Alzheimer’s Disease: The Role of Apolipoprotein E
Alzheimer’s Disease: The Role of Apolipoprotein E
Alzheimer’s Disease: The Role of Apolipoprotein E
Raising awareness of Alzheimer’s Disease
Every year we celebrate Alzheimer’s Day on 21st September to help raise awareness around dementia. Dementia is the medical name attributed to a set of symptoms affecting the brain, including: difficulties with problem solving, thinking, language and memory loss. AD is the most common form of dementia accounting for 60 – 80% of cases and it is believed that half of patients with Alzheimer’s dementia (dementia due to AD) have Alzheimer’s disease 1, 2.
About Alzheimer’s Disease (AD)
AD is one of the most devastating and complex diseases characterised by:
- Neurodegeneration resulting in memory loss 2
- Neurofibrillary tangles composed of tau amyloid fibrils which associates with synapse loss 2
- Accumulation of β-amyloid (Aβ) plaques 2
- Other cognitive functions 2
Figure 1: Alzheimer’s Disease Demographic, 2019 3
It is believed that AD is expected to begin 20 years prior to symptom onset, as the small changes in the functioning of the brain are unnoticeable to the person affected. Overtime, the symptoms progress and begin to interfere with the patient’s ability to perform everyday tasks. The final stages of AD leaves the patient bed-bound, requiring 24/7 care. Ultimately, AD is fatal. Age has been identified as a risk factor for AD with 10% of people over the age of 65 affected. Moreover, AD has been recognised as a leading cause of morbidity and the sixth leading cause of mortality, but the fifth leading cause of death in over 65’s in the US .3
Physiological Significance of Apolipoprotein E
Apolipoprotein E (Apo E) is a lipoprotein composed of 299 amino acids with a molecular weight of 34kDa. Apo E is responsible for the regulation of homeostasis through the mediation of lipid transport from and to bodily cells and tissues. Apo E comprises of three common isoforms: apo E2, apo E3 and apo E4. The apo E isoforms differ due to differences in either the 112 and 158 amino acids, whether either arginine (ARG) or cysteine (CYS) is present 4.
Apo E3 is the parent form of apo E and is responsible for the clearance of triglyceride-rich lipoproteins. Apo E3 is associated with normal lipid plasma concentrations. Apo E2 is the rarest of the apo E isoforms and differs slightly compared to the apo E3 isoform through the substitution of a single amino acid, ARG158Cys, located near the low-density lipoprotein receptor (LDLR) recognition site.
Apo E2 displays impaired binding to the receptor, prohibiting the clearance of triglyceride-rich lipoprotein remnant particles. Apo E2 is strongly associated with type-III hyperlipoproteinemia. Apo E3 also differs from apo E4, again through the substitution of a single amino acid, Cys112Arg. The main difference between apo E3 and apo E4 is that apo E4 is unaffected by the binding of the isoform to LDLR. However, apo E4 is strongly associated with dyslipidemia 5. Fig. 2 provides a visual representation of the variations in the Apo E isoforms.
Figure 2: Variations in the Apo E Isoforms 4
Apo E is expressed in numerous bodily organs with the liver presenting with the highest expression followed by the brain. Astrocytes and, to a lesser extent, microglia are the major cells responsible for the expression of apo E in the brain. In the brain, apo E, apo J and apo A-1 are predominantly expressed on distinct high-density-like lipoprotein particles. Whilst apo A-1 is the major apolipoprotein of high-density lipoproteins (HDL), in the central nervous system (CNS), apo E is the predominant apolipoprotein of HDL-like lipoproteins. HDL-like lipoproteins are the only lipoproteins present in the CNS. It is believed that the cholesterol released from apo E supports synaptogenesis 6.
Clinical Significance of Apolipoprotein E in Alzheimer’s Disease
Whilst apo E3 is the most abundant of the three isoforms, apo E4 has been known for decades to be the most significant genetic risk factor for late-onset AD. Inheriting the one copy of the apo E4 gene increases the risk of AD 2-3-fold, whilst inheriting two copies increases the risk of AD up to 12-fold 7. Whilst the underlying mechanism of apo E’s contribution to AD risk is still unclear and debatable, apo E has been identified as promoting amyloid β (Aβ) deposition and clearance as well as neurofibrillary tangles in the brain. Interestingly, Aβ-independent pathways exist for apo E in AD, which led to the unearthing of the new roles of apo E including the most recent, iron metabolism and mitochondria dysfunction 8, 9. Captivatingly, sex-related hormones may play a role in AD in apo E4 carriers as AD has been recognised to be more pronounced in women 10. Apo E4 has also been identified as impairing lipid transport, microglial responsiveness, glucose metabolism, synaptic plasticity and integrity, and cerebrovascular function and integrity. Some of these pathogeneses are independent of Aβ pathways. Furthermore, therapeutic strategies are aiming to modulate the quantity, lipidation, structural properties, Aβ interaction and receptor expression of Apo E 11.
Key Features of the Randox Apolipoprotein E Assay
Randox are one of the only manufacturers to offer the apo E assay in an automated clinical chemistry format. Utilising the immunoturbidimetric method, the Randox apo E assay is available in a liquid ready-to-use format. Not only does the Randox apo E suffer from limited interferences from bilirubin, haemoglobin, intralipid® and triglycerides for truly accurate results, it has an excellent measuring range of 1.04 – 12.3mg/dl for the comfortable detection of clinically important results. Moreover, apolipoprotein calibrator and controls are available for a complete testing package. Applications are available detailing instrument-specific settings for the convenient use of the Randox apo E assay on a wide range of clinical chemistry analysers.
Biochip Technology – Alzheimer’s Array
Utilising the Biochip Technology, Randox have developed an array to identify the risk of Alzheimer’s disease in just 3 hours with one effective test. In addition to a rapid and accurate diagnosis, this also introduces both cost and time-saving benefits. The apo E4 array is a research use only product developed for the Evidence Investigator, a semi-automated benchtop immunoassay analyser which can process up to 2376 test per hour as well as up to 44 analytes screened per biochip. The apo E4 array measures both total apo E protein levels and apo E4 protein levels directly from plasma samples as well as using a ratio, it can classify patients as negative or positive for apo E4. In turn, we can then assess their risk for the development of Alzheimer’s disease.
Related Products
Randox Reagents Homepage
Evidence Series Immunoanalysers
RX Series Analysers
References
[1] Alzheimer’s Society. Alzheimer’s disease. [Online] [Cited: September 2, 2019.] https://www.alzheimers.org.uk/about-dementia/types-dementia/alzheimers-disease.
[2] Gaugler, Joseph, et al. 2019 Alzheimer’s Disease Facts and Figures. s.l. : Alzheimer’s Association, 2019.
[3] 2014 Update of the Alzheimer’s Disease Neuroimaging Initiative: A review of papers published since its inception. Weiner, Michael W, et al. 6, San Francisco : Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association, 2015, Vol. 11.
[4] Apolipoprotein E and Alzheimer disease: risk, mechanisms, and therapy. Liu, Chia-Chen, et al. 2, Fujian : Nature Reviews Neurology, 2013, Vol. 9.
[5] Apolipoprotein E isoforms and lipoprotein metabolism. Phillips, Michael C. 9, Philadelphia : IUBMB Journals, 2014, Vol. 66.
[6] The Role of Apolipoprotein E in Alzheimer’s Disease. Kim, Jungsu, Basak, Jacob M and Holtzman, David M. 3, St Louis : Neuron, 2009, Vol. 63.
[7] Dacks, Penny. What ApoE Means For Your Health. Cognitive Vitality. [Online] November 16, 2016. [Cited: September 11, 2019.] https://www.alzdiscovery.org/cognitive-vitality/blog/what-apoe-means-for-your-health.
[8] The Complex Role of Apolipoprotein E in Alzheimer’s Disease: an Overview and Update. Mahoney-Sanchez, Laura, et al. 3, Parkville : Journal of Molecular Neuroscience, 2016, Vol. 60.
[9] Understanding the Role of ApoE Fragments in Alzheimer’s Disease. Muñoz, SS, Gerner, B and Ooi, L. 6, Wollongong : Neurochemical Research, 2019, Vol. 44.
[10] ApoE4: an emerging therapeutic target for Alzheimer’s disease. Affieh, Mirna, Korczyn, Amos D and Michaelson, Daniel M. 64, s.l. : BMC Medicine, 2019, Vol. 17.
[11] Apolipoprotein E and Alzheimer disease: pathobiology and targeting strategies. Yamazaki, Yu, et al. 9AB, s.l. : Nature Reviews Neurology, 2019, Vol. 15.
The Importance of Diagnostic Testing in SARS-CoV-2 Adverse Outcomes
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.
Cytokine Storms
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.
Inflammation
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.
Renal Function
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.
Hepatic Function
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.
Related Products
Extended Coronavirus Array
Qnostics SARS-CoV-2 Control
AKI Array
References
[1] Complications coronavirus can cause. https://www.webmd.com/lung/coronavirus-complications#1 (accessed 22 July 2020).
[2] The powerful virus inflammatory response. https://www.mdedge.com/chestphysician/article/189513/infectious-diseases/powerful-virus-inflammatory-response (accessed 4 August 2020).
[3] George A. Cytokine storm: an overreaction of the body’s immune system. https://www.newscientist.com/term/cytokine-storm/ (accessed 22 July 2020).
[5] 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).
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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Medica 2019
Join us for MEDICA 2019!
Randox Laboratories will be attending MEDICA 2019 from the 18th – 22nd November 2019. Our innovative diagnostic solutions have been developed with consolidation and economy in mind, providing cost savings whilst using pioneering technology.
Diagnostics is our passion. We are dedicated to developing solutions that not only meet your needs, but that are of the highest quality, the most reliable and the most cost-effective. We look forward to meeting you in the Messe Düsseldorf, Germany.
New Products
Acusera Infectious Disease Serology Controls
Randox Quality Control are pleased to announce the launch of our new Infectious Disease Serology Internal Quality Controls. Our portfolio includes Lyme Disease, ToRCH, EBV, HIV, HAV, HTLV, CMV, VZV and much more.
All samples are provided in a user-friendly, liquid ready-to-use format. This significantly reduces preparation time and the risk of pipetting errors.
There is approximately 1 million people in the USA living with HIV and around 15% of them are unaware they are infected (CDC, March 2019). Furthermore, the Centers for Disease Control and Prevention (CDC) estimate that around 39,000 new HIV infections are reported per year.
The impact of not only HIV but all infectious diseases is getting much greater. Therefore, laboratories now play a much more important role in providing accurate test results. This is a key component in controlling the spread of infections.
Reporting a false positive result has its own obvious implications, however, what about the consequences of reporting a false negative. This can be just as devastating to a person in terms of the treatment they will receive and even personal lifestyle changes for the patient in question.
Adiponectin
Adiponectin (adipocyte complement-related protein of 30kDa (Acrp30)) is an adipokine (protein hormone) produced and secreted by the adipose tissue, an endocrine organ. Adiponectin acts as a messenger in the communication of adipose tissue and metabolic organs. In doing so, Adiponectin suppresses the production of glucose in the liver through inhibiting the genes involved in glucose production and enhances fatty acid oxidation in skeletal muscle 2. Consequently, Adiponectin is a strong protector against several pathological events in various cells through inhibiting inflammation, suppressing cell death and enhancing cell survival. Adiponectin has been identified as having pleiotropic functions widely associated with anti-atherogenic, anti-diabetic, cardioprotective and anti-inflammatory effects.
Randox Stroke Biochip
The Randox Stroke Biochip is a rapid and highly sensitive blood test that will complement and enhance existing CT scanning technology to facilitate accurate classification of stroke patients and improve patient care pathways.
Using Randox revolutionary patented Biochips, the Randox Stroke Biochip provides a unique solution for simultaneous detection of multiple stroke biomarkers from a single sample, facilitating fast and accurate classification of stroke patients in an emergency setting.
Benefits of the Randox Stroke Biochip
> Multiplex biochip for rapid stroke classification in under 30 minutes from a single plasma sample
> Complements and enhances existing CT scanning ensuring fast and accurate diagnosis
> Fast and accurate diagnostic classification between ischaemic and haemorrhagic stroke
> Simple 2 step process from sample entry to results
> Ensures better outcomes guaranteeing timely therapeutic intervention
The new Evidence+
The fully automated Evidence+ analyzer is set to truly revolutionize laboratories worldwide. Continuing to provide high standards of quality, efficiency and reliability, the fully automated batch immunoanalyzer simultaneously detects multiple drugs and drug metabolites from a single sample.
The Evidence+ analyzer enables both efficient and cost-effective testing whilst providing accurate and reliable results to larger high throughput laboratories.
Meet CLIA requirements with accuracy and ease
Acusera Linearity Sets are designed to challenge a larger section of an instruments reportable range and test if a system’s calibration is still valid. Our linearity materials cover a wide range of testing including, CRP, RF, Lipids, Therapeutic Drugs, Esoterics and more. Designed with user convenience in mind, all our linearity sets are supplied in a liquid format, while also presented in varying levels. Our unique combination of analytes enables laboratories to reduce the number of individual products required while ultimately reducing costs and time.
Complimentary, cloud-based data reduction software is supplied with all linearity sets, providing a graphical representation of results for at-a-glance performance assessment. Access to instantly updated peer group data and automatically generated statistics also helps to speed up data review.
H-FABP in CSA-AKI Testing
Cardiac surgery-associated acute kidney injury (CSA-AKI) is a well-recognised postoperative complication of cardiac surgery and is the second most common cause of AKI in the ICU, occurring in up to 30% of patients. Higher pre-operative values of H-FABP were associated with a higher risk of developing AKI. Following adjustments of certain patient characteristics, the association of pre-operative H-FABP with the development of AKI remained significant. In fact, the researchers observed that a 1 unit increase in log H-FABP was associated with a 3-fold increase in the odds of developing AKI.
What can we offer?
Randox Biosciences is part of Randox Laboratories and is dedicated to advancing scientific discovery, drug development and diagnostics. We provide a variety of services and products to numerous industries including clinical laboratories, biopharma and academic research institutes.
Our revolutionary multiplex Biochip Array Technology includes multiplex protein immunoassays and multiplex nucleic acid arrays, and is delivered via the award winning Evidence range of analysers. Biochip Array Technology is a multi-analyte testing platform facilitating the simultaneous quantitative or qualitative detection of a wide range of analytes from a single sample. Biochip provides a unique platform for assessment in a rapid, accurate and easy to use format.
Vivalytic the newest offering from Randox Biosciences brings innovation to the Molecular Diagnostic industry providing tests for respiratory, genitourinary and hospital acquired infections. The Vivalytic platform is capable of both Hi-Plex and Lo-Plex testing. Nucleic acid extraction, PCR amplification followed by a suite of detection methods are combined in a truly revolutionary, fully automated platform. Manual preparation, cold chain reagents and the use of multiple devices are no longer required making Vivalytic a unique space-saving, hygienic solution for Molecular Diagnostic testing.
Leading provider of true third-party controls
With over 390 parameters available in our Acusera range, choice and flexibility is guaranteed. Moreover, the availability of truly independent third-party controls coupled with the added advantages of highly accurate target values, excellent stability and unparalleled quality will enhance performance, save valuable time and minimize waste in any laboratory. Our comprehensive range of multi-analyte controls have been uniquely developed with user convenience in mind. By combining more than 100 parameters in a single vial, laboratories can significantly reduce the need for multiple, costly single analyte controls.
Online QC software with real-time peer group statistics
Designed to help you efficiently review QC data from multiple laboratory instruments on one centralized platform, Acusera 24.7 allows quick and easy identification of QC failures and emerging trends.
Unique access to live peer group updates will reduce time and money spent troubleshooting, helping you to instantly discover if an issue is isolated to your lab or a widespread problem. The added benefit of automatically generated statistics including Sigma Scores, Measurement Uncertainty & Total Error as well as fully interactive charts & reports will enable quick and easy performance monitoring.
Meet CLIA requirements with accuracy and ease
Acusera Linearity Sets are designed to challenge a larger section of an instruments reportable range and test if a system’s calibration is still valid. Our linearity materials cover a wide range of testing including, CRP, RF, Lipids, Therapeutic Drugs, Esoterics and more. Designed with user convenience in mind, all our linearity sets are supplied in a liquid format, while also presented in varying levels. Our unique combination of analytes enables laboratories to reduce the number of individual products required while ultimately reducing costs and time.
Complimentary, cloud-based data reduction software is supplied with all linearity sets, providing a graphical representation of results for at-a-glance performance assessment. Access to instantly updated peer group data and automatically generated statistics also helps to speed up data review.
RIQAS – The World’s Largest International PT scheme
With over 45,000 laboratory participants in more than 133 countries, the Randox International Quality Assessment Scheme (RIQAS) is truly the largest international PT provider in the world. Our comprehensive product offering currently covers over 360 parameters across 33 flexible programmes. Each RIQAS programme contains a unique combination of parameters meaning laboratories can significantly reduce the number of individual programmes required whilst increasing efficiency and reducing costs. Further benefits to a laboratory include accreditation to ISO 17043:2010, frequent reporting, reduced parameter options and access to comprehensive yet user-friendly reports.
Molecular Infectious Disease Controls
Qnostics is a leading manufacturer of Third Party Quality Control solutions for Molecular Infectious Disease testing. Supplying microbiology/virology laboratories, molecular diagnostic assay manufacturers, EQA providers, pharmaceutical and CRO organisations for over a decade.
Designed to meet the demand of today’s molecular diagnostics laboratory and laboratories carrying out Nucleic Acid Testing (NAT), the Qnostics Molecular Infectious Disease range comprises hundreds of characterised viral, bacterial and fungal targets covering a wide range of Transplant Associated Diseases, Respiratory Infections, Blood Borne Viruses, Sexually Transmitted Infections, Gastrointestinal Diseases and Central Nervous System Diseases.
Randox Reagents are internationally recognised as being of the highest quality, offering reliable and rapid results. Our product portfolio consists of 111 clinical chemistry assays, covering a range of testing panels, including: antioxidants, diabetes, drugs of abuse testing, cardiology and lipids, specific proteins, therapeutic drug monitoring and veterinary testing.
Randox are continuously striving to improve diagnostic solutions worldwide. As a result, Randox have produced 29 niche and superior performance assays, including: 5th Generation Bile Acids, Adiponectin, Aldolase, Copper, Cystatin C, D-3-Hydroxybutyrate, G6PDH, H-FABP, Lipoprotein (a), NEFA, HDL Cholesterol, sdLDL Cholesterol, Total Antioxidant Status and Zinc.
Renowned for quality and reliability, the RX series leads the way with the world’s most extensive dedicated clinical chemistry test menu comprising routine chemistries, specific proteins, lipids, therapeutic drugs, antioxidants, veterinary and diabetes testing. Guaranteeing real cost savings through consolidation of routine and specialised tests onto a single platform, the RX series of analysers delivers excellence in patient care, offering unrivalled precision, accuracy and reliability.
RX misano
The RX misano semi-automated analyser has been developed with the user in mind by incorporating a responsive touch-screen display. The sleek ergonomic design boasts intuitive user-friendly software allowing for test menu personalisation and ease of use. The RX misano is capable of high standard, precise results at a competitive price per test.
RX monaco
The RX monaco is a fully automated solution for low to mid volume clinical chemistry testing offering the ultimate in convenience, performance and confidence. At optimal configuration, the RX monaco performs 170 tests per hour providing cost effective, high quality testing.
RX daytona +
The RX daytona+ is a fully automated, benchtop, clinical chemistry analyser capable of performing high quality testing, with a combined throughput of 450 tests per hour, for accurate results you can trust. The most versatile analyser in its class, the RX daytona+ combines robust hardware and intuitive software with the world leading RX series test menu for unrivalled performance with direct HbA1c testing capabilities.
RX imola
The RX imola is a cost-effective system that delivers consistent high-quality results. Capable of handling the workload of a medium to high throughout laboratory and a combined throughput of 560 tests per hour, the RX imola provides rapid, comprehensive testing on a small footprint analyser with direct HbA1c testing capabilities. The RX imola is a fully automated system with random access and STAT sampling functionality, boosting productivity and saving time when it matters most
RX modena
Capable of performing up to 1,200 tests per hour, with direct HbA1c testing capabilities, the RX modena consolidates all your assay requirements onto one intuitive platform. The RX modena boasts icon based, interactive touch-screen technology adding a modern flair to your laboratory.
Randox Toxicology offer the most comprehensive Drugs of Abuse (DoA) test menu across multiple forensic matrices. Our level of expertise in toxicology research and development allows us to adapt quickly to ever changing market influences and develop assays for current and novel drug trends. Excellent assay precision and performance eliminates false reporting, therefore reducing unnecessary confirmatory tests and time lost in the laboratory as a result. Our Biochip Arrays offer CVs typically less than 10%, producing an accurate drug profile to ensure confidence in results.
Evidence series immunoassay analysers guarantee cost-effective, highly accurate and flexible testing solutions. Having been developed to work with patented Biochip Array Technology, this precision multiplex testing platform allows for the simultaneous quantitative or qualitative detection of a wide range of analytes from a single sample.
This multiplex system delivers an unrivalled increase in patient information, offering a more in-depth diagnostic profile with each patient sample. This further analysis places the focus on the diagnosis, and on improving patient outcomes.
Want to know more?
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APFCB 19
Join us for the 15th APFCB Congress 2019!
Randox Laboratories will be attending the 15th APFCB from the 17th – 20th November 2019. Our innovative diagnostic solutions have been developed with consolidation and economy in mind, providing cost savings whilst using pioneering technology.
Diagnostics is our passion. We are dedicated to developing solutions that not only meet your needs, but that are of the highest quality, the most reliable and the most cost-effective. We look forward to meeting you in the new Jaipur Exhibition & Convention Centre stand P1.
New Products
Acusera Infectious Disease Serology Controls
Randox Quality Control are pleased to announce the launch of our new Infectious Disease Serology Internal Quality Controls. Our portfolio includes Lyme Disease, ToRCH, EBV, HIV, HAV, HTLV, CMV, VZV and much more.
All samples are provided in a user-friendly, liquid ready-to-use format. This significantly reduces preparation time and the risk of pipetting errors.
There is approximately 1 million people in the USA living with HIV and around 15% of them are unaware they are infected (CDC, March 2019). Furthermore, the Centers for Disease Control and Prevention (CDC) estimate that around 39,000 new HIV infections are reported per year.
The impact of not only HIV but all infectious diseases is getting much greater. Therefore, laboratories now play a much more important role in providing accurate test results. This is a key component in controlling the spread of infections.
Reporting a false positive result has its own obvious implications, however, what about the consequences of reporting a false negative. This can be just as devastating to a person in terms of the treatment they will receive and even personal lifestyle changes for the patient in question.
Adiponectin
Adiponectin (adipocyte complement-related protein of 30kDa (Acrp30)) is an adipokine (protein hormone) produced and secreted by the adipose tissue, an endocrine organ. Adiponectin acts as a messenger in the communication of adipose tissue and metabolic organs. In doing so, Adiponectin suppresses the production of glucose in the liver through inhibiting the genes involved in glucose production and enhances fatty acid oxidation in skeletal muscle 2. Consequently, Adiponectin is a strong protector against several pathological events in various cells through inhibiting inflammation, suppressing cell death and enhancing cell survival. Adiponectin has been identified as having pleiotropic functions widely associated with anti-atherogenic, anti-diabetic, cardioprotective and anti-inflammatory effects.
Randox Stroke Biochip
The Randox Stroke Biochip is a rapid and highly sensitive blood test that will complement and enhance existing CT scanning technology to facilitate accurate classification of stroke patients and improve patient care pathways.
Using Randox revolutionary patented Biochips, the Randox Stroke Biochip provides a unique solution for simultaneous detection of multiple stroke biomarkers from a single sample, facilitating fast and accurate classification of stroke patients in an emergency setting.
Benefits of the Randox Stroke Biochip
> Multiplex biochip for rapid stroke classification in under 30 minutes from a single plasma sample
> Complements and enhances existing CT scanning ensuring fast and accurate diagnosis
> Fast and accurate diagnostic classification between ischaemic and haemorrhagic stroke
> Simple 2 step process from sample entry to results
> Ensures better outcomes guaranteeing timely therapeutic intervention
The new Evidence+
The fully automated Evidence+ analyzer is set to truly revolutionize laboratories worldwide. Continuing to provide high standards of quality, efficiency and reliability, the fully automated batch immunoanalyzer simultaneously detects multiple drugs and drug metabolites from a single sample.
The Evidence+ analyzer enables both efficient and cost-effective testing whilst providing accurate and reliable results to larger high throughput laboratories.
Meet CLIA requirements with accuracy and ease
Acusera Linearity Sets are designed to challenge a larger section of an instruments reportable range and test if a system’s calibration is still valid. Our linearity materials cover a wide range of testing including, CRP, RF, Lipids, Therapeutic Drugs, Esoterics and more. Designed with user convenience in mind, all our linearity sets are supplied in a liquid format, while also presented in varying levels. Our unique combination of analytes enables laboratories to reduce the number of individual products required while ultimately reducing costs and time.
Complimentary, cloud-based data reduction software is supplied with all linearity sets, providing a graphical representation of results for at-a-glance performance assessment. Access to instantly updated peer group data and automatically generated statistics also helps to speed up data review.
H-FABP in CSA-AKI Testing
Cardiac surgery-associated acute kidney injury (CSA-AKI) is a well-recognised postoperative complication of cardiac surgery and is the second most common cause of AKI in the ICU, occurring in up to 30% of patients. Higher pre-operative values of H-FABP were associated with a higher risk of developing AKI. Following adjustments of certain patient characteristics, the association of pre-operative H-FABP with the development of AKI remained significant. In fact, the researchers observed that a 1 unit increase in log H-FABP was associated with a 3-fold increase in the odds of developing AKI.
What can we offer?
Randox Biosciences is part of Randox Laboratories and is dedicated to advancing scientific discovery, drug development and diagnostics. We provide a variety of services and products to numerous industries including clinical laboratories, biopharma and academic research institutes.
Our revolutionary multiplex Biochip Array Technology includes multiplex protein immunoassays and multiplex nucleic acid arrays, and is delivered via the award winning Evidence range of analysers. Biochip Array Technology is a multi-analyte testing platform facilitating the simultaneous quantitative or qualitative detection of a wide range of analytes from a single sample. Biochip provides a unique platform for assessment in a rapid, accurate and easy to use format.
Vivalytic the newest offering from Randox Biosciences brings innovation to the Molecular Diagnostic industry providing tests for respiratory, genitourinary and hospital acquired infections. The Vivalytic platform is capable of both Hi-Plex and Lo-Plex testing. Nucleic acid extraction, PCR amplification followed by a suite of detection methods are combined in a truly revolutionary, fully automated platform. Manual preparation, cold chain reagents and the use of multiple devices are no longer required making Vivalytic a unique space-saving, hygienic solution for Molecular Diagnostic testing.
Leading provider of true third-party controls
With over 390 parameters available in our Acusera range, choice and flexibility is guaranteed. Moreover, the availability of truly independent third-party controls coupled with the added advantages of highly accurate target values, excellent stability and unparalleled quality will enhance performance, save valuable time and minimize waste in any laboratory. Our comprehensive range of multi-analyte controls have been uniquely developed with user convenience in mind. By combining more than 100 parameters in a single vial, laboratories can significantly reduce the need for multiple, costly single analyte controls.
Online QC software with real-time peer group statistics
Designed to help you efficiently review QC data from multiple laboratory instruments on one centralized platform, Acusera 24.7 allows quick and easy identification of QC failures and emerging trends.
Unique access to live peer group updates will reduce time and money spent troubleshooting, helping you to instantly discover if an issue is isolated to your lab or a widespread problem. The added benefit of automatically generated statistics including Sigma Scores, Measurement Uncertainty & Total Error as well as fully interactive charts & reports will enable quick and easy performance monitoring.
Meet CLIA requirements with accuracy and ease
Acusera Linearity Sets are designed to challenge a larger section of an instruments reportable range and test if a system’s calibration is still valid. Our linearity materials cover a wide range of testing including, CRP, RF, Lipids, Therapeutic Drugs, Esoterics and more. Designed with user convenience in mind, all our linearity sets are supplied in a liquid format, while also presented in varying levels. Our unique combination of analytes enables laboratories to reduce the number of individual products required while ultimately reducing costs and time.
Complimentary, cloud-based data reduction software is supplied with all linearity sets, providing a graphical representation of results for at-a-glance performance assessment. Access to instantly updated peer group data and automatically generated statistics also helps to speed up data review.
RIQAS – The World’s Largest International PT scheme
With over 45,000 laboratory participants in more than 133 countries, the Randox International Quality Assessment Scheme (RIQAS) is truly the largest international PT provider in the world. Our comprehensive product offering currently covers over 360 parameters across 33 flexible programmes. Each RIQAS programme contains a unique combination of parameters meaning laboratories can significantly reduce the number of individual programmes required whilst increasing efficiency and reducing costs. Further benefits to a laboratory include accreditation to ISO 17043:2010, frequent reporting, reduced parameter options and access to comprehensive yet user-friendly reports.
Molecular Infectious Disease Controls
Qnostics is a leading manufacturer of Third Party Quality Control solutions for Molecular Infectious Disease testing. Supplying microbiology/virology laboratories, molecular diagnostic assay manufacturers, EQA providers, pharmaceutical and CRO organisations for over a decade.
Designed to meet the demand of today’s molecular diagnostics laboratory and laboratories carrying out Nucleic Acid Testing (NAT), the Qnostics Molecular Infectious Disease range comprises hundreds of characterised viral, bacterial and fungal targets covering a wide range of Transplant Associated Diseases, Respiratory Infections, Blood Borne Viruses, Sexually Transmitted Infections, Gastrointestinal Diseases and Central Nervous System Diseases.
Randox Reagents are internationally recognised as being of the highest quality, offering reliable and rapid results. Our product portfolio consists of 111 clinical chemistry assays, covering a range of testing panels, including: antioxidants, diabetes, drugs of abuse testing, cardiology and lipids, specific proteins, therapeutic drug monitoring and veterinary testing.
Randox are continuously striving to improve diagnostic solutions worldwide. As a result, Randox have produced 29 niche and superior performance assays, including: 5th Generation Bile Acids, Adiponectin, Aldolase, Copper, Cystatin C, D-3-Hydroxybutyrate, G6PDH, H-FABP, Lipoprotein (a), NEFA, HDL Cholesterol, sdLDL Cholesterol, Total Antioxidant Status and Zinc.
Renowned for quality and reliability, the RX series leads the way with the world’s most extensive dedicated clinical chemistry test menu comprising routine chemistries, specific proteins, lipids, therapeutic drugs, antioxidants, veterinary and diabetes testing. Guaranteeing real cost savings through consolidation of routine and specialised tests onto a single platform, the RX series of analysers delivers excellence in patient care, offering unrivalled precision, accuracy and reliability.
RX misano
The RX misano semi-automated analyser has been developed with the user in mind by incorporating a responsive touch-screen display. The sleek ergonomic design boasts intuitive user-friendly software allowing for test menu personalisation and ease of use. The RX misano is capable of high standard, precise results at a competitive price per test.
RX monaco
The RX monaco is a fully automated solution for low to mid volume clinical chemistry testing offering the ultimate in convenience, performance and confidence. At optimal configuration, the RX monaco performs 170 tests per hour providing cost effective, high quality testing.
RX daytona +
The RX daytona+ is a fully automated, benchtop, clinical chemistry analyser capable of performing high quality testing, with a combined throughput of 450 tests per hour, for accurate results you can trust. The most versatile analyser in its class, the RX daytona+ combines robust hardware and intuitive software with the world leading RX series test menu for unrivalled performance with direct HbA1c testing capabilities.
RX imola
The RX imola is a cost-effective system that delivers consistent high-quality results. Capable of handling the workload of a medium to high throughout laboratory and a combined throughput of 560 tests per hour, the RX imola provides rapid, comprehensive testing on a small footprint analyser with direct HbA1c testing capabilities. The RX imola is a fully automated system with random access and STAT sampling functionality, boosting productivity and saving time when it matters most
RX modena
Capable of performing up to 1,200 tests per hour, with direct HbA1c testing capabilities, the RX modena consolidates all your assay requirements onto one intuitive platform. The RX modena boasts icon based, interactive touch-screen technology adding a modern flair to your laboratory.
Randox Toxicology offer the most comprehensive Drugs of Abuse (DoA) test menu across multiple forensic matrices. Our level of expertise in toxicology research and development allows us to adapt quickly to ever changing market influences and develop assays for current and novel drug trends. Excellent assay precision and performance eliminates false reporting, therefore reducing unnecessary confirmatory tests and time lost in the laboratory as a result. Our Biochip Arrays offer CVs typically less than 10%, producing an accurate drug profile to ensure confidence in results.
Evidence series immunoassay analysers guarantee cost-effective, highly accurate and flexible testing solutions. Having been developed to work with patented Biochip Array Technology, this precision multiplex testing platform allows for the simultaneous quantitative or qualitative detection of a wide range of analytes from a single sample.
This multiplex system delivers an unrivalled increase in patient information, offering a more in-depth diagnostic profile with each patient sample. This further analysis places the focus on the diagnosis, and on improving patient outcomes.
Want to know more?
Contact us or book a meeting with us
AACC 19
Join us for AACC 2019!
Randox Laboratories will be attending AACC from the 6th – 8th August 2019. Our innovative diagnostic solutions have been developed with consolidation and economy in mind, providing cost savings whilst using pioneering technology.
Diagnostics is our passion. We are dedicated to developing solutions that not only meet your needs, but that are of the highest quality, the most reliable and the most cost-effective. We look forward to meeting you in the Anaheim Convention Centre at stand 1101.
New Products
Acusera Infectious Disease Serology Controls
Randox Quality Control are pleased to announce the launch of our new Infectious Disease Serology Internal Quality Controls. Our portfolio includes Lyme Disease, ToRCH, EBV, HIV, HAV, HTLV, CMV, VZV and much more.
All samples are provided in a user-friendly, liquid ready-to-use format. This significantly reduces preparation time and the risk of pipetting errors.
There is approximately 1 million people in the USA living with HIV and around 15% of them are unaware they are infected (CDC, March 2019). Furthermore, the Centers for Disease Control and Prevention (CDC) estimate that around 39,000 new HIV infections are reported per year.
The impact of not only HIV but all infectious diseases is getting much greater. Therefore, laboratories now play a much more important role in providing accurate test results. This is a key component in controlling the spread of infections.
Reporting a false positive result has its own obvious implications, however, what about the consequences of reporting a false negative. This can be just as devastating to a person in terms of the treatment they will receive and even personal lifestyle changes for the patient in question.
Daytona+
At this year’s AACC, Randox are pleased to announce 510 (K) clearance from the U.S. Food and Drug Administration for the RX daytona+ clinical chemistry analyzer. Renowned for quality and reliability, the RX series leads the way with the world’s most extensive dedicated clinical chemistry test menu comprising routine chemistries, specific proteins, lipids, therapeutic drugs, drugs of abuse, antioxidants, diabetes and veterinary testing. Guaranteeing real cost savings through consolidation of routine and specialized tests onto a single platform, the RX series of analyzers offers excellence in patient care, delivering unrivalled precision, accuracy and reliability.
The RX daytona+ fully automated, benchtop, clinical chemistry analyzer is capable of performing high quality testing including emergency STAT sampling and boasts a combined throughput of 450 tests per hour including ISE. The most versatile chemistry analyzer in its class, the RX daytona+ presents laboratories with a range of benefits offering optimum performance, unrivalled uptime, flexibility, efficiency and functionality.
Randox Stroke Biochip
The Randox Stroke Biochip is a rapid and highly sensitive blood test that will complement and enhance existing CT scanning technology to facilitate accurate classification of stroke patients and improve patient care pathways.
Using Randox revolutionary patented Biochips, the Randox Stroke Biochip provides a unique solution for simultaneous detection of multiple stroke biomarkers from a single sample, facilitating fast and accurate classification of stroke patients in an emergency setting.
Benefits of the Randox Stroke Biochip
> Multiplex biochip for rapid stroke classification in under 30 minutes from a single plasma sample
> Complements and enhances existing CT scanning ensuring fast and accurate diagnosis
> Fast and accurate diagnostic classification between ischaemic and haemorrhagic stroke
> Simple 2 step process from sample entry to results
> Ensures better outcomes guaranteeing timely therapeutic intervention
The new Evidence+
The fully automated Evidence+ analyzer is set to truly revolutionize laboratories worldwide. Continuing to provide high standards of quality, efficiency and reliability, the fully automated batch immunoanalyzer simultaneously detects multiple drugs and drug metabolites from a single sample.
The Evidence+ analyzer enables both efficient and cost-effective testing whilst providing accurate and reliable results to larger high throughput laboratories.
Enhance your Cardiac Testing Panel with sPLA2-IIA!
Randox are pleased to announce the new automated assay for sPLA2-IIA mass. sPLA2-IIA is thought to be the most highly expressed enzyme from the secretory phospholipase A2 family. sPLA2-IIA is expressed in the normal arterial wall and its expression is readily up-regulated by inflammatory stimuli. It’s production of fatty acids and biologically active phospholipids plays an important role in platelet, monocyte, and endothelial activation, processes known to be critical steps in atherogenesis.
Meet CLIA requirements with accuracy and ease
Acusera Linearity Sets are designed to challenge a larger section of an instruments reportable range and test if a system’s calibration is still valid. Our linearity materials cover a wide range of testing including, CRP, RF, Lipids, Therapeutic Drugs, Esoterics and more. Designed with user convenience in mind, all our linearity sets are supplied in a liquid format, while also presented in varying levels. Our unique combination of analytes enables laboratories to reduce the number of individual products required while ultimately reducing costs and time.
Complimentary, cloud-based data reduction software is supplied with all linearity sets, providing a graphical representation of results for at-a-glance performance assessment. Access to instantly updated peer group data and automatically generated statistics also helps to speed up data review.
What can we offer?
Randox Biosciences is part of Randox Laboratories and is dedicated to advancing scientific discovery, drug development and diagnostics. We provide a variety of services and products to numerous industries including clinical laboratories, biopharma and academic research institutes.
Our revolutionary multiplex Biochip Array Technology includes multiplex protein immunoassays and multiplex nucleic acid arrays, and is delivered via the award winning Evidence range of analysers. Biochip Array Technology is a multi-analyte testing platform facilitating the simultaneous quantitative or qualitative detection of a wide range of analytes from a single sample. Biochip provides a unique platform for assessment in a rapid, accurate and easy to use format.
Vivalytic the newest offering from Randox Biosciences brings innovation to the Molecular Diagnostic industry providing tests for respiratory, genitourinary and hospital acquired infections. The Vivalytic platform is capable of both Hi-Plex and Lo-Plex testing. Nucleic acid extraction, PCR amplification followed by a suite of detection methods are combined in a truly revolutionary, fully automated platform. Manual preparation, cold chain reagents and the use of multiple devices are no longer required making Vivalytic a unique space-saving, hygienic solution for Molecular Diagnostic testing.
Leading provider of true third-party controls
With over 390 parameters available in our Acusera range, choice and flexibility is guaranteed. Moreover, the availability of truly independent third-party controls coupled with the added advantages of highly accurate target values, excellent stability and unparalleled quality will enhance performance, save valuable time and minimize waste in any laboratory. Our comprehensive range of multi-analyte controls have been uniquely developed with user convenience in mind. By combining more than 100 parameters in a single vial, laboratories can significantly reduce the need for multiple, costly single analyte controls.
Online QC software with real-time peer group statistics
Designed to help you efficiently review QC data from multiple laboratory instruments on one centralized platform, Acusera 24.7 allows quick and easy identification of QC failures and emerging trends.
Unique access to live peer group updates will reduce time and money spent troubleshooting, helping you to instantly discover if an issue is isolated to your lab or a widespread problem. The added benefit of automatically generated statistics including Sigma Scores, Measurement Uncertainty & Total Error as well as fully interactive charts & reports will enable quick and easy performance monitoring.
Meet CLIA requirements with accuracy and ease
Acusera Linearity Sets are designed to challenge a larger section of an instruments reportable range and test if a system’s calibration is still valid. Our linearity materials cover a wide range of testing including, CRP, RF, Lipids, Therapeutic Drugs, Esoterics and more. Designed with user convenience in mind, all our linearity sets are supplied in a liquid format, while also presented in varying levels. Our unique combination of analytes enables laboratories to reduce the number of individual products required while ultimately reducing costs and time.
Complimentary, cloud-based data reduction software is supplied with all linearity sets, providing a graphical representation of results for at-a-glance performance assessment. Access to instantly updated peer group data and automatically generated statistics also helps to speed up data review.
RIQAS – The World’s Largest International PT scheme
With over 45,000 laboratory participants in more than 133 countries, the Randox International Quality Assessment Scheme (RIQAS) is truly the largest international PT provider in the world. Our comprehensive product offering currently covers over 360 parameters across 33 flexible programmes. Each RIQAS programme contains a unique combination of parameters meaning laboratories can significantly reduce the number of individual programmes required whilst increasing efficiency and reducing costs. Further benefits to a laboratory include accreditation to ISO 17043:2010, frequent reporting, reduced parameter options and access to comprehensive yet user-friendly reports.
Molecular Infectious Disease Controls
Qnostics is a leading manufacturer of Third Party Quality Control solutions for Molecular Infectious Disease testing. Supplying microbiology/virology laboratories, molecular diagnostic assay manufacturers, EQA providers, pharmaceutical and CRO organisations for over a decade.
Designed to meet the demand of today’s molecular diagnostics laboratory and laboratories carrying out Nucleic Acid Testing (NAT), the Qnostics Molecular Infectious Disease range comprises hundreds of characterised viral, bacterial and fungal targets covering a wide range of Transplant Associated Diseases, Respiratory Infections, Blood Borne Viruses, Sexually Transmitted Infections, Gastrointestinal Diseases and Central Nervous System Diseases.
Randox Reagents are internationally recognised as being of the highest quality, offering reliable and rapid results. Our product portfolio consists of 111 clinical chemistry assays, covering a range of testing panels, including: antioxidants, diabetes, drugs of abuse testing, cardiology and lipids, specific proteins, therapeutic drug monitoring and veterinary testing.
Randox are continuously striving to improve diagnostic solutions worldwide. As a result, Randox have produced 29 niche and superior performance assays, including: 5th Generation Bile Acids, Adiponectin, Aldolase, Copper, Cystatin C, D-3-Hydroxybutyrate, G6PDH, H-FABP, Lipoprotein (a), NEFA, HDL Cholesterol, sdLDL Cholesterol, Total Antioxidant Status and Zinc.
Renowned for quality and reliability, the RX series leads the way with the world’s most extensive dedicated clinical chemistry test menu comprising routine chemistries, specific proteins, lipids, therapeutic drugs, drugs of abuse, antioxidants, veterinary and diabetes testing. Guaranteeing real cost savings through consolidation of routine and specialised tests onto a single platform, the RX series of analysers delivers excellence in patient care, offering unrivalled precision, accuracy and reliability.
RX misano
The RX misano semi-automated analyser has been developed with the user in mind by incorporating a responsive touch-screen display. The sleek ergonomic design boasts intuitive user-friendly software allowing for test menu personalisation and ease of use. The RX misano is capable of high standard, precise results at a competitive price per test.
RX monaco
The RX monaco is a fully automated solution for low to mid volume clinical chemistry testing offering the ultimate in convenience, performance and confidence. At optimal configuration, the RX monaco performs 170 tests per hour providing cost effective, high quality testing.
RX daytona +
The RX daytona+ is a fully automated, benchtop, clinical chemistry analyser capable of performing high quality testing, with a combined throughput of 450 tests per hour, for accurate results you can trust. The most versatile analyser in its class, the RX daytona+ combines robust hardware and intuitive software with the world leading RX series test menu for unrivalled performance with direct HbA1c testing capabilities.
RX imola
The RX imola is a cost-effective system that delivers consistent high-quality results. Capable of handling the workload of a medium to high throughout laboratory and a combined throughput of 560 tests per hour, the RX imola provides rapid, comprehensive testing on a small footprint analyser with direct HbA1c testing capabilities. The RX imola is a fully automated system with random access and STAT sampling functionality, boosting productivity and saving time when it matters most
RX modena
Capable of performing up to 1,200 tests per hour, with direct HbA1c testing capabilities, the RX modena consolidates all your assay requirements onto one intuitive platform. The RX modena boasts icon based, interactive touch-screen technology adding a modern flair to your laboratory.
Randox Toxicology offer the most comprehensive Drugs of Abuse (DoA) test menu across multiple forensic matrices. Our level of expertise in toxicology research and development allows us to adapt quickly to ever changing market influences and develop assays for current and novel drug trends. Excellent assay precision and performance eliminates false reporting, therefore reducing unnecessary confirmatory tests and time lost in the laboratory as a result. Our Biochip Arrays offer CVs typically less than 10%, producing an accurate drug profile to ensure confidence in results.
Evidence series immunoassay analysers guarantee cost-effective, highly accurate and flexible testing solutions. Having been developed to work with patented Biochip Array Technology, this precision multiplex testing platform allows for the simultaneous quantitative or qualitative detection of a wide range of analytes from a single sample.
This multiplex system delivers an unrivalled increase in patient information, offering a more in-depth diagnostic profile with each patient sample. This further analysis places the focus on the diagnosis, and on improving patient outcomes.
Want to know more?
Contact us or book a meeting with us
View our list of scientific posters that will be on display at AACC
Development of a Duplex Biochip Assay for the Simultaneous Detection of Anti-thyroglobulin and Anti-thyroid Peroxidase Antibodies on the Fully Automated Evidence Evolution Analyser | Display time: 12.30pm-1.30pm | Presenter: A. Jennings (RCLS)
Development of a New Biochip Based Immunoassay for the Detection of Parathyroid Hormone Applied to the Evidence Evolution Analyser | Display time: 12.30pm-1.30pm | Presenter: H. Winter (Randox R&D)
Human Based Liquid Frozen Multi-Analyte Linearity Verification Material Covering Five Levels of Lipid Profile Components for Accurate Assessment of the Test System Reportable Range | Display time: 12.30pm-1.30pm | Presenter: L. Adams (Randox Laboratories Ltd.)
Development and Evaluation of a Fully-Automated Multiplex Molecular Test for the Detection of Common Causative Agents of Urinary Tract Infections | Display time: 12.30pm-1.30pm | Presenter: M.K. Higgings (Randox R&D Molecular Biology)
Evaluation of a Latex Enhanced Immunoturbidimetric Assay Kit for the Rapid Direct On-Board Measurement of Glycated Haemoglobin (%HbA1c) on the RX daytona + Analyser | Display time: 12.30pm-1.30pm | Presenter: E. Lenehan (Randox Laboratories Ltd)
Development of Monoclonal Antibodies to Chromogranin A, a Biomarker for Neuroendocrine Dysfunction | Display time: 12.30pm – 1.30pm | Presenter: H. Winter (Randox R&D)
Development of Monoclonal Antibodies to Pancreastatin, a Biomarker for Neuroendocrine Dysfunction | Display time: 12.30pm – 1.30pm | Presenter: E. Mathers (Randox R&D)
Development of New Biochip Arrays for the Determination of Five Biomarkers Related to Acute Kidney Injury Applied to the Evidence Investigator Analyser | Display time: 12.30pm-1.30pm | S. O’Donnell (Randox Teoranta R&D)
Overcoming the burden of Diabetes and Cardiovascular Disease
The Prevalence
Cardiovascular disease (CVD) is the number one cause of death globally with more people dying annually from CVD than any other disease state. In 2018, according to the American Heart Association, CVD accounted for nearly 836,546 deaths in the USA (1) with over 17 million known deaths recorded worldwide. It is also proclaimed that around 1.5 million people globally die each year because of diabetes and diabetes related complications. (2) Is there a common link? Can this issue be controlled?
Studies have suggested that diabetes is one of the leading related conditions associated with increased risk of CVD death. A recent study undertaken in 2018 examined the association of many risk factors associated with CVD, the study was broken down by disease state with over 17,000 participants involved. The findings highlighted that 17.9% of these patients suffered from diabetes mellitus and death from a cardiovascular event. (3) Many other pilot and research studies discovered similar findings considering further risk factors such as high blood pressure, abnormal cholesterol and high triglycerides, obesity, lack of exercise and lifestyle choices such as smoking, alcohol and drug abuse. All of which are common with patients who suffer from diabetes, placing them at an increased risk of CVD.
Findings highlighted that over 68% of people aged over 65 living with diabetes die from some form of heart disease with 16% of individuals dying from an ischemic stroke. (4) The ability to tackle the prevalence of increased death from CVD and diagnosis of diabetes has become a global burden with the international diabetes federation projecting that 592 million people worldwide will have diabetes by 2035. (5)
Worldwide, the increase of diabetes is becoming an economic burden on the patient and healthcare systems mainly due to the direct costs of medical care and the indirect costs of moderated productivity, tied to diabetes and CVD related morbidity and mortality. Many scholars have highlighted economic burden as a primary attribute to both macrovascular and microvascular complications such as coronary artery disease, myocardial infarction, hypertension, peripheral vascular disease, retinopathy, end-stage renal disease and neuropathy. (6)
Overcoming the Burden
As CVD is the most prevalent cause of mortality and morbidity in patients with diabetes, effective treatment and analysis is required to control and decrease the number of CVD deaths across the globe. Tackling this issue head on, the Randox RX series introduce Direct HbA1c which refers to glycated haemoglobin which is a product of haemoglobin (a protein which can be found in red blood cells) and glucose from the blood making it glycated.
Testing for HbA1c provides an indication of what an individual’s average blood sugar level has been over recent weeks/months and is generally considered as an indicator of how well the patient is managing and controlling their diabetes. This is significant for those who suffer from diabetes because the higher the levels of HbA1c, the higher the chance of an individual suffering from further diabetes related issues, therefore testing for HbA1c improves the predictions of a CVD event occurring.
The Randox RX series have Direct HbA1c testing capabilities on the RX Daytona +, RX imola and RX modena. Our latex enhanced immunoturbidimetric method which the RX series utilises makes the test simple and quick to perform. The removal of the pre-dilution step removes the risk of human error compromising your results without the need for a separate HbA1c analyser.
Offering the world’s largest test menu, the RX series has an extensive range of cardiac, diabetes and lipid tests with excellent correlation to gold standard methodologies designed to allow laboratories to expand their testing capabilities onto one single platform, providing cost savings through consolidation.
References:
- American Heart Association. (2018). Heart Disease and Stroke Statistics 2018 At-a-Glance.Available: https://www.heart.org/-/media/data-import/downloadables/heart-disease-and-stroke-statistics-2018—at-a-glance-ucm_498848.pdf. Last accessed 7th Feb 2019.
- World Heart Federation. (2017). Cardiovascular diseases (CVDs) – Global facts and figures.Available: https://www.world-heart-federation.org/resources/cardiovascular-diseases-cvds-global-facts-figures/. Last accessed 7th Feb 2019.
- Gomadam, P et al, (2018). Blood pressure indices and cardiovascular disease mortality in persons with or without diabetes mellitus. Journal of Hypertension. 36 (1), 1-5.
- Heart attack and stroke symptoms. (2018). Cardiovascular Disease and Diabetes.Available: https://www.heart.org/en/health-topics/diabetes/why-diabetes-matters/cardiovascular-disease–diabetes. Last accessed 7th Feb 2019.
- Aguiree F, Brown A, Cho NH, Dahlquist G, Dodd S, Dunning T, Hirst M, Hwang C, Magliano D, Patterson C. (2013) IDF Diabetes Atlas.
- Bahia LR, Araujo DV, Schaan BD, Dib SA, Negrato CA, Leão MP, Ramos AJ, Forti AC, Gomes MB, Foss MC, Monteiro RA, Sartorelli D, Franco LJ, Value Health. (2011), 137-40.
Why Choose the Randox RX series?
Why Choose the RX series?
Notorious for quality and reliability, the Randox RX series delivers on precision, reliability and accuracy, revolutionising patient testing in a variety of laboratory types including Clinical Laboratories, University & Research Institutes and Veterinary Laboratories.
The RX series is world renowned for delivering superior performance, our comprehensive test menu comprises over 113 clinical chemistry assays – 22 more than our nearest competitor. In addition to this we offer superior methodology for many assays with excellent correlation to gold standard methods. Our test menu is constanty expanding and currently covers routine chemistry, specific proteins, lipids, cardiac markers, therapeutic drugs, drugs of abuse, antioxidants and diabetes testing including direct HbA1c testing capabilities. Designed to meet the needs of your laboratory, our range of novel tests allow laboratories to expand their test menu without expanding their lab ultimately reducing costs, labour and the risk of error without the need for additional / specialised equipment.
With a versatile range of semi-automated and automated analysers, the RX series offers flexibility to suit the needs of all laboratory requirements. Built on the foundations of robust hardware and intuitive software, the RX series will reduce costly test re-runs and potential misdiagnosis. With minimal analyser downtime significant cost and time savings are a reality.
Our prominent reputation of providing laboratories with unrivalled customer and technical support across the globe surpasses that of any of our competitors complementing our extensive and world leading test menu. We pride ourselves in both the delivery and functionality of high quality clinical chemistry analysers, dedicated reagents and support ensuring accuracy and reliability in reporting patient results.
Offering the World’s Largest Clinical Chemistry Test Menu
Most recently the RX series welcomed the addition of Direct HbA1c to our testing panel, available to be run on the RX Daytona +, RX imola and RX modena. If you are interested in running your assays on a routine biochemistry analyser, Randox offers a large range of high quality routine and niche protein assays that can be run on most automated analysers.
Click to discover more about our world leading RX series Testing menu or contact us today @theRXseries to find out how we can improve your laboratories testing capabilities.
Choose from the RX misano, RX monaco, RX daytona+, RX imola and RX modena to start your journey with the RX series today.
The move from Nephelometry to Immunoturbidimetric Testing
Background
In clinical diagnostics, proteins are part of a wide range of biochemical markers used to identify health and disease in patient samples. Proteins play a key role in the human body, as they are involved in almost every process and can be associated to functions and regulatory pathways that are either signature for disease onset or a target for therapeutic intervention.
There are two main methods used to detect proteins in patient samples; nephelometry and immunoturbidimetry. Nephelometry although traditionally thought to be more sensitive can be expensive due to higher consumable costs. In addition to this nephelometers can be inefficient and are limited by their test menu. Immunoturbidimetric tests are an increasingly accepted alternative to nephelometry for specific protein assays, and studies have shown a close correlation between Randox immunoturbidimetric tests and nephelometry. This particularly lies with the latex enhanced immunoturbidimetry methodology utilised by Randox.
Why the RX series?
Renowned for quality and reliability, the RX series excels in clinical testing combining robust hardware, intuitive software and a world leading test menu featuring routine and novel high performing reagents.
Running specific protein tests on the RX series provides laboratories with a wide range of advantages. The move from nephelometric testing to immunoturbidimetric lowers laboratory costs as nephelometry requires the use of dedicated instruments which are much slower, have higher consumable costs and require highly trained personnel, with the disadvantage of not being able to perform any other type of assay on a single platform.
The RX series improves laboratory efficiencies not just saving costs but also time. Our range of routine clinical chemistry analysers provide users with flexibility and versatility through consolidation of testing onto one single platform.
High Performing and Unique Testing Menu
The RX series of specific protein assays assist in the diagnosis and evaluation of various conditions each with excellent sensitivity and limited inference levels. Randox manufacture immunoturbidimetric kits for the study of a wide range of specific proteins including unique products such as Apolipoprotein C-II, Apolipoprotein C-III, Apolipoprotein E, Cystatin C and Microalbumin.
Most recently the RX series welcomed the addition of Direct HbA1c to our testing panel, available to be run on the RX Daytona +, RX imola and RX modena. If you are interested in running your protein assays on a routine biochemistry analyser, Randox offers a large range of high quality routine and niche protein assays that can be run on most automated analysers.
Click to discover more about our world leading RX series Testing menu or contact us today @theRXseries to find out how we can improve your laboratories testing capabilities.
Automation vs. ELISA
Background
The technological developments and scientific innovations in the field of clinical chemistry from the early 1950’s to date have been vast, enhancing laboratory capabilities and providing the necessary support to clinicians and laboratories to improve patient diagnosis and treatment. (1) Laboratory automation today is a complex integration of robotics, computers, liquid handling and numerous other technologies with a fundamental purpose of saving time and improving performance through the elimination of human error.
Complementing this, in the early 1950’s ready-to-use assay reagent kits, with instructions for use introduced a very significant innovation to the field of automation eliminating the process of manually preparing reagent. (2)
Despite the many advancements in automation many clinical laboratories continue to use manual methods such as ELISA for some specialised tests. (3)
Inefficiencies with ELISA based methods
Manual ELISA based techniques are notoriously inefficient and are particularly draining on time and personnel due to the manual intervention required. The manual nature of the method also means there is greater potential for human error ultimately resulting in lack of sensitivity and potential for cross-reactivity. (4,5)
For many laboratories, the transition from traditional ELISA techniques to an automated method for the detection of the same analyte will significantly improve both costs and time.
Renowned for quality and reliability the RX series range of clinical chemistry analysers ensures confidence in patient testing.
Expanding Capabilities and Performance
With patient care holding a primary focus on clinical chemistry testing, the RX series range of semi-automated and automated analysers offer versatility to suit all laboratory requirements. Expanding your laboratory’s capabilities with our world leading extensive dedicated test menu offers cost savings through consolidation of both routine and specialised tests. By transitioning analytes historically only available as an ELISA based test, laboratories can expand their offering with ease to both patients and clinicians.
Our open system approach to clinical testing offers unique opportunities for consolidation, most of our unique and high-performance assays may be run on any clinical chemistry instrument without the need for specialised equipment.
Outperforming ELISA methodology, the RX series delivers a testing platform that requires limited or no manual preparation. With ELISA, the test is run on a 96 well plate using only a single assay with recommendations to duplicate or triplicate samples to evacuate the extent of errors, therefore increasing time and costs. The RX series of analysers each have different levels of throughput to adapt to the requirements of all laboratories. Utilising robust hardware and intuitive software the RX series guarantees accurate and precise patient testing.
References:
- Olsen K. The first 110 years of laboratory automation: technologies, applications, and the creative scientist. J Lab Autom. 2012; 17:469-80.
- Rosenfeld L. A golden age of clinical chemistry: 1948-1960. Clin Chem. 2000; 46:1705.14.
- Kricja LJ, Savory J. International year of chemistry 2011. A guide to the history of clinical chemistry. Clin Chem. 2011; 57:1118-26.
- Wild D, Sheehan C, Binder S. Introduction to immunoassay product technology in clinical diagnostic testing. In: Wild D, editor. Immunoassay Handbook: Theory and Applications of Ligand Binding, ELISA and Related Techniques. 4th Oxford, UK: Elsevier; 2013.
- Hawker CDED. Laboratory automation: total and subtotal. Clin Lab Med. 2007; 27:749-70.