Rheumatoid Factor: The Most Remarkable Autoantibody in Rheumatoid Arthritis
Rheumatoid Factor: The Most Remarkable Autoantibody in Rheumatoid Arthritis
Rheumatoid Factor:
The Most Remarkable Autoantibody in Rheumatoid Arthritis
Celebrating World Arthritis Day (WAD)
Rheumatoid Factor: The Most Remarkable Autoantibody in Rheumatoid Arthritis
World Arthritis Day (WAD) is celebrated on 12th October to help raise global awareness of the existence and impact of rheumatic and musculoskeletal diseases (RMDs). It is estimated that over one-hundred million people are currently undiagnosed impacting their quality of life and participation in society – including their ability to work and lead a normal life. As a result this increases dependency on state welfare, the healthcare system and the required support from their family and friends.
The European League Against Rheumatism (EULAR) launched the ‘Don’t Delay, Connect Today’ campaign focusing on the importance of early diagnosis and access to care.
Randox Reagents fully supports the importance of early diagnosis – to aid in the early implementation of effective treatment plans, aiding in improved health outcomes – it’s the ethos of our business. This blog delves deeper into rheumatoid factor (RF), the most remarkable autoantibody in rheumatoid arthritis.
Pathobiology of Rheumatoid Arthritis (RA)
The pathophysiology of RA involves various signaling pathways and immune modulators (effector cells and cytokines) as indicated in figure 1. Joint destruction is caused by the intricate interactions of immune modulators, beginning at the synovial membrane and encompassing most IA structures, with synovitis caused by both or individually, the local activation or influx of mononuclear cells, including: B cells, T cells, dendritic cells, plasma cells, mast cells and macrophages. Consequently, “the synovial lining becomes hyperplastic, and the synovial membrane expands and forms villi”. The neutrophils, chondrocytes and synoviocytes secrete enzymes that degrades the cartilage in the joint whereas the osteoclast-rich area of the synovial membrane destroys the bone 4.
Rheumatoid arthritis (RA), “the most common systemic inflammatory autoimmune disease” affecting 1% of the global population, is characterised by fatigue, synovial joint pain, stiffness, swelling and destruction, with severe symptoms resulting in disability. Whilst the exact cause of RA is unknown, it is believed that genetic and environmental factors play a role in triggering the disease 2, 3. Differences in the human leukocyte antigen (HLA)-DRB1 alleles (proteins with a critical role in the immune system) have been identified as a genetic variant for RA, observed in >80% of patients, particularly in those testing positive for RF. Moreover, those with variations in the HLA-DRB1 who smoke, increase their risk of RA. As RA is more common in women (2-fold increased risk in women compared to men), hormonal influences are an area of active research, however, an inverse correlation with breastfeeding has been identified. Women who breastfeed for >13 months aids in reducing the risk of RA compared to women who have never breastfed 3, 4.
Figure 1: Schematic view of (a) a normal joint and (b) a joint affected by RA 4
Clinical Significance of Rheumatoid Factor (RF)
Interestingly, elevated levels of RF have been observed in other autoimmune conditions such as Sjögren syndrome and systemic lupus erythematosus (SLE) as well as non-autoimmune conditions including old age and chronic infections. Despite this, RF in RA patients can be distinguished from RF in healthy individuals. RF in RA patients displays affinity maturation whereas RF in healthy individuals has low affinity and are polyreactive 2.
RF is a class of immunoglobulin (Ig) autoantibodies that are directed against the fragment crystallizable region (Fc region), the tail region of the IgG antibody. In RA, RF are produced by the B cells present in lymphoid follicles and the germinal center(GC)-like structures that mature in inflamed synovium. Most RF are IgM antibodies, but may also be IgG or IgA isoforms. IgM RF are detected in 60% to 80% of RA patients. “RF testing in RA patients has a sensitivity of 60% to 90% and a specificity of 85%” (5). RF is a highly valuable biomarker in RA 5, 2.
Key Features of the Randox Rheumatoid Factor Assay
The Randox automated latex enhanced immunoturbidimetric rheumatoid factor assay provides an accurate assessment of RF titre as the Randox rheumatoid factor calibrator is standardised against the primary WHO material, 1st British Standard 64/2. With a wide measuring range of 6.72 – 104lU/ml for the comfortable detection of clinically important results, the Randox RF assay is available in a liquid ready-to-use format for the comfortable detection of clinically important results. The Randox rheumatoid factor assay does not suffer from interference from C1q complement and is stable until expiry date. With dedicated calibrator and controls for a complete testing package, Randox offer applications, detailing instrument-specific settings for the convenient use of the Randox rheumatoid factor assay on a wide range of clinical chemistry analysers.
Related Products
Randox Reagents Homepage
Randox Reagents Resource Hub
Specific Proteins Panel
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
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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.
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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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Medlab Middle East
Join us for Medlab Middle East 2020!
Randox Laboratories will be attending Medlab Middle East form the 3rd February – 6th February 2020. 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 Dubai International Convention & Exhibition Centre at stand Z5.B10.
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.
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
Lipoprotein(a) [Lp(a)]
Lipoprotein(a) [Lp(a)] is described as “the most complex and polymorphic of the lipoprotein particles” 1. The biggest challenge that exists surrounding Lp(a) measurement is the heterogeneity of the apo(a) isoforms. Standardisation across calibrators is vital as the repeated KIV-2 units in Lp(a) act as multiple epitopes. A lack of standardisation could result in the underestimation of Lp(a) associated CVD risk 2.
Lp(a) assays that are standardised to the WHO/IFCC reference material, transferring values from mg/dl to nmol/l are more uniformed. The Denka Seiken Lp(a) assay is the most reliable commercially available Lp(a) assay, because 2:
- The isoform size variations are reduced as a range of calibrators from separate pools of serum were used which covered a range of Lp(a) concentrations.
- The isoform size and concentrations are inversely correlated better matching calibrants with test samples.
- Methods based on the Denka Lp(a) assay, calibrated in nmol/l and traceable to the WHO/IFCC reference material produced an acceptable bias compared with the Northwest Lipid Metabolism and Diabetes Research Laboratory (NLMDRKL) gold standard method.
HEART UK advocate the widespread clinical utility of Lp(a) to refine the CVD risk assessment. In doing so, HEART UK developed ten statements on Lp(a) (Table 1) utilising the 2016 ACC/AHA Clinical Guideline Recommendation Classification System, to assess the strength of the recommendation and aid in guiding the phrasing of the recommendation 2.
Key Features of the Randox Lp(a) Assay
- The Randox Lp(a) assay is one of the only methodologies on the market that detects the non-variable part of the Lp(a) molecule and therefore suffers minimal size related bias providing more accurate and consistent results. The Randox Lp(a) kit is standardised to the WHO/IFCC reference material (IFCC SRM 2B) and is closest in terms of agreement to the ELISA reference method.
- Five-point calibrator with accuracy-based assigned target values, and control are available, accurately reflecting the heterogeneity of the apo(a) isoforms present in the general population and offering a complete testing package.
- Measuring units are available in nmol/l which is more uniformed and recommended by HEART UK.
- Immunoturbidimetric method is highly sensitive and specific for the detection of Lp(a) in serum and plasma.
- Excellent correlation co-efficient of r=0.995 when compared against other commercially available methods.
- Excellent within run precision of <2.54%.
- Liquid ready-to-use format for convenience and ease-of-use.
- Applications available detailing instrument-specific settings for the convenient use of the Randox Lp(a) assay on a wide range of clinical chemistry analysers.
References
- Marcovina SM, Albers JJ. Lipoprotein (a) measurements for clinical application . Journal of Lipid Research 2019; 57(): 526-537.
- Cegla J, Dermot R, Neely G, France M, Ferns G, et al. HEART UK consensus statement on Lipoprotein(a): A call to action. Atherosclerosis 2019; 291(): 62-70.
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.
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.
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.
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.
With an extensive database of over 2000 participants in over 100 countries, QCMD is one of the largest providers of molecular EQA in the field of molecular diagnostics.
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 117 clinical chemistry assays, covering a range of testing panels, including: antioxidants, diabetes, 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.
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.
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.
Want to know more?
Contact us or book a meeting with us
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?
Contact us or book a meeting with us
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
IBMS 19
Join us for IBMS 2019!
Randox Laboratories will be attending IBMS from the 23rd – 25th September 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 International Convention Centre, Birmingham at stand 407.
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.
Randox Laboratories has this month announced its achievement in being awarded the Manufacturer Certification by the National Glycohemoglobin Standardization Program (NGSP); for direct HbA1c testing on three of its clinical chemistry analysers; the RX modena, RX imola and RX daytona+.
NGSP is recommended for laboratories conducting diabetes-related clinical trials and is only granted on the basis of 98% accuracy. With the global prevalence of diabetes mellitus increasing rapidly, affecting roughly 8% of the total population, the achievement of this certification emphasises that Randox RX series clinical chemistry analysers correlate with global standards and deliver accurate, reliable and precise results for direct HbA1c testing; helping clinicians make informed decisions for patients with diabetes.
The Randox automated immunoturbidmetric HbA1c test exhibits high accuracy and reproducibility with the added advantages of using liquid reagents with good stability, and on-board pre-treatment of samples; therefore, offering an improved method for the rapid direct measurement of HbA1c in human blood.
Randox Direct HbA1c Assay Features
> Sample type – suitable for use with whole blood samples
> Latex enhanced immunoassay method – the Randox assay utilises an immunoassay method making it simple and quick to perform
> Liquid ready to use reagents – for ease of use and convenience
> Excellent stability – all reagents are stable to expiry date when stored at +2-8ºC or 28 days on board the analyser at approximately 10°C
Advantages of the RX series Direct HbA1c Testing
> Fully automated on-board haemolysis function for HbA1c testing
> Continuous loading and STAT sample functionality to enhance productivity in the laboratory (analyser dependent)
> Low sample volumes required
> 1200 tests per hour including ISE (RX modena)
Randox was awarded NGSP Certification for Direct HbA1c testing on 1st July 2019.
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.
Revealing H-FABP for AKI Testing
A new testing application for the biomarker heart-type fatty acid-binding protein (H-FABP) has been announced by global diagnostic company Randox Laboratories.
Whilst H-FABO is most commonly recognised as an early biomarker of myocardial infarction, the assay’s clinical utility in cardiac surgery-associated acute kidney injury (CSA-AKI) is notable. Studies have shown that patients who developed AKI following cardiac surgery had elevated levels of H-FABP both pre-and post-operatively compared to patients who did not.
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.
Register your attendance at our workshop
Advances in Quality Control - Tools to calculate Measurement Uncertainty | Room 116 | Mon 23 September, 11am - 12pm
ISO 15189:2012 requires laboratories to determine Measurement Uncertainty (MU) for each measurement procedure and regularly review estimates of MU. In this session, Margaret will explore these requirements focusing on what is MU, how MU is calculated and tools available to assist laboratories in meeting these requirements.
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.
Molecular External Quality Control
QCMD is a world leading External Quality Assessment (EQA) / Proficiency Testing (PT) scheme, dedicated to improving the quality of molecular diagnostic assays used in the detection of infectious diseases. With an extensive database of over 2000 participants in over 100 countries, QCMD is one of the largest providers of molecular EQA in the field of infectious disease testing.
EQA participants receive an individual report outlining their performance relative to their method and technology groups. A supplementary report may be commissioned – this includes any additional relevant information regarding the annual EQA distribution, as well as scientific expert commentary and feedback on the overall results within that distribution.
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
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)
Africa Health 2019
Join us for Africa Health 2019!
Randox Laboratories will be attending Africa Health from the 28th – 30th May 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 Gallagher Convention Centre in Johannesburg , at our stand #4.D16.
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
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.
Acusera
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 minimise 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.
Acusera 24.7
Online QC software with real-time peer group statistics
Designed to help you efficiently review QC data from multiple laboratory instruments on one centralised 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.
Acusera Verify
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.
The World’s Largest International EQA scheme
With over 45,000 laboratory participants in more than 133 countries, the Randox International Quality Assessment Scheme (RIQAS) is truly the largest international EQA 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 programs required while 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.
Molecular External Quality Control
QCMD is a world leading External Quality Assessment (EQA) / Proficiency Testing (PT) scheme, dedicated to improving the quality of molecular diagnostic assays used in the detection of infectious diseases. With an extensive database of over 2000 participants in over 100 countries, QCMD is one of the largest providers of molecular EQA in the field of infectious disease testing.
EQA participants receive an individual report outlining their performance relative to their method and technology groups. A supplementary report may be commissioned – this includes any additional relevant information regarding the annual EQA distribution, as well as scientific expert commentary and feedback on the overall results within that distribution.
Randox Reagents are internationally recognised as being of the highest quality, offering reliable and rapid results. Our product portfolio consists of 113 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, HDL2/3 Cholesterol, sdLDL Cholesterol, Total Antioxidant Status and Zinc.
Enhance your Cardiac Testing Panel with sPLA2-IIA!
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.
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