ministers and MPs Praise Randox’s ‘Life-Saving’ Role In Delivering Mass Testing During Pandemic

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18th November 2021

Speaking in the House of Commons on behalf of the government on November 17, Health Minister Gillian Keegan praised Randox’s 40 years of experience in testing and diagnostics. She confirmed to the House that as early as March 2020, Randox already had lab-based PCR testing capacity for Covid-19.

Recognising the imperative of testing as a weapon against the pandemic and facing a shortage of proven testing capacity, she said “the Government had made the common sense decision to work with companies that had existing diagnostic capability.”

The Minister continued: “The initial challenge that (Randox) faced was the challenge facing governments the world over: a shortage of machinery and transport. Nonetheless, it quickly overcame them to play a critical role in our pandemic response.”

She also confirmed that in June 2020, Randox was ahead of all other labs in process, plans, and reporting. A six-month-extension was agreed in September 2020, and by March 2021 Randox was exceeding contract targets, processing more than 120,000 tests in a single day.

Keegan said to date, that Randox has carried out over 15 million tests for Covid-19, and identified over 700,000 positive cases. “That is 700,000 people who might otherwise have gone on to spread the disease,” She continued: “As a result of this testing capacity, they received the right advice to isolate, thereby protecting their friends, their family and society at large.”

Her recognition of Randox’s crucial role in combatting the pandemic at its height was echoed by Maggie Throup MP, Minister for Vaccines and Public Health, who said that working with Randox was a decision which had “saved many thousands of lives”.

She told the House: “contracts with companies such as Randox have been some of the essential building blocks without which we would never have built what is now one of the largest testing networks in the world.”

Throup said she “utterly rejected” the idea that Randox had received any kind of special treatment.

“Our partnership with Randox is simply a reflection of the situation in which we found ourselves in March 2020”, she clarified, “facing a global pandemic of unknown and unprecedented proportions and acting as a responsible Government should. We worked against genuine fears that we would run out of vital testing equipment, that we would not have the capacity to test people and that the deadly virus might continue to spread from person to person, silent and undetected.” 

“Working with Randox was the right thing to do, it was the responsible thing to do and, quite simply, it was a decision that has saved many thousands of lives”, she told MPs.

 

For all media enquiries, please contact Ian Monk on ian@ianmonk.com or  +44 7970 026072 / + 44 203 011 1933

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House of Commons Debate | Randox Statement

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17th November 2021: House of Commons Debate | Randox Statement

Randox will be pleased to co-operate fully in laying before the House all the material required.

Public disclosure will demonstrate the extraordinary efficiency and value for money provided by Randox through contracts awarded in full compliance with government regulations at a time of national crisis.

Contrary to much of what has been written and broadcast, lobbying played no role in the awarding of these contracts.

The company has 40 years experience in testing and diagnostics. It is proud of its performance and delivery under the contracts awarded to it on merit by the Government. They resulted in the delivery of more than 21 million Covid tests, 15 million of them to the National Testing Programme from the start of the emergency in the Spring of 2020.

At this time, hindered by global shortages and less experience than Randox, other laboratories were simply not able to provide whole-system capabilities to deliver the tests which the World Health Organisation and the UK government agreed were crucial to combating the pandemic.

 

11th November 2021: COVID Contracts | Randox Statement

Randox  states categorically that political lobbying played no role in the award of Covid contracts to the company. The Department of Health and Social Care (DHSC) contracts to provide Covid-19 testing were awarded on merit to Randox as the largest healthcare diagnostic company from the UK. The entire process was transparent and compliant with government regulations in a time of national crisis.

Randox has almost 40 years experience in testing and diagnostics: it was one of the first companies in the world to develop a Covid-19 test and to have developed extensive laboratory, IT and logistic infrastructure to support large scale testing operations. The decision to award Covid-19 contracts was fully validated by the company’s performance and delivery under the terms of the contracts.

The company was awarded its initial Covid contract on 30 Mar 20 and, within a short period, had exceeded the initial Covid-19 testing capability of the entire NHS.

Subsequent DHSC planning required Randox to deliver 17,000 tests per day by the end of April and more beyond then. To facilitate and ultimately enable these extraordinary levels of delivery, Randox was temporarily allocated 5 extraction systems from universities in order to increase capacity. DHSC directed the Army to collect equipment, in line with their support for all Pillar 2 laboratories.

This was a pragmatic and transparent move by the DHSC to meet a critical national need to save lives and ease overwhelming pressure on the NHS.  The extraction systems were returned once the systems ordered by Randox, against the backdrop of a global shortage of such equipment, had been delivered and installed.

Randox and its staff have striven tirelessly and innovatively to support the national Covid-19 testing effort. We are proud of our collective achievement at a time of crisis in being the only Pillar 2 laboratory to have reported in excess of 100,000 Covid-19 results in one day.

 

For all media enquiries, please contact Ian Monk on ian@ianmonk.com or  +44 7970 026072 / + 44 203 011 1933

 

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COVID Contracts | Randox Statement

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11th November 2021: COVID Contracts | Randox Statement

Randox  states categorically that political lobbying played no role in the award of Covid contracts to the company. The Department of Health and Social Care (DHSC) contracts to provide Covid-19 testing were awarded on merit to Randox as the largest healthcare diagnostic company from the UK. The entire process was transparent and compliant with government regulations in a time of national crisis.

Randox has almost 40 years experience in testing and diagnostics: it was one of the first companies in the world to develop a Covid-19 test and to have developed extensive laboratory, IT and logistic infrastructure to support large scale testing operations. The decision to award Covid-19 contracts was fully validated by the company’s performance and delivery under the terms of the contracts.

The company was awarded its initial Covid contract on 30 Mar 20 and, within a short period, had exceeded the initial Covid-19 testing capability of the entire NHS.

Subsequent DHSC planning required Randox to deliver 17,000 tests per day by the end of April and more beyond then. To facilitate and ultimately enable these extraordinary levels of delivery, Randox was temporarily allocated 5 extraction systems from universities in order to increase capacity. DHSC directed the Army to collect equipment, in line with their support for all Pillar 2 laboratories.

This was a pragmatic and transparent move by the DHSC to meet a critical national need to save lives and ease overwhelming pressure on the NHS.  The extraction systems were returned once the systems ordered by Randox, against the backdrop of a global shortage of such equipment, had been delivered and installed.

Randox and its staff have striven tirelessly and innovatively to support the national Covid-19 testing effort. We are proud of our collective achievement at a time of crisis in being the only Pillar 2 laboratory to have reported in excess of 100,000 Covid-19 results in one day.

 

For all media enquiries, please contact Ian Monk on ian@ianmonk.com or  +44 7970 026072 / + 44 203 011 1933

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Vivalytic | Extensive SARS-CoV-2 Pooling

Vivalytic | Extensive SARS-CoV-2 Pooling Test

15 Samples, 1 Cartridge 

Simultaneous SARS-CoV-2 detection from up to 15 pooled samples

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    Detection from real-time PCR using saliva lollipop swab collection.
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    Up to 15 patient samples may be pooled and added to a single cartridge targeting the E gene sequence

     

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    The SARS-CoV-2 pooling test has recently received CE marking.
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    Simple and easy to use POC analyser with a small footprint making it suitable for use in laboratory and non-laboratory settings
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    Rapid turnaround time of less than 45 minutes for results.
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    Convenient 4 step process from sample entry to results. No laboratory training required

Extensive SARS-CoV-2 Pooling is a rapid real-time PCR test cartridge, providing clear and concise results in a timely manner, direct at the point of care on the Vivalytic. The SARS-CoV-2 polling test with lollipop swab allows for the screening of up to 15 patient samples. One of the first rapid pooling PCR tests on the market, the Vivalytic produces results in less than 45 minutes delivering high accuracy for extensive and faster testing ideal for rapid and confirmatory SARS-CoV-2 screening in any environment.

Ideal for mass testing, the pooling could be done at the level of a ward, medical speciality, social bubble, or group of colleagues. It has potential for use in other settings, such as pre-operative screening, schools and universities, prisons, nursing homes, primary care, and large workplaces. Sample pooling allows more people to be tested quickly using fewer testing resources.

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.

“AWARD-WINNING DESIGN DELIVERS
AN UNCOMPLICATED USER EXPERIENCE”

Download Vivalytic Brochure

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