Update on Sample Kits

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Update on Sample Kits

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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.

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

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Bilirubin (Jendrassik)

Bilirubin (Jendrassik)

A Marker of Hepatic Dysfunction

Benefits of the Randox Jendrassik Bilirubin Assay

Exceptional Correlation

Excellent correlation

The Randox Jendrassik assay has a correlation coefficient > 0.99% CV when compared to commercially available methods.

Direct-Total

Direct & Total bilirubin assays available

Randox offer both direct & total bilirubin assays offering choice and flexibility.

Wide measuring range

Wide measuring range

The Randox Jendrassik assay has a measuring range of 0.95 – 606µmol/l for the comfortable detection of clinically important results.

Liquid ready-to-use

Liquid ready-to-use

The Randox Jendrassik assay is available in a liquid ready-to-use format for convenience and ease-of-use.

Calibrator and dedicated control available

Calibrator and dedicated control available offering a complete testing package.

Applications available

Applications available detailing instrument-specific settings for the convenient use of the Randox Jendrassik assay on a variety of clinical chemistry analysers.

  • Ordering Information
  • Physiological Significance
  • Clinical Significance
  • COVID-19

Direct Jendrassik

Cat NoSize    
BR23622 x 250 (L)EnquireKit Insert RequestMSDSBuy Online
BR3807R1 2 x 30ml (L)
R2 8 x 4ml
EnquireKit Insert RequestMSDSBuy Online
BR8035R1 4 x 16ml (L)
R2 8 x 4ml
EnquireKit Insert RequestMSDSBuy Online
(L) Indicates liquid option

Total Jendrassik

Cat NoSize    
BR23612 x 250ml (L)EnquireKit Insert RequestMSDSBuy Online
BR3859R1 2 x 50ml (L)
R2 8 x 4ml
EnquireKit Insert RequestMSDSBuy Online
BR243R1 1 x 100ml (L) (DCA)
R2 2 x 100ml
EnquireKit Insert RequestMSDSBuy Online
BR8036R1 2 x 50ml (L)
R2 8 x 4ml
EnquireKit Insert RequestMSDSBuy Online
(L) Indicates liquid option

Direct & Total Jendrassik

Cat NoSize    
BR4111 x 225ml (L) EnquireKit Insert RequestMSDSBuy Online

Instrument Specific Applications (ISA’s) are available for a wide range of biochemistry analysers.  Contact us to enquire about your specific analyser.

Bilirubin is a metabolite of haem, derived from haem-containing proteins, including myoglobin, haemoglobin and various P450 enzymes, that serves to coordinate iron in various proteins. Half of it is excreted into bile and the rest contributes to blood bilirubin turnover 1. It is mainly produced in the spleen and liver but can also occur elsewhere in the body by macrophages and renal tubular cells 2. The internal hydrogen bonding causes it to be water-insoluble and so required enzyme-mediated glucuronidation in the liver for biliary excretion. Under normal conditions, it is mostly unconjugated and bound tightly to albumin 3.

Bilirubin is one of the most common diagnostic tests utilised in the diagnosis and monitoring of hepatic dysfunction. It is impaired in cholestatic and parenchymal liver diseases. The most common condition associated with elevated levels is jaundice (a clinical sign of hyperbilirubinaemia), characterised by the yellow colouring of skin, mucous membranes and sclera 3.

Today, it is recognised as being more than just an end-product and considered to be a fundamental substance. Bilirubin is recognised as acting as an antioxidant and anti-inflammatory agent in serum. Evidence exists that states that it can neutralise free radicals, prevent peroxidation of lipids and protects the cardiovascular system, hepatobiliary system, immune system, neuronal system and pulmonary system 4.

It has been established that bilirubin levels are significantly elevated in COVID-19 patients 5. Patients with abnormal liver function tests were at a significantly higher risk of progressing to a severe disease, such as pneumonia. The presence of abnormal liver function tests became more pronounced during hospitalisation within two weeks, with total bilirubin levels elevated 3 times the upper normal limit 6.

Want to know more?

Contact us or download the antioxidants brochure to learn more.

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Clinical Chemistry Calibrator

Bilirubin Elevated Control

Clinical Chemistry EQA

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We Are Randox | Information Security Manager Kris Hughes on his return to racing

About Us       News        Vacancies 

06 August 2020

Information Security Manager Kris Hughes on his return to racing

 

We Are Randox | Information Security Manager Kris Hughes on his return to racing

On the first weekend of August, our Information Security Manager Kris Hughes took part in a weekend of F100 National Kart Racing.

He had this to say about taking part in the competition;

F100 is a national kart racing series embracing what is regarded to be the best ever era of karting, covering the periods known as Formula A and Formula ICA during the 1990s. The engines are two stroke 100cc air cooled and capable of revving up to 21,000 rpm and 70 mph +.

Drivers such as Jenson Button and Lewis Hamilton both raced in this class before going up the ladder to F1.

I used to race this class back in the 90’s as a Junior and Senior shortly before the class was done away with globally.

I then made a short return to karting in 2012 to try racing in a different class called “Rotax Max”, but just didn’t get that same rush I had before.

Over the last few months, everything that has been going on in the world has reminded me that life is very short and that it’s so important to try to live life to the fullest.

This led me back to my passion for Karting.

I was amazed to find out that the class I was passionate about had been restarted a few years ago in the form of a dedicated “retro” British Championship, consisting of six rounds throughout the UK. There is also a round at the end of the year in Lonato, Italy.

The race weekend that I took part in between 30 July to 2 August 2020 was the F100 British Championship Round 1, Pre 200 class, held in the Lydd Kart Circuit. The event consisted of two full days of pre testing and one day of racing, comprising of three heats and one final.

I started in pole position for 1st race but could not maintain this ranking due to Carburettor problems, which didn’t get remediated until the final when I swapped out onto another carb. The next two heats where much the same as the 1st.

In the final I started in 14th position and was running well until my chain broke along with part of my kart chassis. This unfortunately took me out of the race, but I still had an amazing weekend.

It’s hard to put into words to summarise the whole event, and being back in the class for the first time since the 90’s, but I can honestly say it was amazing to be back doing something I love and would encourage everyone else to do the same.

It is so important to do what you love and follow your passion.

 

We are delighted to have Kris with us as part of the IT team at Randox and are proud of him for pursuing his passion.

For current vacancies at Randox please visit randox.getgotjobs.co.uk

 

For more We Are Randox stories about our amazing colleagues, make sure to follow us on Facebook, Instagram and Twitter and follow the hashtag #WeAreRandox.

For further information please email recruitment@randox.com or phone 028 9442 2413.

Want to know more?

Contact us or visit our Randox Careers

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H-FABP (Cardiac) Assay

H-FABP (Cardiac)

A Superior Marker of Acute Coronary Syndrome

Benefits of the Randox H-FABP (Cardiac) Assay

Superior Performance

Superior method

The Randox latex enhanced immunoturbidimetric (L.E.I) method offers a more convenient, high performing and time efficient (results in 14 minutes, depending on analyser) method compared to traditional ELISA testing.

Excellent Correlation

Excellent correlation

correlation coefficient of r=0.97 was displayed when the Randox methodology was compared against commercially available methods.

Wide measuring range

Wide measuring range

The Randox H-FABP assay can comfortably detect levels outside of the healthy range, measuring between 0.747 – 120ng/ml.

Liquid ready-to-use

Liquid ready-to-use assay

The Randox H-FABP assay is available in a liquid ready-to-use format for convenience and ease-of-use.

Dedicated calibrator and controls available

Dedicated H-FABP calibrator and controls available offering a complete testing package.

Applications available

Applications available detailing instrument-specific settings for the convenient use of the Randox H-FABP assay on a variety of clinical chemistry analysers.

  • Ordering Information
  • Physiological Significance
  • ACS
  • hs-Troponin
  • Prognostic Value
  • Troponin Negative Patients
Cat NoSize    
FB4025R1 1 x 19ml
R2 1 x 7ml
EnquireKit Insert RequestMSDSBuy Online

Instrument Specific Applications (ISA’s) are available for a wide range of biochemistry analysers.  Contact us to enquire about your specific analyser.

Fatty acid-binding proteins (FABPs) are small cytoplasmic proteins that are abundantly expressed in tissues with an active fatty acid metabolism, including the heart and liver.  Heart-type fatty acid-binding protein (H-FABP) is an unbound, low molecular weight protein (15kDa), located in the cytoplasm of cardiac myocytes 1 2.

The primary function of H-FABP is to transport intracellular long-chain fatty acids.  When compared to traditional cardiac proteins, H-FABP is smaller than myoglobin (18kDa), troponin I (TnI) (22kDa), troponin T (TnT) (37kDa) and creatine kinase-muscle/brain (CK-MB) (86kDa) 3.  H-FABP freely circulates in the cytoplasm, this coupled with its low molecular weight makes, H-FABP a more reliable and sensitive indicator of at-risk patients as indicated in Fig 1.

Fig 1. The early release of H-FABP following myocardial infarction (MI) 3

Fig 1. The early release of H-FABP following myocardial infarction (MI)

H-FABP has been studied as a cardiac biomarker since the early 1990s however, early progress in clinical studies was hampered due to the lack of monoclonal antibodies and high quality (quantitative) assays. Gradual improvements in H-FABP antibodies and assays over recent years means that the true clinical value of the biomarker is now evident. Several key publications advocate the early diagnosis of ACS utilising the H-FABP test:

1. JAMA (2011): Serial changes in highly sensitive troponin I assay and early diagnosis of myocardial infarction 4

Objective: A study prospectively evaluated 1,813 patients with suspected ACS were consecutively enrolled at the chest pain units of the University Heart Centre Hamburg, Germany on admission and after 3 and 6 hours, A variety of biomarkers were measured at each time point.

Conclusion: H-FABP offer superior diagnostic performance or acute myocardial infarction (AMI) compared to a range of novel ACS biomarkers (based on the ROC analysis produced in this study).

2. Scandinavian Journal of Clinical and Laboratory Investigation (2012): Clinical and analytical evaluation of an immunoturbidimetric heart-type fatty acid-binding protein assay 5

Objective: A study prospectively evaluated patient samples and pools of samples to assess functional sensitivity, linearity, precision, limit of detection, recovery of recombinant H-FABP with troponin in samples routinely received from chest patient samples.

Conclusion: H-FABP an be run in a bury routine laboratory and on non-proprietary analytic platforms, offering excellent performance and precision.

Chest pain is a common symptom for patients reporting to an emergency department (ED), representing ≈10% of all ED consultations. It is vital that patients who present with chest pain of suspected cardiac origin are screened for ACS. Only 10% to 20% of these patients will be diagnosed as experiencing an acute myocardial infarction (AMI) 6.

Recently, high sensitivity troponin has made its way onto the market. H-FABP is not a replacement test for hs-TnT/ hs-TnI, however, measurement of H-FABP in combination with hs-TnT/hs-TnI is optimal for improving the early diagnosis of ACS and can offer clinical utility in the ED. Recent publications advocate testing H-FABP in combination with high sensitivity troponin (hs-TnT or hs-TnI) for optimal performance:

1. BMC Emergency Medicine (2016): Heart-type fatty acid-binding protein and cardiac troponin: development of an optimal rule-out strategy for acute myocardial infarction 7

Objective: A study prospectively evaluated hd-TnI, hsTnT and H-FABP in 1,016 patients presenting at a New Zealand ED with symptoms triggering investigation for possible ACS.

Conclusion: H-FABP in combination with hs-TnI without ischaemic ECG changes improved the rule-out of AMI upon presentation at an ED, compared to hs-TnI and ECG, while maintaining >99% sensitivity for AMI. The implementation of this strategy would enable up to 40% of patients to be classed as low risk and suitable for early discharge, reducing the number of in-hospital stays.

2. Journal of Clinical and Experimental Cardiology (2018): Diagnostic performance of a combination biomarker algorithm for rule-out of acute myocardial infarction at time of presentation to the emergency department, using heart-type fatty acid-binding protein and high-sensitivity troponin T tests 8

Objective: A study prospectively examine 548 patients with suspected cardiac chest pain presenting at a hospital ED in Northern Ireland for the development of a rule-out algorithm based H-FABP and hs-TnT. Blood samples were collected at presentation and after 1, 2, 3, 6, 12 and 24 hours and 20 parameters were measured.

Conclusion: The implementation of a combined H-FABP hs-TnT algorithm at an ED could aid in the identification of non-AMI patients on arrival, with the potential to reduce hospital admission by 36.8%. Moreover, this combined algorithm could potentially have a significant impact on patient health, ensuring the appropriate and effective implementation of a treatment plan for patients identified as high risk.

Not only is H-FABP useful in the diagnosis of cardiac conditions such as ACS or AMI, it also offers clinical utility in the prognosis of cardiac conditions.

1. The American Journal of Cardiology (2009): Prognostic value of a multimarker approach for patients presenting to hospital with acute chest pain 9

Objective: A study prospectively examined 664 patients exhibiting acute ischaemic-type chest pain. The study evaluated novel biomarkers of myocardial injury, neurohormonal activity, haemostasis, and vascular inflammation. Those of greatest significance were tested in the risk stratification during the 1 year follow up.

Conclusion: The measurement of H-FABP upon hospital admission provides useful prognostic value compared to the measurement of baseline and 12-hour TnT.

In addition to significant diagnostic values in ACS, H-FABP has been consistently and robustly shown to offer significant value in the long-term prognosis of ACS patients, even when compared to hs-troponin assays10. Several key publications advocate the long-term prognosis of patients utilising the H-FBP test:

1. Journal of the American College of Cardiology (2010): Heart-type fatty acid-binding protein predicts long-term mortality and re-infarction in consecutive patients with suspected acute coronary syndrome who are troponin negative 11

Objective: A study prospectively evaluated 995 patients presenting with suspected ACS. Utilising the ultra-TnI and the Randox Randox assays, samples were collected 12 to 24 hours following the onset of symptoms.

Conclusion: The prognostic value of elevated H-FABP levels is additive to troponin in low and intermediate risk patients with suspected ACS. The long-term prognostic value of H-FABP in troponin-negative patients is independent of age and serum creatinine.

2. British Medical Journal (2011): In acute coronary syndromes, heart-type fatty acid-binding protein is a more accurate predictor of long term prognosis then troponin 12

Objective: A study prospectively examined 1,448 ACS patients who had serum H-FABP levels measured upon hospital admission. The study provides a six-year mortality overview following on from the one-year mortality data published in 2007.

Conclusion: Whilst the patterns between both studies are very similar, except for TnI- / H-FABP+ group of patients. The TnI- / H-FABP+ cohort exhibit the highest mortality rates after six years. Not only is H-FABP an independent prognostic marker but it also identifies high-risk patients who are TnI negative.

Want to know more?

Contact us or download the cardiology & lipid testing brochure to learn more.

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H-FABP Calibrator

H-FABP Controls

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Vivalytic | Viral Respiratory Infection Array

Vivalytic | 10-Plex Viral Respiratory Infection Array

Detecting SARS-CoV-2 (COVID-19)

Detecting SARS-CoV-2 (COVID-19)

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    Detection of up to 10 viral targets simultaneously from a single patient sample in 2.5 hours
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    Full molecular workflow consolidated into one small benchtop platform
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    Comprises sarbecovirus as a confirmatory target accurately diagnosing COVID-19
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    Powered by Randox Biochip Technology enabling multiple results from one patient sample
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    Target genes in line with WHO & CDC recommendations
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    Easy 4 step process from sample entry to results. No laboratory training required.

The new Viral Respiratory Infection Array (VRI) will be conducted on Vivalytic, a point of care platform brought to the market by Randox Laboratories and Bosch. The Vivalytic system is a fully-automated, cartridge-based platform capable of both Hi-Plex and Lo-Plex testing. The VRI test can identify SARS-CoV-2 (COVID-19) and differentiate it from nine other respiratory infections with similar symptoms, including influenza and all known coronaviruses.

Vivalytic cartridges are compact, technologically advanced Molecular Diagnostic tests utilising micro-fluidics to enable simple and accurate diagnostic testing. Randox patented Biochip Array Technology powers Vivalytic, enabling end-point qualitative PCR and providing multiple test results from each sample.

 

 

Viral Respiratory Infection Array (10-plex)

VIRUSES
SARS-CoV-2 (COVID-19)Sarbecovirus
(SARS, SARS like, SARS-CoV-2)
Influenza A
Coronavirus 229E/NL63Adenovirus A/B/C/D/EInfluenza B
Coronavirus OC43/HKUIEnterovirus A/B/CRhinovirus A/B
Middle East Respiratory
Syndrome Coronavirus (MERS-CoV)

Vivalytic Workflow

Intuitive engineering of Vivalytic ensures the analyser is user friendly. The process of patient sample to result comprises a very simple 4 step workflow.

To begin the test, the user scans or enters sample information. The cartridge code is then scanned into the embedded Vivalytic software. The user then adds sample into the dedicated cartridge slot, closes the lid and inserts the cartridge into the Vivalytic.

The touchscreen display will countdown the time remaining to test completion. Results will be displayed on the screen. Multiple Vivalytics can be wirelessly connected allowing the user to control multiple tests at one time all reporting to a master Vivalytic platform.

“AWARD-WINNING DESIGN DELIVERS
AN UNCOMPLICATED USER EXPERIENCE”

Download Vivalytic Brochure

Want to know more?

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

Related Products

Randox Biosciences

Extended Coronavirus Array

Vivalytic

Vivalytic Test Menu


Enzymatic Creatinine Assay

Creatinine (Enzymatic)

A Highly Sensitive & Reproducible Method

Benefits of the Randox Enzymatic Creatinine Assay

Superior Performance

Superior method

The Randox enzymatic method offers a superior specificity when compared to the traditional Jaffe method.

Precision

Excellent precision

The Randox creatinine assay displayed a within run precision of < 2.18% CV.

Exceptional Correlation

Exceptional correlation

The Randox enzymatic creatinine assay displayed a correlation coefficient of at least r=0.99 when compared to commercially available methods.

Limited Interference

Limited interferences

The Randox enzymatic creatinine assay suffers minimal interferences from Bilirubin, Haemoglobin, Intralipid® and Triglycerides, for truly accurate results and ensures suitability with paediatric samples.

Calibrator and controls available

Calibrator and controls available offering a complete testing package.

Applications available

Applications available detailing instrument-specific settings for the convenient use of the Randox enzymatic creatinine assay on a variety of clinical chemistry analysers.

  • Ordering Information
  • Methodology
  • Physiological Significance
  • Renal Function
  • Diabetes
  • COVID-19
Cat NoSize    
CR2336R1 4 x 50ml (S)
R2 4 x 10ml
EnquireKit Insert RequestMSDSBuy Online
CR2337R1 4 x 100ml (S)
R2 4 x 20ml
EnquireKit Insert RequestMSDSBuy Online
CR4037R1 4 x 50ml (L)
R2 4 x 19.5ml
EnquireKit Insert RequestMSDSBuy Online
CR8122R1 4 x 65ml (L)
R2 4 x 32.3ml
EnquireKit Insert RequestMSDSBuy Online
CR8317R1 4 x 20ml (L)
R2 4 x 9.5ml
EnquireKit Insert RequestMSDSBuy Online
(L) Indicates liquid option (S) Indicates standard included in kit

Instrument Specific Applications (ISA’s) are available for a wide range of biochemistry analysers.  Contact us to enquire about your specific analyser.

The Laboratory Working Group of the National Kidney Disease Education Program (NKDEP) released guidelines for the improvement of glomerular filtration rate (GFR) estimation as well as the measurement of serum creatinine (SCr). The recommendation included the recalibration and standardisation of SCr methods to be traceable to the isotope dilution-mass spectrometry (IDMS) reference method. Two IDMS traceable creatinine methods are commercially available: enzymatic assays and compensated Jaffe assays 1.

Of the two enzymatic assays available, the Randox enzymatic creatinine assay converts creatinine to ammonia (NH3) and I-Methylhydantoin. Ammonia then reacts with α-oxoglutarate in the presence of GLDH with oxidation of the co-enzyme NADPH. The decrease of NADPH is proportional to the creatinine concentration and is measured at 340nm 1, 2.

The Randox enzymatic creatinine assay exhibits high sensitivity and reproducibility with the added advantage of liquid ready-to-use reagents with good stability. The enzymatic method represents an improvement for use in the accurate and reliable determination of creatinine.

Creatinine is the end-product of muscle catabolism of creatine. In humans, creatinine production is relatively stable, but mainly depends on muscles mass. Consequently, any physiological changes in muscle mass will cause a variation in the creatinine pool independently of GFR changes. Creatinine is freely filtered by the glomerulus at a constant rate with 10% to 40% secreted by the tubules 1.

According to the National Institutes of health, the overall prevalence of chronic kidney disease (CKD) is approximately 14% 3. Creatinine is the most commonly utilised assay in the assessment of renal function 4. The National Kidney Disease Education Program recommends calculating GFR from SCr. Creatinine measurements are useful in the monitoring of disease progression, with the diagnosis of renal failure when SCr levels are greater than the upper normal interval 5.

Creatinine measurements are useful in the diagnosis and monitoring of diabetic nephropathy, the leading cause of kidney disease in patients commencing renal replacement therapy, affecting 40% of diabetics (type 1 and type 2) 6. The RENAAL risk score for end-stage renal disease (ESRD) emphasizes the importance of the identification of elevated SCr, alongside other renal markers, in the prediction of end-stage renal disease (ESRD) development in patients with type 2 diabetes mellitus (T2DM) and nephropathy 7.

Acute kidney injury (AKI) is a common complication in COVID-19 patients 8. The analysis of creatinine in COVID-19 patients on hospital admission and after 2 to 4 days highlighted impaired renal function and is the leading cause of death in these patients 9. The National Institute of Care Excellence (NICE), have set out four guidelines for acute kidney injury in hospitalised suspected or confirmed COVID-19 patients and highlights the importance of creatinine testing 10.

Want to know more?

Contact us or download the diabetes portfolio brochure to learn more.

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Clinical Chemistry Calibrator

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COVID-19 Testing Service Testimonial: The Irish Football Association

News       About Us       COVID-19

 

25 July 2020

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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Click one of the links below.

COVID-19 Products and Services

HOME TEST

ANTIBODY TEST

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COVID-19 Cytokine Testing Solutions

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COVID-19 Risk Stratification & Treatment Monitoring

Randox Cytokine Testing Solutions

COVID-19 Risk Stratification and Treatment Monitoring

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    Simultaneous detection of up to 12 cytokines and growth factors from a single patient sample
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    Suitable for use with serum and plasma samples
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    Fully automated and semi-automated solutions available to suit all laboratory throughputs
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    Excellent analytical performance
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    Comprehensive test menu comprising 26 cytokines, cytokine receptors and growth factors
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    Availability of complementary quality controls for a complete testing package

Randox offer testing solutions for a comprehensive range of cytokines, cytokine receptors and growth factors designed to assist with COVID-19 risk stratification, monitoring of treatment efficacy and recovery. Utilising patented Biochip technology up to 12 cytokines and growth factors may be detected simultaneously 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 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 (COVID-19) 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.

 

 

 

Biochip

Cytokine Array I (12-plex)

  • IL-1α
  • IL-1β
  • IL-2
  • IL-4
  • IL-6
  • IL-8
  • IL-10
  • IFNγ
  • EGF
  • MCP-1
  • TNFα
  • VEGF

Interleukin-1 (IL-1) is a regulatory and inflammatory cytokine, which exists in two forms, (IL-1α) and (IL-1β), which share 25% homology at amino acid level. IL-1α is produced as a biologically active 31 kDa precursor, which undergoes proteolytic cleavage yielding a 17 kDa protein of 159 amino acids.

There are two forms of IL-1, IL-1α and IL-1β ,which share 25% homology at amino acid level. IL-1β is synthesised as a biologically inactive precursor of 269 amino acids with a molecular mass of 31 kDa , which undergoes proteolytic cleavage by IL1 converting enzyme (ICE), which yields a 17kDa protein of 153 amino acids.

Interleukin-2 (IL-2) is an interleukin, a type of cytokine signaling molecule in the immune system. It is a 15 – 18 kDa protein which has varying degrees of glycosylation accounting for the observed molecular weight range. IL-2 regulates the activities of white blood cells (leukocytes, often lymphocytes) that are responsible for immunity.

IL-4 is a glycoprotein synthesised as a precursor protein of 153 amino acids. The first 24 amino acid residue signal peptide is cleaved to produce a 129 amino acid 15-19 kDa protein.

IL-6 is synthesised as a precursor protein of 212 amino acids. The N-terminal 28 amino acid residue signal peptide is cleaved to produce a 21kDa protein. It has two potential N-glycosylation sites which have no effect on bioactivity. Different post-translational alterations such as glycosylation and phosphorylation give various forms of IL-6 with molecular masses of 21.5-28 kDa. The IL-6 receptor is a strongly glycosylated 80 kDa protein of 449 amino acids. Two different forms of the receptor have been described that bind IL-6 with differing affinities, a soluble form of the IL-6 receptor has also been described. The IL-6 receptor is expressed on T cells, mitogen activated B cells, peripheral monocytes and some macrophage and B cell derived tumour cell types. IL-6 also influences antigen-specific immune responses and inflammatory reactions.

IL-8 is a member of a structurally similar family of cytokines called chemokines, which demonstrate chemotactic activity for neutrophils. IL-8 is a non-glycosylated protein of 8 kDa and consists of 99 amino acids with a 22 residue signal peptide that is cleaved to generate a 77 amino acid sequence. IL-8 is produced in response to proinflammatory stimuli. It is produced by monocytes, macrophages, fibroblasts, endothelial cells, keratinocytes, melanocytes, hepatocytes, chondrocytes, T-cells, neutrophils, and astrocytes.

Interleukin-10 (IL-10), alternatively known as B-cell-derived T-cell growth factor (B-TCGF), cytokine synthesis inhibitory factor (CSIF) or T-cell growth inhibitory factor is a homodimeric protein with a molecular weight of 18 kDa. It is produced as a 178 amino acid residue precursor, which is cleaved to give a mature protein of 160 amino acids. IL-10’s primary function is as an anti-inflammatory agent, which inhibits cytokine production by T cells and natural killer cells caused by activation of monocytes/macrophages.

IFN-γ is a cytokine critical to both innate and adaptive immunity, and functions as the primary activator of macrophages, in addition to stimulating natural killer cells and neutrophils. Biologically active interferon gamma is a 20 or 25 kDa glycoprotein depending on its glycosylation state. This lymphokine is synthesised as a 166 amino acid sequence but is cleaved to give a 143 amino acid residue.

Human EGF is produced as a long precursor protein of 1207 amino acids which is released by proteolytic cleavage to give a globular protein of 6.4 kDa consisting of 53 amino acids. EGF is a common mitogenic factor that stimulates the proliferation of different types of cells, especially fibroblasts and epithelial cells. EGF activates the EGF receptor (EGFR/ErbB), which initiates, in turn, intracellular signaling.

Monocyte chemoattractant protein (MCP-1) is part of the chemotactic family of cytokines called chemokines. ). It is a 76 amino acid peptide and has a molecular weight of 8.6 kDa. MCP-1 in particular chondrocytes confirming its role in inflammatory responses. MCP-1 has been implicated in a wide variety of inflammatory diseases such as artherosclerosis, delayed hypersensitivity reactions, rheumatoid arthritis, alveotitis and idiopathic pulmonary fibrosis.

Tumour necrosis factor alpha (TNFα) is a 157 amino acid 26 kDa transmembrane protein which is secreted as a soluble mature 233 amino acid homotrimer of 17 kDa by proteolytic cleavage. TNF-α is secreted by macrophages in response to stimuli for the induction of systemic inflammation. The binding of the ligand TNF-α to the TNF receptor (TNFR1) initiates the pro-inflammatory and pro-apoptotic signaling cascades.

Vascular endothelial growth factor (VEGF), also known as vascular permeability factor (VPF), is secreted as a glycosylated homodimeric protein of 46 kDa that is made up of two 24 kDa subunits linked by disulphide bonds. VEGF is expressed by vascularised tissue such as pituitary, brain, lungs, kidneys, heart and adrenal glands, although it is assumed that all tissues have the potential to produce the growth factor. VEGF is stimulated when cells become deficient in oxygen or glucose or under inflammatory conditions.

Ordering Information

 

Cat. NumberDescriptionKit Size
EV3508Cytokine Array I Evidence360 Biochips
EV3544Cytokine Array I Evidence180 Biochips
EV3513Cytokine Array I Evidence Investigator54 Biochips
EV3623Cytokine Array I High Sensitivity Evidence Investigator54 Biochips

Cytokine Array III (4-plex)

  • IL-5
  • IL-15
  • GM-CSF
  • MIP-1 α

Interleukin-5 (IL-5) is a disulphide linked homodimer and belongs to a family of structurally related proteins that includes: interleukin-2, interleukin-4, macrophage colony-stimulating factor, granulocyte macrophage colony-stimulating factor and growth hormone. It is a glycoprotein with the apparent molecular weight of recombinant IL-5 produced by mammalian cells in the range 45 to 60 kDa. The large variation in the molecular weight caused predominantly by the addition of heterogeneous carbohydrate chains.

Interleukin-15 (IL-15) is a 14 to 15 kDa protein of 114 amino acids. It contains 2 disulphide bonds and 2 N-linked glycosylation sites at the C-terminus1. IL-15 is expressed at the mRNA level in numerous normal human tissues in a broad range of cell types, including activated monocytes, dendritic cells, osteoclasts and fibroblasts. IL-15 has an essential role in natural killer (NK) cell development. It activates NK cell proliferation, cytotoxicity, and cytokine production and regulates NK cell/macrophage interaction. Studies have suggested that IL-15 may have a role in establishing innate immune responses and maintaining neutrophil-mediated inflammatory processes.

Granulocyte-macrophage colony stimulating factor (GMCSF) isolated from human sources is glycosylated with an apparent molecular mass of 23 kDa. The mature protein has 127 amino acids and is preceded by a hydrophobic leader sequence of 25 amino acids.

Macrophage inflammatory protein-1α (MIP-1α, CCL3) is a member of the CC chemokine subfamily whose members are known for chemotactic and proinflammatory effects and also for the promotion of homeostasis. MIP-1α is synthesised as a 92 amino acid precursor that is proteolytically processed to a mature protein of about 70 amino acids. MIP-1α has roles in inflammatory responses at sites of injury or infection by recruiting proinflammatory cells.

Ordering Information

 

Cat. NumberDescriptionKit Size
EV3680Cytokine Array III Evidence180 Biochips
EV3678Cytokine Array III Evidence Investigator54 Biochips

Cytokine Array IV (5-plex)

  • MMP-9
  • sIL-2Rα
  • sIL-6R
  • sTNFR I
  • sTNFR II

Matrix metalloproteinase-9 (MMP-9) (gelatinase B) (92 kDa) is a member of the matrix metalloproteinase (MMP) family. MMP-9, one of the most widely investigated MMPs, regulates pathological remodeling processes that involve inflammation and fibrosis.

Soluble IL-2 receptor α (sIL-2Rα) results from the proteolytic cleavage of IL-2Rα at the cell surface by a membrane metalloproteinase; which is encoded by IL2RA on human chromosome. It’s widely noted in research that sIL-2Rα has been found in diseases caused by infections, autoimmune disease and organ transplantation.

Interleukin-6 (IL-6) is a multifunctional cytokine that regulates pleiotropic roles in immune regulation, inflammation, hematopoiesis, and oncogenesis. The IL-6 receptor complex belongs to the haematopoietic receptor superfamily and mediates the biological activities of IL-6. It consists of two distinct membrane bound glycoproteins, an 80 kDa cognate receptor subunit (IL-6R) and a 130 kDa signal-transducing element (gp130). The gp130 subunit is expressed in almost all organs including heart, kidney, spleen, liver, lung, placenta and brain.

Tumour necrosis factor receptor I is one of two specific, high affinity cell surface receptors that function as transducing elements, providing the intracellular signal for cell responses to tumour necrosis factor (TNF). TNF is a proinflammatory cytokine mainly produced by stimulated monocytes, macrophages and T-lymphocyte subsets. It has a key role in host defence and immunosurveillance, mediating complex cellular responses of a different, even contrasting nature. TNFRI has a molecular mass of 55 kDa1 and is expressed by almost all cell types2 especially those cells that are susceptible to the cytotoxic action of TNFI. TNFRs are detectable in normal serum, but their concentration increases significantly in inflammatory and non-inflammatory diseases.

Tumour necrosis factor receptor II (TNFRII) is one of two specific, high affinity cell surface receptors that function as transducing elements, providing the intracellular signal for cell responses to tumour necrosis factor (TNF). TNF is a proinflammatory cytokine mainly produced by stimulated monocytes, macrophages and T-lymphocyte subsets. It has a key role in host defence and immunosurveillance, mediating complex cellular responses of a different, even contrasting nature. TNFRII has a molecular mass of 75 kDa1. Although TNFRII is expressed by almost all cell types, it is expressed primarily by cells of the immune system, cells of myeloid origin and endothelial cells.

Ordering Information

 

Cat. NumberDescriptionKit Size
EV3659Cytokine Array IV Evidence180 Biochips
EV3661Cytokine Array IV Evidence Investigator54 Biochips

Cytokine Array V (5-plex)

  • IL-3
  • IL-7
  • IL-12p70
  • IL-13
  • IL-23

Interleukin-3 (IL-3) possesses diverse biological activities and was discovered independently in studies on its biological activities. IL-3 is a heavily glycosylated protein with a polypeptide chain of 133 amino acids. It occurs naturally in a diversity of glycoforms generated by the addition of carbohydrate groups which results in size heterogeneity from 28 to 45 kDa. The function of the extensive carbohydrate modifications of the IL-3 polypeptide is not known however IL-3 has been linked with various diseases including colorectal and pancreatic cancers.

Interleukin-7 (IL-7) is classified as a type 1 short-chain cytokine of the haematopoietin family, a group that also includes IL-2, IL-3, IL-4, IL-5, GM-CSF, IL-9, IL-13, IL-15, M-CSF, and stem cell factor. The human gene for IL-7 is located on chromosome 8q12-13. The amino acid sequence of IL-7 predicts a molecular weight of 17.4 kDa, but glycosylation results in an active protein of 25 kDa. IL-7 appears to be involved in the development of an effective immune system and also in the generation and maintenance of strong and effective cellular immune responses directed against cancer cells, or infectious diseases.

Interleukin-12 (IL-12) is a 75 kDa heterodimeric glycoprotein cytokine composed of disulphide linked p40 (40 kDa) and p35 (35 kDa) subunits that are derived from separate genes1. p35 is expressed in a limiting and tightly regulated fashion by many different cell types, however the expression of p40, though in greater quantities than required for p70 formation, appears to be restricted to antigen presenting cells. IL-12 stimulates IFN production, which is essential in resistance to intracellular protozoan, fungal and bacterial infections and, in addition, tumours. Traditionally, IL-12 is accepted as an important mediator of autoimmunity and is involved in a number of autoimmune diseases including rheumatoid arthritis, psoriasis, inflammatory bowel disease and insulin-dependent diabetes mellitus.

Interleukin-13 (IL-13) is a 12 kDa protein that folds into four I-helical bundles. It contains four potential N-glycosylation sites and four cysteine residues that form two intramolecular disulphide bonds. IL-13 shares a number of structural features and functional characteristics with IL-4. The IL-13 protein is approximately 25% homologous1 with IL-4 and belongs to the same I-helix protein family. IL-13 plays a dominant role in resistance to most gastrointestinal nematodes and also modulates resistance to intracellular organisms by regulating cell mediated immunity. IL-13 is the central mediator of allergic asthma, where it regulates eosinophilic inflammation, mucus secretion, and airway hyperresponsiveness. Although IL-13 is associated primarily with the induction of airway disease, it also has anti-inflammatory properties.

Interleukin 23 (IL-23) is member of the IL-12 family. The IL-12 family consists of cytokines IL-12(p40p35), IL-23(p40p19) and IL-27(EBI13p28), and monomeric and homodimeric p401. IL-23 is a heterodimeric cytokine composed of disulphide linked p19 and p40 subunits. IL-23 plays a role in a signaling pathway that triggers inflammation.

Ordering Information

 

Cat. NumberDescriptionKit Size
EV3666Cytokine Array V Evidence Investigator54 Biochips

Immunoassay Platforms

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

Related Products

Cytokine Array I Control

Cytokine Array I High Sensitivity Control

Cytokine Array III Control

Cytokine Array IV Control


Temporary Precautionary Measure

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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

Randox Biosciences          Acute Kidney Injury          COVID-19

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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