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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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Aldolase: A Myositis Biomarker

29 May 2019

Aldolase: A Myositis Biomarker

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

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

Did you know?

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

Table 1 reviews the different forms of myositis

A table comparing the different types of Myositis

Table 2 reviews complications with or due to myositis

Complications with or due to Myositis

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

Aldolase Testing

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

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

Objective:

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

Conclusion:

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

Findings:

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

Objective:

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

Conclusion:

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

Findings:

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

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Could H-FABP Have Potential Benefits in Diagnostics Beyond Cardiac Health Problems?

14th March 2019

Could H-FABP Have Potential Benefits in Diagnostics Beyond Cardiac Health Problems?

To date, the most traditional diagnostic test for renal impairment is creatinine. However, although most commonly used, problems can arise when implementing this test as a number of factors are not considered. On this World Kidney Day, Randox will explore the potential utility of H-FABP as a clinical diagnostic marker for cardiac surgery-associated acute kidney injury.

Acute Kidney Injury (AKI) is defined as an acute decline in renal function that can lead to structural changes. It involves a sudden drop in kidney function that usually arises due to a complication of another serious illness such as impaired renal perfusion, exposure to nephrotoxins, outflow obstruction or intrinsic renal disease. As a result, a patient can experience effects such as impaired clearance and regulation of homeostasis, altered acid/base and electrolyte regulation and impaired volume regulation.1

The mortality rate associated with AKI varies depending on severity, patient related factors and setting including whether the patient is in intensive care (ICU) or not.2 In the UK, AKI has been found to affect 1 in 5 people admitted to hospital as an emergency and has been found to be deadlier than a heart attack, contributing to around 100,000 deaths each year. Conversely, in the US, age-standardized rates of acute kidney injury hospitalisations increased by 139% among adults with diagnosed diabetes and by 230% among those without diabetes.3, 4

The rising incidence of AKI comes at price. Patients tend to survive ICU but will be discharged with various degrees of chronic kidney disease (CKD), placing an increasing strain on the health care system. At present, the cost to the NHS is estimated to be between £434 and £620 million, which is more than the costs associated with breast cancer, or lung and skin cancer combined. However, this increased cost and strain could be unnecessary, as research has shown that 30% of the reported 100,000 deaths in the UK could have been prevented with the right care and treatment.3,4

These unfavourable statistics are the result of late detection of AKI, as to date, a superior method of detection has not been found.

Cardiac surgery-associated acute kidney injury (CSA-AKI)

CSA-AKI is a well-recognised postoperative complication of cardiac surgery and is the second most common cause of AKI in the intensive care unit, occurring in up to 30% of patients.5,6 Of these patients, an estimated 1% will require dialysis and the majority will remain dependent on dialysis leading to an increase in mortality. Certain patient groups are more susceptible to CSA-AKI and vulnerability can depend on age, sex, pre-existing cardiac dysfunction, pre-existing CKD, previous cardiac surgery or comorbidity.7

The pathogenesis of AKI involves multiple pathways including hemodynamic, inflammatory and nephrotoxic factors that overlap  leading to kidney injury.6 Figure 1 illustrates the pathophysiology of AKI following cardiac surgery. It shows that there are multiple physiological processes that are associated with the development of AKI as a result of cardiac surgery.8

Figure 1 Illustrates the pathophysiology of AKI following cardiac surgery and the various mechanisms that contribute.8

What is H-FABP?

Fatty acid-binding proteins (FABPs) are small cytoplasmic proteins that are abundantly expressed in tissues with an active fatty acid metabolism, with their primary function being the facilitation of intracellular long-chain fatty acid transport.9 Elevated FABP serum concentrations are related to a number of common comorbidities including heart failure, CKD, diabetes mellitus and metabolic syndrome, which represent important risk factors for postoperative AKI.10

H-FABP is most commonly associated with being a marker for acute coronary syndrome (ACS) as its concentrations peak at approximately 6-8 hours after symptom onset, making it easier to detect. Recently studies have highlighted H-FABP as a potential biomarker for the detection of AKI after cardiac surgery. This potential would mean earlier diagnosis of patients, reducing the mortality rate and costs to the health service.

Potential Mechanism for the release of H-FABP in AKI

There are a number of hypotheses regarding the release of H-FABP, with myocardial injury being considered the major reason for an increased level. The mechanisms involved in this increase have been found to differ depending on the severity of a patients ACS situation including whether they are in ICU.11

One possible explanation for the release of H-FABP is the effects of ischemic stress. Ischemic stress induced by non-cardiogenic shock is a type of mechanical stretching which can lead to the leakage of small amounts of macromolecules. This process would lead to the release of H-FABP into the blood. In non-cardiac patients, minor myocardial injury alone may not adequately explain this observed increase. Other factors such as a reduction in the amount of skeletal muscle tissue, lipid disorders, release of free radicals and an increase in free acids produced by the catabolism of glycogen could also contribute to a rise in H-FABP levels.11

One final process that could lead to increased H-FABP is the damage of vital organ functions which occurs in almost all non-surgical intensive care patients. The degree of leakage of H-FABP may vary depending on the severity of a patient’s condition and whether they have suffered from multiple organ failure or vital organ damage. AKI is a component of multiple organ failure suggesting that serum H-FABP levels may increase in AKI patients as a result. Also, serum H-FABP is excreted by renal tubular cells and patients with an acutely diminished renal function are unable to clear large amounts of H-FABP resulting in increasing levels. These potential mechanisms of H-FABP and its release during AKI provide further confirmation that the measurement of serum H-FABP is an effective biomarker in patients with AKI.11

Comparison of H-FABP Measurement Against Traditional Acute Kidney Disease Measurement Tools

For years, no standard method for definition or diagnosis  was in place for AKI. The RIFLE classification was introduced in 2004, which defined and staged renal failure over seven days into five classes of increasing severity including; risk, injury, failure, loss and end-stage kidney disease.

The RIFLE criteria were then revised by the Acute Kidney Injury Network (AKIN) and introduced four main changes including replacing the period of seven days for serum creatinine (SCr) with forty eight  hours and implementing SCr changes as low as 0.3 mg/dL as the lowest measure considered as AKI. However, despite these changes the Kidney Disease Improving Global Outcome (KDIGO) proposed that AKI is defined when any of the three criteria are met including increase in SCr by 50% in seven days, increase in SCr > 0.3 mg/dL or oliguria.7

However, despite these advances, identification and management of AKI is still difficult for two main reasons. The change of SCr does not occur until two to three days after the initial insult. Also, serum creatinine can rise for a variety of reasons such as tubular injury, hemodynamic alterations or cardio-renal interactions.

The utility of SCr as biomarker for CSA- AKI is questionable as changes occur 48 hours to seven days after the original insult.5 The delays in diagnosis of CSA-AKI may have detrimental effects as prolonging the diagnosis period may result in the disease already being well established.12

Also, a main issue concerning the AKI criteria established is its relevance to the perioperative period. Many surgical patients arrive in hospital without preoperative SCr concentrations being measured, potentially leading to over-diagnosis of AKI. However, when patients do arrive with a preoperative SCr concentration, the opposite can occur and immediate postoperative period SCr concentrations can be lower than baseline as a result of haemodilution.  A comparison of the postoperative and preoperative values can lead to under-diagnosis of AKI and consequently delayed treatment.12

The research conducted has illustrated that SCr is not the most appropriate biomarker for diagnosis of AKI. Studies have demonstrated that H-FABP has more clinical utility and is released less than thirty minutes after myocardial injury and renally excreted within 24 hours, showing that as a biomarker it responds faster than creatinine.12

How Randox can Help

The Randox H-FABP test tests utilises an immunoturbidimetric method, offers a wide measuring range and is available liquid ready-to-use for convenience and ease of use.

Want to know more?

Contact us or visit the Randox H-FABP Site

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  • References

    1. National Kidney Foundation. Acute Kidney Injury (AKI). National Kidney Foundation. [Online] National Kidney Foundation. [Cited: February 3, 2019.] https://www.kidney.org/atoz/content/AcuteKidneyInjury.
    2. Biomarkers for the prediction of acute kidney injury: a narrative review on current status and future challenges. Geus, de, MG, Betjes and J , Bakker. 2, s.l. : NCBI, 2012, Vol. 5.
    3. Kidney Care UK. A range of useful facts and stats about kidneys. Kidney Care UK. [Online] Kidney Care UK. [Cited: February 15, 2019.] https://www.kidneycareuk.org/news-and-campaigns/facts-and-stats/.
    4. Centers for Disease Control and Prevention. Trends in Hospitalizations for Acute Kidney Injury — United States, 2000–2014. Centers for Disease Control and Prevention. [Online] Centers for Disease Control and Prevention, March 16, 2018. [Cited: February 22, 2019.] https://www.cdc.gov/mmwr/volumes/67/wr/mm6710a2.htm.
    5. Cardiac Surgery-Associated Acute Kidney Injury. Mao, h, et al. s.l. : Karger, 2013, Vol. 3.
    6. Acute Kidney Injury Associated with Cardiac Surgery. Rosner, Mitchell and Okusa, Mark. 1, s.l. : Clinical Journal of American Society of Nephrology, 2016, Vol. 1.
    7. Cardiac surgery-associated acute kidney injury. Loubon, Christian, et al. 4, s.l. : NCBI, 2016, Vol. 19.
    8. Acute kidney injury following cardiac surgery: current understanding and future directions. O’Neal, Jason, Shaw, Andrew and Billings, Frederic. s.l. : NCBI, 2016, Vol. 20.
    9. Heart-type fatty acid-binding protein predicts long-term mortality after acute coronary syndrome and identifieshigh-risk patients across the range of troponin values. Kilcullen, N, et al. 20, s.l. : Epub, 2012, Vol. 50.
    10. Preoperative serum h-FABP concentration is associated with postoperative incidence of acute kidney injury in patients undergoing cardiac surgery. Oezkur, Mehmet, et al. 117, s.l. : BMC Cardiovascular Disorders, 2014, Vol. 14.
    11. The serum heart-type fatty acid-binding protein (HFABP) levels can be used to detect the presence of acute kidney injury on admission in patients admitted to the non-surgical intensive care unit. Shirakabe, A, et al. 1, s.l. : NCBI, 2016, Vol. 16.
    12. Perioperative acute kidney injury. Goren, O and Matot, I. 2, s.l. : British Journal of Anaesthesia, 2015, Vol. 115.

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.

Learn more about the Randox Apolipoprotein B Test

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.

Learn more about the Randox Total Cholesterol test

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?

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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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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.

Want to know more?

Contact us or visit our Diabetes panel page to learn more.




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Resource Hub

  • 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]


Iron Deficiency Anaemia during Pregnancy

On a global scale, 1.62 billion people are affected by anaemia which is equivalent to 24.8% of the population . According to a review carried out by WHO of various national surveys, anaemia affects approximately 42% of pregnant women worldwide and it is also estimated that at least 50% of all anaemia cases are due to iron deficiency.

Anaemia caused by iron deficiency is usually expected during pregnancy. This is due to several reasons: the increased demand for iron by a pregnant woman’s body from increased total blood cell volume, requirements of the foetus and placenta as well as mass blood loss during labour₂. Although iron cost is unbalanced by the lack of loss of menstrual blood during pregnancy, the net cost is still high enough that iron recommendations are higher than in non-pregnant women. Also, iron is critical during pregnancy considering its involvement in foetal growth: 600-800mg of iron is required during pregnancy with around 300mg needed just for the foetus, a minimum of 25mg for the placenta and almost 500mg due to the increase in volume of red blood cells. ₃

Iron deficiency is the most common micronutrient deficiency in pregnant women leading to iron deficiency anaemia if left untreated. However, iron deficiency can be difficult to measure in some populations due to the lack of availability of field-specific biomarkers. For example, anaemia can affect up to 56% of pregnant women in developing countries, which suggests a high prevalence of iron deficiency anaemia: around 25%. In settings with endemic malaria, such as certain countries in Africa, the number of pregnant women with anaemia is much higher: around 65%.

There are various factors that may increase the risks of iron deficiency anaemia. For example, a diet influenced by religious beliefs can cause a lack of iron in the diet, such as vegetarianism which is common in countries such as India where religious beliefs dictate this. Iron levels can also be affected by consumption of nutrients which inhibit proper absorption of iron, such as calcium or ones that promote iron absorption, such as vitamin C. Other circumstantial risks include infections, multiple pregnancies and adolescent pregnancy while socioeconomic factors and access to healthcare mean some women won’t have access to anaemia control programs, iron supplements or even access to information about iron deficiency anaemia during pregnancy.

To prevent iron deficiency, international guidelines state that iron supplementation to manage iron deficiency is recommended during pregnancy. ₄ However, this is not always available, especially in developing countries.

Iron deficiency anaemia during pregnancy can cause several complications for the mother including:

  • Increased fatigue
  • Short-term memory loss
  • Decreased attention span
  • Increased pressure on the cardiovascular system due to insufficient haemoglobin and blood oxygen levels
  • Lower resistance to infections
  • Reduced tolerance to significant blood loss and surgical implications during labour.

As expected, neonates with mothers who suffered from iron deficiency anaemia during pregnancy will also be confronted with risks and, even if iron deficiency is only mild to moderate, can result in a premature birth, complications with foetal brain development, low birth weight and even foetal death. Additionally, it has been proven that cognitive and behavioural abnormalities can be seen in children for up to ten years after iron insufficiency in the womb.

Randox Soluble Transferrin Receptor (sTfR) Reagent

Randox Reagents offer a Soluble Transferrin Receptor assay to expand upon our current iron testing offering.

In iron deficiency anaemia, soluble transferrin receptor levels are significantly increased, however, remain normal in acute phase conditions including: chronic diseases and inflammation.  As such, sTfR measurements are useful in the differential diagnosis of anaemia: anaemia of chronic disease or iron deficiency anaemia.

In iron deficiency anaemia, increased sTfR levels have also been observed in haemolytic anaemia, sickle cell anaemia and B12 deficiency.

The benefits of the Randox Soluble Transferrin Receptor (sTfR) Reagent include:

  • Latex enhanced immunoturbidimetric method facilitating testing on biochemistry analysers and eliminating the need for dedicated equipment.
  • Liquid ready-to-use reagents for convenience and ease-of-use
  • Stable to expiry date when stored at +2 to +8 °C
  • Excellent measuring range of 0.5 – 11.77mg/L, comfortably detecting levels outside of the normal health range of 0.65 – 1.88mg/L
  • Excellent correlation coefficient of r=0.977 when compared against other commercially available methods
  • Applications available detailing instrument-specific settings for a wide range of clinical chemistry analysers

Find out more at: https://www.randox.com/stfr/

References:

  1. de Benoist B et al., eds.Worldwide prevalence of anaemia 1993-2005WHO Global Database on Anaemia Geneva, World Health Organization, 2008.
  2. Harvey et al, Assessment of Iron Deficiency and Anemia in Pregnant Women: An Observational French Study, Women’s Health, Vol 12 Issue 1, 2016
  3. Burke et al, Identification, Prevention and Treatment of Iron Deficiency during the First 1000 Days, Nutrients, Vol 6 Issue 10, 2014
  4. Guideline: Daily Iron and Folic Acid Supplementation in Pregnant Women. World Health Organization; Geneva, Switzerland: 2012

If you are a clinician or laboratory who are interested in running assays to test iron status, Randox offer a range of assays, including: Iron, Total Iron-Binding Capacity (TIBC), Transferrin and Ferritin .  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/stfr / or email: reagents@randox.com 


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