Lipase Reagent

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Lipase Reagent

Randox Reagents Fructosamine

Key Benefits of the Randox Lipase Assay

Excellent precision

The Randox lipase assay displayed a precision of  <5% CV.

Exceptional correlation

The Randox lipase assay displayed an exceptional correlation coefficient of r=1.00 when compared against other commercially available methods.

Fully automated protocols

Fully automated protocols are available for a variety of clinical chemistry analysers.

Further Benefits of the Randox Lipase Assay

Colorimetric method.

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

Measuring range of 2.0 – 744U/l for the comfortable detection of abnormal levels.

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

Cat NoSize    
LI3837R1 3 x 9ml
R2 3 x 6ml
EnquireKit Insert RequestMSDSBuy Online
LI7979R1 6 x 20ml
R2 3 x 20ml
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LI8050R1 4 x 16.2ml
R2 4 x 10ml
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(L) Indicates liquid option

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

About Lipase Testing

  • Clinical Significance
  • Physiological Significance

Elevated lipase concentrations 3-to-4-fold greater than the upper normal limit is indicative of pancreatitis, however, the degree of elevations does not correlate with the severity of the disease 2, 3.

In pancreatic dysfunction, lipase concentrations rise between 4 and 6 hours, peaking at 48 hours and returning to baseline within 8 to 14 days. It has a half-life of 6.7 to 13.7 hours in plasma. The half-life of amylase (another assay utilised in the diagnosis of pancreatic dysfunction) is less, however, lipase is filtered by the glomerulus and reabsorbed by the tubules which may contribute towards the longer half-life of lipase.

Lipase offers a few advantages over amylase including: a slightly better specificity, greater sensitivity for patients presenting late, due to the longer half-life, and greater sensitivity in alcoholic pancreatitis 4.

Furthermore, for prolonged longitudinal injuries, lipase activity tends to be more sensitive compared to amylase as lipase concentrations within the zymogen granules are approximately 4.5 times than those of amylase. Consequently, recurring injuries are more likely to be recognised due to the leakage of lipase into the bloodstream. Moreover, lipase concentrations are less affected by intestinal injury or renal dysfunction compared to amylase 2.

Derived from zymogen granules of pancreatic acinar cells, lipase is involved in the digestion of lipids for the subsequent absorption in the small intestine 1, 2. The pancreas is located in the anterior abdominal cavity adjacent to the liver, duodenum and stomach to allow the secretion of digestive enzymes into the small intestine, and to convert ingesta into absorbable lipids, carbohydrates and proteins. The exocrine pancreas provides a microenvironment for pancreatic islet cells. The pancreatic islet cells provide the embedded endocrine function of the pancreas which in turn enables the hepatic and peripheral tissues to modulate blood glucose levels and other functions 2.

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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.

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Superior Performance & Unique Tests

Superior Performance & Unique Tests

Specialty Reagents Designed to Expand Your Routine Testing Panel

Superior Performance & Unique Tests – Innovating clinical diagnostics and enhancing laboratory testing!

In vitro diagnostics is the heart and soul of the healthcare system as healthcare professionals not only rely on diagnostic tests to diagnose and treat patients, but also to rule out the different contributing causes of a disease state. The implementation of superior performance & unique tests can aid in the early and accurate diagnosis of disease states, enabling the appropriate and effective implementation of a personalised treatment plan 1.

Benefits of the Randox Superior Performance & Unique Tests

Superior Performance Offering

Offering a range of assays with superior methodologies, including: Denka Seiken lipoprotein(a), enzymatic fuctosamine, enzyme cycling bile acids and vanadate oxidation bilirubin. These superior methods deliver more accurate and specific results compared to traditional methods, providing a competitive edge and increased revenue growth.

Unique Offering

Unqiue Offering

Offering a range of unique assays meaning that Randox are one of the only manufacturers to offer these tests in an automated biochemistry format pm the marker. Our range comprises many unique assays including adiponectin, cystatin C, G6PDH, glutathione peroxidase (Ransel) and H-FABP. By adopting such niche assays in your lab you can expand your test menu and eliminate the need to outsource patient testing.

Confidence in Patient Results

All our superior performance & niche diagnostic reagents are validated against gold – standard methods, offering low CV’s and excellent precision giving you the confidence that you are sending out the accurate patient results.

Applications Available

Applications are available detailing instrument-specific settings for the convenient use of the Randox niche & superior performance assays on a wide variety of clinical chemistry analysers. To make your laboratory testing easier, a range of our niche & superior performance diagnostic assays are available in dedicated bottles that are optimised for use on a range of specific clinical chemistry analysers.

  • Superior Performance & Niche Assays
  • Risk Assessment using Randox Reagents
Lp(a)

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.

Bile Acids

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.

Bilirubin

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.

Adioponectin

Adiponectin has been identified as having pleiotropic functions widely associated with anti-atherogenic, anti-diabetic, cardioprotective and anti-inflammatory effects. Adiponectin levels inversely correlate with insulin levels, BMI, triglyceride levels, insulin resistance (IR), glucose, and most importantly, visceral fat accumulation.

sTfR

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.

Fructosamine

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.

Current Challenges

CVD
  • Cardiovascular Disease (CVD)

    CVD accounts for 45% of all deaths in europe and 37% of all deaths in the EU. Atherogenesis is a circulatory disease whereby atheromas are formed (plaque build-up) within the artery.  Plaque is a combination of cholesterol, fat, calcium, lipids and other substances within the blood stream.  As time progresses, the plaque hardens, narrowing the arteries.  This is known as atherosclerosis. Consequently, blood flow through the narrowed artery is reduced, limiting the supply of blood to vital organs and bodily tissues.  As atherogenesis can affect any artery within the body, different diseases may develop based on the artery that is affected.  Such diseases include: coronary heart/artery disease, carotid artery disease, peripheral artery disease and chronic kidney disease 2, 3, 4.

  • Type 2 Diabetes Mellitus (T2DM)

    425 million people are living with type 2 diabetes mellitus (T2DM) and 352 million are at risk of developing T2DM. T2DM is a serious condition whereby blood glucose levels are elevated (hyperglycaemia). T2DM is characterised by insulin resistance or insulin deficiency. T2DM is the most common form of diabetes, accounting for 90% of cases. The key to T2DM is control. Implementing lifestyle changes, oral medication and in more severe cases, insulin, a diabetic can take control of their disease, keeping glucose levels stable. When glucose levels are not monitored and controlled, associated complications may arise including: diabetic nephropathy, CVD and renal impairment 5, 6.

  • Chronic Kidney Disease (CKD)

    Worldwide 1/5 of men and 1/4 of women between 65 and 74 years of age have Chronic kidney disease (CKD). CKD is an umbrella term encompassing a wide range of renal conditions from commonly prevalent sub-clinical, asymptomatic to rare end-stage renal disease requiring dialysis or a transplant to sustain life. Kidney disease is ranked in stages from stage 1 (very mild damage) through to stage 5 (kidney failure) 7. Symptoms are commonly expressed in the later stages of renal impairment, however, at this point dangerous levels of fluid, electrolytes and waste products can build up inside the body. The aim of CKD treatment is to slow the progression of the disease, thus early intervention is vital 8.

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January Featured Reagent – Cystatin C

Featured Reagent - Cystatin C

Kidney Disease

Kidney disease is a huge global health crisis, increasing healthcare costs, mortality and morbidity rates.  The global prevalence of chronic kidney disease (CKD) has continued to rise during a short lifespan.  In 2016, 1 in 10, equivalent to 10 percent of the global population were identified with having CKD with the highest prevalence’s reported in Europe, the Middle East, East Asia and Latin America, estimated at 12 per cent and the lowest in South Asia, estimated at 7 percent1.

The early risk assessment of renal function is vital.  In 1990, CKD was ranked the 27th leading cause of death in the Global Burden of Disease study2, rising to 18th 3 in 2010, 13th in 20132 and 12th by 2015.  From 2005-2015, the overall CKD mortality rate has risen by 31.7 percent, accounting for 1.1 million deaths globally in 20154.

Inadequacies of Traditional CKD Biomarkers

 

The most commonly used screening test for renal impairment is creatinine.  When testing for CKD using creatinine, certain factors must be taken into consideration, including: age, gender, ethnicity, and muscle mass.  As such, black men and black women will present with higher creatinine levels compared to white men and white women respectively5.

Serum creatinine is not an adequate screening test for renal impairment in the elderly (65 years of age and over) due to their decreased muscle mass.  As such, patients are misdiagnosed, thus, patients with severe renal failure are receiving suboptimal care6.

The main disadvantage of using creatinine to screen for renal impairment is that up to 50 percent of renal function can be lost before significant creatinine levels become detectable as creatinine is insensitive to small changes in the glomerular filtration rate (GFR).  Consequently, treatment is not provided at the appropriate time which can be fatal, thus, an earlier and more sensitive biomarker for renal function is vital7.

Cystatin C

 

  • Benefits of the Randox Cystatin C Assay
  • Biological Significance of Cystatin C
  • Clinical Significance of Cystatin C

The Randox cystatin C assay utilises the latex enhanced immunoturbidimetric method offering numerous key features:

A niche product from Randox meaning that Randox are one of the only manufacturers to provide the cystatin C test in an automated biochemistry format

An automated assay which removes the inconvenience and time consumption associated with traditional ELISA testing

Applications are available detailing instrument-specific settings for the convenient use of the Randox cystatin C assay on a wide range of biochemistry analysers

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

Latex enhanced immunoturbidimetric method delivering high performance

Extensive measuring range for the detection of clinically important results

Complementary controls and calibrators available offering a complete testing package

Limited interference from Bilirubin, Haemoglobin, Intralipid® and Triglycerides

Cystatin C does not suffer from a ‘blind area’ like creatinine due to cystatin C’s sensitivity to small changes in GFR enabling the early detection renal impairment

An exceptional correlation coefficient of r=1.00 when compared against standard methods

Cystatin C is a small (13 kDa) cysteine proteinase inhibitor, produced by all nucleated cells at a constant rate.  Cystatin C travels through the bloodstream to the kidneys where it is freely filtered by the glomerular membrane, resorbed and fully catabolised by the proximal renal tubes.  Consequently, cystatin C is the ideal biomarker of GFR function8.

The National Institute for Health and Care Excellence (NICE) (2014) guidelines recommend cystatin C testing due to its higher specificity for significant disease outcomes than those based on creatinine. As such, eGFR cystatin C measurements will significantly reduce the number of misdiagnosed patients, thus reducing the overall CKD burden9.

In 2017, a systematic literature search found 3,500 investigations into cystatin C as a marker of GFR. The study concluded that eGFRcystatinc was a significantly more superior than eGFRcreatinine10.

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  • References

    [1] Bello, AK, et al. Global Kidney Health Atlas: A report by the Internal Society of Nephrology on the current state of organization and structures for kidney care across the globe. Brussels : Internal Society of Nephrology, 2017.

    [2] Bikbov, Boris. Chronic kidney disease: impact on the global burden of mortality and morbidity. The Lancet. [Online] 2015. http://www.thelancet.com/campaigns/kidney/updates/chronic-kidney-disease-impact-on-global-burden-of-mortality-and-morbidity.

    [3] National Kidney Foundation. Global Facts: About Kidney Disease. National Kidney Foundation. [Online] National Kidney Foundation, 2015. https://www.kidney.org/kidneydisease/global-facts-about-kidney-disease#_ENREF_1.

    [4] Neuen, Brendon Lange, et al. Chronic kidney disease and the global NCDs agenda. s.l. : BMJ Global Health, 2017.

    [5] Lascano, Martin E and Poggio, Emilio D. Kidney Function Assessment by Creatinine-Based Estimation Equations. Cleveland Clinic. [Online] August 2010. [Cited: May 16, 2018.] http://www.clevelandclinicmeded.com/medicalpubs/diseasemanagement/nephrology/kidney-function/.

    [6] Swedko, Peter J, et al. Serum Creatinine Is an Inadequate Screening Test for Renal Failure in Elderly Patients. Research Gate. [Online] February 2003. [Cited: May 6, 2018.] https://www.researchgate.net/publication/8243393_Serum_Creatinine_Is_an_Inadequate_Screening_Test_for_Renal_Failure_in_Elderly_Patients.

    [7] Mishra, Umashankar. New technique developed to detect chronic kidney disease. Business Line. [Online] May 07, 2018. [Cited: May 17, 2018.] https://www.thehindubusinessline.com/news/science/new-technique-to-detect-chronic-kidney-disease/article23803316.ece.

    [8] Chew, Janice SC, et al. Cystatin C-A Paradigm of Evidence Based Laboratory Medicine. NCBI. [Online] May 29, 2008. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2533150/.

    [9] National Institute for Health and Care Excellence. Chronic kidney disease in adults: assessment and management: 2 Implementation: getting started. NICE. [Online] January 2015. [Cited: April 19, 2018.] https://www.nice.org.uk/guidance/cg182/chapter/implementation-getting-started.

    [10] Grubb, Anders. Cystatin C is Indispensable for Evaluation of Kidney Disease. NCBI. [Online] December 28, 2017. [Cited: April 19, 2018.] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5746836/.


World Diabetes Day: The Biggest Burden on the NHS

14 November 2018

World Diabetes Day

Diabetes

Approximately 400,000 people in the UK are living with type 1 diabetes, with over 29,000 being children and young people [1]. Type 1 diabetes affects 96% of all children with diabetes in England and Wales, with incidences increasing by approximately 4% each year.

Globally, the UK has the fifth highest rate of type 1 diabetes diagnosis in children (aged up to 14) with 85% of these children having no family history of the condition. Whilst the condition isn’t fatal and can be managed, it cannot be cured. Type 1 diabetes increases the risk of developing other health problems such as heart disease, stroke, foot and circulation problems, sight problems including blindness, nerve damage and kidney problems. However, many of these related conditions are preventable and it is recommended to stabilise blood sugar levels, attend diabetes appointments regularly and complete a diabetes course to educate patients and family members and prevent the risk of further help complications[2].

Diabetes in children

Children under five are at the highest risk of developing diabetic ketoacidosis due to a late diagnosis and it is also thought to be due to of lack of public knowledge of the signs and symptoms attributed to type 1 diabetes. Such symptoms include:

  • Frequent urination as the kidneys are trying to expel excess sugar in the blood, resulting in dehydration which leads to extreme thirst.
  • Increased hunger or unexpected weight loss because the body is unable to attain enough energy from food
  • Slow healing cuts as high blood sugar levels can affect blood flow which can cause nerve damage.
  • Fatigue as the body is unable to convert sugar into energy
  • Irritable behaviour combined with other symptoms can be a means of concern

Diabetes and the NHS

Diabetes costs the NHS approximately £9.8 billion per year, an estimate of 10% of total expenditures. Hospital admissions of children and young people with diabetes presents a considerable burden on themselves, their families and the NHS. It is estimated that approximately 80% of these cases are potentially avoidable.

A report produced by the National Paediatric Diabetes Audit found that although the numbers of admissions didn’t significantly differ year to year, it highlighted differences in terms of socio-economic risk factors:

  • Living in a deprived area increases the risk of hospital admissions which can be attributed to lack of education in the community about diabetic symptoms and the management of diabetes.
  • Children below 5 years of age have a 35% increased risk of hospitalisation compared to those aged 5-9
  • Females have a 33% increased risk of developing type 1 diabetes compared to males.
  • Children with poor diabetes control have a twelve-fold increased risk of hospital admission
  • Insulin pump users have a 27% increased risk of hospital admission compared to those who use insulin injections.
Figure A. Number of preventable paediatric diabetes admissions  [3] 

Prevention

There are campaigns in place to aid in the early diagnosis of type 1 diabetes which mainly focus on raising awareness of the signs and symptoms of diabetes. On this World Diabetes Day, it is important to know that it is not just simply the responsibility of the diabetic patient to prevent admission but the main responsibility lies with the diabetic teams that inform the families with children who are diagnosed with type 1 diabetes.

Paediatric diabetes teams should ensure that the families and the children receive structured education for self-management when diagnosed and throughout the illness. In doing so, the diabetic teams should implement blood ketone testing from diagnosis and utilise the nationally agreed hypoglycaemia management guidelines. It is also important that diabetic teams are fully aware of the patient characteristics associated with a greater risk of admission and that they use this knowledge to develop anti-admission strategies specifically tailored to the needs of each individual group.

Primary care practitioners should seek access to a specialist diabetic team who they can refer to when deciding if a patient requires admission to hospital. Furthermore, they should access blood glucose and ketone testing to identify patients at risk of diabetic ketoacidosis that require hospital admission.

How Randox can Help

Randox offer a range of assays to diagnosis and monitor diabetes and to monitor associated complications.  Some of these tests are unique to Randox, including:

Fructosamine

The Randox fructosamine assay employs 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.

Learn more about the Randox Fructosamine test

D-3-Hydroxybutyrate (Ranbut)

The Randox D-3-Hydroxybutyrate (Ranbut) assay detects the most abundant and sensitive ketone in the body, D-3-Hydroxybutyrate. The Randox Ranbut assay is used for the diagnosis of ketosis, more specifically diabetic ketoacidosis. Other commercially available tests, such as the nitroprusside method, are less sensitive as they only detect acetone and acetoacetate, not D-3-Hydroxybutyrate.

Learn more about the Randox D-3-Hydroxybutyrate test

Adiponectin

The Randox adiponectin assay is a biomarker in diabetes testing as adiponectin is a protein hormone responsible for regulating the metabolism of lipids and glucose and influences the body’s response to insulin. Adiponectin levels inversely correlates with abdominal visceral fat levels.

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  • References

    [1] National Paediatric Diabetes Audit and Royal College of Paediatrics and Child Health, National Paediatric Diabetes Audit Report 2012-15: Part 2, 2017

    [2] NHS, “Avoiding Complications” – Type 1 Diabetes, Available at: https://www.nhs.uk/conditions/type-1-diabetes/avoiding-complications/ [Accessed on 24th October 2018].

    [3] “Potentially Preventable Pediatric Hospital Inpatient Stays for Asthma and Diabetes, 2003-2012”, www.hcup-us.ahrq.gov, 2015. [Online] Available: https://www.hcup-us.ahrq.gov/reports/statbriefs/sb192-Pediatric-Preventable-Hospitalizations-Asthma-Diabetes.jsp [Accessed 08-Nov-18]


Could there be 5 types of diabetes?

A peer-reviewed study, published in The Lancet Medical Journal suggests there are five types of diabetes. Could diabetes be more complex than we once thought? Could diabetes be segmented into five separate diseases?

 

What is diabetes?

Diabetes is an incurable disease which prohibits the body’s ability to produce and respond to insulin.  Currently, diabetes is classified into two main forms, type 1 and type 2.

Type 1 diabetes is an autoimmune disease which manifests in childhood.  In type 1 diabetes, the body’s white blood cells attack the insulin-producing cells in the pancreas.  As a result, individuals with Type 1 diabetes rely on the injection of insulin for the remainder of their lives.

Type 1 diabetes affects 10 percent of individuals with diabetes.  96 percent of children diagnosed with diabetes have type 1.  Type 1 diabetes in children is commonly diagnosed between the ages of 10 and 14.  The prevalence of type 1 diabetes in children and young people (under the age of 19) is 1 in every 430-530 and the incidence of type 1 in children under 14 years of age is 24.5/100,000 (Diabetes UK, 2014).

Type 2 diabetes is the result of insulin resistance, meaning that the pancreas does not produce enough insulin or the body’s cells do not respond to the insulin produced.  As type 2 diabetes is a mixed condition, with varying degrees of severity, there are a few methods to manage the disease, including dietary control, medication and insulin injections.

Type 2 diabetes is the most common form of diabetes, affecting 90 percent of individuals with diabetes, and has now become a global burden.  The global prevalence of diabetes has almost doubled from 4.7 percent in 1980 to 8.5 percent in 2014, with a total of 422 million adults living with diabetes in 2014.  It is expected to rise to 592 million by 2035.  In 2012, diabetes accounted for 1.5 million deaths globally with hypertension causing a further 2.2 million deaths.  43 percent of these deaths occurred before 70 years of age.  Previously type 2 diabetes was commonly seen in young adults but is now commonly seen in children as well.  In 2017, 14% more children and teenagers in the UK were treated for diabetes compared to the year before (World Health Organization, 2016).

In both forms of diabetes, hyperglycemia can occur which can lead to number of associated complications including renal disease, cardiovascular disease, nerve damage and retinopathy.

 

The novel subgroups of adult-onset diabetes and their association with outcomes: a data-driven cluster analysis of six variables – peer-review study

This new research studied 13,270 individuals from different demographic cohorts with newly diagnosed diabetes, taking into consideration body weight, blood sugar control and the presence of antibodies, in Sweden and Finland.

This peer-reviewed study identified 5 disease clusters of diabetes, which have significantly different patient characteristics and risk of diabetic complications.  The researchers also noted that the genetic associations in the clusters differed from those seen in traditional type 2 diabetes.

Cluster One – Severe autoimmune diabetes (SAID)

SAID is similar to type 1 diabetes.  SAID manifests in childhood, in patients with a low BMI, have poor blood sugar and metabolic control due to insulin deficiency and GADA.  6% of individuals studied in the ANDIS study were identified with having SAID.

Cluster Two – Severe insulin-deficient diabetes (SIDD)

SIDD is similar to SAID, however, GADA is negative.  This means that the characteristics of SIDD are the same as SAID, young, of a healthy weight and struggled to make insulin, however, SIDD is not the result of an autoimmune disorder as no autoantibodies are present.  Patients have a higher risk of diabetic retinopathy.  18% of subjects in the ANDIS study were identified with having SIDD.

Cluster Three – Severe insulin-resistant diabetes (SIRD)

SIRD is similar to that of type 2 diabetes and is characterised by insulin-resistance and a high BMI.  Patients with SIRD are the most insulin resistant and have a significantly higher risk of kidney disease, and microalbuminuria, and non-alcoholic fatty liver disease.  15% of subjects in the ANDIS study were identified as having SIRD.

Cluster Four – Mild obesity-related diabetes (MOD)

MOD is a mild form of diabetes which generally affects a younger age group. This is not characterised by insulin resistance but by obesity as their metabolic rates are close to normal.  22% of subjects in the ANDIS study were identified as having MOD.

Cluster Five – Mild age-related diabetes (MARD)

MARD is the most common form of diabetes manifesting later in life compared to the previous four clusters.  Patients with MARD have mild problems with glucose regulation, similar to MOD.  39% of subjects in the ANDIS study were identified with having MARD.

This new sub-classification of diabetes could potentially enable doctors to effectively diagnose diabetes earlier, through the characterisation of each cluster, including: BMI measurements, age, presence of autoantibodies, measuring HbA1c levels, ketoacidosis, and measuring fasting blood glucose levels.  This will enable a reduction in the incidence of diabetes complications and the early identification of associated complications, and so patient care can be tailored, thus improving healthcare (NHS, 2018) (The Week, 2018) (Ahlqvist, et al., 2018) (Collier, 2018) (Gallagher, 2018).

The Randox diabetes reagents cover the full spectrum of laboratory testing requirements from risk assessment, using our Adiponectin assay, to disease diagnosis and monitoring, using our HbA1c, glucose and fructosamine assays, to the monitoring of associated complications, using our albumin, beta-2 microglobulin, creatinine, cystatin c, d-3-hydroxybutyrate, microalbumin and NEFA assays.

Whilst this study is valuable, alone it is not sufficient for changes in the diabetes treatment guidelines to be implemented, as the study only represents a small proportion of those with diabetes.  For this study to lead the way, the clusters and associated complications will need to be verified in ethnicities and geographical locations to determine whether this new sub-stratification is scientifically relevant.

 

References

Ahlqvist, E. et al., 2018. Novel subgroups of adult-onset diabetes and their association with outcomes: a data-driven cluster analysis of six variables. [Online]
Available at: http://www.thelancet.com/journals/landia/article/PIIS2213-8587(18)30051-2/fulltext?elsca1=tlpr
[Accessed 16 April 2018].

Collier, J., 2018. Diabetes: Study proposes five types, not two. [Online]
Available at: https://www.medicalnewstoday.com/articles/321097.php
[Accessed 16 April 2018].

Diabetes UK, 2014. Diabetes: Facts and Stats. [Online]
Available at: https://www.diabetes.org.uk/resources-s3/2017-11/diabetes-key-stats-guidelines-april2014.pdf
[Accessed 16 April 2018].

Gallagher, J., 2018. Diabetes is actually five seperate diseases, research suggests. [Online]
Available at: http://www.bbc.co.uk/news/health-43246261
[Accessed 16 April 2018].

NHS, 2018. Are there actually 5 types of diabetes?. [Online]
Available at: https://www.nhs.uk/news/diabetes/are-there-actually-5-types-diabetes/
[Accessed 16 April 2018].

The Week, 2018. What are the five types of diabetes?. [Online]
Available at: http://www.theweek.co.uk/health/92048/what-are-the-five-types-of-diabetes
[Accessed 16 April 2018].

World Health Organization, 2016. Global Report on Diabetes, Geneva: World Health Organization.

If you are a clinician, dietitian or laboratory who are interested in running diabetes assays, Randox offer a wide range of high-quality routine and niche assays including: fructosamine, glucose, HbA1c for diagnosing and monitoring diabetes, albumin, beta-2 microglobulin, creatinine, cystatin c, NEFA, microalbumin, and d-3-hydroxybutyrate to monitor associated complications, and adiponectin  as a biomarker for diabetes risk assessment.  These assays can be run on most automated biochemistry analysers.

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

For more information, visit: https://www.randox.com/diabetes-reagents or email: reagents@randox.com 


Innovations in Gestational Diabetes testing

More and more women in the United States are waiting until they’re older to start having children.

The number of births to women aged 45–49 rose 14% in 2013 from 2012, according to the Centers for Disease Control and Prevention’s National Vital Statistics Report.  With this comes the responsibility by clinicians and laboratories to better assess those at risk of gestational diabetes and to aid better control of the condition for those who already have it.  Quick and precise detection of risk of gestational diabetes and associated complications by clinical labs will provide women with the autonomy to take control of their maternal health.

Innovations in maternal health testing have meant that analysis such as adiponectin and enzymatic fructosamine are now available in automated biochemistry formats and with more accurate methodologies; allowing laboratories to assess gestational diabetes risk, and evaluate control of the condition with ease, speed and accuracy.  Testing of such analytes have historically been non-routine and not easily accessible for clinical laboratories, and now with little adjustment within the laboratory, these can be added to the test menu allowing for detailed patient testing profiles.

Current innovations in the area of gestational diabetes testing will ultimately secure the health, both during and post-pregnancy, of mother and baby.

Randox Laboratories are a global manufacturer of automated adiponectin and fructosamine biochemistry assays.  For further information, download our brochure or contact reagents@randox.com


Diabetes Control Calibrator

Therapeutic Drug Quality Control

Adiponectin Calibrator

Dedicated Adiponectin calibrator specifically designed for use with the Randox Adiponectin assay.

Features & Benefits

  • Liquid ready-to-use
  • Human based serum
  • Stable to expiry date at 2°C – 8°C
  • Once opened stable to expiry date at 2°C – 8°C
DescriptionSizeAnalytesCat No 
Adiponectin Calibrator6 x 1ml1AO8156

Analytes

  • Adiponectin

Fructosamine Calibrator

Dedicated Fructosamine calibrator specifically designed for use with the Randox Fructosamine assay.

Features & Benefits

  • Lyophilised for enhanced stability
  • Human based serum
  • Stable to expiry date at 2°C – 8°C
  • Reconstituted stability of 4 weeks at 2°C – 8°C
DescriptionSizeAnalytesCat No 
Fructosamine Calibrator3 x 1ml1FR2993

Analytes

  • Fructosamine

HbA1c Calibrator

A human based whole blood calibrator designed for use in the routine calibration of the HbA1c assay.

Features & Benefits

  • Liquid ready-to-use
  • 100% human whole blood
  • Treated in the same manner as a patient sample
  • Once opened stable to expiry date at 2°C – 8°C
DescriptionSizeAnalytesCat No 
HbA1c Calibrator Series5 x 2ml
1 x 8ml
1HA3444

Analytes

  • HbA1c

HbA1c II Calibrator

A human whole blood calibrator designed for use in the routine calibration of the HbA1c II assay.

Features & Benefits

  • Supplied in a lyophilised format
  • 100% human whole blood
  • Treated in the same manner as a patient sample
  • Once opened the calibrator is stable for 14 days at +2°C to +8°C
DescriptionSizeAnalytesCat No 
HbA1c II Calibrator Series5 x 0.5mL1HA8124

Analytes

  • HbA1c II

Fructosamine Quality Control

Therapeutic Drug Quality Control

The Randox Acusera Fructosamine control is specifically designed to monitor the accuracy and precision of fructosamine assays. An extended reconstituted stability of 28 days at 2°C – 8°C keeps waste to a minimum and helps to reduce costs.

Features & Benefits

  • Lyophilised for enhanced stability
  • Human based serum
  • Assayed target values provided
  • Stable to expiry date at 2°C – 8°C
  • Reconstituted stability of 28 days at 2°C – 8°C
DescriptionSizeAnalytesCat No 
Fructosamine Control Level 13 x 1 ml1FR2994
Fructosamine Control Level 33 x 1 ml1FR2996

Analytes

  • Fructosamine

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