Update on Sample Kits
Update on Sample Kits
STATEMENT FROM RANDOX: 07 August 2020
Randox Laboratories have today taken 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 has, 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.
This recall applies only to sample collection kits within the UK National Test and Trace Programme. Randox private customers or kits are not affected.
Press enquiries should be emailed to randox@newcenturymedia.co.uk
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Ergot Alkaloids ELISA now available from Randox Food Diagnostics
28 July 2020
Ergot Alkaloid ELISA now available from Randox Food Diagnostics
Available now, the Randox Food Diagnostics Ergot Alkaloid ELISA (Catalogue Number EA3491) is:
Compliant with the lowest proposed maximum levels being considered by the European Commission for the total of 12 main ergot alkaloids applicable from July 2020, including the stricter drafted limits from July 2022, for cereal-based feed, wheat and rye milling products.
Accurately detects the sum of 12 main ergot alkaloids to test the most affected type of cereal – rye flour. Randox’s ELISA results show an excellent 95% correlation with the assigned concentration within FAPAS Proficiency Test scheme.
Unrivalled in the detection of low contamination levels. The Z-score of FAPAS PT of -0.6 for baby multigrain food was obtained using Randox Ergot Alkaloids ELISA.
Validated based on Commission Regulation (EC) No 519/2014 as a semi-quantitative screening method for cereal-based feed, wheat and rye milling products. The same regulation was followed for fit-for-purpose approach assessment for confirmatory method, which approves Randox Ergot Alkaloids ELISA as being a method for official control. It is successfully assessed by fit-for-purpose approach according to Commission Regulation (EC) No 401/2006 as approved method of analysis.
Evaluated by third-party laboratory (Wageningen Food Safety research / WFSR, 2019) and proved to be able to distinguish between negative and positive samples. Randox’s ELISA displayed no false-negatives and no false-positives in this study. Across all commercially available ELISA tests, Randox Food Diagnostics Ergot Alkaloids ELISA was the only test which showed good performance with all 3 sample types, including 11 matrices and a total of 24 samples.
Reference reports are available upon request.
For more information visit https://www.randoxfood.com/feed-and-cereals-analysis/ergot-alkaloids/ or email us directly at info@randoxfooddiagnostics.com
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COVID-19 Testing Service Testimonial: The Irish Football Association
COVID-19 Testing Service Testimonial: The Irish Football Association
As we move towards a new ‘normal’ and sporting organisations begin the process of restarting their games, many teams will be wondering how to ensure a safe and reassuring training environment for their players and their staff.
Thanks to our COVID-19 testing service, The Irish Football Association was able to facilitate a timely and efficient return to play by confirming their players as ‘COVID-safe.’
Our ‘Back to Business’ programme has enabled the IFA to demonstrate their commitment to their players, their staff, and their fans, as well as get back to business by ensuring the highest level of safety.
Corinne Lannie, Risk Manager at the Irish Football Association, commented;
“The test kits were very straightforward to use. The instructions were clear as was the YouTube guidance video. The recording onto the Randox system was easy and the speed of results was exceptional.
“The support provided by Paul (Randox Business Development Executive) was amazing – he was extremely helpful and supportive and really went above and beyond.”
At Randox, we offer two types of testing;
PCR (diagnostic) testing, and antibody testing, which can give an indication that an individual has been previously infected with COVID-19.
Sample collection services are available.
David Hallendorff, Business Relations Manager at Randox Health commented;
“Collectively we are all working towards a timely return to a more normal society, which will see companies reopening and people returning to work.
“To facilitate this recovery of the economy, without compromising the health of workers or of the wider general public, workplaces have a responsibility to provide a safe working environment.
“It is great to see so many companies putting the health of their staff as a priority and taking a proactive approach to testing.”
To find out more about our Back to Business COVID-19 Testing Service, please email info@randoxhealth.com or phone 0800 2545 130
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Temporary Precautionary Measure
STATEMENT FROM RANDOX: TEMPORARY PRECAUTIONARY MEASURE
16 July 2020
As an immediate precautionary measure we have temporarily suspended distribution of sample collection kits using one particular batch / supplier of swabs. This is a temporary measure and does not apply to our private business which uses a different supplier of swabs.
Test results from Randox kits are not affected.
For more information please contact the Randox PR team by emailing randoxpr@randox.com
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Early Detection of Acute Kidney Injury in COVID-19 patients
15 July 2020
The Importance of Early Detection of Acute Kidney Injury in COVID-19 patients
Randox are proud to provide an early detection assay, capable of detecting Acute Kidney Injury in COVID-19 positive patients. AKI is an innovative diagnostic tool with the ability to identify four early and highly sensitive markers of kidney injury.
The National Institute for Health and Care Excellence has highlighted that is important that COVID-19 patients are assessed for AKI on admission to hospital or transfer, monitored for AKI throughout their stay and that AKI is managed appropriately if it develops. (NICE, 2020)
The novel test, which includes biomarkers recommended by the U.S. Food and Drug Administration and the European Medicines Agency detects KIM-I, NGAL, Cystatin C, and Clusterin.
Kidney failure associated with COVID-19 is emerging as a common side effect with further studies underway. Early detection to prevent further renal damage, is vital for an individual’s long-term health, wellbeing and overall survival.
The biomarkers on the Randox AKI Biochip have been identified as more sensitive than traditional testing methods, which, based on urine output and levels of serum creatinine, are grossly insensitive and not specific for the accurate diagnosis and monitoring of AKI.
The Randox AKI assay provides results in 2.5 hours. The new testing panel also facilitates increased lab efficiency and reduced sample prep from the laboratory technician. Using just one urine sample, Randox’s patented Biochip Technology tests for all four AKI biomarkers simultaneously, resulting in time and cost saving benefits, which drive towards an increase in clinical performance.
For further information on our Acute Kidney Injury Array please visit the Randox Biosciences website.
For any other enquiries please email info@randoxbiosciences.com
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RX modena and Randox Reagents used in COVID-19 hospital in India
RX modena and Randox Reagents used in COVID-19 hospital in India
Randox Laboratories has installed an RX modena into a COVID-19 hospital in India; the Netaji Subhash Chandra Bose Medical College in Madhya Pradesh state.
The installation, which marks the first RX modena to be used in an Indian Government Medical College, replaces existing instrumentation in the Medical College laboratory, an initiative which was driven by College Dean Dr. Pradeep Kumar Kasar and Head of Department Dr. Ashok Kumar Sahu.
The RX modena will cater for an additional 38 samples compared to the previous instrumentation, and is running a range of biochemistry tests that play a pivotal role in COVID-19 patient management, including C-Reactive Protein (CRP), Ferritin, and Lactate Dehydrogenase (LDH).
Dr. Ashok Kumar Sahu, Head of Biochemistry at Netaji Subhash Chandra Bose Medical College, commented;
“We are very pleased with the performance of the RX modena, and in particular with its wide menu of tests that can be utilized for COVID-19 patient management. Its high throughput and versatility have been a great support for the clinicians working in our COVID-19 hospital, in determining risk stratification, disease progression, and response to treatment.”
The RX modena is a high volume, floor standing, fully automated clinical chemistry analyser with a world leading test menu which covers specific proteins, lipids, therapeutic drugs, antioxidants, diabetes and veterinary testing. The versatile analyser offers advanced methodologies with excellent correlation to the gold standard, and excellent reagent CV ranges.
Shail Dholabhai, Randox India Sales Manager, commented;
“We are delighted that the team at Netaji Subhash Chandra Bose Medical College have chosen the RX modena to fulfil the testing requirements of this COVID-19 hospital. Offering an unrivalled test menu of routine and specialized chemistries, the RX modena provides laboratories with the superior precision, reliability and accuracy that the Randox RX series is renowned for.
“Capable of performing a total of 1200 tests per hour including ISE, the RX modena presents a new class of efficiency which will result in faster and more accurate diagnoses, and ultimately, lead to better patient outcomes.”
Benefits of the RX modena
- Capable of performing 800 photometric and a total of 1200 tests per hour including ISE.
- World-leading extensive test menu covering routine chemistries, specific proteins, lipids, antioxidants, cardiac, diabetes and veterinary testing, offering cost savings through consolidation of routine and novel tests on a single platform.
- Economic platform with low water consumption of less than 20 litres per hour saving on consumable costs. The RX modena also requires less than 5 minutes minimal maintenance.
- Interactive touch-screen technology with integrated barcode readers for reagent and sample identification. Increased functionality with 13 wavelengths generated via diffraction grating (340-800nm) ensuring a multitude of chemistries are possible on one system.
- Easy-to-use advanced Microsoft 10 software with a built-in Inventory Management System calculating the number of tests remaining, providing alerts of shortages and expired reagents and calibrators. The RX modena also features automatic test re-run function and sample dilution.
- Dedicated reagent and sample pipettes to minimise the risk of errors and contamination. The RX modena also features a continuous loading hatch to allow for samples to be analysed quickly and easily during a run.
- Advanced QC capabilities with daily, monthly and batch QC with data archiving, Levey-Jennings charts and automatic QC and calibration. There are also 7 different calibration options available.
For further information about the RX modena click here.
For information about laboratory tools for COVID-19 patient management please click here.
For other enquiries please contact marketing@randox.com
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COVID-19 Testing: PCR (Diagnostic) vs Antibody
18 June 2020
COVID-19 Testing: PCR (Diagnostic) vs Antibody
The advice from the World Health Organisation in relation to the COVID-19 pandemic has been simple; Test. Test. Test.
But what are the different types of COVID-19 tests and what are they used for?
Diagnostic (PCR) Testing
This type of testing detects SARS-CoV-2 (the virus that causes COVID-19) within the body and will tell you if you currently have COVID-19. PCR tests cannot tell you if you have had past infection.
Sample collection for a PCR test can vary, though it is usually in the form of a swab, which will gather an individual’s nasopharyngeal (nose and throat) secretions.
PCR tests for COVID-19 all use methods that detect a specific part of the viral genome – for example Viral RNA or Antigen.
A sample is prepared by extracting the chosen section of the genome, and then PCR (Polyamerase Chain Reaction) techniques are used to amplify (replicate) the genome section, ready for detection.
Viral RNA Tests
This type of test detects the RNA (Ribonucleic acid) contained within the SARS-CoV-2 virus.
It is this type of test, for RNA, that is recommended by The World Health Organisation for COVID-19 diagnosis.
Antigen Tests
Antigens are molecular structures on the surface of viruses that are recognized by the immune system and are capable of triggering an immune response.
Antigen tests detect the presence of the SARS-CoV-2 virus by looking for the antigen on the surface of the virus.
Randox COVID-19 Test
The Randox COVID-19 test, as recommended by the World Health Organisation, detects the RNA contained within the SARS-CoV-2 virus.
After sample extraction and amplification, the virus is detected on our patented Randox Biochip Technology platform.
The Randox Biochip, which can run multiple tests simultaneously, performs two tests for COVID-19 – one specific and one confirmatory – as recommended by the WHO. This delivers extra assurance of the correct diagnosis and avoids the need to repeat the test.
Antibody (Serology) Tests
Antibody (also known as serology) tests, are usually performed on a patient blood sample, and look for antibodies (a type of protein) that may have been developed by the patient’s immune system to fight off disease.
If present, antibodies may provide a degree of immunity for the patient against COVID-19 in the future.
However, there is still much unknown about the body’s antibody response to COVID-19, including;
- Whether all patients who have been infected with SARS-CoV-2 will generate antibodies (recent studies and news reports indicate that this isn’t the case. Click here for an example.)
- Whether those who have had more severe symptoms as a result of COVID-19 will produce more antibodies than those who had mild symptoms, or were asymptomatic.
- If antibodies from other coronaviruses previously experienced by the patient may be enough to fight off the virus, therefore eliminating the need for COVID-19 specific antibodies.
- How long any COVID-19 specific antibody response will last for.
- How much future immunity is provided by COVID-19 antibodies. Will it prevent the patient from being infected, or will future infection just be less severe?
If antibodies for the SARS-CoV-2 virus are present this can give an indication that the patient has been previously infected with COVID-19. Antibody tests do not confirm the real-time presence of the virus in your system.
For example, a negative antibody result does not necessarily mean the body has not been exposed to the SARS-CoV-2 virus. It could in fact, be currently infected, but has not yet generated antibodies. A diagnostic test will confirm current presence of the virus.
Therefore, it is recommended that antibody tests are used in tandem with a diagnostic test to determine a complete overview of the patient’s COVID-19 status.
Randox Health currently offers both diagnostic testing and antibody testing for SARS-CoV-2 (COVID-19).
A combination of diagnostic and antibody testing is available for individual purchase, or as part of our ‘Back to Business’ COVID-19 testing service, for staff screening.
Visit Randox Health to find out more.
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COVID-19 Laboratory Tools for Disease Management
17 June 2020
COVID-19 – Laboratory Tools for Disease Management
In addition to tests for the detection of SARS-CoV-2, the virus that causes COVID-19, laboratory diagnostics play a pivotal role in patient management, risk stratification, monitoring of disease progression, associated complications and response to treatment.
Randox offers a comprehensive range of laboratory solutions including; diagnostics reagents, revolutionary Biochip technology and quality control designed to provide clinicians with valuable insights into disease severity ultimately helping to improve patient care.
Patients with comorbidities such as diabetes mellitus, cardiovascular disease (CVD) and chronic kidney disease (CKD) are particularly susceptible to COVID-19 infection and are at greater risk of developing severe illness. The Randox portfolio may also be used to diagnose and monitor such at risk patients with underlying health concerns.
Biochemistry Reagents
Our extensive test menu comprises 113 assays, including many unique tests and a range of biomarkers designed to assist laboratories when screening for a variety of COVID-19 related health issues.
Randox Reagents are internationally recognised as being of the highest quality; producing accurate and precise results. Applications are available detailing instrument-specific settings for the majority of clinical chemistry analysers.
Elevated markers of inflammation and infection such as CRP may indicate severe viral infection. CRP is elevated in up to 86% of COVID-19 patients who are admitted to hospital. Testing for CRP is useful in assessing prognosis, and when monitoring improvement. It is recommended that CRP is measured at baseline and then at intervals, a sudden increase in levels will prompt surveillance for secondary infection or other cause of deterioration.
As an acute phase reactant, Ferritin levels increase in response to inflammation. High levels have been identified in approximately 60% of individuals hospitalised as a result of COVID-19 infection. In critically ill patients, elevated Ferritin levels may be indicative of a cytokine storm and secondary haemophagocytic lymphohistiocytosis, a hyperinflammatory syndrome associated with organ failure.
Liver Function Tests (Albumin, ALT, AST, Bilirubin)
Patients with COVID-19 may be at higher risk of liver injury or impairment of liver function. Liver function markers such as ALT, AST and Bilirubin are notably higher in more severe infections, decreased albumin levels have also been documented in severe cases. Drug induced liver injury as a result of COVID-19 treatment should not be ignored and should be monitored.
Renal Function Tests (Creatinine, Cystatin C)
Emerging evidence suggests that SARS-CoV-2 may directly affect kidney function, as such COVID-19 patients should be assessed for Acute Kidney Injury (AKI) on admission to hospital and monitored throughout their stay. AKI can lead to worse outcomes for patients.
LDH levels may be a convenient marker for the identification of COVID-19 patients at higher risk of developing severe respiratory failure. It is well documented that high LDH levels are indicative of haematological malignancy and acute lung injury. LDH levels might therefore reflect tissue necrosis related to immune hyperactivity and thus are related to poor clinical outcomes in individuals with COVID-19.
Chloroquine has been investigated as a potential treatment for COVID-19, the anti-malaria drug however could have devastating consequences for those with a G6PDH deficiency. G6PDH deficiency is a genetic disorder affecting the red blood cells, causing them to break down prematurely. The most common complication of deficiency is haemolytic anaemia. An estimated 400 million people globally have G6PDH deficiency, it is most common in certain parts of Africa, Asia, the Mediterranean and Middle East.
Randox Biochip Solutions
Randox Biochip technology is extremely versatile with applications in not only the diagnosis of COVID-19 but also the identification of individuals at risk of developing more severe illness.
Unique to Randox, Biochip technology is capable of simultaneous detection of a panel of related disease markers. An extensive range of Biochip panels are available, each optimised to provide the best performance.
Cytokines play a vital role in the immune system and are known to be involved in the body’s response to a variety of inflammatory and infectious diseases. The over stimulation of these cytokines in response to infection is referred to as a ‘cytokine storm’ and strongly correlates with poor disease outcomes. Cytokine storms are a common complication of SARS-CoV-2 infection triggering viral sepsis, where viral replication and excessive, uncontrolled systemic inflammation may lead to pneumonitis, Acute Respiratory Distress Syndrome (ARDS), respiratory failure, shock, multiple organ failure, secondary bacterial pneumonia, and potentially death. Cytokines such as IL-6 appear to be elevated in patients with more severe illness and may be used to monitor response to treatment as levels decrease as the condition improves.
Quality Control Solutions
Randox offer a range of Quality control and External Quality Assessment (EQA) solutions designed to ensure the accuracy and reliability of patient testing.
Decreased blood counts have been frequently identified in COVID-19 patients and may be indicative of a decreased immunological response to the virus, bacterial infection or consumption.
Blood Gas tests are used to help diagnose and monitor critically ill patients in intensive care units (ICU) and emergency departments. Blood Gas testing continues to play a critical role in the management of COVID-19 patients providing an indication of a patient’s oxygenation levels. Monitoring of these levels will enable healthcare professionals to make ventilator adjustments if required.
Increased levels of cardiac markers including Troponin and CK-MB may be associated with a higher mortality rate in COVID-19 patients.
Patients with severe COVID-19 infection are more likely to have coagulopathy, a condition in which the bloods ability to form clots is impaired. Activation of blood coagulation factors such as Prothrombin Time (PT) and D-dimer are significant predictors of disease severity and mortality.
Procalcitonin is an acute phase reactant released by most tissues during inflammation and is particularly associated with bacterial infection. Although it is not usually elevated in viral infections such as SARS-CoV-2 levels may increase as a result of severe systemic inflammation. It may also be used to help detect secondary infections.
For further information about any of the above Laboratory Tools for COVID-19 Disease Management please email marketing@randox.com
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Cytokine testing for COVID-19 risk stratification and treatment monitoring
11 June 2020
Cytokine testing for COVID-19 risk stratification and treatment monitoring
On Biomedical Science Day 2020, an innovative method of monitoring treatment efficacy and recovery of COVID-19 has been unveiled by global diagnostics company Randox Laboratories.
The test, which looks for the presence of cytokines (a type of small protein) is performed on Randox’s patented Biochip Technology, which can simultaneously detect multiple analytes from a single patient sample.
Cytokines play a vital role in the immune system and are known to be involved in the body’s response to a variety of inflammatory and infectious disease, such as COVID-19.
Lynsey Adams, Randox Marketing Manager, commented;
“Cytokine storms, which are the overstimulation of cytokines in response to infection, are a common complication of severe cases of COVID-19, and can trigger excessive, uncontrolled systemic inflammation.
“The monitoring of cytokine proteins therefore offers a unique opportunity to identify patients who, as a result of this viral sepsis, are at risk of poor disease outcomes including pneumonitis, Acute Respiratory Distress Syndrome, respiratory failure, shock, or even organ failure.
“Treatment for any infection, COVID-19 included, is most effective when administered at an early stage, and so the detection of cytokine storms within COVID-19 patients could provide vitally important information that will direct the appropriate patient care pathway and facilitate improved patient outcomes.”
The comprehensive cytokine testing menu from Randox comprises of 26 different cytokines, across four different biochip panels.
Designed to make cost, time and resource savings for a range of diagnostic laboratories, Randox Cytokine Biochips can detect up to 12 cytokines and growth factors from a single patient sample.
Lynsey continued;
“The multiplex capabilities of the Randox Biochip will provide clinicians with a more comprehensive picture of the patient’s condition.
“Compatible with our Evidence and Evidence Investigator analysers, which are capable of processing 2960 and 2376 tests per hour respectively, Randox Cytokine Biochip panels offer a comprehensive testing method for these proteins which play such a central role in the immune system.”
In addition to COVID-19 risk stratification, cytokine testing has also been linked to monitoring for allergies, vascular diseases, cancer, and a range of autoimmune diseases.
Key Benefits of Randox Cytokine Testing
- Simultaneous detection of up to 12 cytokines and growth factors from a single patient sample
- Fully automated and semi-automated testing platforms available to suit all laboratory throughputs
- Comprehensive test menu comprising 26 cytokines, cytokine receptors and growth factors
- Suitable for use with serum and plasma samples
- Excellent analytical performance
- Availability of complementary quality controls for a complete testing package
For more info please visit www.randox.com/cytokine-testing-solutions/, email marketing@randox.com or phone 028 9442 2413
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