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.
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 Randox COVID-19 assay 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.
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 £85m since March 2020 in the building and equipping of over 80,000 sq ft of molecular laboratory space and the development of new innovations in testing technology in our COVID-19 testing facilities at the Randox Science Park in Northern Ireland.
We have hired more than 850 new staff, and are recruiting for an additional 400 across science, accessioning, customer support and manufacturing.
Find out more here.
On 9th April 2021, Randox processed its 12 millionth sample within the UK COVID-19 National Testing Programme, representing approximately 21% of all PCR tests executed in the UK.
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 for testing from the general public – for COVID-safe travel and business.
The Randox COVID-19 test is available to purchase as part of our ‘Get Back to Business’ COVID-19 testing service, for staff screening.
On 13th April 2021 Randox announced its support for British holidaymakers and the travel industry by reducing the cost of its PCR travel test to £60. In order to achieve the £60 price, purchasers will need to apply a discount code which can be obtained from airlines when booking travel. Major airlines including British Airways, Jet2, Easyjet and Ryanair have signed up to provide discount codes for their passengers.⠀
For COVID-19 press enquiries please email firstname.lastname@example.org
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