Jaffe Creatinine Assay
Jaffe Creatinine Assay
Reagent | Creatinine (Jaffe)
A Marker of GFR Function
Benefits of the Randox Jaffe Creatinine Assay
Excellent precision
The Randox Jaffe creatinine assay displayed a within run precision of < 4.0% CV.
Exceptional correlation
The Randox Jaffe creatinine assay displayed a correlation coefficient of at least r=0.99 when compared to commercially available methods.
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
| Cat No | Size | ||||
|---|---|---|---|---|---|
| CR510 | 1 x 200ml (S)(L) | Enquire | Kit Insert Request | MSDS | Buy Online |
| CR3814 | R1 6 x 51ml (L) R2 3 x 28ml | Enquire | Kit Insert Request | MSDS | Buy Online |
| CR8022 | R1 6 x 68ml (L) R2 6 x 20ml | Enquire | Kit Insert Request | MSDS | Buy Online |
| CR8316 | R1 4 x 20ml (L) R2 4 x 7ml | Enquire | Kit Insert Request | MSDS | Buy Online |
| (L) Indicates liquid option (S) Indicates standard included in kit |
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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.
More useful information
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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References
[2] Gounden V, Bhatt H, Jialal I. Renal Function Tests. Treasure Island: StatPearls Publishing; 2020. https://www.ncbi.nlm.nih.gov/books/NBK507821/ (accessed 24 July 2020).
[6] Dabla PK. Renal function in diabetic nephropathy. World Journal of Diabetes 2010; 1(2): 48-56
[7] Mahmoudi H, Alikhani MY, Taheri NM, Behzadi A. Assessment of changes in blood urea and creatinine levels in patients with coronavirus disease 2019 (COVID-19). v 2020: https://www.researchsquare.com/article/rs-25164/v1 (accessed 16 July 2020)
[9] National Institute of Care Excellence (NICE). COVID-19 rapid guideline: acute kidney injury in hospital. https://www.nice.org.uk/guidance/ng175/chapter/4-Assessing-for-AKI-in-patients-with-suspected-or-confirmed- COVID-19 (accessed 16 July 2020).
Enzymatic Creatinine Assay
Reagent | Creatinine (Enzymatic)
A Highly Sensitive And Reproducible Method
Powered by BiozBenefits of the Randox Enzymatic Creatine Assay
Superior method
The Randox enzymatic method offers a superior specificity when compared to the traditional Jaffe method.
Excellent precision
The Randox creatinine assay displayed a within run precision of < 2.18% CV.
Exceptional correlation
The Randox enzymatic creatinine assay displayed a correlation coefficient of at least r=0.99 when compared to commercially available methods.
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
| Cat No | Size | ||||
|---|---|---|---|---|---|
| CR2336 | R1 4 x 50ml (S) R2 4 x 10ml | Enquire | Kit Insert Request | MSDS | Buy Online |
| CR2337 | R1 4 x 100ml (S) R2 4 x 20ml | Enquire | Kit Insert Request | MSDS | Buy Online |
| CR4037 | R1 4 x 50ml (L) R2 4 x 19.5ml | Enquire | Kit Insert Request | MSDS | Buy Online |
| CR8122 | R1 4 x 65ml (L) R2 4 x 32.3ml | Enquire | Kit Insert Request | MSDS | Buy Online |
| CR8317 | R1 4 x 20ml (L) R2 4 x 9.5ml | Enquire | Kit Insert Request | MSDS | Buy Online |
| (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.
More Information
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.
Related Products
Clinical Chemistry Calibrator
Clinical Chemistry Controls
Clinical Chemistry EQA
References
[2] Randox Laboratories. Creatinine (Enzymatic UV) CR2336. 2020
[3] Gounden V, Bhatt H, Jialal I. Renal Function Tests. Treasure Island: StatPearls Publishing; 2020. https://www.ncbi.nlm.nih.gov/books/NBK507821/ (accessed 24 July 2020).
[7] Dabla PK. Renal function in diabetic nephropathy. World Journal of Diabetes 2010; 1(2): 48-56.
[8] Mahmoudi H, Alikhani MY, Taheri NM, Behzadi A. Assessment of changes in blood urea and creatinine levels in patients with coronavirus disease 2019 (COVID-19). v 2020: https://www.researchsquare.com/article/rs-25164/v1 (accessed 16 July 2020)
[10] National Institute of Care Excellence (NICE). COVID-19 rapid guideline: acute kidney injury in hospital. https://www.nice.org.uk/guidance/ng175/chapter/4-Assessing-for-AKI-in-patients-with-suspected-or-confirmed- COVID-19 (accessed 16 July 2020).
Cystatin C Assay
Reagent | Cystatin C
An Indispensable Marker of Renal Impairment
Benefits of the Randox Cystatin C Assay
Exceptional Correlation
A correlation coefficient of r=1.00 was displayed when the Randox methodology was compared against commercially available methods.
Excellent Precision
The Randox Cystatin C assay displayed a within run precision of < 4.2%.
Wide Measuring Range
The Randox Cystatin C assay has a measuring range 0.4 – 10mg/l for the comfortable detection of clinically important results.
Dedicated Cystatin C Calibrator and Controls
Dedicated Cystatin C Calibrator and Controls available offering a complete testing package.
Applications Available
Applications available detailing instrument-specific settings for the convenient use of the Randox cystatin C assay on a variety of clinical chemistry analysers.
Ordering Information
| Cat No | Size | Analyser | Easy Read | Easy Fit | |
|---|---|---|---|---|---|
| CYS4004 | R1 2 x 17.6ml (L) R2 2 x 6.1ml | Enquire | Kit Insert Request | MSDS | Buy Online |
| (L) Indicates liquid option | |||||
Instrument Specific Applications (ISA’s) are available for a wide range of biochemistry analysers. Contact us to enquire about your specific analyser.
Diagnostic Uses
Serum creatinine (SCr) is the most commonly utilised screening test for renal impairment; however, SCr can be affected by age, dietary protein intake, ethnicity, gender, and lean muscle mass. Consequently, the sensitivity of SCr for the early detection of kidney disease is poor and not suitable for the renal assessment in the elderly 1.
The biggest drawback of SCr is that up to 50% of renal function can be lost before significant SCr levels become detectable as SCr is insensitive to small changes in GFR. Consequently, treatment is not provided at the appropriate time which can be fatal, and so an earlier and more sensitive biomarker for renal function is imperative 2.
Cystatin C (CysC) is a low-molecular-weight (13.3kDa) non-glycosylated protein belonging to the cystatin protease inhibitor family 2, 3. Formed at a constant rate by all nucleated cells, CysC is freely filtered by the glomerular membrane in the kidneys, reabsorbed and fully catabolised by the proximal renal tubule and is not returned to the bloodstream, and so is the ideal marker of glomerular filtration rate (GFR) 3, 4.
Serum CysC levels are inversely correlated with GFR 3. The main advantage of CysC as a marker of renal function is in the creatinine ‘blind’ area, the elderly and in paediatrics 5. It has been reported that CysC has important associations with mortality across the GFR range, including those who are grouped as ‘preclinical kidney disease’ (GFR between 60 and 90mL/min per 1.73m2). Moreover, CysC has been identified as a stronger predictor of adverse cardiovascular outcomes compared to SCr. Combining SCr, CysC and urine albumin to SCr ratio improves risk stratification for kidney disease progression and mortality 6.
Acute kidney injury (AKI) presents with elevated levels of CysC in those with severe COVID-19 in comparison to those with mild COVID-19. CysC can be utilised to determine the extent of kidney damage as well as distinguishing those with severe and mild COVID-19 7.
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H-FABP for Acute Kidney Injury Testing Revealed by Randox
A new testing application for the biomarker Heart-Type Fatty Acid-Binding Protein (H-FABP) has been announced by global diagnostics company Randox Laboratories.
Whilst H-FABP is most commonly recognized as an early biomarker of myocardial infarction, the assay’s clinical utility in cardiac surgery associated acute kidney injury (CSA-AKI) is notable. Studies have shown that patients who developed AKI following cardiac surgery had elevated levels of H-FABP both pre-and postoperatively compared to the patients who did not.
Susan Hammond, Randox Product Specialist, explained the new application for H-FABP;
“Cardiac surgery-associated acute kidney injury (CSA-AKI) is a well-recognized postoperative complication of cardiac surgery and is the second most common cause of AKI in the intensive care unit (ICU) – occurring in up to 30% of patients.
“Several AKI studies exist focusing on the measurement of H-FABP levels before, during and after cardiac surgery, one of which found that the post-operative H-FABP levels in patients who experienced any AKI increased 8-fold. It was also noted that the levels of those with severe AKI increased 13-fold and that 10.8% of patients who died from subsequent AKI all had elevated pre-operative levels of H-FABP.
“The Randox H-FABP assay is therefore an independent marker of AKI following cardiac surgery, and can furthermore be used as a CSA-AKI risk assessment assay even in advance of the procedure.”
It has been identified that certain patient groups are more susceptible to CSA-AKI and vulnerability can depend on age, sex, pre-existing cardiac dysfunction, pre-existing chronic kidney disease (CKD), previous cardiac surgery or comorbidity.
Susan Hammond added;
“The ability to include biomarkers that aid in the risk assessment and treatment plan management of a patient is significant. Utilizing H-FABP alongside traditional biomarkers to assess CSI-AKI risk allows the clinician to gain stronger clinical insight in how to improve patient outcomes.”
Key Benefits of the Randox H-FABP assay
A niche product from Randox meaning that Randox are one of the only manufacturers to offer the H-FABP assay in an automated biochemistry format
CE marked for diagnostic use
Automated assay offering a more convenient and time efficient method for H-FABP measurements compared to traditional testing
Exceptional correlation of r=0.97 when compared against other commercially available methods
Applications available detailing instrument-specific settings for the convenient use of the Randox H-FABP assay on a wide range of clinical chemistry analysers
Liquid ready-to-use format for convenience and ease-of-use
Latex enhanced immunoturbidimetric method delivering high performance compared to traditional ELISA testing
Rapid results within fourteen minutes, depending on the analyser.
Wide measuring range of 0.747 – 120ng/ml for the early detection of clinically important results
Dedicated H-FABP controls and calibrator available offering a complete testing package
Superior Performance & Unique Tests
Superior Performance & Niche Reagents
Randox offer a range of high performance, unique and niche reagents that are designed to enhance your laboratory testing capabilities.
Our impressive portfolio of high performance & unique tests together with our standard assays sets us apart in the in vitro diagnostics market. Our superior performance reagents and methodologies deliver highly accurate and specific results, that can facilitate earlier diagnosis of disease states with confidence and precision.
Benefits of High Performance Reagents
Reduce Costs
We can help create cost-savings for your laboratory through excellent stability, eliminating the requirement for costly test re-runs. Our quality reagents also come in a range of different kit sizes to reduce waste and for your convenience.
Confidence in Patient Results
Our traceability of material and extremely tight manufacturing tolerances ensure uniformity across our reagent batches. All of our assays are validated against gold-standard methods.
Applications Available
Applications are available detailing instrument-specific settings for the convenient use of the Randox superior performance & unique assays on a wide variety of clinical chemistry analysers.
Superior Performance Offering
Randox offer an extensive range of 115 assays across routine and niche tests, and cover over 100 disease makers. Our high performance assays deliver superior methodologies, more accurate and specific results compared to traditional methods.
Reduce Labour
Reduce valuable time spent running tests. Randox reagents come in liquid ready-to-use formats and various kit sizes for convenient easy-fit. Barcode scanning capabilities for seamless programming.
Unique Offering
Our range of unique assays means that Randox are one of the only manufacturers to offer these tests in an automated biochemistry format.
The in vitro diagnostics market is continuously adapting to the changes in laboratory testing. Consequently, Randox have continued to reinvest in R&D to produce superior performance & unique tests offering laboratories choice, quality and innovation.
The Randox Lp(a) assay is calibrated in nmol/l and traceable to the WHO/IFCC reference material (IFCC SRM 2B) and provides an acceptable bias compared with the Northwest Lipid Metabolism Diabetes Research Laboratory (NLMDRKL) gold standard. A five-point calibrator with accuracy-based assigned target values (in nmol/l) is available, accurately reflecting the heterogeneity of the apo(a) isoforms.
The Randox bile acids test utilises an advanced enzyme cycling method which displays outstanding sensitivity and precision when compared to traditional enzymatic based tests. The Randox 5th Generation Bile Acids test is particularly useful in paediatrics where traditional bile acids tests are affected by haemolytic and lipaemic samples.
A superior assay from Randox, the vanadate oxidation method offers several advantages over the diazo method, including less interference by haemolysis and lipaemia, which is particularly evident for infant and neonatal populations.
The Randox Fructosamine assay utilises the enzymatic method which offers improved specificity and reliability compared to conventional NBT-based methods. The Randox enzymatic method does not suffer from non-specific interferences unlike other commercially available fructosamine assays.
Soluble transferrin receptor (sTfR) is a marker of iron status. In iron deficiency anaemia, sTfR levels are significantly increased, however remain normal in the anaemia of inflammation. Consequently, sTfR measurement is useful in the differential diagnosis of microcytic anaemia.
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Obesity and Kidney Disease: What is the Connection?
30th January 2019
Obesity and Kidney Disease: What is the Connection?
The month of January has forever been the month of resolutions with many choosing to ditch the sweets and join the gym. However, for many these efforts are limited to January and bad habits are quick to remerge. Obesity has been a burden on the health service for many years with the problem, like many people’s waist lines, only continuing to expand.
Recent findings have shown that this problem is no longer just increasing in developed countries but also in developing countries. In fact, worldwide obesity has tripled since 1975. In 2016, more than 1.9 million adults were classed as overweight, of which over 650 million were obese.1 These are shocking statistics for a condition that is preventable. As a global concern, it is important to assess all the potential risks of this problem.
The most common diseases associated with obesity are cardiovascular disease (CVD) and diabetes. However, the associated risks are much greater than this. Being overweight may also increase the risk of certain types of cancer, sleep apnea, osteoarthritis, fatty liver disease and kidney disease.2
Obesity is now recognised as a potent risk factor for the development of renal disease.3 Excess weight has a direct impact on the development and progression of chronic kidney disease (CKD). Globally, the prevalence of diabetic kidney disease rose by 39.5% between 2005 and 2015, coinciding with the increased CKD prevalence.4 In obese individuals, the kidneys have to work harder, filtering more blood than normal to meet the metabolic demands of increased body weight, increasing the risk of kidney disease.
The traditional diagnostic test for renal impairment is creatinine. This test is carried out through the measurement of creatinine levels in the blood to assess the kidneys ability to clear creatinine from the body. This is called the creatinine clearance rate which helps to estimate the glomerular filtration rate (GFR), which is the rate of blood flow through the kidneys.5
Problems arise when using creatinine for CKD testing as a number of factors need to be taken into consideration including age, gender, ethnicity and muscle mass. For this reason, black men and women exhibit higher creatinine levels than white men and women, raising concern over the accuracy of this test for certain patient groups.6 In addition, serum creatinine is not an adequate screening test for renal impairment in the elderly due to their decreased muscle mass.7
The main disadvantage of using creatinine to screen for renal impairment is that up to 50% of renal function can be lost before significant creatinine levels become detectable as creatinine is insensitive to small changes in GFR. Consequently, treatment is not provided at the appropriate time which can be fatal, therefore, an earlier and more sensitive marker for renal function is vital.8
These disadvantages have not only been highlighted in research but also by the national institute for health and care excellence (NICE). NICE updated the classification of CKD in 2004 to include the albumin: creatinine ratio (ACR). They split chronic kidney disease patients into categories based on GFR and ACR. Figure 1 highlights the different categories and risk of adverse outcomes. NICE recommend using eGFR Cystatin C for people in the CKD G3aA1 and higher.9
Figure 1 Classification of Chronic Kidney Disease using GFR and ACR categories.9
Despite these suggestions, Creatinine is still being used for G3a1 and increasing risk levels.
The utility of cystatin C as a diagnostic biomarker for kidney disease has been documented to show superiority of traditional CKD tests. There is no ‘blind area’ making it very sensitive to small changes in GFR and capable of detecting early reductions. Furthermore, this marker is less influenced by diet or muscle mass and has proven to be a beneficial test in patients who are overweight.8
A number of studies support the statement: ‘Cystatin C levels are higher in overweight and obese patients’. This is important because when cystatin c levels are too high, it may suggest that the kidneys are not functioning properly. One study conducted, using a nationally representative sample of participants, found that overweight and obesity maintained a strong association with elevated serum cystatin C. This suggests that weight can affect the levels of cystatin C and therefore the likelihood of developing kidney disease.10
How Randox can Help
The Randox automated Latex Enhanced Immunoturbidimetric Cystatin C tests offers an improved method for assessing CKD risk, combined with a convenient format for routine clinical use, for the early assessment of at risk patients. Randox is currently one of the only diagnostic manufacturers who offer an automated biochemistry test for Cystatin C measurement, worldwide.
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References
- World Health Organization. Obesity and Overweight . int. [Online] WHO. [Cited: January 22, 2019.] https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight.
- Health Risks of Being Overweight. NIDDK. [Online] National Institute of Diabetes and Digestive and Kidney Diseases. [Cited: March 24, 2019.] https://www.niddk.nih.gov/health-information/weight-management/health-risks-overweight.
- Kidney Health Australia . Obesity and Chronic Kidney Disease: The Hidden Impact. Kidney Health Week/ World Kidney Day 2017. [Online] Kidney Health Australia. [Cited: January 22, 2019.] https://kidney.org.au/cms_uploads/docs/kidney-health-australia-report-obesity-and-chronic-kidney-disease–the-hidden-impact_06.03.17.pdf.
- Neuen, Brendon Lange, et al. Chronic kidney disease and the global NCDs agenda. s.l. : BMJ Global Health, 2017
- Creatinine and Creatinine Clearance Blood Tests. WebMD. [Online] WebMD. [Cited: January 22, 2019.] https://www.webmd.com/a-to-z-guides/creatinine-and-creatinine-clearance-blood-tests#1.
- Lascano, Martin E and Poggio, Emilio D. Kidney Function Assessment by Creatinine-Based Estimation Equations. Cleveland Clinic. [Online] August 2010. [Cited: 16 May 2018.] http://www.clevelandclinicmeded.com/medicalpubs/diseasemanagement/nephrology/kidneyfunction/.
- Swedko, Peter J, et al. Serum Creatinine Is an Inadequate Screening Test for Renal Failure in Elderly Patients. Research Gate. [Online] February 2003. [Cited: 6 May 2018.] https://www.researchgate.net/publication/8243393_Serum_Creatinine_Is_an_Inadequate_ Screening_Test_for_Renal_Failure_in_Elderly_Patients.
- Mishra, Umashankar. New technique developed to detect chronic kidney disease. Business Line. [Online] 07 May 2018. [Cited: 17 May 2018.] https://www.thehindubusinessline.com/news/science/new-technique-to-detect-chronic-kidney-disease/article23803316.ece.
- National Institute for Health and Care Excellence. Chronic kidney disease in adults: assessment and management: 1 Recommendations. National Institute for Health and Care Excellence. [Online] January 2015. https://www.nice.org.uk/guidance/cg182/chapter/1- recommendations#classification-of-chronic-kidney-disease-2.
- Overweight and Obesity and Elevated Serum Cystatin C Levels in US Adults . Muntner, Paul, et al. 4, s.l. : NCBI, 2008, Vol. 121.
Securing the future with in vitro diagnostic tests
The aim of Biomedical Science Day is to raise the public’s awareness of the importance of biomedical science and the vital role it plays in the world. Randox are dedicated to improving healthcare worldwide through placing a major focus on research and development. The Randox scientists work in pioneering research into a range of common illnesses such as cancer, cardiovascular disease and Alzheimer’s disease.
A recent blog from Doris-Ann Williams, the Chief Executive at BIVDA, explains how “increased funding is not enough to sustain the NHS” and how “we need to make better use of in vitro diagnostics to ensure a successful future”.
The National Health Service (NHS) is a publicly funded, primarily taxation, national healthcare system in the United Kingdom. It was first set-up on July 5th, 1948 by Aneurin Bevan as he believed that everyone, regardless of wealth, should have access to good healthcare. Whilst the NHS is an extremely important aspect of healthcare in the UK, in vitro diagnostics are the heart and soul of the healthcare system as healthcare professionals not only rely on blood tests to diagnose and treat patients, but also to rule out the different contributing causes to a disease state. In vitro diagnostics also plays a key role in monitoring chronic disease states. In vitro diagnostics can also aid in reducing hospital stays, reduce misdiagnosis and support patients in looking after their own health and to deliver personalised treatment plans.
The Randox scientists have developed several niche assays to improve patient diagnosis, monitor treatment and eliminate misdiagnosis.
Adiponectin
Adiponectin is a protein hormone secreted by adipocytes with anti-inflammatory and insulin-sensitising properties. It plays an important role in a number of metabolic processes including glucose regulation and fatty acid oxidation. Adiponectin levels are inversely correlated with abdominal visceral fat which have proven to be a strong predictor of several pathologies, including: metabolic syndrome, type 2 diabetes mellitus (T2DM), cancers and cardiovascular disease (CVD). For more information on the importance of testing Adiponectin levels, check out our Adiponectin Whitepaper.
Cystatin C
Cystatin C is an early risk marker for renal impairment. The most commonly run test for renal impairment is Creatinine. Creatinine measurements have proven to be inadequate as certain factors must be taken into consideration, including age, gender, ethnicity etc. The National Institute for Health and Care Excellence (NICE) have updated their guidelines, which now recommends Cystatin C as a more superior test for renal impairment due to its higher specificity for significant disease outcomes than those based on Creatinine. For more information on the importance of testing Cystatin C levels, check out our Cystatin C Whitepaper.
Small-dense LDL Cholesterol (sdLDL-C)
LDL Cholesterol (LDL-C) consists of two parts: the large and buoyant LDL Cholesterol and the small and dense LDL Cholesterol. Whilst all LDL-C transports triglycerides and cholesterol to bodily tissues, their atherogensis varies according to their size. As sdLDL-C is small and dense, they can more readily permeate the arterial wall and are more susceptible to oxidation. Research indicates that individuals with a predominance of sdLDL-C have a 3-fold increased risk of myocardial infarction. It has been noted that sdLDL-C carries less Cholesterol than large LDL, therefore a patient with predominately sdLDL-C particle may require nearly 70% more sdLDL-C particles to carry the same amount of cholesterol as the patient with predominately LDL-C particles. For more information on the importance of testing sdLDL-C levels, check out our sdLDL-C Whitepaper.
These three niche in vitro diagnostics tests developed by Randox scientists can aid in reducing NHS costs due to their higher performance compared to the traditional tests. Randox are constantly striving to improve healthcare worldwide.
For more information on the extensive range of Randox third-party in vitro diagnostic reagents, visit: https://www.randox.com/diagnostic-reagents/ or contact reagents@randox.com.
Could there be 5 types of diabetes?
A peer-reviewed study, published in The Lancet Medical Journal suggests there are five types of diabetes. Could diabetes be more complex than we once thought? Could diabetes be segmented into five separate diseases?
What is diabetes?
Diabetes is an incurable disease which prohibits the body’s ability to produce and respond to insulin. Currently, diabetes is classified into two main forms, type 1 and type 2.
Type 1 diabetes is an autoimmune disease which manifests in childhood. In type 1 diabetes, the body’s white blood cells attack the insulin-producing cells in the pancreas. As a result, individuals with Type 1 diabetes rely on the injection of insulin for the remainder of their lives.
Type 1 diabetes affects 10 percent of individuals with diabetes. 96 percent of children diagnosed with diabetes have type 1. Type 1 diabetes in children is commonly diagnosed between the ages of 10 and 14. The prevalence of type 1 diabetes in children and young people (under the age of 19) is 1 in every 430-530 and the incidence of type 1 in children under 14 years of age is 24.5/100,000 (Diabetes UK, 2014).
Type 2 diabetes is the result of insulin resistance, meaning that the pancreas does not produce enough insulin or the body’s cells do not respond to the insulin produced. As type 2 diabetes is a mixed condition, with varying degrees of severity, there are a few methods to manage the disease, including dietary control, medication and insulin injections.
Type 2 diabetes is the most common form of diabetes, affecting 90 percent of individuals with diabetes, and has now become a global burden. The global prevalence of diabetes has almost doubled from 4.7 percent in 1980 to 8.5 percent in 2014, with a total of 422 million adults living with diabetes in 2014. It is expected to rise to 592 million by 2035. In 2012, diabetes accounted for 1.5 million deaths globally with hypertension causing a further 2.2 million deaths. 43 percent of these deaths occurred before 70 years of age. Previously type 2 diabetes was commonly seen in young adults but is now commonly seen in children as well. In 2017, 14% more children and teenagers in the UK were treated for diabetes compared to the year before (World Health Organization, 2016).
In both forms of diabetes, hyperglycemia can occur which can lead to number of associated complications including renal disease, cardiovascular disease, nerve damage and retinopathy.
The novel subgroups of adult-onset diabetes and their association with outcomes: a data-driven cluster analysis of six variables – peer-review study
This new research studied 13,270 individuals from different demographic cohorts with newly diagnosed diabetes, taking into consideration body weight, blood sugar control and the presence of antibodies, in Sweden and Finland.
This peer-reviewed study identified 5 disease clusters of diabetes, which have significantly different patient characteristics and risk of diabetic complications. The researchers also noted that the genetic associations in the clusters differed from those seen in traditional type 2 diabetes.
Cluster One – Severe autoimmune diabetes (SAID)
SAID is similar to type 1 diabetes. SAID manifests in childhood, in patients with a low BMI, have poor blood sugar and metabolic control due to insulin deficiency and GADA. 6% of individuals studied in the ANDIS study were identified with having SAID.
Cluster Two – Severe insulin-deficient diabetes (SIDD)
SIDD is similar to SAID, however, GADA is negative. This means that the characteristics of SIDD are the same as SAID, young, of a healthy weight and struggled to make insulin, however, SIDD is not the result of an autoimmune disorder as no autoantibodies are present. Patients have a higher risk of diabetic retinopathy. 18% of subjects in the ANDIS study were identified with having SIDD.
Cluster Three – Severe insulin-resistant diabetes (SIRD)
SIRD is similar to that of type 2 diabetes and is characterised by insulin-resistance and a high BMI. Patients with SIRD are the most insulin resistant and have a significantly higher risk of kidney disease, and microalbuminuria, and non-alcoholic fatty liver disease. 15% of subjects in the ANDIS study were identified as having SIRD.
Cluster Four – Mild obesity-related diabetes (MOD)
MOD is a mild form of diabetes which generally affects a younger age group. This is not characterised by insulin resistance but by obesity as their metabolic rates are close to normal. 22% of subjects in the ANDIS study were identified as having MOD.
Cluster Five – Mild age-related diabetes (MARD)
MARD is the most common form of diabetes manifesting later in life compared to the previous four clusters. Patients with MARD have mild problems with glucose regulation, similar to MOD. 39% of subjects in the ANDIS study were identified with having MARD.
This new sub-classification of diabetes could potentially enable doctors to effectively diagnose diabetes earlier, through the characterisation of each cluster, including: BMI measurements, age, presence of autoantibodies, measuring HbA1c levels, ketoacidosis, and measuring fasting blood glucose levels. This will enable a reduction in the incidence of diabetes complications and the early identification of associated complications, and so patient care can be tailored, thus improving healthcare (NHS, 2018) (The Week, 2018) (Ahlqvist, et al., 2018) (Collier, 2018) (Gallagher, 2018).
The Randox diabetes reagents cover the full spectrum of laboratory testing requirements from risk assessment, using our Adiponectin assay, to disease diagnosis and monitoring, using our HbA1c, glucose and fructosamine assays, to the monitoring of associated complications, using our albumin, beta-2 microglobulin, creatinine, cystatin c, d-3-hydroxybutyrate, microalbumin and NEFA assays.
Whilst this study is valuable, alone it is not sufficient for changes in the diabetes treatment guidelines to be implemented, as the study only represents a small proportion of those with diabetes. For this study to lead the way, the clusters and associated complications will need to be verified in ethnicities and geographical locations to determine whether this new sub-stratification is scientifically relevant.
References
Ahlqvist, E. et al., 2018. Novel subgroups of adult-onset diabetes and their association with outcomes: a data-driven cluster analysis of six variables. [Online]
Available at: http://www.thelancet.com/journals/landia/article/PIIS2213-8587(18)30051-2/fulltext?elsca1=tlpr
[Accessed 16 April 2018].
Collier, J., 2018. Diabetes: Study proposes five types, not two. [Online]
Available at: https://www.medicalnewstoday.com/articles/321097.php
[Accessed 16 April 2018].
Diabetes UK, 2014. Diabetes: Facts and Stats. [Online]
Available at: https://www.diabetes.org.uk/resources-s3/2017-11/diabetes-key-stats-guidelines-april2014.pdf
[Accessed 16 April 2018].
Gallagher, J., 2018. Diabetes is actually five seperate diseases, research suggests. [Online]
Available at: http://www.bbc.co.uk/news/health-43246261
[Accessed 16 April 2018].
NHS, 2018. Are there actually 5 types of diabetes?. [Online]
Available at: https://www.nhs.uk/news/diabetes/are-there-actually-5-types-diabetes/
[Accessed 16 April 2018].
The Week, 2018. What are the five types of diabetes?. [Online]
Available at: http://www.theweek.co.uk/health/92048/what-are-the-five-types-of-diabetes
[Accessed 16 April 2018].
World Health Organization, 2016. Global Report on Diabetes, Geneva: World Health Organization.
If you are a clinician, dietitian or laboratory who are interested in running diabetes assays, Randox offer a wide range of high-quality routine and niche assays including: fructosamine, glucose, HbA1c for diagnosing and monitoring diabetes, albumin, beta-2 microglobulin, creatinine, cystatin c, NEFA, microalbumin, and d-3-hydroxybutyrate to monitor associated complications, and adiponectin as a biomarker for diabetes risk assessment. These assays can be run on most automated biochemistry analysers.
Instrument Specific Applications (ISA’s) are available for a wide range of biochemistry analysers. Contact us to enquire about your specific analyser.
For more information, visit: https://www.randox.com/diabetes-reagents or email: reagents@randox.com
Acetaminophen-Induced Acute Kidney Failure
Acetaminophen is a commonly used medicine for pain-relief. During cold and flu season, it is common to resort to pain-relief medicines to relieve headaches, and ache and pain symptoms associated with a cold or flu as there is no cure. However, the therapeutic range for acetaminophen is 10-30 mg/l, which is small and very easy to go over. During cold and flu season, it is important to monitor the amount of paracetamol entering your body as acetaminophen is more dangerous than suspected. At therapeutic levels, acetaminophen does not produce any adverse effects, however, long-term treatment, prolonged use, and taking a few more than the recommended dose can be severely damaging and fatal. Accidental acetaminophen overdose took the lives of 1,500 people in the U.S between 2001 and 2010. The Randox Acetaminophen assay is used to determine the concentration levels of acetaminophen in the blood to determine if an overdose has taken place.
It is commonly recognised that acetaminophen overdose causes hepatotoxicity, but it is less commonly recognised that it can also cause nephrotoxicity in less than 2% of patients. Nephrotoxicity is toxicity of the kidneys and is often associated with a reduced amount of glutathione which is important for normal cellular metabolism in the kidneys. The Randox Glutathione Reductase assay is required for the regeneration of reduced glutathione. Glutathione is often discussed in association with the Randox Glutathione Peroxidase, which requires reduced glutathione for activation. Both Glutathione reagents are unique to Randox.
Acute renal failure due to acetaminophen manifests as acute tubular necrosis, which can occur alone or in combination with hepatic necrosis. Nephrotoxicity can also occur when the therapeutic levels of acetaminophen are not exceeded. This most commonly occurs when acetaminophen is taken in combination with alcohol. Upon testing acetaminophen levels and the results fall within the therapeutic range, the Randox Ethanol assay can test alcohol levels to determine if a combination of alcohol and acetaminophen caused nephrotoxicity. Renal impairment may be more common than previously suspected as acute renal failure occurs in 10-40% of patients with severe hepatic necrosis. Upon testing acetaminophen to determine toxicity, Randox also offer the following renal tests to test for nephrotoxicity:
- Creatinine (Enzymatic and JAFFE)
- Cystatin C
- IgG
For more information visit: https://www.randox.com/acetaminophen
To request an application for your specific analyser, contact reagents@randox.com
