Randox listed on Gov.uk as provider of Day 2 Lateral Flow COVID tests
22nd October 2021: Randox listed on Gov.uk as provider of Day 2 Lateral Flow COVID tests
Following changes to government travel guidance, lateral flow (antigen) tests will be the Day 2 requirement for any fully vaccinated passengers arriving into England, from 24th October. This change applies only to fully vaccinated international travellers and most under 18s arriving into England from non-red list countries, and will replace the previous PCR testing requirement.
This change will come into effect for anyone returning into England, following the half-term break and tests can be completed on or before day two of their arrival.
Randox is listed on Gov.uk as a provider of Day 2 Lateral Flow COVID tests.
Randox offers multiple lateral flow testing solutions, including the new Randox CertiFly rapid antigen test, which will allow you to complete your Day 2 test in the comfort of your own home from only £19.99.
The Randox CertiFly Lateral Flow test is designed to simplify foreign travel for passengers and facilitate the efficient transfer of secure and verified information through an easy to use mobile app.
Available for free through the App Store and coming soon on Google Play, the app securely identifies customers and processes testing results within 3 hours.
To order a Lateral Flow Home Testing Kit visit https://covid.randox.com/day-2-test-at-home/
If your preference is to take your Day 2 test on arrival at the airport then you have the option of visiting one of our many travel centres conveniently located across the UK.
From £35 you can organise for a Sample Collection Officer to take your swab at clinics including Manchester Airport, Heathrow Airport, Stansted Airport, East Midlands Airport, Liverpool ONE, and Waterloo Station London.
To book an in-clinic Day 2 Lateral Flow appointment visit https://covid.randox.com/day-2-test-in-clinic/
Background to Government changes
Eligible fully vaccinated arrivals and those with an approved vaccine from non-red countries will be able to replace the test taken as soon as possible on arrival, referred to as the Day 2 PCR test, with a self-administered lateral flow device (“LFD”). Arrivals must have had a complete course of a recognised vaccine at least 14 days before arriving in England. They will not be required to take a Pre-Departure Test or a Day 8 test.
Passengers who do not meet the “eligible traveller” criteria will still have to take a pre-departure test, a Day 2 and Day 8 PCR test and self-isolate for 10 days upon their return from a non-red list country. Test to Release will remain an option for unvaccinated passengers who wish to shorten their isolation period.
How will the new lateral flow system work?
Passengers will be required to take a photograph of their completed lateral flow test alongside their booking reference number which Randox will provide via email on receipt of order. Randox will then verify the result of your sample. Passengers will still be required to complete a passenger locator form to return to England.
Anyone who tests positive will be required to self-isolate and take a confirmatory PCR test. The government have confirmed that anyone who has previously purchased a Randox PCR test will not need to buy another lateral flow (antigen) test.
With proven testing capability and well-established logistics and customer support services, Randox is strongly placed to allow all travellers to the UK to complete their antigen test with ease – offering same day results up to 11.59pm.
For further information on our Day 2 Lateral Flow testing please click here.
To read more on official UK government announcement please click here.
For customer enquiries please contact our Customer Support team on 028 9434 3005.
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Randox receives UKAS Accreditation for testing of SARS-CoV-2 (COVID-19)
Randox Laboratories has today confirmed its UKAS accreditation for the detection of the SARS-CoV-2 virus (COVID-19), granted on 7th October 2021.
UKAS is the National Accreditation Body for the United Kingdom and is appointed by government to assess and accredit organisations that provide testing services. Given the unprecedented requirement for nationwide testing over the past two years, the need for the public to have confidence in testing remains more important than ever.
Randox has been at the forefront of COVID-19 testing since the outset of the pandemic, is amongst the very largest COVID-19 laboratories in the UK and Europe, and to date has processed almost 20 million tests.
Today this final UKAS documentation confirms that Randox has continuously met all ongoing Government and UKAS requirements and submission deadlines, to remain fully active as a national COVID-19 testing provider, and listed on the Gov.uk website.
Randox, with almost 40 years of diagnostics experience, and multiple UKAS accreditations for a range of testing methods, is well placed to support the testing requirements associated with international travel.
For further information please contact Amy Millar, Randox Public Relations Team Leader on 028 9442 2413 or firstname.lastname@example.org
To order a Randox home test kit (PCR or Lateral Flow) visit covid.randox.com
For any enquiries on our Covid testing services please contact the Randox Covid Customer Support team on +44 (0) 28 9434 3005.
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20th October 2021: Health Minister Robin Swann visits Randox COVID testing laboratories
Health Minister Robin Swann has today thanked local staff for their ongoing role in COVID-19 testing while visiting Randox Laboratories.
During his visit to the testing facility at Randox Science Park on the outskirts of Antrim, the Health Minister heard how the company significantly increased its testing capacity since the beginning of the pandemic.
Following a tour of the facility, Minister Swann, said: “Randox continues to play an important ongoing role in the fight against COVID-19 as part of the National Testing Programme and has enabled thousands of people in Northern Ireland to get tested quickly.
“There is no doubt, that we are in a very fortunate position in Northern Ireland to have companies like Randox. We have seen how the company and its highly skilled and expert workforce have been able to innovate and advance its testing capabilities to greatly support the pandemic. I want to personally thank the staff at Randox for all they have done in helping to keep people safe.”
Minister Swann added: “We are continuing to see a high number of positive cases each day in Northern Ireland which is concerning. Therefore I would again remind people of the importance of getting tested should they develop symptoms. Alongside vaccination and contact tracing, COVID-19 testing remains one of the main pillars of protection against this virus. Please do the right thing.”
Dr Peter FitzGerald, Randox Managing Director said:
“We are delighted to welcome Minister Swann to our COVID testing laboratories at the Randox Science Park in Antrim, to witness first-hand the incredible efforts of our hard-working staff, who have been at the forefront of COVID-19 testing since the outset of the pandemic and as such have played a vital role in the global fight against coronavirus.
“Thanks to their ongoing commitment to serve our communities in these difficult times, Randox remains amongst the very largest COVID-19 laboratories in the UK and Europe, and to date has processed almost 20 million tests for the UK National Testing Programme and testing for international travel.
“Randox have built on 40 years of diagnostic experience, and extensive R&D, to provide our extensive COVID-19 testing capabilities and we will continue to support the community and the needs of travellers for as long as that is required. Thereafter we know that diagnostics have a key role in future healthcare, to both prevent disease and optimise its treatment, and will refocus our efforts to that end.”
Since March 2020, Randox has invested a total of £150 million in the development of new innovations in testing technology and in the building and equipping of world-class testing laboratories, sample collection clinics, and associated logistics networks. The company has also grown its workforce by more than 850, and continues to recruit across science, manufacturing and customer support.
For further information please contact Amy Millar, Randox Public Relations Team Leader; email@example.com or 028 9442 2413
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18th October 2021: Randox launch authentication app for Day 2 Lateral Flow tests for vaccinated international arrivals
Randox, the UK’s largest diagnostics company, today announces that it is launching the Randox CertiFly App, a mobile application designed to securely process and certify results for both pre departure and Day 2 lateral flow tests – the latter a requirement for vaccinated international arrivals in the UK from 24th October.
The app, which applies ID verification technology, is designed to simplify foreign travel and facilitate the efficient transfer of secure and verified information through three simple steps:
Step 1 – Download the Randox CertiFly App and scan your passport to register
Step 2 – Collect your sample using a Randox CertiFly lateral flow testing kit
Step 3 – Scan your result using the app and receive certificate in app and by email
The app, which is solely for use with Randox Certifly lateral flow tests, is free to download. The lateral flow tests, which are ordered from Randox and cost as little as £20, are then used in combination with the app to capture the individual’s ID and securely upload the test result. The identity of users will be validated by scanning passports into the system, with future versions of the app featuring facial recognition software to further increase security.
Available in just 15 minutes, test results are processed using Randox CertiFly’s AI software, before being confirmed manually by a healthcare professional. As applicable, a Day 2 or fit-to-fly certificate will then be issued to the user and stored in the app for easy access.
Each Randox CertiFly lateral flow testing kit has a unique single-use QR code that can be registered with the app. Testing kits, which can be purchased from the Randox Health website, include swab, extraction buffer tube, waste bag, tube holder, package insert and test cassette. The app is available now for iOS and Android devices.
Commenting on the announcement, Dr Peter FitzGerald CBE, Managing Director at Randox, said:
“COVID-19 has severely impacted the way that we travel but, thankfully, testing technology has been able to help the world open up again. At Randox, we are proud to have been at the heart of UK testing and we are continuously looking at ways to make improvements for our customers. Randox has been helping millions of passengers travel safely since the onset of the pandemic by providing innovative testing solutions, like the Randox CertiFly app, that fulfil testing requirements for those who need to travel, whilst keeping costs as low as possible.”
Alex Rusak, Randox VP Business Development, said:
“With Day 2 lateral flow test results a requirement for vaccinated international arrivals in the UK from 24th October, we are pleased to launch our first lateral flow test certification app. The features of the app maximise security and allow the efficient flow of accurate and secure information to provide customers with a verified results certificate, without the need for time-consuming and costly video consultations. With the ability to process more than 100,000 certificates in 24h, the Randox CertiFly App rapidly provides validated test results, with the ultimate goal of making sure that travel is accessible, affordable, and importantly, safe.”
Fintan O’Rourke, Head Of Global partnerships at at CertiFly, added:
“We are encouraged to see testing policy adapt to make international travelling easier and we believe that it’s crucial for technology to adapt alongside this to keep the country as safe as possible. Technology plays a vital role in ensuring the integrity of COVID-19 testing and that’s why CertiFly has developed an app with Randox to reduce the risks associated with fraudulent testing. We have built in the same verification technology that banks use to eliminate identity fraud and a two-step validation process for test results, with AI analysis followed by verification from a healthcare professional. As restrictions evolve, is it important to maintain rigorous testing standards in support of the UK’s fight against COVID-19, and we are proud to be part of this.”
The Randox Certifly App is available to download for iOS and Android devices following purchase of a lateral flow test at covid.randox.com
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SARS-CoV-2 (COVID-19), a highly contagious disease, primarily manifests as an acute respiratory illness, however, for those with health complications, including: autoimmune diseases, asthma, heart disease and diabetes, the risk of developing serious illness and adverse outcomes is much greater. It is estimated that 1 in 6 will experience adverse outcomes that could be life-threatening 1. The spread and devastation of COVID-19 highlights the vital role laboratory diagnostics plays in the diagnosis and management of suspected and affected patients. As the COVID pandemic continues, it is imperative that fast and accurate diagnostic testing strategies are implemented for effective risk stratification and monitoring of treatment and recovery.
In this article, we will review how Randox Reagents can aid in diagnosing and managing SARS-CoV-2 adverse outcomes.
The immune system activates a pro-inflammatory response to enhance host immunity against viruses and decrease colonisation and infection, but only if the pro-inflammatory response is controlled. Uncontrolled pro-inflammatory responses can result in a cytokine storm 2. A cytokine storm is a serious complication associated with SARS-CoV-2, which can trigger life-threatening pneumonia, acute respiratory distress syndrome (ARDS) and multiple organ failure 3, 4. Cytokine storms occur in 5% of severe COVID-19 cases, with several inflammatory cytokines observed at high levels. Due to the elevation of several pro-inflammatory and anti-inflammatory cytokines, a multiplex immunoassay approach can offer several advantages over the widely utilised single ELISA tests. The simultaneous detection of multiple cytokines from a single patient sample will provide clinicians with a comprehensive overview of cytokine markers and complete patient profile, facilitating a personalised treatment plan to be implemented 5, 6.
In COVID-19 patients, CRP testing has proved to perform well in discriminating disease severity and predicting adverse outcomes 7. Elevated CRP levels have been identified in 86% of patients admitted to hospital. CRP measurements are useful in diagnosis, prognosis and monitoring for clinical improvements or deterioration. Moreover, the acute phase reactant, ferritin, has been observed to increase in approximately 60% of COVID-19 patients. In the critically ill COVID-19 patients, extremely elevated ferritin concentrations were recorded, which could be attributed to a cytokine storm and secondary haemophagocytic lymphohistiocytosis (a hyper-inflammatory syndrome associated with multi-organ failure) 8.
Acute kidney injury (AKI) is a common complication in diabetic patients who test positive for COVID-19. Regardless, the National Institute for Health and Care Excellence (NICE) recommend AKI testing in all COVID-19 patients upon hospital admission and their condition monitored throughout their stay 9.
The most commonly utilised screening test for renal impairment is serum creatinine (SCr); however, it is important to consider the accuracy and reliability of the method. Two commercially available methods exist for SCr determination: Jaffe and enzymatic. Whilst the Jaffe method is less expensive, it is more susceptible to interferences which can lead to the misdiagnosis of patients, which isn’t ideal in the current pandemic 7. Moreover, the sensitivity of SCr, regardless of method, in the early detection of renal disease is poor, as SCr is insensitive to small changes in glomerular filtration rate (GFR). Up to 50% of renal function can potentially be lost before significant SCr levels become detectable 8, 9. In comparison, cystatin C (CysC) is a superior marker of renal function and is useful in the determination of the extent of renal damage, as well as distinguishing those with severe and mild COVID-19 10.
Abnormal liver function tests significantly increases a COVID-19 patients risk of developing severe disease and complications such as pneumonia 11. Bilirubin levels, 3 times the upper limit have been observed in COVID-19 patients 11, 12. Whilst the diazo method is commonly utilised in bilirubin testing, superior methods exist. The vanadate oxidation (VO) method offers several advantages particularly in haemolytic and lipemic samples. These advantages are particularly evident in neonatal and infant populations where haemolysis is extremely common. Moreover, the VO method offers a wider analytical measurement range for the comfortable detection of clinically important results 13.
Other liver function markers are known to be elevated in COVID-19 patients including both AST and ALT, with markers like albumin decreased.
The Importance of Lp(a) Testing
Lipoprotein(a) / Lp(a), a strong independent marker of cardiovascular disease risk has recently been identified as a key risk marker of cardiovascular complications in COVID-19 patients. Those with either baseline elevated or elevated levels of Lp(a) following COVID-19 infection may be at a significantly increased risk of developing thromboses. Consideration should be given to measurement of Lp(a) and prophylactic anticoagulation of infected patients to reduce the risk. Elevated Lp(a) levels may also cause acute destabilization of pre-existing but quiescent, atherosclerotic plaques, which could induce an acute myocardial infarction (AMI) or cerebrovascular accident (CVA) (stroke) 14.
The size heterogeneity of apo(a) isoforms represents the biggest challenge faced by laboratories in accurately measuring Lp(a). The variable numbers of repeated KIV-2 units in act as multiple epitopes, and so standardisation across calibrators is vital. Unless the calibrants have the same range of isoforms as test samples, those with higher numbers of the KIV-2 repeat, will represent with an overestimation in Lp(a) concentrations and those with smaller numbers of the KIV-2 repeat, will represent with an underestimation. The smaller isoforms are strongly associated with higher Lp(a) concentrations 15.
Lp(a) assays that are standardised to the WHO/IFCC (World Health Organization/International Federation of Clinical Chemistry) reference material, transferring values from mg/dl to nmol/l are more uniform. The assay considered the most reliable commercially available Lp(a) assay is so because: 15
1. The isoform size variations are reduced as a range of calibrators from separate pools of serum used, which covered a range of Lp(a) concentrations.
2. The isoform size and concentrations are inversely correlated, better matching calibrants with test samples.
3. Methods are calibrated in nmol/l and traceable to WHO/IFCC reference material and give acceptable bias compared with the Northwest Lipid Metabolism and Diabetes Research Laboratory (NLMDRKL) gold standard method.
Want to know more?
Contact us or visit our COVID-19 disease management webpage.
Extended Coronavirus Array
Qnostics SARS-CoV-2 Control
 Complications coronavirus can cause. https://www.webmd.com/lung/coronavirus-complications#1 (accessed 22 July 2020).
 Sinha P, Matthey MA, Calfee CS. Is a “cytokine storm” relevant to COVID-19? JAMA 2020; (): 1-3. https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2767939#:~:text=Why%20has%20the%20%E2%80%9Ccytokine%20storm,and%20associated%20with%20adverse%20outcomes.&text=Several%20early%20case%20series%20in,elevated%20above%20the%20normal%20range. (accessed 22 July 2020).
 Del Valle DM, Kim-Schulze S, Huang HH, Beckmann M, Nirenberg S, et al. An inflammatory cytokine signature helps predict COVID-19 severity and death. The Preprint Server for Health Sciences https://www.medrxiv.org/content/10.1101/2020.05.28.20115758v1.full.pdf (accessed 24 July 2020).
 The Royal College of Pathologists. Guidance on the use and interpretation of clinical biochemistry tests in patients with COVID-19 infection. https://www.rcpath.org/uploads/assets/3f1048e5-22ea-4bda-953af20671771524/G217-RCPath-guidance-on-use-and-interpretation-of-clinical-biochemistry-tests-in-patients-with-COVID-19-infection.pdf (accessed 14 June 2020).
 Dhungana N, Morris C, Krasowski MD. Operational impact of using a vanadate oxidase method for direct bilirubin measurements at an academic medical center clinical laboratory. Practical Laboratory Medicine 2017; 8(2017): 77-85.
 Moriarty PM, Gorby LK, Stroes ES, Kastelein JP, Davidson M, et al. Lipoprotein(a) and its potential association with thrombosis and inflammation in COVID-19: a testable hypothesis. Current Atherosclerosis Reports 2020; 22(48): 1-8.
Reagent | G6PDH
A Biomarker of G6PDH Deficiency
Benefits of the Randox G6PDH Assay
A correlation coefficient of r=0.9903 was displayed when the Randox G6PDH assay was compared to commercially available methods.
Excellent measuring range
The Randox G6PDH assay has a measuring range of 154 – 4303U/l for the comfortable detection of clinically important results.
The Randox G6PDH assay displayed a precision of <4.65% CV.
The Randox G6PDH assay has a reconstituted stability of 4 weeks when stored at +2oC to +8oC.
Dedicated G6PDH controls available
Dedicated G6PDH controls available offering a complete testing package.
Applications available detailing instrument-specific settings for the convenient use of the Randox G6PDH assay on a variety of clinical chemistry analysers.
Instrument Specific Applications (ISA’s) are available for a wide range of biochemistry analysers. Contact us to enquire about your specific analyser.
The G6PD gene provides the instructions for marking the glucose-6-phosphate dehydrogenase (G6PDH) enzyme 1. G6PDH is a cytosolic enzyme located on the long arm of the X-chromosome of bodily cells and so is an inherited x-linked disorder. G6PDH is involved in the normal processing of carbohydrate and the prevention of cellular damage from reactive oxygen species (ROS). In doing so, G6PDH provides substrates to prevent oxidative damage. G6PDH plays a critical role in red blood cells, protecting them from damage and premature destruction. The two main products of G6PDH are: ribose-5-phosphatase which is important for DNA, the chemical cousin of RNA; and NADPH which protects the body from ROS 1, 2.
Glucose-6-phosphate dehydrogenase (G6PDH/G6PD) deficiency is the most common enzyme deficiency in the pentose phosphate pathway, affecting more than 400 million people globally. G6PDH deficiency is an X-linked recessive disorder mainly affecting RBC’s 2.
A defect in the G6PDH enzyme results in premature haemolysis (break down of RBC’s). If the bone marrow cannot compensate for the reduction of RBC’s, haemolytic anaemia can occur. Many individuals that are glucose-6-phosphate dehydrogenase deficient are asymptomatic most of the time, however when they are exposed to certain triggering factors, they can develop acute haemolytic anaemia (AHA), which can be life-threatening, especially in children. Symptoms associated with G6PDH deficiency can include paleness, jaundice, dark urine, fatigue, shortness of breath, a sudden rise in body temperature, lower back pain, splenomegaly (enlarged spleen) and a rapid heart rate. Other symptoms can include nausea, diarrhoea or abdominal discomfort. It has been noted that glucose-6-phosphate dehydrogenase deficiency is a significant cause of mild to severe jaundice in new-borns. Early and accurate diagnosis of G6PDH deficiency is essential in ensuring the successful management of haemolytic anaemia 1, 2.
Of all malaria cases reported in Latin America and the Caribbean, 42% are attributed to Brazil. However, in recent years, progress has been made towards the elimination of the malaria burden, reaching the lowest levels in the past 35 years (143, 910 cases and 41 confirmed malaria-related deaths). Whilst the transmission area of malaria has significantly reduced, 99.5% of Brazil’s malaria burden is attributed to the Amazon Basin 3. The predominant contributor to the malaria outbreak in Brazil is attributed to the plasmodium vivax parasites which can cause severe and fatal complications in glucose-6-phosphate dehydrogenase (G6PDH) deficient individuals. Individuals infected with malaria are treated with primaquine, however, in G6PDH deficient individuals, this treatment can induce haemolytic anaemia, and so, G6PDH screening is vital 4.
A Brazilian study, published in the Malaria Journal prospectively evaluated 516 male volunteers within the Alto do Juruá, an area characterized by a high prevalence of plasmodium vivax, to determine the prevalence of G6PDH. The study found that 4.5% of the study group were G6PDH deficient and were at a high risk of haemolytic anaemia if treated with primaquine. As such, the routine screening of G6PDH deficiency in Brazil to personalize the treatment of patients with vivax malaria, is crucial for malaria elimination 4.
Chloroquine, an anti-malaria drug, has been selected to aid in treating those with COVID-19 following preliminary research and a limited study in Australia which highlighted that chloroquine showed promise in eradicating the virus. Moreover, Chinese research highlighted the efficacy and safety of chloroquine in treating pneumonia in COVID-19 patients 5.
It is believed that COVID-19 is expected to spread to areas where G6PDH deficiency is more common, however, serious consideration must be given to treatment decisions using chloroquine as chloroquine-induced haemolysis is the result to decreased G6PDH activity 6.
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Reagents Resource Hub
 Genetics Home Reference. G6PD gene. https://ghr.nlm.nih.gov/gene/G6PD (accessed 13 March 2020).
 Vick DJ. Chloroquine Is Not a Harmless Panacea for COVID-19 — There’s a real safety concern with malaria drug. https://www.medpagetoday.com/infectiousdisease/covid19/85552 (accessed 12 June 2020).