Jaffe Creatinine Assay

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Jaffe Creatinine Assay

Creatinine (Jaffe)

A Marker of GFR Function

Benefits of the Randox Jaffe Creatinine Assay

Precision

Excellent precision

The Randox Jaffe creatinine assay displayed a within run precision of < 4.0% CV.

Exceptional Correlation

Exceptional correlation

The Randox Jaffe creatinine assay displayed a correlation coefficient of at least r=0.99 when compared to commercially available methods.

Wide measuring range

Wide measuring range

The Randox Jaffe creatinine assay has a measuring range of 16 – 2448µmol/l for the comfortable detection of clinically important results.

Liquid ready-to-use

Liquid ready-to-use

The Randox Jaffe creatinine assay is available in a liquid ready-to-use format for convenience and ease-of-use.

Calibrator and controls available

Calibrator and controls available offering a complete testing package.

Applications available

Applications available detailing instrument-specific settings for the convenient use of the Randox Jaffe creatinine assay on a variety of clinical chemistry analysers.

  • Ordering Information
  • Physiological Significance
  • Renal Function
  • Diabetes
  • COVID-19
Cat NoSize    
CR5101 x 200ml (S)EnquireKit Insert RequestMSDSBuy Online
CR5246 x 500ml (S)EnquireKit Insert RequestMSDSBuy Online
CR3814R1 6 x 51ml
R2 3 x 28ml
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CR7948R1 7 x 50ml
R2 2 x 40ml
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CR8022R1 6 x 68ml
R2 6 x 20ml
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CR8316R1 4 x 20ml
R2 4 x 7ml
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(S) Indicates standard included in kit

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

Creatinine is the end-product of muscle catabolism of creatine. In humans, creatinine production is relatively stable, but mainly depends on muscles mass. Consequently, any physiological changes in muscle mass will cause a variation in the creatinine pool independently of GFR changes. Creatinine is freely filtered by the glomerulus at a constant rate with 10% to 40% secreted by the tubules 1.

According to the National Institutes of health, the overall prevalence of chronic kidney disease (CKD) is approximately 14% 2. Creatinine is the most commonly utilised assay in the assessment of renal function 3. The National Kidney Disease Education Program recommends calculating GFR from SCr. Creatinine measurements are useful in the monitoring of disease progression, with the diagnosis of renal failure when SCr levels are greater than the upper normal interval 4.

Creatinine measurements are useful in the diagnosis and monitoring of diabetic nephropathy, the leading cause of kidney disease in patients commencing renal replacement therapy, affecting 40% of diabetics (type 1 and type 2) 5. The RENAAL (Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan) study risk score for end-stage renal disease (ESRD) emphasizes the importance of the identification of elevated SCr, alongside other renal markers, in the prediction of end-stage renal disease (ESRD) development in patients with type 2 diabetes mellitus (T2DM) and nephropathy 6.

Acute kidney injury (AKI) is a common complication in COVID-19 patients 7. The analysis of creatinine in COVID-19 patients on hospital admission and after 2 to 4 days highlighted impaired renal function and is the leading cause of death in these patients 8. The National Institute of Care Excellence (NICE), have set out four guidelines for acute kidney injury in hospitalised suspected or confirmed COVID-19 patients and highlights the importance of creatinine testing 9.

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H-FABP (Cardiac) Assay

H-FABP (Cardiac)

A Superior Marker of Acute Coronary Syndrome

Benefits of the Randox H-FABP (Cardiac) Assay

Superior Performance

Superior method

The Randox latex enhanced immunoturbidimetric (L.E.I) method offers a more convenient, high performing and time efficient (results in 14 minutes, depending on analyser) method compared to traditional ELISA testing.

Excellent Correlation

Excellent correlation

correlation coefficient of r=0.97 was displayed when the Randox methodology was compared against commercially available methods.

Wide measuring range

Wide measuring range

The Randox H-FABP assay can comfortably detect levels outside of the healthy range, measuring between 0.747 – 120ng/ml.

Liquid ready-to-use

Liquid ready-to-use assay

The Randox H-FABP assay is available in a liquid ready-to-use format for convenience and ease-of-use.

Dedicated calibrator and controls available

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

Applications available

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

  • Ordering Information
  • Physiological Significance
  • ACS
  • hs-Troponin
  • Prognostic Value
  • Troponin Negative Patients
Cat NoSize    
FB4025R1 1 x 19ml
R2 1 x 7ml
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Instrument Specific Applications (ISA’s) are available for a wide range of biochemistry analysers.  Contact us to enquire about your specific analyser.

Fatty acid-binding proteins (FABPs) are small cytoplasmic proteins that are abundantly expressed in tissues with an active fatty acid metabolism, including the heart and liver.  Heart-type fatty acid-binding protein (H-FABP) is an unbound, low molecular weight protein (15kDa), located in the cytoplasm of cardiac myocytes 1 2.

The primary function of H-FABP is to transport intracellular long-chain fatty acids.  When compared to traditional cardiac proteins, H-FABP is smaller than myoglobin (18kDa), troponin I (TnI) (22kDa), troponin T (TnT) (37kDa) and creatine kinase-muscle/brain (CK-MB) (86kDa) 3.  H-FABP freely circulates in the cytoplasm, this coupled with its low molecular weight makes, H-FABP a more reliable and sensitive indicator of at-risk patients as indicated in Fig 1.

Fig 1. The early release of H-FABP following myocardial infarction (MI) 3

Fig 1. The early release of H-FABP following myocardial infarction (MI)

H-FABP has been studied as a cardiac biomarker since the early 1990s however, early progress in clinical studies was hampered due to the lack of monoclonal antibodies and high quality (quantitative) assays. Gradual improvements in H-FABP antibodies and assays over recent years means that the true clinical value of the biomarker is now evident. Several key publications advocate the early diagnosis of ACS utilising the H-FABP test:

1. JAMA (2011): Serial changes in highly sensitive troponin I assay and early diagnosis of myocardial infarction 4

Objective: A study prospectively evaluated 1,813 patients with suspected ACS were consecutively enrolled at the chest pain units of the University Heart Centre Hamburg, Germany on admission and after 3 and 6 hours, A variety of biomarkers were measured at each time point.

Conclusion: H-FABP offer superior diagnostic performance or acute myocardial infarction (AMI) compared to a range of novel ACS biomarkers (based on the ROC analysis produced in this study).

2. Scandinavian Journal of Clinical and Laboratory Investigation (2012): Clinical and analytical evaluation of an immunoturbidimetric heart-type fatty acid-binding protein assay 5

Objective: A study prospectively evaluated patient samples and pools of samples to assess functional sensitivity, linearity, precision, limit of detection, recovery of recombinant H-FABP with troponin in samples routinely received from chest patient samples.

Conclusion: H-FABP an be run in a bury routine laboratory and on non-proprietary analytic platforms, offering excellent performance and precision.

Chest pain is a common symptom for patients reporting to an emergency department (ED), representing ≈10% of all ED consultations. It is vital that patients who present with chest pain of suspected cardiac origin are screened for ACS. Only 10% to 20% of these patients will be diagnosed as experiencing an acute myocardial infarction (AMI) 6.

Recently, high sensitivity troponin has made its way onto the market. H-FABP is not a replacement test for hs-TnT/ hs-TnI, however, measurement of H-FABP in combination with hs-TnT/hs-TnI is optimal for improving the early diagnosis of ACS and can offer clinical utility in the ED. Recent publications advocate testing H-FABP in combination with high sensitivity troponin (hs-TnT or hs-TnI) for optimal performance:

1. BMC Emergency Medicine (2016): Heart-type fatty acid-binding protein and cardiac troponin: development of an optimal rule-out strategy for acute myocardial infarction 7

Objective: A study prospectively evaluated hd-TnI, hsTnT and H-FABP in 1,016 patients presenting at a New Zealand ED with symptoms triggering investigation for possible ACS.

Conclusion: H-FABP in combination with hs-TnI without ischaemic ECG changes improved the rule-out of AMI upon presentation at an ED, compared to hs-TnI and ECG, while maintaining >99% sensitivity for AMI. The implementation of this strategy would enable up to 40% of patients to be classed as low risk and suitable for early discharge, reducing the number of in-hospital stays.

2. Journal of Clinical and Experimental Cardiology (2018): Diagnostic performance of a combination biomarker algorithm for rule-out of acute myocardial infarction at time of presentation to the emergency department, using heart-type fatty acid-binding protein and high-sensitivity troponin T tests 8

Objective: A study prospectively examine 548 patients with suspected cardiac chest pain presenting at a hospital ED in Northern Ireland for the development of a rule-out algorithm based H-FABP and hs-TnT. Blood samples were collected at presentation and after 1, 2, 3, 6, 12 and 24 hours and 20 parameters were measured.

Conclusion: The implementation of a combined H-FABP hs-TnT algorithm at an ED could aid in the identification of non-AMI patients on arrival, with the potential to reduce hospital admission by 36.8%. Moreover, this combined algorithm could potentially have a significant impact on patient health, ensuring the appropriate and effective implementation of a treatment plan for patients identified as high risk.

Not only is H-FABP useful in the diagnosis of cardiac conditions such as ACS or AMI, it also offers clinical utility in the prognosis of cardiac conditions.

1. The American Journal of Cardiology (2009): Prognostic value of a multimarker approach for patients presenting to hospital with acute chest pain 9

Objective: A study prospectively examined 664 patients exhibiting acute ischaemic-type chest pain. The study evaluated novel biomarkers of myocardial injury, neurohormonal activity, haemostasis, and vascular inflammation. Those of greatest significance were tested in the risk stratification during the 1 year follow up.

Conclusion: The measurement of H-FABP upon hospital admission provides useful prognostic value compared to the measurement of baseline and 12-hour TnT.

In addition to significant diagnostic values in ACS, H-FABP has been consistently and robustly shown to offer significant value in the long-term prognosis of ACS patients, even when compared to hs-troponin assays10. Several key publications advocate the long-term prognosis of patients utilising the H-FBP test:

1. Journal of the American College of Cardiology (2010): Heart-type fatty acid-binding protein predicts long-term mortality and re-infarction in consecutive patients with suspected acute coronary syndrome who are troponin negative 11

Objective: A study prospectively evaluated 995 patients presenting with suspected ACS. Utilising the ultra-TnI and the Randox Randox assays, samples were collected 12 to 24 hours following the onset of symptoms.

Conclusion: The prognostic value of elevated H-FABP levels is additive to troponin in low and intermediate risk patients with suspected ACS. The long-term prognostic value of H-FABP in troponin-negative patients is independent of age and serum creatinine.

2. British Medical Journal (2011): In acute coronary syndromes, heart-type fatty acid-binding protein is a more accurate predictor of long term prognosis then troponin 12

Objective: A study prospectively examined 1,448 ACS patients who had serum H-FABP levels measured upon hospital admission. The study provides a six-year mortality overview following on from the one-year mortality data published in 2007.

Conclusion: Whilst the patterns between both studies are very similar, except for TnI- / H-FABP+ group of patients. The TnI- / H-FABP+ cohort exhibit the highest mortality rates after six years. Not only is H-FABP an independent prognostic marker but it also identifies high-risk patients who are TnI negative.

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Enzymatic Creatinine Assay

Creatinine (Enzymatic)

A Highly Sensitive & Reproducible Method

Benefits of the Randox Enzymatic Creatinine Assay

Superior Performance

Superior method

The Randox enzymatic method offers a superior specificity when compared to the traditional Jaffe method.

Precision

Excellent precision

The Randox creatinine assay displayed a within run precision of < 2.18% CV.

Exceptional Correlation

Exceptional correlation

The Randox enzymatic creatinine assay displayed a correlation coefficient of at least r=0.99 when compared to commercially available methods.

Limited Interference

Limited interferences

The Randox enzymatic creatinine assay suffers minimal interferences from Bilirubin, Haemoglobin, Intralipid® and Triglycerides, for truly accurate results and ensures suitability with paediatric samples.

Calibrator and controls available

Calibrator and controls available offering a complete testing package.

Applications available

Applications available detailing instrument-specific settings for the convenient use of the Randox enzymatic creatinine assay on a variety of clinical chemistry analysers.

  • Ordering Information
  • Methodology
  • Physiological Significance
  • Renal Function
  • Diabetes
  • COVID-19
Cat NoSize    
CR2336R1 4 x 50ml (S)
R2 4 x 10ml
EnquireKit Insert RequestMSDSBuy Online
CR2337R1 4 x 100ml (S)
R2 4 x 20ml
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CR4037R1 4 x 50ml (L)
R2 4 x 19.5ml
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CR8122R1 4 x 65ml (L)
R2 4 x 32.3ml
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CR8317R1 4 x 20ml (L)
R2 4 x 9.5ml
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(L) Indicates liquid option (S) Indicates standard included in kit

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

The Laboratory Working Group of the National Kidney Disease Education Program (NKDEP) released guidelines for the improvement of glomerular filtration rate (GFR) estimation as well as the measurement of serum creatinine (SCr). The recommendation included the recalibration and standardisation of SCr methods to be traceable to the isotope dilution-mass spectrometry (IDMS) reference method. Two IDMS traceable creatinine methods are commercially available: enzymatic assays and compensated Jaffe assays 1.

Of the two enzymatic assays available, the Randox enzymatic creatinine assay converts creatinine to ammonia (NH3) and I-Methylhydantoin. Ammonia then reacts with α-oxoglutarate in the presence of GLDH with oxidation of the co-enzyme NADPH. The decrease of NADPH is proportional to the creatinine concentration and is measured at 340nm 1, 2.

The Randox enzymatic creatinine assay exhibits high sensitivity and reproducibility with the added advantage of liquid ready-to-use reagents with good stability. The enzymatic method represents an improvement for use in the accurate and reliable determination of creatinine.

Creatinine is the end-product of muscle catabolism of creatine. In humans, creatinine production is relatively stable, but mainly depends on muscles mass. Consequently, any physiological changes in muscle mass will cause a variation in the creatinine pool independently of GFR changes. Creatinine is freely filtered by the glomerulus at a constant rate with 10% to 40% secreted by the tubules 1.

According to the National Institutes of health, the overall prevalence of chronic kidney disease (CKD) is approximately 14% 3. Creatinine is the most commonly utilised assay in the assessment of renal function 4. The National Kidney Disease Education Program recommends calculating GFR from SCr. Creatinine measurements are useful in the monitoring of disease progression, with the diagnosis of renal failure when SCr levels are greater than the upper normal interval 5.

Creatinine measurements are useful in the diagnosis and monitoring of diabetic nephropathy, the leading cause of kidney disease in patients commencing renal replacement therapy, affecting 40% of diabetics (type 1 and type 2) 6. The RENAAL risk score for end-stage renal disease (ESRD) emphasizes the importance of the identification of elevated SCr, alongside other renal markers, in the prediction of end-stage renal disease (ESRD) development in patients with type 2 diabetes mellitus (T2DM) and nephropathy 7.

Acute kidney injury (AKI) is a common complication in COVID-19 patients 8. The analysis of creatinine in COVID-19 patients on hospital admission and after 2 to 4 days highlighted impaired renal function and is the leading cause of death in these patients 9. The National Institute of Care Excellence (NICE), have set out four guidelines for acute kidney injury in hospitalised suspected or confirmed COVID-19 patients and highlights the importance of creatinine testing 10.

Want to know more?

Contact us or download the diabetes portfolio brochure to learn more.

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Clinical Chemistry Calibrator

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Featured Reagent – Adiponectin

Adiponectin | Featured Reagent

1st October 2019

Physiological Significance

Adiponectin (ADPN) (adipocyte complement-related protein of 30kDa (Acrp30)) is an adipokine (protein hormone) produced and secreted by the adipose tissue, an endocrine organ 1. ADPN acts as a messenger in the communication of adipose tissue and metabolic organs. In doing so, ADPN suppresses the production of glucose in the liver through inhibiting the genes involved in glucose production and enhances fatty acid oxidation in skeletal muscle 2.

Consequently, ADPN is a strong protector against several pathological events in various cells through inhibiting inflammation, suppressing cell death and enhancing cell survival 2.

ADPN has been identified as having pleiotropic functions widely associated with anti-atherogenic, anti-diabetic, cardioprotective and anti-inflammatory effects. ADPN levels inversely correlate with insulin levels, BMI, triglyceride levels, insulin resistance (IR), glucose, and most importantly, visceral fat accumulation 3. Moreover, physiological functions of adiponectin have also been observed in inflammation and cardiovascular disease (CVD), especially in atherosclerosis 2.

Fig. 1. Proposed salutary effects of adiponectin 1

Did you know?

Obesity causes altercations in the adipose tissue promoting metabolic dysregulation. Consequently, these alterations are the precursors in the development of IR and CVD 4.

Adiponectin Testing

  • Benefits of the Randox Adiponectin Assay
  • Visceral Fat
  • T2DM
  • Metabolic & Insulin Concerns
  • Cardiac
  • Cancer
Reduce labour copy

Latex Enhanced Immunoturbidimetric Method
The automated latex enhanced immunoturbidimetric method produces results in as little as ten minutes, facilitating faster patient diagnosis and treatment plan implementation compared to traditional ELISA based testing.

correlation

Exceptional correlation
correlation coefficient of r=0.989 was displayed when compared to commercially available methods.

measuring range

Extensive measuring range
The healthy range for adiponectin is 2 – 22μg/ml. The Randox adiponectin assay can comfortably detect levels outside of the healthy range, measuring between 0.32 – 23.8μg/ml.

liquid

Liquid ready-to-use assay
The Randox adiponectin assay is available in a liquid ready-to-use format for convenience and ease-of-use.

stability

Stability
The Randox adiponectin assay is stable to expiry date when stored at +2 to +8°C and has an onboard stability of 28 days when stored at +10oC.

applications

Applications are available
Applications are available detailing instrument-specific settings for the convenient use of the Randox adiponectin assay on a variety of clinical chemistry analysers. Contact us to enquire about your specific analyser.

APDN has an inverse correlation with abdominal visceral fat (AVF). Low levels of ADPN increases the risk of metabolic abnormalities. Furthermore, excess adipose tissue, especially visceral adipose tissue (VAT) is an important risk factor for IR, correlating with an increased risk of CVD 5.

The most commonly utilised methods for the assessment of AVF are waist circumference and BMI. Waist circumference does not measure total AVF reliably as the visceral fat / subcutaneous fat ratios vary by gender and ethnicity 6 and BMI cannot distinguish between muscle and fat and so classes those with high muscle and low fat mass as being overweight. Moreover, BMI also cannot distinguish between visceral fat and fat that sits beneath the skin 7.

Adiponectin levels are inversely correlated with AVF, proving to be a reliable indicator of at-risk patients.

The traditional biomarkers utilised in the assessment of T2DM risk include: oral glucose tolerance test (OGTT), fasting plasma glucose (FPG) and HbA1c. However, each of these tests are inadequate and a superior biomarker for T2DM risk assessment is vital.

1. JAMA (2009): Adiponectin levels and risk of type 2 diabetes: A systematic review and meta-analysis 8

Higher ADPN levels are associated with a lower risk of T2DM across diverse populations and is currently the strongest and most consistent biomarker of T2DM risk assessment.

2. BMJ Open Diabetes Research & Care (2016): Adiponectin levels predict prediabetes risk: The pathobiology in a biracial cohort (POP-ABC) study 9

Baseline ADPN levels were inversely related to the risk of pre-diabetes among the healthy African Americans and European Americans with a parental history of T2DM enrolled on the POP-ABC study. Despite gender and ethnic difference, this predictive relationship was evident.

The most commonly observed component of metabolic syndrome (MetS) is abdominal obesity. MetS encompasses several conditions
including: hypercholesterolemia, triglyceridemia, glycaemia, hypertension, abdominal obesity and dyslipidaemia. The prevalence of MetS is 31% and is associated with a 1.5-fold increased risk of all-cause mortality, a 2-fold increased risk of coronary heart disease (CHD) and cerebrovascular accident (CVA), and a 5-fold increased risk of T2DM 10, 11, 12.

Adiponectin has been identified as a glucose regulator and lipid homeostasis through its insulin sensitising properties which are associated with MetS.

1. Nutrition and Diabetes (2011): Serum adiponectin level is not only decreased in metabolic syndrome but also in borderline metabolic abnormalities 13

Decreasing ADPN levels begins at an early stage before the onset of hypertension, diabetes, MetS or dyslipidaemia. Moreover, in those with metabolic abnormalities / physiological abnormalities, adiponectin is an important biomarker for the risk assessment of atherosclerosis, both independently and as a reflection of the accumulation of AVF.

2. Cardiovascular Diabetology (2015): Role of adiponectin and free fatty acids on the association between abdominal visceral fat and insulin    resistance 14

Subjects with high AVF or low ADPN had a 3-fold increased risk of IR. The combination of low ADPN with high AVF doubled this probability.

It has been recognised that mRNA expression of the ADPN gene and the section of high molecular weight (HMW) oligomeric ADPN are impaired in adipose tissue of obese patients. Epidemiological studies undertaken in different ethnic groups established that low ADPN levels, especially in HMW oligomer, is an independent risk factor for CVD 15. Fig. 2 illustrates the pleiotropic role of adiponectin in the cardiovascular system.

1. PLOS ONE (2013): Adiponectin provides additional information to conventional cardiovascular risk factors for assessing the risk of atherosclerosis in both genders 16

The risk of carotid intima media thickness (CIMT) inversely correlates with ADPN levels in both genders. Adiponectin testing is a significant marker of atherosclerosis and can provide additional information in the assessment of atherosclerotic risk in both genders, independent of conventional cardiovascular risk factors.

2. European Journal of Preventive Cardiology (2015): Adiponectin, type 2 diabetes and cardiovascular risk 17

Increasing ADPN levels in plasma is associated with a decreased risk of T2DM and subsequently, a reduced risk of CVD.

Fig. 2. The pleiotropic role of adiponectin in the cardiovascular system 15

Excess body fat is not only associated with T2DM and CVD, but also with various types of malignancies. Many cancer cell lines express ADPN receptors, and adiponectin in vitro limits cell proliferation and induces apoptosis. Evidence exists supporting adiponectin as a novel risk marker in the diagnosis and prognosis of cancer 17. Fig. 3 illustrates the association between obesity, low levels of adiponectin and cancer progression.

1. Medicine (2018): Serum adiponectin in breast cancer: A meta – analysis 19

The meta-analysis indicates an intriguing association between low levels of ADPN and an increased risk of breast cancer (BC). Furthermore, APDN has the potential to serve as a biomarker of BC risk and aid in the identification of those at a high risk of developing BC.

Fig. 3. The association between obesity, low adiponectin levels and cancer progression 18

2. International Brazilian Journal of Urology (2019): Role of adiponectin in prostate cancer 20

Oxidative stress has been identified as a key event in the initiation, development and progression of PC. ADPN increased cellular anti-oxidative defence mechanisms and inhibited oxidative stress through increasing the NADPH oxidase NOX2 and NOX4 expressions in human 22Rv1 and DU – 145 PC cell lines. The review support ADPN as a protective and safe factor to prevent the progression of PC.

Obesity: The Risk Factor

Obesity, a major global health epidemic that burdens on healthcare systems, has increased at an alarming rate with 39% of adults (18+) classed as overweight and 13% classed as obese in 2016. Moreover, in the same year, 340 million children aged between 5 and 16 were identified as overweight or obese and 41 million children under 5 years of age were also classed as overweight or obese. Worldwide, obesity prevalence rates have almost tripled between 1975 and 2016 21, 22.

The main reason obesity is a massive health problem is because of the secondary diseases that develop due to obesity. Obesity has contributed to 23% of ischaemic heart disease cases, 7 – 41% of specific cancer cases and 44% of diabetes cases. Obesity is now no longer confined to developed countries. As the industrialisation of developing countries continues to emerge, high calorie diets and subsequently obesity increases 23.

Obesity reduces the number of disease free years. It was uncovered that those who were mildly obese lost 3 – 4 more disease – free years and those who were severely obese lost 7-8 more disease free years than non-obese individuals. Consequently, at least 2.8 million deaths per year are attributed to obesity 24, 25.

Obesity is a major risk factor for T2DM, IR, CVD and various types of malignancies. These secondary health-related problems cost the economy “$2 trillion annually and roughly 2.8% of the global gross domestic product (GDP)”. Moreover, childhood obesity costs the economy $14.1 billion annually 26, 27, 23. Whilst there are numerous parties involved to aid in the prevention of obesity, urgent actions are required to prevent obesity and the subsequent secondary health – related problems.

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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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Tim Cogley Foundation and Randox Health partner with Liverpool universities to bring cardiac health awareness to the city

 An event on preventative healthcare and cardiac screening is being delivered in Liverpool this week by a wealth of world-leading industry and academic speakers.

Hosted by the sponsor of the Randox Health Grand National, in association with Liverpool John Moores University, Liverpool Hope University and the Tim Cogley Cardiac Screening Foundation, the event, entitled the Preventative Cardiac and Metabolic Health Seminar, runs on Wednesday 3rd April and is open to the public.

It follows a morning of engaging fitness programmes, including boxing, taekwondo and indoor cycling, for local pupils and teachers from across Merseyside and Cheshire. During these exercises, which will also include the opportunity to experience life as a jockey by having a go on a horse simulator, the children will also have some physiological measurements taken, including their heart rate.

Prevention is always better than cure”, says Managing Director Dr Peter FitzGerald. “Our aim is to empower people to take control of their health, to live longer and more healthy lives.

“We are delighted to be teaming up with Liverpool John Moores, Liverpool Hope and the Tim Cogley Cardiac Screening Foundation ahead of the Randox Health Grand National. The world’s greatest race offers us the perfect platform to spread our message of preventative health, and we look forward to sharing our knowledge with the audiences at this exciting event.”

This is the third year that the educational event from Randox Health has been held in the city, and for the second time will be championed by Frank Cogley of the Tim Cardiac Screening Foundation, whose son suffered a fatal heart attack due to a genetic condition. Frank is now working to raise the profile of cardiac health checks for young people.

He commented;

“It’s been recently reported that at least 12 under-35s die from undiagnosed heart conditions every week in the UK. The current lack of routine screening of 18 to 40-year-olds leaves a gaping chasm in our healthcare provision.

“With our highly motivated partners, through events like this, we hope to redress this through lifestyle changes and preventative medical programmes.

 “The Tim Cogley Cardiac Screening Foundation is committed to delivery positive, action-focused and life-changing programmes. I can’t imagine a legacy more in tune with the generous, kind and supportive person that was Tim.”

Tickets for the Randox Health seminar, which focuses on health screening and how the right approach can deliver significant benefits, are priced at £3 and are available at https://www.eventbrite.co.uk/e/preventative-cardiac-and-metabolic-health-seminar-tickets-59041545853?aff=ebdshpsearchautocomplete

£2.27 of each ticket payment will go towards the ‘Tim Cogley Cardiac Screening Foundation’ charity. Each attendee at the event will also be entered into a raffle on the day, with the winning prize being general admission tickets for the Randox Health Grand National on Saturday 6th April.

For further information please contact the Randox PR team by emailing randoxpr@randox.com or phoning 028 9442 2413

 

 

 

 

 

 


Diagnosing prediabetes with the Randox Adiponectin Assay

Talking about diabetes can be tough, but it doesn’t have to be.

This month, we’re joining the conversation on diabetes to help raise awareness of the condition, and importantly, how it can be diagnosed, managed, and even prevented.

Today, our focus is on a lesser-known variant of the chronic illness and one which you may not have heard of – prediabetes.

A third of all adults in the UK have prediabetes and with the UK’s estimated 3.8million diabetics estimated to climb to 5million by 2025 – largely as a result of obesity and the ageing population – it’s more important than ever to check if you’re suffering from this pre-cursor to diabetes.

WHAT IS PREDIABETES?

Illness doesn’t just happen overnight. Over time, your body begins to display symptoms but, often, irregularly has been present for some time. Prediabetes is an early indicator of type 2 diabetes which is characterised by the presence of blood glucose levels that are higher than normal but not yet high enough to be classed as diabetes.

For this reason, prediabetes is often described as the “grey area” between normal blood sugar and diabetic levels. In the UK, around 7 million people are estimated to have prediabetes and thus have a high risk for developing type 2 diabetes.

WHAT ARE THE SYMPTOMS OF PREDIABETES?

93% of the 60 million people with prediabetes globally are unaware they have it. This is because the condition often develops gradually without any warning signs or symptoms. In many cases, the sufferer only learns of their diabetic state once the symptoms of type 2 diabetes start to appear.

TESTING FOR PREDIABETES

Traditional biomarker tests used to diagnose type 2 diabetes include Fasting Plasma Glucose, Oral Glucose Tolerance Test, and HbA1c.  However, these cannot be utilised as tests for prediabetes, as beta cell damage has already occurred, and insulin insensitivity is already underway.

Adiponectin, a hormone responsible for regulating glucose metabolism has proven to be a strong predictor of type 2 diabetes at a crucial stage – before it has fully manifested.

Adiponectin’s ability to diagnose prediabetes is due to its relationship with a hazardous type of fat within the body which wraps around internal organs. This visceral fat is particularly dangerous because it can occur even within individuals deemed to have a healthy waist circumference, making them appear deceptively healthy simply because they are slim.

By measuring Adiponectin levels, clinicians can identify someone with high levels of visceral fat and therefore at risk of type 2 diabetes long before they would be identified by tests which measure blood sugar levels.

THE BENEFIT OF A PREDIABETES DIAGNOSIS

Whilst being diagnosed with prediabetes may come as a real shock, it offers a unique opportunity for lifestyle modification and prevention that is often not possible with other illnesses.

And this is because prediabetes is reversible. In fact, up to 80% of all cases of type 2 diabetes are preventable – if detected early. We want to help more and more people understand their health as early as possible so they can take reversible action now when there’s the best chance of a positive outcome.

With this information at your disposal, you can then take the necessary action to stop diabetes in its tracks.

For more information about Adiponectin; please visit https://www.randox.com/adiponectin/

To book the world’s most advanced health check which assess up to 350 different indicators of disease at their very earliest stage, including diabetes, visit www.randoxhealth.com

For further information, please contact Randox PR by emailing randoxpr@randox.com or phoning 028 9442 2413.

 

 

 

 

 


Detecting the earliest possible signs of type 2 diabetes

Randox Laboratories is this month driving awareness of diabetes and the need for early and accurate diagnosis to enable patients to take preventive action before the condition worsens.

Diabetes UK have stated that diabetes is the fastest growing health threat of our times and an urgent public health issue. Statistics show that since 1996, the number of people living with diabetes has more than doubled. It has been estimated that there are 1.1 million people living with diabetes in the UK that have yet to be diagnosed, including 84,836 people in Northern Ireland.

According to Diabetes UK around 700 people a day are diagnosed with diabetes, which equates to one person every two minutes. If nothing changes, it is estimated that diabetes will affect one in ten people by 2040. This will raise diabetes prevalence from 415 million to 642 million by 2040.  With current treatment taking up almost 9% of the annual NHS budget – roughly £8.8bn a year – the implications for future healthcare budgets are clear if this dangerous trend persists.

The good news however, is that recent research has found that type 2 diabetes is preventable through lifestyle changes. The NHS recently released the UK’s National Diabetes Prevention Programme which is aimed at tackling the increasing growing threat of diabetes.

However, following a warning raised by an Oxford University study, which looked into efforts of this Prevention Programme, it was found that it is unlikely to have much impact because the blood tests used were inaccurate at detecting pre-diabetes – the stage at which diabetes is reversible.

The blood tests used in the National Diabetes Prevention Programme were only effective at detecting diabetes at a stage when damage had already been done.

At Randox, we have developed a number of tests that can help detect the earliest possible signs of diabetes, often before symptoms have even manifested – including a pioneering test for the hormone Adiponectin.

Assessing Adiponectin levels allows doctors to calculate a patient’s levels of visceral fat – a dangerous, internal fat stored around organs. This deep fat, which is not visible to the naked eye, is linked to health problems including Type-2 diabetes.

Low levels of adiponectin equate to high levels of visceral fat which can be combated by improving your diet, exercise habits and even stress levels. Given that 70% of Type-2 diabetes can be prevented by lifestyle changes, there is strong correlation that by detecting low levels of Adiponectin and taking corrective and preventive action, it could result in a decrease in the numbers of people who develop the life-altering condition.

In addition to a test for the Adiponectin biomarker, Randox Biosciences have created a Metabolic Syndrome Array that measures 12 markers associated with metabolic syndrome and cardiovascular disease. Metabolic Syndrome is a is a group of cardiovascular risk factors that affects over 20% of adults and results in a person being three times more likely to have a stroke or heart attack, and five times more likely to develop diabetes.

Ultimately, we would like to see all medical professionals who are at the forefront of patient care armed with the most accurate diagnostic tools available. Updating traditional practice may not be easy but we believe it is imperative to do so, if we are to effectively challenge this global epidemic.

Randox remains focused on providing early diagnoses and preventing illnesses by providing innovative diagnostics tests that will continue to revolutionise the healthcare landscape.

For further information, please contact Randox PR by emailing randoxpr@randox.com or phoning 028 9442 2413.

 

 

 


Randox – Diabetes

During December, we aim to highlight how the Randox product portfolio can be used for accurate diagnosis and monitoring of diabetes, with a focus on the Randox Reagents diabetes panel which offers a total of 12 assays for accurate and reliable diabetes testing.

Diabetes is one of the leading causes of death worldwide and it is estimated by WHO (World Health Organisation) that 2.2 million additional deaths are being caused by the condition each year.  The number of people with the condition has being growing rapidly in the last 30 years, the International Diabetes Federation predicts that approximately 438 million people will have diabetes by 2030. Early diagnosis and constant monitoring of diabetes is essential in order to manage the condition, as diabetes can lead to other health problems such as heart disease, kidney damage or failure, nerve damage and even blindness.

Randox knows that this condition cannot be ignored as each year it is increasingly becoming a burden on the health service. Randox Reagents are committed to advancing diabetes related testing and offer an extensive range of high quality reagents: from diabetes diagnosis, to the monitoring of diabetes-related complications, the Randox Reagents diabetes testing panel covers the full spectrum of clinical testing requirements.

Reagents Diabetes Testing Assays

To aid with the growing concern of diabetes, Randox Reagents offer a comprehensive range of 12 assays within their diabetes testing panel including assays for the diagnosis and monitoring of diabetes which includes fructosamine, glucose and HbA1c and also those which monitor diabetes-related complications such as adiponectincystatin c, microalbumin and NEFA. The Randox diabetes reagents offer a range liquid ready-to-use and lyophilised formats for increased efficiency, applications are also available for a wide range of biochemistry analysers.

Randox Reagents

RX series Direct HbA1c Testing Capabilities

Renowned for quality and reliability the RX series range of clinical chemistry analysers boasts a world leading test menu with an extensive range of high performing and unique assays available. In addition to NEFA, D-3-Hydroxybutyrate (Ranbut) and Fructosamine the RX series welcomes Direct HbA1c testing on the RX Daytona +, RX imola and RX modena. The latex enhanced immunoturbidimetric method improves laboratory performance and time, highly improving accuracy and precision by revolutionising your diabetes testing capabilities.

Direct HbA1c Testing

Quality Control

Designed for use in the Quality Control of both HbA1c and Total Haemoglobin assays, our Acusera HbA1c controls are an ideal match for laboratories running these parameters and POCT testing. Available in liquid ready-to-use or lyophilised formats, these controls offer attractive stability and flexibility for labs and healthcare practices of any size. Manufactured using human whole blood which ensures commutability, our controls directly mimic the performance of real patient samples helping deliver reliable results. 

Quality Control

RIQAS Glycated Haemoglobin Programme

Designed to monitor the performance of HbA1c, our RIQAS glycated haemoglobin EQA program is suitable for both qualitative and quantitative methods of analysis.  As the largest EQA scheme in the world, access to large peer groups is guaranteed.  Additional benefits include; monthly analysis, user-friendly reports allowing at-a-glance performance assessment, ability to register up to five instruments per programme and cost savings via our unrivalled consolidation.

EQA

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.




Related Products

Randox Reagents

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]


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