Randox approved for COVID-19 test to release scheme

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Randox approved for COVID-19 test to release scheme

RANDOX approved for COVID-19 test to release

21 December 2020: RANDOX approved for COVID-19 test to release

Randox has been added to the Department of Health and Social Care’s list of private providers of coronavirus testing.

This includes the lists for both general testing and test to release, a scheme which is applicable to those in England who need to self-isolate on their return from international travel.

If after 5 days you take a test and receive a negative result, you can stop self-isolating.

To purchase your COVID-19 test kit for test to release, visit; https://www.randoxhealth.com/covid-19-home-testing-kit-2/

Please Note: The earliest you can take the test is 5 full days after you left the country not on the travel corridor list. Individuals who do not opt into the Test to Release scheme will need to self-isolate until 10 full days have passed since they were last in a country not on the travel corridors list.

To opt into the scheme, visit https://www.gov.uk/provide-journey-contact-details-before-travel-uk

You must complete this form within 48 hours of arriving back in the UK and will require your booking reference number and name of the test provider.

To view the list of test and release testing providers, visit; https://www.gov.uk/government/publications/list-of-private-providers-of-coronavirus-testing/list-of-private-providers-of-coronavirus-testing

It is important to keep up to date with government guidelines by visiting https://www.gov.uk/guidance/travel-advice-novel-coronavirus to find out more.

For further information please contact covidcustomersupport@randox.com

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20th December 2020: 7 million tests on the National Testing Programme

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20TH DECEMBER: THE 7 MILLION MILESTONE 

We are pleased to let you know that on Sunday 20th December, Randox surpassed 7 million tests within the UK COVID-19 National Testing Programme.

That’s an incredible 7 million samples accessioned, tested and reported by our dedicated and talented staff.

Our staff are our best asset and have risen to the challenge this pandemic has created.

They have worked hard and flexibly, been creative and innovative, and pulled together as a team to make an impact in the fight against COVID-19.

We are very proud of their efforts and teamwork.

Let us once again say thank you to each and every member of Team Randox, for the efforts they have made in 2020.

What we do at Randox remains vital to the national and global management of COVID-19 and our work is making a real and positive difference.

We continue to work hard and improve, for the sake of our family, friends and communities.

For further information please email randoxpr@randox.com

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Vivalytic’s rapid coronavirus test delivers results for positive samples in less than 30 minutes

   

18th December 2020

Cloud-based software update means a faster PCR test for SARS-CoV-2

We are happy to announce that due to improved software for the Vivalytic analysis device, the CE marked Vivalytic SARS-CoV-2 rapid coronavirus test, which uses polymerase chain reactions (PCR), now delivers its results even faster. By applying optimized evaluation strategies, the Vivalytic analysis device can detect a positive SARS-CoV-2 sample through its high viral load in less than 30 minutes, right where the sample is collected.

This modified product is part of a research and development project relating specifically to COVID-19, funded by the German Federal Ministry of Education and Research (BMBF) to the tune of 4.97 million euros. The project’s aim is to expand the options for detecting acute infections of the coronavirus, looking particularly at on-the-spot testing in which the sample is analyzed in a fully automatic PCR process, as this offers rapid yet reliable results.

  • Improved software for Vivalytic: turnaround time for positive SARS-CoV-2 samples reduced to under 30 minutes.
  • Update from the cloud: Vivalytic analysis devices are updated over the internet.

Dr. Volkmar Denner, chairman of the board of management of Robert Bosch GmbH said;

“In the fight to contain the coronavirus pandemic, speed is of the essence. With Vivalytic, we are delivering cutting-edge medical technology. Our IT and software expertise have helped to make the Bosch Corona test for positive samples even faster – all within a short period of time.”

The new update is available for the SARS-CoV-2 singleplex test and the SARS-CoV-2 pooled test. Updating the Vivalytic testing devices is simple and straightforward – all that is required is an internet connection to access the Bosch cloud platform Vivasuite. Developed in-house at Bosch, the Vivasuite cloud platform allows users to digitally manage and update all their Bosch Healthcare Solutions devices. This is also an advantage when Vivalytic devices are in use in the field. The platform meets the strictest security standards and data privacy is guaranteed at all times: for example, there is no remote access to Vivalytic devices, and no possibility of accessing patient data.

The turnaround time for samples negative for SARS-CoV-2 is still 39 minutes. PCR tests are considered the gold standard, and Bosch’s rapid coronavirus tests have a sensitivity of 98 percent and a specificity of 100 percent.

Contact marketing@randox.com for further information on the latest vivalytic software update for SARS-CoV-2 testing. 

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Randox launches Mobile COVID-19 Lab for Workplace Testing

Randox launches Mobile COVID-19 Lab for Workplace Testing

11 December 2020: Randox launches Mobile COVID-19 Lab for Workplace Testing

World-leading diagnostics company Randox Laboratories has today unveiled a new Mobile Laboratory Service which will offer rapid and reliable COVID-19 workplace testing.

The service from Randox, which is the largest COVID-19 testing provider in the UK and Ireland, and a partner in the UK Government’s National COVID-19 Testing Programme, uses gold standard PCR technology to generate results in 1 – 3 hours.

Each Mobile Laboratory will be capable of processing up to 1000 samples per day, to allow employers to uphold COVID safety within the workplace and maintain maximum output.

Dr Peter FitzGerald, Randox Managing Director, said;

“As the nation continues to navigate the working challenges caused by the COVID-19 pandemic, an increasing number of organisations will want to implement a COVID-19 testing regime so that they can sustain safe working environments.

 “With this in mind we continue to expand our portfolio of bespoke testing products and services, and our latest addition, the Mobile Testing Laboratory, in conjunction with our work within the National Testing Programme, brings us one step closer to a timely return to a more normal society.”

As part of the Randox Mobile COVID-19 testing service, a team of healthcare professionals will collect the samples on site, and a Laboratory Technician will subsequently expedite the sample and reports the results.

The Mobile Laboratory is available across the UK from 14th December 2020.

Dr FitzGerald continued;

“Since a new study by researchers at the University College London revealed that 86% of people who tested positive for COVID-19 did not have virus symptoms1, frequent screening of asymptomatic patients, is vital to identify any hotspots and limit further spread.

 “Our Mobile COVID-19 Laboratory, which uses gold standard PCR technology and can visit the location of your choice for immediate service, will promote safe working practices, allow companies to demonstrate their commitment to their staff, and facilitate recovery of the UK economy.”

The Randox Mobile COVID-19 Laboratory comes fully staffed and stocked for testing, and is suitable for any and all industries – Construction, Aviation, Hospitality, Retail and more.

Find out more at https://www.randoxhealth.com/mobile-covid-19-testing-laboratory/

For further information please email mobiletesting@randox.com

 

References

    1 https://www.ucl.ac.uk/news/2020/oct/symptoms-covid-19-are-poor-marker-infection  

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    Randox plans to build new Covid-19 testing lab at Donegal site

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    04 December: Randox Laboratories plans to build new Covid-19 testing lab at Donegal site

    Healthcare diagnostics company Randox has announced it plans to build a new Covid-19 testing laboratory at Randox Teoranta in Dungloe.

    The company, a partner in the UK’s National Covid-19 Testing Programme, is expected to open the new lab in Donegal in early 2021.

    The facilities will complement the already existing Covid labs at its County Antrim site, which has completed more than six million tests since the coronavirus pandemic began.

    Randox Founder and Managing Director Dr Peter FitzGerald, commented;

    “Our research and development facility at Randox Teoranta in Dungloe is already responsible for about 14% of our overall manufacturing and R&D work, and a lot of the technology we have developed there is fundamental to our work – not only for Covid-19 but for other health issues including Alzheimer’s disease, Chronic Kidney Disease and Stroke.

    “Our new Covid-19 laboratory in Donegal is an exciting new capability which will, when complete, add significant capacity to Randox’s current Covid-19 testing programme.”

    With its overall daily testing capacity having grown from just 150 tests a day in March this year, to 80,000 tests in December, Randox has taken on more than 750 new staff this year.

    The company, which now conducts testing for passengers at Dublin Airport, hopes to create up to 50 new jobs at Randox Teoranta in support of the new Covid-19 laboratory.

    Dr FitzGerald continued;

    “We are very lucky at Randox that we benefit from a strong talent pool of candidates across science, engineering and manufacturing, and those with experience in these areas have responded well to our call for support in the fight against Covid-19.

    “We look forward to expanding our team at Randox Teoranta so that we may continue to retain and attract top scientific talent within Ireland.”

    Randox Teoranta, based in Dungloe, County Donegal, was established in 2008, is a client company of Údarás na Gaeltachta, and currently employs 110 people.

    For further information please email randoxpr@randox.com

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    SARS-CoV-2 IgG (NP & RBD) DETECTION ARRAY

    SARS-CoV-2 IgG (RBD & NP) ARRAY

    Uniquely measuring antibodies reactive to both RBD and NP

    Uniquely measuring antibodies reactive to both RBD and NP

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      Simultaneous detection of IgG antibodies to RBD & NP maximises assay sensitivity reducing false negatives
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      Confirmation of an adaptative immune response to SARS-CoV-2
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      Distinguish vaccinated from naturally infected individuals
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      Specificity of 99.5% and sensitivity of 100% ≥ 10 days post SARS-CoV-2 PCR confirmation
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      Identify incidence of SARS-CoV-2 infection in vaccinated individuals
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      Qualitative and semi-quantitative results provided

    The Randox CE marked SARS-CoV-2 IgG (RBD & NP) array utilises patented biochip technology to simultaneously detect IgG antibodies against both leading COVID-19 diagnostic antigens; Spike Receptor Binding Domain (RBD) and Nucleocapsid protein (NP). The SARS-CoV-2 IgG (RBD & NP) array is compatible with both capillary and venous blood collection. 

    Maximum sensitivity is ensured through detection of antibodies against both proteins making the assay superior compared to other commercially available serology tests where false negative results may occur.  Measurement of both RBD and NP IgG antibodies also provides an opportunity to discriminate vaccinated versus naturally infected individuals. Spike is one of the major vaccine targets against SARS-CoV-2 with antibodies against Spike RBD correlating well with protection while Nucleocapsid is an immunodominant protein expressed with high immunogenicity during the early stages of SARS-CoV-2 infection.

    Highly sensitive and specific serological assays are crucial for surveillance, to help uncover the burden of disease and to get accurate estimates of morbidity and mortality associated with SARS-CoV-2. Serological assays are also required to evaluate immunological response at an individual/population level and during vaccine trials.

    Crucially, simultaneous measurement of antibodies to RBD and NP provides a tool to monitor breakthrough SARS-CoV-2 infection in vaccinated individuals. This testing approach has wider societal implications in the context of measuring ongoing vaccine effectiveness against evolving SARS-CoV-2 variants such as the Delta variant.

    SARS-CoV-2 IgG (RBD & NP) Array

    • RBD
    • NP

    The S protein consisting of S1 and S2 subunits is located on the surface of the SARS-CoV-2 virus making it highly immunogenic.  The S protein plays an important role in viral attachment, fusion and entry to the host cell, as such it serves as a target for the development of antibodies, entry inhibitors and vaccines. The Receptor Binding Domain (RBD) located on the S1 subunit is the key target for neutralising antibodies. Unlike N protein, RBD is associated with less cross reactivity with other coronaviruses and is therefore highly specific to SARS-CoV-2.

    The nucleocapsid protein (NP) is abundantly expressed in individuals infected with SARS-CoV-2 and is highly immunogenic. N protein is normally very conserved, because of this homology recent research cautions against the use of serology tests that detect antibodies against the N protein alone.

    Ordering Information

    DescriptionCat Code
    SARS-CoV-2 IgG (RBD & NP) ArrayEV4447
    SARS-CoV-2 IgG (RBD & NP) Array Control KitEV4448

    Available Platforms

    Evidence Investigator

    Cost effective and efficient semi-automated multiplex testing solution

    Medium to high throughput (54 samples in 1.5 hours)

    Limited sample volume requirement (10ul)

    Comprehensive immunoassay and molecular test menu available

    Evidence Investigator

    Evidence+

    Fully automated batch immunoanalyser for
    faster testing & accurate results

    High throughput (2070 samples per day)

    Limited sample volume requirement (10ul)

    Comprehensive immunoassay test menu available

    Want to know more?

    Contact us or visit our COVID-19 Monitoring & Management page

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    The Six Million Tests Milestone: 2nd December 2020

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    2ND DECEMBER: THE 6 MILLION MILESTONE 

    We are pleased to let you know that on 2nd December, Randox surpassed 6 million tests within the UK COVID-19 National Testing Programme.

    That’s an incredible 6 million samples accessioned, processed and tested by our dedicated and talented staff.

    Our staff are our best asset and have risen to the challenge this pandemic has created.

    They have worked hard and flexibly, been creative and innovative, and pulled together as a team to make an impact in the fight against COVID-19.

    We are very proud of their efforts and teamwork.

    Let us once again say thank you to each and every member of Team Randox, for the efforts they have made in 2020.

    What we do at Randox remains vital to the national and global management of COVID-19 and our work is making a real and positive difference.

    We continue to work hard and improve, for the sake of our family, friends and communities.

    For further information please email randoxpr@randox.com

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    Response to Channel 4 Dispatches Monday 16th November

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    The claims made about Randox in the Channel 4/Dispatches documentary ‘Lockdown Chaos: How the Government lost Control’ are underhand, deceptive, dishonest and defamatory and the producers have been notified of the true position.

     

    Underhand, deceptive and dishonest behaviour hampers the fight against the pandemic

    “This Channel 4 Dispatches “investigation” and use of an undercover reporter grossly misrepresents the facts on the ground and – more importantly – the hard work of all the staff at Randox to expand operations quickly so we can play an important supportive role in the national effort to defeat the pandemic. The journalist was employed for just 10 days in manufacturing and only spent a very limited time in accessioning.  He was not qualified to carry out an “investigation” on quality control measures used in the diagnostics sector. Furthermore, the consultant microbiologist who reviewed the findings of the journalist is a historic opponent of the Pillar 2 testing programme and as such clearly could not provide unbiassed expertise in his review.

    “If Dispatches had approached us in an upfront and honest manner with legitimate questions, then we would have worked with them to deliver an accurate and factual programme. This is hatchet job journalism of the worst kind.”

     

    Randox wish to state the following:

    Randox strongly refute those allegations made regarding Randox’s laboratory operations within the Channel 4 documentary, ‘Lockdown Chaos: How the Government lost Control’, transmitted on 16th November.  Responses to the key allegations are below these more general comments.

    Randox wish to state that it is particularly disappointing that Channel 4 and Dispatches appear focussed in portraying a national story of chaos and negativity – without reflecting what has been achieved during the Covid-19 pandemic.

    From a standing start, Randox used its extensive experience to develop an innovative assay for Covid-19, built and equipped over 45,000 square feet of specialist molecular laboratories, developed and equipped  a further 50,000 square feet of logistic and technical support space, and mobilised its global supply chains to source equipment and consumables.  Extensive R&D capabilities were also refocussed to support innovation within Covid-19 operations.

    Over 750 new staff have been employed.  Randox have invested over £68m of private money in building and resourcing new facilities and have taken testing capacity from 150 molecular assays per day at the end of March 2020 to 80,000 assays per day by early November.  In just over 7 months Randox have reported over 5 million molecular test results to the UK’s Covid-19 National Testing Programme.

    There have been significant challenges to face and Randox have committed to the provision of safe, accurate, reliable and timely results at scale, within a culture of continuous process improvement.  As a result Randox often operates efficiently above its committed capacity to the National Testing Programme and meets, or improves upon, the required turnaround times for test results.

    Randox, and our staff, do find the use of a covert reporter within our workforce to be disingenuous.  By default that reporter had very limited access, very limited understanding and, it appears, a particularly negative mindset.  Channel 4 could easily have asked for more open access and ensured much more balanced and reputable journalism.

    Randox staff are exceptionally dedicated, working to both support and assist those in need of testing, and to optimise processes.  Randox would like to reinforce their thanks and appreciation to all staff who have achieved so much throughout this pandemic.

     

    Key Rebuttals:

    Allegation: Boxes of samples are unpacked at speed and he (the reporter) was warned there is a recurrent problem of swab samples mistakenly being thrown into the waste with cardboard packaging.

    Response: This is a complete misrepresentation; all samples are unpacked for processing and safety checks are carried out on bulk boxes after they have been unpacked.  On the very rare occasion a sample gets accidently caught in the cardboard packaging (estimated 1 in 100,000) it is found and returned to accessioning. There are no recorded cases of samples going to waste.   It is also physically impossible, should there ever be missed samples, for any staff member to ‘get samples all over them’ due to the stringent safety measures of the compactor/baler.  Supervisors do continually stress and can occasionally embellish the importance of due diligence in accessioning, as was evidenced.

    Allegation:  Randox accessioning processes run a risk of cross-contamination.

    ResponseValid samples are separated from leaked samples, whilst still in leakproof packaging, at the point of accessioning.   Valid samples are wiped down with disinfectant once unpacked; disinfectant is clearly visible on the cloth being used to wipe the tubes, illustrating that tubes are disinfected.  Tubes are then racked in an upright position.  There is no possibility of cross contamination.

     

    ‘The Expert’

    Randox also wish to record their disappointment in the approach undertaken by the ‘expert’ Dr Tom Lewis,  and note the previous stance he has taken on non-NHS laboratories.  Dr Lewis has never operated at the scale or efficiency Randox have achieved, reporting up to 80,000 Covid-19 samples in a single day.  He did not peer review his comments or, noting the inexperience of the undercover reporter (who spent only 4.5 hours in the accessioning area), seek any clarification on processes or procedures from Randox before making his comments.

     

    Press enquiries should be emailed to randox@newcenturymedia.co.uk 

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    Randox launches €99 Express COVID-19 Testing Service at Dublin Airport

    Randox launches €99 Express COVID-19 Testing Service at Dublin Airport

    16 November 2020: Randox launches 99 Express COVID-19 Testing Service at Dublin Airport

    A 99 Express COVID-19 Testing Service which launches this week in a new Travel Testing Centre at Dublin Airport, will see the creation of 50 new jobs.

    The testing service from Randox, a laboratory partner in the UK’s National COVID-19 Testing Programme, utilises a robust and reliable method of testing known as PCR, which Junior Minister for Transport Hildegarde Naughton described as “the gold standard” for travel testing.

    The launch of the Randox Health Travel Centre, which offers rapid next day delivery of results for pre-departure screening as well as on-arrival testing to reduce quarantine timeframes, comes just after Ireland aligned itself with the new EU ‘traffic light’ system to co-ordinate international travel, on Sunday 8th November.

    Sophie Boyd, Project Manager for the Randox Express COVID-19 Testing Service, explained;     

     “With the introduction of the new EU traffic lights system, some people will need a COVID-19 test before travelling or equally, will want a negative test result simply for their peace of mind.

    “We are delighted to have secured a location at Dublin Airport, that allows us to extend our rapid and reliable COVID-19 Testing Service, already used by a range of well-known companies, airlines and elite sporting organisations, to individual passengers and consumers.”

    The Irish Government has agreed that, whilst those arriving from red zones currently have to quarantine for 14 days, this could soon be waived following a negative result from a COVID-19 PCR test taken five days after arrival in Ireland.

    Sophie continued;

    “Travel requirements during the pandemic continue to evolve, but with the introduction of the EU traffic light system, a common prerequisite to travel or to shorten existing quarantine periods will be a negative PCR COVID-19 test, which is currently the only method of COVID-19 testing recognised and approved by every country worldwide.

    “With significant capacity in place to implement high volume PCR testing, we welcome the opportunity to bolster the travel industry’s enormous efforts to restore public confidence in international travel.

    “We are committed to providing the most cost-effective and accurate test in the market to assist with the normalisation of travel, and so Randox will be opening a number of regional travel centres across Ireland over the coming weeks.”

    Dublin Airport Managing Director Vincent Harrison said the health and safety of passengers and staff had been the airport’s key priority during the pandemic and that continued to be the case;

    “We continue to operate a range of globally-recognised COVID-19 safety measures for the health and wellbeing of all airport visitors, and with the official opening of the Randox Health Travel Centre at Dublin Airport we can further support our passengers by offering them access to testing facilities onsite at the airport.”

    The Randox €99 Express COVID-19 Testing Service is open to all asymptomatic individuals and operates from the Randox Health Travel Centre beside Terminal 2 at Dublin Airport, as well as at a testing facility in Leopardstown Dublin.

    In the coming weeks Randox Health Travel Centres will also open in Galway, Limerick and Cork.

    Visit booking.randox.ie to book your appointment.

    For further information please email info@randoxhealth.com or phone 0800 2545 130.

       

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      COVID-19 | qPCR Assay

      COVID-19 | qPCR Assay

      Detecting SARS-CoV-2 (COVID-19)

      Accurate PCR Detection of SARS-CoV-2

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        Validated for use on either the Applied Biosystems™ QuantStudio™ 5 (0.2 mL 96 well block) or Applied Biosystems™ 7500
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        High throughput: 96 samples including controls from extraction to analysis from automated nucleic acid isolation
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        CE marked assay detecting all known SARS-CoV-2 variants of concern
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        Multiplex PCR assay accurately detecting both SARS-CoV-2 (ORF1ab) and Sarbecovirus (E-gene)
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        Rapid turnaround time & PCR run time of 70 minutes
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        High sensitivity and specificity with 98% agreement. Low LOD: 250 copies/mL

      Randox Laboratories have recently developed a COVID-19 qPCR assay, which can be used for the detection of nucleic acid from SARS-CovV-2 (ORF1ab) and Severe Acute Respiratory Syndrome ((SARS)/SARS-like) viruses (E-gene). PCR based assays are recommended to include two tests. One to detect a universal SARS-like gene and a secondary confirmatory test for gene sequences exclusive to SARS-CoV-2.

      In a multiplex format, the Randox qPCR assay allows for differentiation of SARS-CoV-2 and SARS-like corona infections from other seasonal respiratory illnesses caused by viruses to prevent rapid spread of infection through the isolation of positive cases.

      Our assay is compatible with sample matrices including nasal / throat swabs. This test is intended for use in the clinical setting as an aid in the screening and isolation of individuals that require quarantine and immediate intervention.

      Internal control provided to monitor assay/sample integrity through the extraction and PCR process.

      Want to know more?

      Contact us or visit our COVID-19 Monitoring & Management page

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