Frequently Asked Media Questions
Randox have almost 40 years of experience as a primary manufacturer in the IVD (in vitro diagnostics) industry. Last year we manufactured over 3 billion tests and exported to 145 countries. Randox are an ISO 13485 accredited manufacturer of in-vitro diagnostic medical devices, are a provider of a global laboratory accreditation scheme (RIQAS) accredited to ISO 17043, and run a number of ISO 17025 accredited laboratories. As an exporter to 145 countries and a manufacturer to other diagnostic companies we undergo multiple external audits each year, in order to remain engaged with our global markets.
At the time of the emergence of the COVID-19 threat, Randox had already developed seven CE marked assays for a range of viruses, including a number of other coronaviruses.
Upon identifying the latest strain of coronavirus as a significant global threat, Randox was able to harness our R&D capability, and some 40 years’ in diagnostics, including viral tests, to develop an effective COVID-19 assay with the same rigorous validation processes that we applied to all our other assays.
The Randox COVID-19 test underwent evaluation within, and was accepted by, Public Health England.
In its evaluation of the Randox COVID-19 test, Public Health England’s report noted that the assay correctly identified all positive and negative samples without exception.
As one of the UK’s major life sciences companies, providing diagnostic capabilities both within the UK and globally for almost 40 years, Randox has maintained regular contact with senior officials directly responsible for Life Sciences in the UK, particularly in the fields of diagnostic capability and innovation. We had developed our COVID-19 testing capability by mid-February 2020, and notified officials as such.
Over a number of weeks, we worked collaboratively with government to determine how best we might be able to support the national testing programme.
Our contribution to this programme, which was announced on 27th March, was the culmination of significant engagement, from the identification of the threat, until that date.
The UK Government showed significant confidence in Randox’s capability and conducted full engagement and planning subject to PHE acceptance of the Randox test. When PHE acceptance was granted, the Randox part in the national plan had been prepared and was quickly initiated.
Randox are providing high volume testing within our laboratories.
It should be noted that Randox is only one partner within a multi-partner, national testing programme being run and coordinated by the Department of Health and Social Care.
In order for the testing programme to work efficiently, all partners work to ensure effective processes at each stage of the testing journey – from testing kit distribution and sample collection to transportation and delivery, and finally, the testing of the sample.
For our part, we are focused diligently on processing all tests in a timely manner after receipt of sample at our laboratory.
It is our priority to ensure that we support the national effort to fight COVID-19, by testing at scale, as we know that this is the most effective way to save lives and promote a timely return to a more normal society.
Our COVID-19 testing currently (as at June 2020) accounts for up to 17% of the national testing programme.
PHE managed the validation process for each of England, Wales, Scotland and Northern Ireland.
We understand that the national plan for COVID-19 testing is exactly that, a national plan, inclusive of Northern Ireland. The planning for the national distribution of test kits is being managed by the various statutory agencies however Randox made the case that tests should be made available locally.
Following that engagement, Randox tests were made directly available within Northern Ireland, and sent, for example, to the drive-through test centre at the SSE arena.
Randox will continue to support Northern Ireland within the UK national plan.
The Randox COVID-19 test is a molecular-based test which looks for SARS-CoV-2 (the virus that causes COVID-19) within the body. PCR (Polyamerase Chain Reaction) techniques are used to detect viral RNA (ribonucleic acid) contained inside the SARS-CoV-2 virus.
The platform used for testing is Randox’s proprietary Biochip Technology, which allows multiple tests to be carried out simultaneously.
The COVID-19 Biochip conducts two tests – one specific and one confirmatory – as recommended by the World Health Organisation and the Centres for Disease Control and Prevention.
The majority of results are reported within 24 hours of receipt of sample at our laboratories.
There will always be challenges within the first few months of an unprecedented programme facing an unprecedented threat and the associated global supply chain issues affecting all countries and organisations.
We are successfully overcoming these issues, ramping up our testing capacity, and moving forward positively with all stakeholders. We remain committed to the provision of optimal support to the national testing programme and the wider effort to fight COVID-19.
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 helps explain the variation between the UK and other countries.
Read an Opinion Piece from our Managing Director, Dr Peter FitzGerald, on the Telegraph Online, by clicking here.
In support of our role within the national testing programme we have invested £30m in a new COVID-19 testing laboratory at the Randox Science Park in Northern Ireland.
We have hired almost 300 new staff, and are recruiting for an additional 200 across science, engineering and manufacturing.
Find out more here.
As we continue to ramp up our testing capabilities, and work alongside the government to offer this testing to an increasing list of individuals, we also recognize a demand from a range of businesses who wish to adopt our innovative COVID-19 testing technologies to address their own particular testing requirements, without impacting on the public health need.
The Randox COVID-19 test is available to purchase as part of our ‘Get Back to Business’ COVID-19 testing service, for staff screening.
Since developing our COVID-19 assay, we have had various discussions with interested parties from countries such as China, Italy, Japan, Spain and of course the UK, on how to utilise the test to help their country’s response to the coronavirus outbreak.
On 7th August we took 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, 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.
The decision to recall Randox sample collection kits within the UK National Test and Trace Programme does not apply to our private business which uses a different supplier of swabs.
Randox private customers or kits are not affected.
For COVID-19 press enquiries please email email@example.com
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