Rheumatoid Factor: The Most Remarkable Autoantibody in Rheumatoid Arthritis

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Rheumatoid Factor: The Most Remarkable Autoantibody in Rheumatoid Arthritis

Rheumatoid Factor: The Most Remarkable Autoantibody in Rheumatoid Arthritis

The European League Against Rheumatism (EULAR) launched the ‘Don’t Delay, Connect Today’ campaign in 2017, continuing into 2019 for World Arthritis Day. The day is a global awareness day focusing on promoting the symptoms associated with rheumatic and musculoskeletal diseases (RMDs). Moreover, the world awareness day focuses on the importance of early diagnosis and access to care 1. Randox Reagents fully supports the importance of early diagnosis which aids in the early implementation of effective treatment plans, aiding in improved health outcomes. On this World Arthritis Day, Randox Reagents will delve deeper into rheumatoid factor (RF), the most remarkable autoantibody in rheumatoid arthritis.

Pathobiology of Rheumatoid Arthritis (RA)

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.

The pathophysiology of RA involves various signalling 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.

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.

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Alzheimer’s Disease: The Role of Apolipoprotein E

21 September 2019

Alzheimer’s Disease: The Role of Apolipoprotein E

Since 2012, September has been devoted to raising awareness of Alzheimer’s disease (AD) with Alzheimer’s Day on 21st September each year. 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

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.

Figure 1: Alzheimer’s Disease Demographic, 2019 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.

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H-FABP for Acute Kidney Injury Testing Revealed by Randox

2 August 2019

H-FABP for Acute Kidney Injury Testing

Revealed by Randox

A new testing application for the biomarker Heart-Type Fatty Acid-Binding Protein (H-FABP) has been announced by global diagnostics company Randox Laboratories.

Whilst H-FABP is most commonly recognized 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 postoperatively compared to the patients who did not.

 

Susan Hammond, Randox Product Specialist, explained the new application for H-FABP;

“Cardiac surgery-associated acute kidney injury (CSA-AKI) is a well-recognized postoperative complication of cardiac surgery and is the second most common cause of AKI in the intensive care unit (ICU) – occurring in up to 30% of patients.

“Several AKI studies exist focusing on the measurement of H-FABP levels before, during and after cardiac surgery, one of which found that the post-operative H-FABP levels in patients who experienced any AKI increased 8-fold. It was also noted that the levels of those with severe AKI increased 13-fold and that 10.8% of patients who died from subsequent AKI all had elevated pre-operative levels of H-FABP.

“The Randox H-FABP assay is therefore an independent marker of AKI following cardiac surgery, and can furthermore be used as a CSA-AKI risk assessment assay even in advance of the procedure.”

It has been identified that certain patient groups are more susceptible to CSA-AKI and vulnerability can depend on age, sex, pre-existing cardiac dysfunction, pre-existing chronic kidney disease (CKD), previous cardiac surgery or comorbidity.

Susan Hammond added;

“The ability to include biomarkers that aid in the risk assessment and treatment plan management of a patient is significant.  Utilizing H-FABP alongside traditional biomarkers to assess CSI-AKI risk allows the clinician to gain stronger clinical insight in how to improve patient outcomes.”

 

Key Benefits of the Randox H-FABP assay

A niche product from Randox meaning that Randox are one of the only manufacturers to offer the H-FABP assay in an automated biochemistry format

CE marked for diagnostic use

Automated assay offering a more convenient and time efficient method for H-FABP measurements compared to traditional testing

Exceptional correlation of r=0.97 when compared against other commercially available methods

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

Liquid ready-to-use format for convenience and ease-of-use

Latex enhanced immunoturbidimetric method delivering high performance compared to traditional ELISA testing

Rapid results within fourteen minutes, depending on the analyser.

Wide measuring range of 0.747 – 120ng/ml for the early detection of clinically important results

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


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

  • Serology Controls
  • HbA1c
  • Stroke Biochip
  • Evidence+
  • H-FABP & AKI
  • Acusera Verify

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.

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vivalytic

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.

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.

Book a live demonstration for Acusera 24.7

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.

Find out more about Direct HbA1c
Book a demonstration of one of our analysers

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.

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Total Bile Acids: The Value of Fifth Generation Tests

22 July 2019

Total Bile Acids: The Value of Fifth Generation Tests

Bile acids are water-soluble, amphipathic end products of cholesterol metabolism and are involved in liver, biliary and intestinal diseases. They are formed in the liver and are absorbed in the small intestine before being excreted. The fundamental role of bile acids is to aid in the digestion and absorption of fats and fat-soluble vitamins in the small intestine.1

Intrahepatic Cholestasis of Pregnancy

Intrahepatic cholestasis of pregnancy (ICP) is a pregnancy-specific liver disorder. It can be indicated by pruritus, jaundice, elevated total bile acids and/or serum transaminases and usually affects women during the second and third trimester of pregnancy.2,3

Intrahepatic Cholestasis of pregnancy or Obstetric Cholestasis is a condition that restricts the flow of bile through the gallbladder resulting in a build-up of bile acids in the liver.3 Due to the build-up, bile acids leak into the bloodstream where they are detected at concerning levels. It is an extremely serious complication of pregnancy that can lead to the increased risk of premature birth or even stillbirth, as such it is vital that women with the disease are monitored carefully.

In healthy pregnancies, there is very little increase in total bile acid levels although a slight increase is likely to be seen in the third trimester. Measurement of total bile acids in serum is thought to be the most suitable method of diagnosing and monitoring ICP.6

According to several reports total bile acid levels in ICP can reach as high as 100 times the upper limit of a normal pregnancy. It has been reported that a doubling in maternal serum bile acids, results in a 200% increased risk of stillbirth with total bile acids thought to trigger the onset of preterm labour. Additionally, bile acids can affect the foetal cardiovascular system as it has been found that there are often cardiac rhythm disturbances in the foetus due to the elevated bile acids in circulation.5

Although it is a rare condition, with only 0.3-0.5% of women likely to develop ICP, it can have extreme risks and so it is important to properly diagnose and monitor the condition.6 ICP increases the risk of meconium staining of the amniotic fluid and is reported to be a sign of foetal distress. This complication is found in 16-58% of all ICP cases, worryingly 100% of cases have resulted in foetal death. The frequency of this condition is found to be greater in pregnancies with higher levels of serum total bile acids.

Did you know?

Liver disease is the only major cause of death still increasing every year with 2 million deaths per year being caused by it.4

Risk factors

There are several risk factors associated with ICP such as a family history of ICP, use of oral contraceptives, assisted reproduction techniques and multiple gestation. Genetic influence accounts for approximately 15% of ICP cases. Dietary selenium is a contributing environmental factor as serum selenium levels often decrease throughout pregnancy. Further to this, incidences of ICP rise in the winter months, most likely due to the fact selenium levels are naturally less during these months.7,8

Total Bile Acids

In addition to ICP, bile acid levels are also measured in the diagnosis of other liver disorders. The bile acids test in an extremely sensitive indicator of liver function, capable of detecting changes in hepatic function before clinical symptoms arise, thus providing valuable information that standard liver function tests cannot. As a result of its high sensitivity, bile acids can be used to assess liver function in transplant patients, allowing monitoring of the transplant success and of antirejection therapy. The bile acids test is most beneficial when used in conjunction with standard liver function tests such as ALT and AST which are markers of liver damage rather than liver function.

Measurement of Total Bile Acids

The enzyme cycling method, also known as the Fifth Generation Bile Acids test, is a method that allows for signal amplification through cycled regeneration reactions as can be seen in Figure 1. In the presence of Thio-NAD, the enzyme 3-α hydroxysteroid dehydrogenase (3-α  HSD) converts bile acids to 3-keto steroids and Thio-NADH.  The reaction is reversible and 3-α  HSD can convert 3-keto steroids and Thio-NADH to bile acids and Thio-NAD.  In the presence of excess NADH, the enzyme cycling occurs efficiently and the rate of formation of Thio-NADH is determined by measuring specific change of absorbance at 405 nm and is proportional to the amount of total bile acids in the sample. The analysing capability of the fifth generation total bile acids assay is far beyond the performance of conventional bile acid tests.10,11

Figure 1: The assay principle

Inadequacies of Traditional Bile Acids Assays

Determining the cause and extent of liver damage is important in guiding treatment decisions and preventing disease progression. Standard liver function tests include; ALT, AST, ALP, GGT and Bilirubin. The measurement of TBA is most beneficial in conjunction with these standard liver tests and offers unrivalled sensitivity allowing identification of early stage liver dysfunction. There are several commercial methods available for the detection and measurement of TBA in serum. Traditional TBA tests based on the enzymatic method use nitrotetrazolium blue (NBT) to form a formazan dye. The reaction is measured at 546nm and the intensity of the colour is proportional to the concentration of bile acids.

Newer methods such as the enzyme cycling method or fifth generation methods offer many advantages including greater sensitivity, liquid reagents, small sample volumes and reduced instrument contamination from formazan dye. Additionally, the fifth generation assay does not suffer from interference from lipaemic or haemolytic samples. Both lipemia and haemolysis are common in new-borns and pregnant women, so this further supports that the fifth generation test is more sensitive for these sample types.12

Want to know more?

Contact us or download our total bile acids whitepaper

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Randox Reagents

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  • References

    [1] The continuing importance of bile acids in liver and intestinal disease. A.f., Hofmann. 1999, Arch Intern Med, pp. 2647-2658.

    [2] Diagnostic and Therapeutic Profiles of Serum Bile Acids in Women with Intrahepatic Cholestasis of Pregnancy – A Pseudo-Targeted Metabolomics Study. Cui, Yue. Xu, Biao. Zhang, Xiaoqing. He, Yifan. Shao, Yong. Ding, Min. s.l. : Clinica Chimica, 2018, Vol. 483.

    [3] Randox Laboratories. Bile Acids Test for Obstetric Cholestasis – A serious complication of pregnancy. 2012.

    [4] British Liver Trust (2019) Facts about Liver Disease, Available at: https://www.britishlivertrust.org.uk/about-us/media-centre/facts-about-liver-disease/ (Accessed: 18th June 2019).

    [5] .Geenes, Victoria. Williamson, Catherine. 17, s.l. : World J Gastroenterol, 2009, Vol. 15.

    [6] Howland, Genevieve. Cholestasis of Pregnancy: Why You Can’t Ditch the Itch. Mama Natural. [Online] December 22, 2018. [Cited: February 19, 2019.] https://www.mamanatural.com/cholestasis-of-pregnancy/.

    [7] Bile Acid Levels and Risk of Adverse Perinatal Outcomes in Intrahepatic Cholestasis of Pregnancy: A Meta-Analysis. Cui, Donghua, et al.

    [8] Intrahepatic Cholestasis of Pregnancy. Chivers, Sian. Williamson, Catherine. 7, 2018, Vol. 28.

    [9] Masoud, N; Neill, S.H. Serum bile acids as a sensitive biological marker for evaluating hepatic effects of organic solvents. Available from URL: https://www.ncbi.nlm.nih.gov/pubmed/23885947 [Accessed 1 November 2018]

    [10] Microassay of Serum Bile Acids by an Enzymatic Cycling Method. Komiyama, Y, et al. 10, s.l. : Chemical and Pharmaceutical Bulletin, 1982, Vol. 30.

    [11] Evaluation of a Colorimetric Enzymatic Procedure for Determining the Total Bile Acids in the Blood. Agape, V, et al. 3, s.l. : Minerva Gastroenterologica e Dietologica, 1989, Vol. 35.

    [12] Total Bile Acids Test & Clinical Diagnosis. Diazyme. 2019.


Diabetes: The Role of Fructosamine

13 June 2019

Diabetes: The Role of Fructosamine

Diabetes Week is an annual week to raise awareness of diabetes. This year, the aim is to increase the public’s understanding of diabetes 1. Diabetes mellitus (DM) is a global epidemic, increasing at an alarming rate and burdening healthcare systems 2.  DM is a life-long condition characterised by the body’s inability to produce / respond to insulin resulting in the abnormal metabolism of carbohydrates and elevated blood glucose levels.

Whilst it is important to increase the public’s understanding of DM, it is imperative that clinicians and physicians are aware of the different in vitro diagnostic tests to diagnose and monitor DM. Not only is this vital, but is also important that clinicians and physicians also understand the different methodologies available when choosing the diagnostic test.

It has been highlighted in numerous clinical studies that diabetic complications may be reduced through the long-term monitoring and tight control of blood glucose levels. Both fasting plasma glucose (FPG) and glycated haemoglobin A1c (HbA1c) tests are universally accepted as reliable measurements of diabetic control. However, studies have emerged highlighting the role of fructosamine in diabetes monitoring. Whilst HbA1c provides an index of glycaemia over 2 to 3 months, fructosamine provides this index over the course of 2 to 3 weeks, enabling closer monitoring of diabetic control 1.

Did you know?

Diabetes is estimated to be the seventh leading cause of death with 1.6 million deaths attributed to diabetes in 2016 3

Drawbacks of Traditional Diabetes Tests

The FPG test measures the level of blood sugars which is used to diagnose and monitor diabetes based on insulin function. The main drawback of this test is that a hormone called glucagon, produced in the pancreas, is triggered during prolonged fasting, signalling the liver to release glucose into the bloodstream. In diabetic conditions, either the body is unable to generate enough insulin or cannot appropriately respond to insulin. Consequently, FPG levels remain high 4.

In the 1980’s, HbA1c was incorporated into clinical practice as HbA1c levels correlated well with glycaemic control over a 2 to 3-month period. The main drawback of this test is that any condition that reduces the survival rate of erythrocytes such as haemolytic anaemia will falsely lower the HbA1c test results, regardless of the assay method utilised 5.

Fructosamine Testing

In a diabetic patient where blood glucose levels are abnormally elevated, the concentration levels of fructosamine also increase as fructosamine is formed by a non-enzymatic Maillard reaction between glucose and amino acid residues of proteins. During this glycation process, an intermediate labile Schiff base is produced which is converted to a more stable ketoamine (fructosamine) via an Amadori rearrangement 2.

Fructosamine has been identified as an early indicator of diabetic control compared to other markers such as HbA1c. Red blood cells live for approximately 120 days, HbA1c represents the average blood glucose levels for the previous 2 to 3 months. Conversely fructosamine has a shorter lifespan, about 14 to 21 days, reflecting average blood glucose levels from the previous 2 to 3 weeks. Due to the shorter time span of fructosamine, it is also used to evaluate the effectiveness of medication changes and to monitor the treatment of gestational diabetes. The test is also particularly useful in situations where HbA1c cannot be reliably measured e.g. haemolytic anaemia, thalassemia or with genetic haemoglobin variants 5.

Fructosamine Assay Methodology

The most commonly utilised method for fructosamine testing is the colorimetric method. Whilst widely available, automated and inexpensive, the main drawback is the lack of standardisation across the different fructosamine assays 4.

Randox, on the other hand, utilise an enzymatic method, offering improved specificity and reliability compared to conventional NBT-based methods. The Randox enzymatic method does not suffer from non-specific interferences unlike existing methods which can also be time consuming and difficult to automate.

The Randox fructosamine assay is also standardised to the highest level as the Randox fructosamine calibrator and control is assigned relative to human serum glycated with 14C-glucose, which directly reflects the nature of the patient sample.

With an excellent stability of 28 days on-board the analyser, the Randox fructosamine assay is developed in a liquid ready-to-use format for convenience and ease-of-use.

Randox offer fully automated applications detailing instrument-specific settings for the convenient use of the Randox fructosamine assay on a wide range of clinical chemistry analysers.

Want to know more?

Contact us or download our diabetes brochure

Related Products

Randox Reagents

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Diabetes Panel


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

  • Serology Controls
  • Daytona+
  • Stroke Biochip
  • Evidence+
  • sPLA₂-IIA
  • Acusera Verify

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 Afamily. 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?

  • Biosciences
  • Acusera
  • RIQAS
  • Qnostics
  • Reagents
  • RX Series
  • Toxicology
  • Evidence Series
vivalytic

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.

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.

Book a live demonstration for Acusera 24.7

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.

Find out more about Direct HbA1c
Book a demonstration of one of our analysers

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

  • Tuesday 6th August 2019
  • Wednesday 7th August 2019

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)


Aldolase: A Myositis Biomarker

29 May 2019

Aldolase: A Myositis Biomarker

The month of May is devoted to myositis awareness, a muscle-wasting disease resulting in reduced muscle strength and fatigue. The term ‘myositis’ is an umbrella term referring to the “general inflammation or swelling of the muscle”.  However, myositis is more often referred to as a disease involving chronic inflammation of the muscles which does not improve with rest. This condition is also known as idiopathic inflammatory myopathy (IIM) 1.

Myositis is an autoimmune disease characterised by pain, muscle weaknesses, swelling and extreme fatigue which often gradually appear. Myositis can be potentially life-threatening, especially dermatomyositis which affects the heart muscle and lungs. Whilst a rare disease, it is estimated that 75,000 Americans suffer from myositis, however, many are undiagnosed or misdiagnosed with more common autoimmune diseases. Most physicians are unfamiliar with the disease and symptoms and so the consequences of this can be catastrophic in terms of long-term physical muscle damage, disability and even death 1, 2, 3.

Did you know?

5,000 to 6,000 people in the UK have a form of myositis 3.

Table 1 reviews the different forms of myositis

A table comparing the different types of Myositis

Table 2 reviews complications with or due to myositis

Complications with or due to Myositis

It is vital that physicians are educated to include myositis despite it being a rare disease as it is essential that myositis patients are diagnosed quickly to ensure appropriate treatment plans are implemented.

Aldolase Testing

Aldolase testing has been recognised as a marker in the differential diagnosis of muscle weakness as aldolase levels remain consistent where weakness is caused by neurological problems such as multiple sclerosis (MS). Aldolase is an enzyme specifically found in skeletal muscle and the liver. When either the muscle or liver are damaged, aldolase is released into the bloodstream 13 . A few studies support aldolase testing in the diagnosis of myositis:

 1.  Arthritis Research & Therapy (2012): Aldolase predicts subsequent myopathy occurrence in systemic sclerosis 14

Objective:

A French monocentric 4-year study prospectively evaluated n=137 systemic sclerosis (SSc) patients without proximal muscle weakness to assess the risk of myopathy related systemic sclerosis (Myo-SSc) according to the European Neuro Muscular Centre criteria. Aldolase, creatine kinase (CK), C-reactive protein (CRP), alanine transaminase (ALT) and aspartate transaminase (AST) were evaluated.

Conclusion:

Aldolase is a valuable diagnostic tool in the identification of SSc patients at a high risk of developing subsequent Myo-SSc. This enables clinicians to monitor at-risk patients as well as identifying Myo-SSc in its earliest stages, enabling the effective and swift implementation of an appropriate treatment plan when the muscle damage is still in a reversible stage.

Findings:

2.  Clinical and Experimental Rheumatology (2013): Isolated elevation of aldolase in the serum of myositis patients: a potential biomarker of damaged early regenerating muscle cells 15

Objective:

The in vitro analysis of the gene and protein expression levels of aldolase and CK during muscle cell differentiation.

Conclusion:

Aldolase A is expressed in the absence of CK in undifferentiated muscle cells and in the early differentiation process. Isolated elevated serum aldolase A in myositis patients reflects preferential immune-mediated damage of early regenerative cells. Aldolase is a biomarker of damaged early regenerating muscle cells.

Findings:

Myositis can be a potentially life-threatening disease when undiagnosed or misdiagnosed. Aldolase is recognised as a biomarker in the diagnosis and monitoring of myositis. Randox are one of the only in-vitro diagnostic manufacturers to offer the aldolase assay in an automated and manual biochemistry format. Not only does the Randox methodology have an excellent correlation coefficient to r=0.9917 when compared against standard methods, the Randox assay is lyophilised for enhanced stability with an excellent measuring range of 1.73 – 106U/l. Moreover, applications are available detailing instrument-specific settings for the convenient use of the Randox aldolase assay on a wide range of clinical chemistry analysers.

Want to know more?

Contact us or download our high performance & unique tests brochure

Related Products

Randox Reagents

Reagents Resource Hub

Clinical Chemistry Panel


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?

  • Biosciences
  • Acusera
  • RIQAS
  • Qnostics
  • QCMD
  • Reagents
  • RX Series
  • Toxicology
  • Evidence Series
vivalytic

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.

Find out more about Direct HbA1c
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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.

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