Diabetes: The Role of Fructosamine
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.
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
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Diabetes Panel
References
[1] Diabetes UK. Diabetes Week. [Online] 2019. [Cited: May 31, 2019.] https://www.diabetes.org.uk/get_involved/diabetes-week.
[2] Gounden, Verena and Jialal, Ishwarlal. Fructosamine. [Online] January 23, 2019. [Cited: April 11, 2019.] https://www.ncbi.nlm.nih.gov/books/NBK470185/.
[3] World Health Organization (WHO). Diabetes. [Online] October 30, 2018. [Cited: May 2, 2019.] https://www.who.int/news-room/fact-sheets/detail/diabetes.
[4] Manzella, Debra. The Fasting Plasma Glucose Test. very well health. [Online] November 16, 2018. [Cited: April 11, 2019.] https://www.verywellhealth.com/understanding-the-fasting-plasma-glucose-test-1087680.
[5] BMJ. Using haemoglobin A1c to diagnose type 2 diabetes or to identify people at high risk of diabetes. [Online] 2014. [Cited: April 11, 2019.] https://www.bmj.com/content/348/bmj.g2867/rr/695927.
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)
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.
Table 1 reviews the different forms of myositis
Table 2 reviews 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
References
[1] The Myositis Association. About Myositis. [Online] [Cited: May 3, 2019.] https://www.myositis.org/about-myositis/.
[2] Kobert, Linda. Myositis, a rare muscular inflammatory disease that ofen goes undiagnosed or misdiagnosed, disproportionally impacts women of color. s.l. : The Myositis Organisation.
[3] Muscular Dystophy UK. Myositis. [Online] [Cited: May 6, 2019.] https://www.musculardystrophyuk.org/about-muscle-wasting-conditions/myositis/.
[4] The Myositis Association. Types of Myositis. [Online] [Cited: May 3, 2019.] https://www.myositis.org/about-myositis/types-of-myositis/.
[5] —. Sporadic Inclusion Body Myositis. [Online] [Cited: May 3, 2019.] https://www.myositis.org/about-myositis/types-of-myositis/sporadic-inclusion-body-myositis/.
[6] —. Dermatomyositis. [Online] [Cited: May 3, 2019.] https://www.myositis.org/about-myositis/types-of-myositis/dermatomyositis/.
[7] —. Polymyositis. [Online] [Cited: May 3, 2019.] https://www.myositis.org/about-myositis/types-of-myositis/polymyositis/.
[8] —. Necrotizing Myopathy. [Online] [Cited: May 3, 2019.] https://www.myositis.org/about-myositis/types-of-myositis/necrotizing-myopathy/.
[9] —. Juvenile Myositis. [Online] [Cited: May 3, 2019.] https://www.myositis.org/about-myositis/types-of-myositis/juvenile-myositis/.
[10] —. Cancer-associated myositis. [Online] [Cited: May 3, 2019.] https://www.myositis.org/about-myositis/complications/cancer-associated-myositis/.
[11] —. Infection. [Online] [Cited: May 3, 2019.] https://www.myositis.org/about-myositis/complications/infection/.
[12] —. Cardiovascular Disease. [Online] [Cited: May 3, 2019.] https://www.myositis.org/about-myositis/complications/cardiovascular-disease/.
[13] —. Blood Tests. [Online] [Cited: May 3, 2019.] https://www.myositis.org/about-myositis/diagnosis/blood-tests/.
[14] Aldolase predicts subsequent myopathy occurrrence in systemic sclerosis. Tolédano, Cécile, et al. Faubourg Saint-Antoine : Arthritis Research & Therapy, 2012.
[15] Isolated elevation of aldolase in the serum of myositis patients: a potential biomarker of damaged early regenerating muscle cells. Casciola-Rosen, Livia, et al. Baltimore : Clinical and Experimental Rheumatology, 2013.
Superior Performance & Unique Tests
Superior Performance & Niche Reagents
Randox offer a range of high performance, unique and niche reagents that are designed to enhance your laboratory testing capabilities.
Our impressive portfolio of high performance & unique tests together with our standard assays sets us apart in the in vitro diagnostics market. Our superior performance reagents and methodologies deliver highly accurate and specific results, that can facilitate earlier diagnosis of disease states with confidence and precision.
Benefits of High Performance Reagents
Reduce Costs
We can help create cost-savings for your laboratory through excellent stability, eliminating the requirement for costly test re-runs. Our quality reagents also come in a range of different kit sizes to reduce waste and for your convenience.
Confidence in Patient Results
Our traceability of material and extremely tight manufacturing tolerances ensure uniformity across our reagent batches. All of our assays are validated against gold-standard methods.
Applications Available
Applications are available detailing instrument-specific settings for the convenient use of the Randox superior performance & unique assays on a wide variety of clinical chemistry analysers.
Superior Performance Offering
Randox offer an extensive range of 115 assays across routine and niche tests, and cover over 100 disease makers. Our high performance assays deliver superior methodologies, more accurate and specific results compared to traditional methods.
Reduce Labour
Reduce valuable time spent running tests. Randox reagents come in liquid ready-to-use formats and various kit sizes for convenient easy-fit. Barcode scanning capabilities for seamless programming.
Unique Offering
Our range of unique assays means that Randox are one of the only manufacturers to offer these tests in an automated biochemistry format.
The in vitro diagnostics market is continuously adapting to the changes in laboratory testing. Consequently, Randox have continued to reinvest in R&D to produce superior performance & unique tests offering laboratories choice, quality and innovation.
The Randox Lp(a) assay is calibrated in nmol/l and traceable to the WHO/IFCC reference material (IFCC SRM 2B) and provides an acceptable bias compared with the Northwest Lipid Metabolism Diabetes Research Laboratory (NLMDRKL) gold standard. A five-point calibrator with accuracy-based assigned target values (in nmol/l) is available, accurately reflecting the heterogeneity of the apo(a) isoforms.
The Randox bile acids test utilises an advanced enzyme cycling method which displays outstanding sensitivity and precision when compared to traditional enzymatic based tests. The Randox 5th Generation Bile Acids test is particularly useful in paediatrics where traditional bile acids tests are affected by haemolytic and lipaemic samples.
A superior assay from Randox, the vanadate oxidation method offers several advantages over the diazo method, including less interference by haemolysis and lipaemia, which is particularly evident for infant and neonatal populations.
The Randox Fructosamine assay utilises the enzymatic method which offers improved specificity and reliability compared to conventional NBT-based methods. The Randox enzymatic method does not suffer from non-specific interferences unlike other commercially available fructosamine assays.
Soluble transferrin receptor (sTfR) is a marker of iron status. In iron deficiency anaemia, sTfR levels are significantly increased, however remain normal in the anaemia of inflammation. Consequently, sTfR measurement is useful in the differential diagnosis of microcytic anaemia.
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Featured Reagent Home
Featured Reagent – G6PDH
Featured Reagent | G6PDH
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Glucose-6-phosphate dehydorgenase (G6PDH/G6PD) deficiency is an x-linked and sex-linked metabolic disorder, commonly affecting men more so than women1. The G6PDH enzyme is critical for the proper functioning of red blood cells (RBC’s). Depleated levels of G6PDH can cause the premature destruction of RBC’s (haemolysis). If the bone marrow cannot compensate for the reduction in RBC’s, heamolyic anaemia can develop. It is important to note that a deficiency in the G6PDH enzyme is not enough to promote the onset of haemolysis, but rather additional factors are required to promote the onset of symptoms2.
Some of the common side effects of G6PDH deficiency include: paleness, dark urine, yellowing of the skin and whites of the eyes, a rapid heart rate and shortness of breath. Common triggers for the development of haemolytic anaemia in those who are G6PDH deficient include: bacterial and viral infections, certain drugs (medications and antibiotics to treat malaria), and favism (inhaling the pollen from fava plants and ingesting fava beans)3
G6PDH deficiency has been recognised as a significant cause of mild to severe jaundice in newborns. It has been noted that those with this disorder commonly will not experience any signs or symptoms making them unaware that they have the condition3.
Haemolytic Anaemia
Haemolytic anaemia is an umbrella term used to describe the premature destruction of red blood cells (RBC’s). This disorder encompasses numerous conditions including: autoantibodies, medications, underlying malignancy, bone marrow failure, infection and heredity conditions including sickle cell disease or haemoglobinopathies4 5.
The severity of haemolytic anaemia depends on whether the onset of haemolysis is gradual or rapid and on the extent of RBC destruction. Patients with mild haemolysis can be asymptomatic whereas the anaemia in severe haemolysis can be life-threatening and can cause angina and cardiopulmonary decompensation. Haemolytic anaemia is an intravascular phenomenon meaning that this type of haemolysis occurs within the blood vessels and is caused by the following conditions: prosthetic cardiac valves, glucose-6-phosphate dehydrogenase (G6PDH) deficiency, thrombotic thrombocytopenic purpura, disseminated intravascular coagulation, transfusion of ABO incompatible blood and paroxysmal nocturnal haemoglobinuria (PNH)6.
Heredity disorders can also cause haemolysis due to the erythrocyte membrane and haemoglobin abnormalities, and enzymatic defects. Some hereditary disorders include: G6PDH deficiency, hereditary spherocytosis and sickle cell anaemia6.
Glucose-6-phosphate dehydrogenase (G6PDH) is a cytosolic enzyme located on the X-chromosome found in bodily cells. G6PDH is involved in the normal processing of carbohydrates and plays a critical role in RBC, protecting them from damage and premature destruction. The two main products of G6PDH are ribose-5-phosphate which is important for DNA, the chemical cousin of RNA. The chemical reaction produces NADPH which protects bodily cells from reactive oxygen species1.
Benefits of the G6PDH Assay
A niche assay from Randox meaning that Randox are one of the only manufacturers to offer a G6PDH assay in an automated biochemistry format.
Superior stability of 4 weeks upon reconstitution and stored at +2°C to +8°C. Many other commercially available assays offer only 5 days stability, leading to product wastage.
Minimal interference as the sample pre-wash step included in the Randox G6PDH testing method serves to purify the sample, leading to no known interferences being observed.
Excellent correlation coefficient of r=0.99 when compared against other commercially available methods.
Lyophilised reagent for enhanced stability.
UV method
G6PDH controls offering a complete testing package.
Applications available detailing instrument-specific settings for the convenient use of the Randox G6PDH assay on a wide range of clinical chemistry analsyers.
References
[1] Croom, Edward. Progress in Molecular Biology and Translational Science. 2012. ISBN 9780124158139 / ISSN 1877-1173.
[2] National Organization for Rare Disorders. Glucose-6-Phosphate Dehydrogenase Deficiency. [Online] no date. [Cited: January 31, 2019.] https://rarediseases.org/rare-diseases/glucose-6-phosphate-dehydrogenase-deficiency.
[3] U.S. National Library of Medicine. Glucose-6-phosphate dehydrogenase deficiency. [Online] May 2017. [Cited: January 30, 2019.] https://ghr.nlm.nih.gov/condition/glucose-6-phosphate-dehydrogenase-deficiency.
[4] National Heart, Lung, and Blood Institute. Hemolytic Anemia. [Online] no date. [Cited: January 28, 2019.] https://www.nhlbi.nih.gov/health-topics/hemolytic-anemia.
[5] BMJ Publishing Group. Hemolytic anemia. BMJ Best Practice. [Online] March 2018. [Cited: January 28, 2019.] https://bestpractice.bmj.com/topics/en-us/98.
[6] Schick, Paul. Hemolytic Anemia. Medscape. [Online] December 29, 2018. [Cited: Janaury 28, 2018.] https://emedicine.medscape.com/article/201066-overview.
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Featured Reagent – sPLAā-IIA
Featured Reagent | sPLA2-IIA
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Benefits
A niche assay from Randox which means that Randox is one of the only manufacturers to offer an sPLA2-llA mass assay in an automated biochemistry format
Applications available detailing instrument-specific settings for the convenient use of the Randox sPLA2-IIA assay on a wide range of clinical chemistry analysers
Complementary controls and calibrators available offering a complete testing package
Automated assay which removes the inconvenience and time consumption associated with traditional ELISA based testing
Excellent correlation coefficient of r = 0.95 when compared against other commercially available methods
Liquid ready-to-use format for convenience and ease of use
Latex enhanced immunoturbidimetric method delivers high performance and confidence in results
NOTE: sPLA2 -IIA Assay – For Research Use Only
Clinical Significance
sPLA2-llA 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.1
Unlike traditional cardiac biomarkers used to predict adverse outcomes in patients with acute coronary syndrome (ACS), sPLA2-llA has been shown to act at multiple pathways involved in atherogenesis, from lipid oxidation to modulation of vascular & inflammatory cell activation and apoptosis.2
Biological Significance of sPLA2-IIA
Key observations through research has found that sPLA2-llA mediated modification of lipoproteins plays a role in the development of atherosclerosis. The surface of both low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) is surrounded by phosphatidylcholine (PC) a type of phospholipid which has been scientifically proven to serve as a good extracellular target for several isoforms of sPLA2-llA. sPLA2-llA works by hydrolysing these phospholipids resulting in the production of free fatty acids and lysophophatidylcholine (LPC) which can generate pro-inflammatory actions, accelerating atherosclerosis.1
Hydrolysis of LDL-C correlates with the production of the more atherogenic, small dense LDL cholesterol (sdLDL-C). The sPLA2-llA -processed low-density lipoprotein (LDL) contains a large amount of lysophospholipids and exhibit the property of “small-dense” or “modified” LDL, which facilitates foam cell formation from macrophages. Research has shown that high plasma levels of sdLDL-C compared to less dense, larger LDL-C create a higher risk of coronary heart disease.
Cardiovascular Disease
Regular cardiovascular screening is important to ensure that cardiac risk factors are detected at the earliest possible stages. Cardiovascular disease (CVD) encompasses a number of diseases of the heart and blood vessels. Four of the main types of CVD include: coronary heart disease (CHD), cerebrovascular disease (CVA), peripheral arterial disease (PAD) and aortic disease. It is vital that at risk patients are diagnosed as quickly and efficiently as possible to ensure effective treatment plan implementation.4
The early diagnosis of CVD aids in reducing the risk of a secondary cardiovascular event and to ensure the patient receives appropriate treatment to prevent premature deaths. Early risk assessment is particularly important in people who are at a greater risk of CVD. This is evaluated through the identification of one or more risk factors including: hypertension, diabetes or hyperlipidaemia. 3 ,5
It is believed that by 2030, almost 23.6 million people will die from CVD, mainly CHD and CVA, and is projected to remain the single leading cause of death. This provides further confirmation that early diagnosis is vital to prevent and reduce the number of deaths attributed to CVD.3
Biological Significance of sPLA2-IIA
Key observations through research has found that sPLA2-llA mediated modification of lipoproteins plays a role in the development of atherosclerosis. The surface of both low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) is surrounded by phosphatidylcholine (PC) a type of phospholipid which has been scientifically proven to serve as a good extracellular target for several isoforms of sPLA2-llA. sPLA2-llA works by hydrolysing these phospholipids resulting in the production of free fatty acids and lysophophatidylcholine (LPC) which can generate pro-inflammatory actions, accelerating atherosclerosis.1
Hydrolysis of LDL-C correlates with the production of the more atherogenic, small dense LDL cholesterol (sdLDL-C). The sPLA2-llA -processed low-density lipoprotein (LDL) contains a large amount of lysophospholipids and exhibit the property of “small-dense” or “modified” LDL, which facilitates foam cell formation from macrophages. Research has shown that high plasma levels of sdLDL-C compared to less dense, larger LDL-C create a higher risk of coronary heart disease.
Cardiovascular Disease
Regular cardiovascular screening is important to ensure that cardiac risk factors are detected at the earliest possible stages. Cardiovascular disease (CVD) encompasses a number of diseases of the heart and blood vessels. Four of the main types of CVD include: coronary heart disease (CHD), cerebrovascular disease (CVA), peripheral arterial disease (PAD) and aortic disease. It is vital that at risk patients are diagnosed as quickly and efficiently as possible to ensure effective treatment plan implementation.4
The early diagnosis of CVD aids in reducing the risk of a secondary cardiovascular event and to ensure the patient receives appropriate treatment to prevent premature deaths. Early risk assessment is particularly important in people who are at a greater risk of CVD. This is evaluated through the identification of one or more risk factors including: hypertension, diabetes or hyperlipidaemia. 3 ,5
It is believed that by 2030, almost 23.6 million people will die from CVD, mainly CHD and CVA, and is projected to remain the single leading cause of death. This provides further confirmation that early diagnosis is vital to prevent and reduce the number of deaths attributed to CVD.3
References
[1] Secreted phospholipase A2, lipoprotein hydrolysis, and atherosclerosis: integration with lipidomics. Kei, Yamamoto, et al. 7, s.l. : Analytical and Bioanalytical Chemistry, 2011, Vol. 400.
[2] Circulatory secretory phospholipase A2 activity predicts recurrent events in patients with severe acute coronary syndromes. . Mallat, Ziad, Steg, Gabriel and Benessiano, Joelle. 7, s.l. : Journal of the American College of Cardiology, 2005, Vol. 46.
[3] World Health Organization. Cardiovascular Diseases. World Health Organization. [Online] World Health Organization, May 17, 2017. [Cited: August 21, 2018.] https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds).
[4] National Health Service (NHS). Cardiovascular disease. [Online] September 17, 2018. [Cited: November 30, 2018.] https://www.nhs.uk/conditions/cardiovascular-disease/.
[5] National Institute for Health and Care Excellence (NICE). Cardiovascular disease risk assessment and prevention. [Online] no date. [Cited: ovember 30, 2018.] https://bnf.nice.org.uk/treatment-summary/cardiovascular-disease-risk-assessment-and-prevention.html.
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Niche Reagents – Zinc, Copper & Aldolase
Reagents | Zinc, Copper & Aldolase
Advancing Routine Testing with Randox Reagents
Randox offer an extensive range of 115 third party diagnostic reagents which are internationally recognised as being of the highest quality; producing accurate and precise results. Continually reinvesting in R&D, Randox continue to offer the opportunity to expand your test menu without expanding your lab. Not only does Randox offer superior performance assays, but also niche assays, meaning that Randox are one of the only manufacturers to offer the test in an automated biochemistry format.
Zinc
A niche assay from Randox meaning that Randox are one of the only manufacturers to offer a clinical chemistry zinc assay
Strong correlation with standard methods as the Randox zinc assay showed a correlation coefficient of r=0.9946 when compared against standard methods
A measuring range of 11.3 – 159 µmol/l for the comfortable and accurate detection of abnormal levels
Liquid ready-to-use reagents for convenience and ease-of-use
Stable to expiry date when stored at +15 to +25°C
Applications are available detailing instrument-specific settings for the convenient use of the Randox zinc assay on a wide range of clinical chemistry analysers
An essential trace metal and the only metal present in all enzyme classes, zinc is the second most abundant micronutrient in humans after iron. Zinc is required for a healthy immune system, a healthy growth rate during pregnancy, childhood and adolescence, wound health and synthesizing DNA. Zinc can modulate brain excitability and is vital in the synaptic plasticity of the brain which is thought to contribute towards memory and learning. Zinc has also been identified as a neurotoxin which suggests that zinc homeostasis is involved in the normal functioning of the central nervous system and the brain 1.
Zinc deficiency is identified as a malnutrition problem worldwide, especially in areas of high cereal intake and low animal food intake. However, other factors may contribute to low zinc levels including: the bioavailability of zinc, chronic illnesses such as diabetes, malignancy, hepatic disease and sickle cell disease. Higher zinc requirements have been identified in infants, children, adolescents, and pregnant and lactating women compared to adults. During periods of growth, zinc deficiency can result in growth failure. The most common organs affected by zinc deficiency clinically include: central nervous system, gastrointestinal, epidermal, skeletal, immune, and reproductive systems 2 3.
Copper
A niche assay from Randox meaning that Randox are one of the only manufacturers to offer a clinical chemistry copper assay
Exceptional correlation with standard methods as the Randox copper assay showed a correlation coefficient of r=0.99 when compared against standard methods
A wide measuring range of 6.6 – 86 µmol/l for the comfortable and accurate detection of abnormal levels
Lyophilised reagents for enhanced stability
Excellent stability of 2 weeks when stored at +2 to +8°C
Applications are available detailing instrument-specific settings for the convenient use of the Randox copper assay on a wide range of clinical chemistry analysers
An essential trace metal, copper is the third most abundant micronutrient in humans after iron and zinc. Copper is mainly found in the brain, liver, kidneys, heart and skeletal muscle with the highest quantities found in the liver and muscles. It aids in some of the key bodily functions including: the production of red blood cells, the maintenance of nerve cells and the immune system, the formation of collagen to absorb iron for energy production, and the formation of melanin, bone and connective tissue. Ceruloplasmin is the protein responsible for the transportation of copper around the body 4.
There are various health problems that can cause abnormal copper levels, however deficiency is less likely than toxicity because a normal diet contains plenty of copper including: organic meats, beans and wholegrains. Deficiency is more likely to occur in those who are malnourished, more likely children.
Deficiency more commonly occurs in premature babies, resulting in bone abnormalities and fractures. Menkes Disease is a rare inherited genetic disorder of copper metabolism and is characterised by sparse and kinky hair as children with this disorder are unable to absorb enough copper 5.
Toxicity can be caused by consuming too many dietary supplements high in copper, from drinking contaminated water, or from fungicides containing copper sulphates. Wilson disease is a rare inherited disorder that prohibits the liver from safely storing and excreting copper resulting in it seeping out of the liver and building up in the eyes, liver, kidneys and brain causing nerve damage, and if untreated, it can be fatal 6.
Aldolase
A niche assay from Randox meaning that Randox are one of the only manufacturers to offer a clinical chemistry aldolase assay
Excellent correlation coefficient of r=0.9917 when compared against other commercially available methods
A wide measuring range of 1.73 – 106 µmol/l for the comfortable and accurate detection of abnormal levels
Lyophilised reagents for enhanced stability
UV Method
Applications are available detailing instrument-specific settings for the convenient use of the Randox aldolase assay on a wide range of clinical chemistry analysers
There are three types of Aldolase enzymes that can be can be found throughout the body: A, B and C. It is responsible for converting glucose into energy.
A is primarily contained within the muscle and erythrocytes, whereas B is contained within the liver, enterocytes and kidney, and A and C can be found within the brain. Despite the Aldolase enzyme existing throughout the body, the highest concentration levels of it can be found in the liver and the skeletal muscle, although testing this enzyme is routinely used for skeletal muscle damage 7.
Elevated levels of type A aldolase in the blood can be found in patients with damage to the skeletal muscle as the result of a trauma which includes dermatpmyositis, infectious mononucleosis, muscular dystrophy, myocardial infarction, hepatic cancer due to the damaged cells triggering the release of A into the blood. On the other hand, the concentration levels of A in the blood remain normal in situations where weakness is caused as the result of a neurological disease such as multiple sclerosis. Measuring A concentration levels in the blood can therefore be used to determine the root cause of muscle weakness, whether muscle trauma or neurological myopathy, in patients 7.
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References
[1] Osredkar, Josko and Sustar, Natasa. Copper and Zinc, Biological Role and Significance of Copper/Zinc Imbalance. 1, s.l. : Journal of Clinical Toxicology, 2011, Vol. 3.
[2] Jockers, Dr. David. How To Test Zinc Levels At Home. DrJockers.com. [Online] 2019. [Cited: November 28, 2018.] https://drjockers.com/test-zinc-levels-home/..
[3] Roohani, Nazanin, et al. Zinc and its importance for human health: An integrative review. National Center for Biotechnology Information. [Online] J Res Med Sci, February 18, 2013. [Cited: November 28, 2018.] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3724376/..
[4] Nordqvist, Joseph. What are the health benefits of zinc? Medical News Today. [Online] December 5, 2017. [Cited: November 28, 2018.] https://www.medicalnewstoday.com/articles/263176.php.
[5] Macfarlane, Susan. Understanding Nutrient Ratios: Zinc/Copper. Susan Macfarlane. [Online] October 29, 2017. [Cited: November 28, 2018.] https://susanmacfarlanenutrition.com/understanding-nutrient-ratios-zinccopper/.
[6] National Center for Advancing Translational Sciences. Menkes disease. National Center for Advancing Translational Sciences. [Online] Genetic and Rare Disease Information Center, April 7, 2017. [Cited: November 30, 2018.] https://rarediseases.info.nih.gov/diseases/1521/menkes-disease.
[7] Berridge, Brian R, Van Vleet, John F and Herman, Eugene. Chapter 46 – Cardiac, Vascular, and Skeletal Muscle Systems. 2013.
Rare Disease Day: 28th February 2019
28th February 2019
Rare Disease Day: 28th February 2019
Rare Disease Day raises awareness of rare diseases and how patients’ lives are affected. Many rare diseases remain incurable and many go undiagnosed. 1 in 20 people will live with a rare disease at some point in their life and this is why it is so important to raise awareness.1
What is a rare disease?
There is no single definition for a rare disease, as many countries identify them differently. In the United States, the Rare Diseases Act of 2002 defines a rare disease by its prevalence: “any disease or condition that affects fewer than 200,000 people in the United States”. However, the EU defines a rare disease as a condition that affects less than 5 in 10,000 of the population. There are approximately 7000 rare diseases and disorders and 50% of people affected by rare diseases are children.2,3
Hyperlipoproteinemia type III
This rare disease day, Randox will be raising awareness of hyperlipoproteinemia type III. Hyperlipoproteinemia type III, also known as dysbetalipoproteinemia or broad beta disease, is a rare genetic disorder characterised by improper breakdown of lipids, specifically cholesterol and triglycerides. The condition is caused by mutations in the Apo-E gene, however the inheritance of this condition is complicated due to the development of symptoms having to be triggered by a secondary factor to raise lipid levels. These factors include diabetes, obesity or hypothyroidism.
It is unknown exactly what the prevalence of the condition is, but it is estimated to affect approximately 1 in 5,000 – 10,000 of the general population and it has been found that it affects males more often than females, with women rarely being affected until after menopause.4,5
Figure A. Example of cholesterol and lipid build-up [6]
Symptoms
Symptoms for hyperlipoproteinemia type III will vary for each individual and some people may even be asymptomatic. The most common symptom is the development of xanthomas which are deposits of fatty material, the lipids, in the skin and underlying tissue. Xanthomas may appear on the palms of the hands, eyelids, soles of the feet or on the tendons of the knees and elbows.
> Chest pain or other signs of coronary artery disease
> Cramps in the calves when walking
> Sores on toes
> Stroke-like symptoms such as trouble speaking, dropping on one side of the face, weakness in an arm or a leg and a loss of balance6
Complications can arise if the condition is left untreated and these can include: myocardial infarction, ischemic stroke, peripheral vascular disease, intermittent claudication and gangrene of the lower extremities.7
Diagnosis
Although there is no specific diagnostic test for hyperlipoproteinemia type III, diagnosis is based on clinical evaluation and identification of symptoms. Research has indicated that an algorithm comprising a number of dysbetalipoproteinemia indices may be helpful in the diagnosis of the disease. These include:
> Low apolipoprotein B to total cholesterol ratio
> Elevated levels of triglycerides
> Elevated levels of total cholesterol8
Managing the condition
The condition cannot be cured but treatment is to control conditions such as obesity, hypothyroidism and diabetes. Most patients will go through dietary therapy to control their intake of cholesterol and saturated fat. This prevents xanthomas, high levels of lipids in the blood, exercise will also help to lower lipid levels. However, dietary changes may not be effective for some individuals and this is where drugs may be used to lower lipid levels instead.
How Randox can Help
Randox offer a range of routine and niche assays within the lipid testing panel to monitor lipid levels and to identify associated complications. Some of these tests include:
Apolipoprotein B
The Randox Apolipoprotein B tests utilises an immunoturbidimetric method, offers a wide measuring range and is available liquid ready-to-use for convenience and ease of use.
Total Cholesterol
The Randox Total Cholesterol test utilises the CHOD-PAP method and offers an extensive measuring range with a wide range of kits available to suit a wide range of laboratory sizes.
Triglycerides
The Randox Triglycerides test utilises the GPO-PAP method while offering an extensive measuring range with both liquid and lyophilised formats available offering choice and flexibility.
Want to know more?
Contact us or download our Cardiology and Lipid Testing brochure to learn more.
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References
[1] Rare Disease Day. What is Rare Disease Day? Rare Disease Day. [Online] 2019. [Cited: February 21, 2019.] https://www.rarediseaseday.org/article/what-is-rare-disease-day
[2] Genetic Alliance UK. What is a Rare Disease? Rare Disease UK. [Online] 2018. [Cited: February 21, 2019.] https://www.raredisease.org.uk/what-is-a-rare-disease/
[3] NZORD. Rare Disease Facts and Figures. NZORD. [Online] 2019. [Cited: February 21, 2019.] https://www.nzord.org.nz/helpful-information/rare-disease-facts-and-figures.
[4] NORD. Hyperlipoproteinemia Type III. NORD. [Online] 2019. [Cited: February 21, 2019.] https://rarediseases.org/rare-diseases/hyperlipoproteinemia-type-iii/
[5] GARD. Hyperlipidemia Type 3. National Centre for Advanciing Translational Sciences. [Online] December 29, 2016. [Cited: February 21, 2019.] https://rarediseases.info.nih.gov/diseases/6703/hyperlipidemia-type-3
[6] Falck, Suzanne. Everything you need to know about hyperlipidemia. Medical News Today. [Online] December 21, 2017. [Cited: February 21, 2019.] https://www.medicalnewstoday.com/articles/295385.php
[7] Medline Plus. Familial Dysbetalipoproteinemia. Medline Plus. [Online] May 16, 2018. [Cited: February 21, 2019.] https://medlineplus.gov/ency/article/000402.htm.
[8] Dysbetalipoproteinemia: Two cases report and a diagnostic algorithm. Kei, Anastazia, et al. 4, s.l. : World Journal of Clinical Cases, 2015, Vol. 3.
Obesity and Kidney Disease: What is the Connection?
30th January 2019
Obesity and Kidney Disease: What is the Connection?
The month of January has forever been the month of resolutions with many choosing to ditch the sweets and join the gym. However, for many these efforts are limited to January and bad habits are quick to remerge. Obesity has been a burden on the health service for many years with the problem, like many people’s waist lines, only continuing to expand.
Recent findings have shown that this problem is no longer just increasing in developed countries but also in developing countries. In fact, worldwide obesity has tripled since 1975. In 2016, more than 1.9 million adults were classed as overweight, of which over 650 million were obese.1 These are shocking statistics for a condition that is preventable. As a global concern, it is important to assess all the potential risks of this problem.
The most common diseases associated with obesity are cardiovascular disease (CVD) and diabetes. However, the associated risks are much greater than this. Being overweight may also increase the risk of certain types of cancer, sleep apnea, osteoarthritis, fatty liver disease and kidney disease.2
Obesity is now recognised as a potent risk factor for the development of renal disease.3 Excess weight has a direct impact on the development and progression of chronic kidney disease (CKD). Globally, the prevalence of diabetic kidney disease rose by 39.5% between 2005 and 2015, coinciding with the increased CKD prevalence.4 In obese individuals, the kidneys have to work harder, filtering more blood than normal to meet the metabolic demands of increased body weight, increasing the risk of kidney disease.
The traditional diagnostic test for renal impairment is creatinine. This test is carried out through the measurement of creatinine levels in the blood to assess the kidneys ability to clear creatinine from the body. This is called the creatinine clearance rate which helps to estimate the glomerular filtration rate (GFR), which is the rate of blood flow through the kidneys.5
Problems arise when using creatinine for CKD testing as a number of factors need to be taken into consideration including age, gender, ethnicity and muscle mass. For this reason, black men and women exhibit higher creatinine levels than white men and women, raising concern over the accuracy of this test for certain patient groups.6 In addition, serum creatinine is not an adequate screening test for renal impairment in the elderly due to their decreased muscle mass.7
The main disadvantage of using creatinine to screen for renal impairment is that up to 50% of renal function can be lost before significant creatinine levels become detectable as creatinine is insensitive to small changes in GFR. Consequently, treatment is not provided at the appropriate time which can be fatal, therefore, an earlier and more sensitive marker for renal function is vital.8
These disadvantages have not only been highlighted in research but also by the national institute for health and care excellence (NICE). NICE updated the classification of CKD in 2004 to include the albumin: creatinine ratio (ACR). They split chronic kidney disease patients into categories based on GFR and ACR. Figure 1 highlights the different categories and risk of adverse outcomes. NICE recommend using eGFR Cystatin C for people in the CKD G3aA1 and higher.9
Figure 1 Classification of Chronic Kidney Disease using GFR and ACR categories.9
Despite these suggestions, Creatinine is still being used for G3a1 and increasing risk levels.
The utility of cystatin C as a diagnostic biomarker for kidney disease has been documented to show superiority of traditional CKD tests. There is no ‘blind area’ making it very sensitive to small changes in GFR and capable of detecting early reductions. Furthermore, this marker is less influenced by diet or muscle mass and has proven to be a beneficial test in patients who are overweight.8
A number of studies support the statement: ‘Cystatin C levels are higher in overweight and obese patients’. This is important because when cystatin c levels are too high, it may suggest that the kidneys are not functioning properly. One study conducted, using a nationally representative sample of participants, found that overweight and obesity maintained a strong association with elevated serum cystatin C. This suggests that weight can affect the levels of cystatin C and therefore the likelihood of developing kidney disease.10
How Randox can Help
The Randox automated Latex Enhanced Immunoturbidimetric Cystatin C tests offers an improved method for assessing CKD risk, combined with a convenient format for routine clinical use, for the early assessment of at risk patients. Randox is currently one of the only diagnostic manufacturers who offer an automated biochemistry test for Cystatin C measurement, worldwide.
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References
- World Health Organization. Obesity and Overweight . int. [Online] WHO. [Cited: January 22, 2019.] https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight.
- Health Risks of Being Overweight. NIDDK. [Online] National Institute of Diabetes and Digestive and Kidney Diseases. [Cited: March 24, 2019.] https://www.niddk.nih.gov/health-information/weight-management/health-risks-overweight.
- Kidney Health Australia . Obesity and Chronic Kidney Disease: The Hidden Impact. Kidney Health Week/ World Kidney Day 2017. [Online] Kidney Health Australia. [Cited: January 22, 2019.] https://kidney.org.au/cms_uploads/docs/kidney-health-australia-report-obesity-and-chronic-kidney-disease–the-hidden-impact_06.03.17.pdf.
- Neuen, Brendon Lange, et al. Chronic kidney disease and the global NCDs agenda. s.l. : BMJ Global Health, 2017
- Creatinine and Creatinine Clearance Blood Tests. WebMD. [Online] WebMD. [Cited: January 22, 2019.] https://www.webmd.com/a-to-z-guides/creatinine-and-creatinine-clearance-blood-tests#1.
- Lascano, Martin E and Poggio, Emilio D. Kidney Function Assessment by Creatinine-Based Estimation Equations. Cleveland Clinic. [Online] August 2010. [Cited: 16 May 2018.] http://www.clevelandclinicmeded.com/medicalpubs/diseasemanagement/nephrology/kidneyfunction/.
- Swedko, Peter J, et al. Serum Creatinine Is an Inadequate Screening Test for Renal Failure in Elderly Patients. Research Gate. [Online] February 2003. [Cited: 6 May 2018.] https://www.researchgate.net/publication/8243393_Serum_Creatinine_Is_an_Inadequate_ Screening_Test_for_Renal_Failure_in_Elderly_Patients.
- Mishra, Umashankar. New technique developed to detect chronic kidney disease. Business Line. [Online] 07 May 2018. [Cited: 17 May 2018.] https://www.thehindubusinessline.com/news/science/new-technique-to-detect-chronic-kidney-disease/article23803316.ece.
- National Institute for Health and Care Excellence. Chronic kidney disease in adults: assessment and management: 1 Recommendations. National Institute for Health and Care Excellence. [Online] January 2015. https://www.nice.org.uk/guidance/cg182/chapter/1- recommendations#classification-of-chronic-kidney-disease-2.
- Overweight and Obesity and Elevated Serum Cystatin C Levels in US Adults . Muntner, Paul, et al. 4, s.l. : NCBI, 2008, Vol. 121.