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.

Correlation

Exceptional correlation

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

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 & Controls

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
EnquireKit Insert RequestMSDSBuy Online
CR7948R1 7 x 50ml
R2 2 x 40ml
EnquireKit Insert RequestMSDSBuy Online
CR8022R1 6 x 68ml
R2 6 x 20ml
EnquireKit Insert RequestMSDSBuy Online
CR8316R1 4 x 20ml
R2 4 x 7ml
EnquireKit Insert RequestMSDSBuy Online
(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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Chronic Kidney Disease

Chronic Kidney Disease

Early Multiplex Detection of Chronic Kidney Disease

Early Multiplex Detection of Chronic Kidney Disease from a Single Sample

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    Simultaneous and quantitative detection of multiple serum biomarkers of kidney damage-related analytes
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    Identifies the risk of CKD development / progression following an AKI episode
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    Unique combination of analytes ensures better sensitivity and accuracy compared to traditional serum creatinine measurement
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    Utilised widely in safety endpoint monitoring or drug-related renal toxicity during clinical trials
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    The Randox CKD arrays utilises biomarkers to profile slow verus rapid CKD progression
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    Biochip Technology effectively diagnoses early CKD, differentiates between stages and predicts a decline in a patient’s renal function

Chronic Kidney Disease is an abnormal kidney function and/ or structure, present for a minimum period of 3 months.

Typically diagnosed on the basis of serum creatine concentration, however, currently employed urine biomarkers do not reliably detect the early stages of CKD at which intervention could be more effective. Screening for CKD and any subsequent required treatments may then alter the course of early stage CKD and reduce complications and/or the associated health conditions.

Utilising patented Biochip Technology, the Randox Chronic Kidney Disease (CKD) arrays could improve patient risk stratification whilst monitoring the effectiveness of treatment. Diagnosis of CKD at early stages will allow earlier intervention for the treatment of kidney disease, and the prevention of further kidney damage.

Randox Chronic Kidney Disease (CKD) Array I (7-plex)

  • EGF
  • IL-8
  • sTNFR1
  • FABP1
  • sTNFR2
  • D-Dimer
  • MIP-1 alpha

EGF regulates renal cell proliferation, fibrosis and inflammation and is produced in response to renal injury.

IL-8 endothelial-derived chemokine involved in recruiting neutrophils to sites of injury and stimulating their response.

sTNFR1 is used to identify an increase in inflammatory conditions such as CKD.

FABP1 binds long-chain fatty acids, contributing to reducing oxidative stress in the kidneys.

sTNFR2 is used to identify an increase in inflammatory conditions such as CKD.

D-Dimer is a fibrin degradation product, and an index of both coagulation and fibrinolysis.

MIP-1 alpha plays a roles in inflammatory responses at sites of injury or infection.

Randox Chronic Kidney Disease (CKD) Array II (4-plex)

  • CRP
  • Cystatin C
  • C3a Des Arg
  • NGAL

CRP is an acute phase reactant involved in inflammation.

Cystatin C is well recognised marker of kidney filtration dysfunction and injury.

C3a des Arg is a representative of complement component C3a which produces local inflammatory responses.

NGAL is among the current state-of-the-art in CKD biomarkers.

The Evidence Investigator

Meet the Evidence Investigator

The Randox CKD arrays have both been developed for the Evidence Investigator, a semi-automated benchtop immunoassay analyser.

The CKD array’s would improve patient risk stratification whilst monitoring the effectiveness of treatment. Diagnosis of CKD at early stages will allow earlier intervention for the treatment of kidney disease, and the prevention of further kidney damage. Currently available for RUO.

Evidence Investigator

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Contact us or visit our Investigator Webpage


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.

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.

Calibrator & Controls

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
EnquireKit Insert RequestMSDSBuy Online

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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H-FABP Calibrator

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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.

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 & Controls

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
EnquireKit Insert RequestMSDSBuy Online
CR4037R1 4 x 50ml (L)
R2 4 x 19.5ml
EnquireKit Insert RequestMSDSBuy Online
CR8122R1 4 x 65ml (L)
R2 4 x 32.3ml
EnquireKit Insert RequestMSDSBuy 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.

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 superior performance & unique tests brochure to learn more.

Related Products

Clinical Chemistry Calibrator

Clinical Chemistry Controls

Clinical Chemistry EQA

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Cystatin C Assay

Cystatin C

An Indispensable and Sensitive Marker of Renal Impairment

Benefits of the Randox Cystatin C Assay

Correlation

Exceptional correlation

A correlation coefficient of r=1.00 was displayed when the Randox methodology was compared against commercially available methods.

Precision

Excellent precision

The Randox cystatin C assay displayed a within run precision of < 4.2%.

Measuring range

Wide measuring range

The Randox cystatin C assay has a measuring range 0.4 – 10mg/l for the comfortable detection of clinically important results.

Stable to expiry date

The Randox cystatin C assay is stable to expiry date when stored at +2oC to +8oC.

Calibrator & Controls

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
  • TRADITIONAL CKD BIOMARKERS
  • PHYSIOLOGICAL SIGNIFICANCE
  • CLINICAL SIGNIFICANCE
  • COVID-19
Cat NoSizeAnalyserEasy Read
Easy Fit
 
CYS4004R1 2 x 17.6ml
R2 2 x 6.1ml
EnquireKit Insert RequestMSDSBuy Online

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

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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Contact us or download the superior performance & unique tests brochure to learn more.

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Cystatin C Calibrator

Cystatin C Control

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Kidney Testing on the Randox Biosciences Evidence Series

March is National Kidney Month, a full month dedicated to raising awareness about kidney disease.

There are two kinds of kidney disease; Chronic Kidney Disease (CKD) and Acute Kidney Injury (AKI).

Chronic Kidney Disease (CKD) affects 3 million people in the UK1. Chronic Kidney is defined as a condition that causes damage and stress on the kidneys, therefore decreasing the ability to keep your body healthy.

The kidneys play a vital role of removing any waste and extra water from the blood to form urine. The kidneys also make hormones that help control your blood pressure, make red blood cells, and keep your bones strong and healthy.2

It is crucial to look after your kidneys. If kidney disease gets worse, the excess waste can build to high levels in your blood, resulting in complications such as high blood pressure, anemia, weak bones, poor nutritional health and nerve damage, as well as increasing the risk of developing heart and blood vessel disease.

Chronic Kidney Disease if often caused by diabetes or having a high blood pressure, which can both be prevented by early detection and treatment. Without treatment the kidney disease will worsen resulting in kidney failure which requires dialysis or a kidney transplant to maintain life.

Chronic Kidney Disease I:

  • Fatty Acid Binding Protein I – FABPI
  • Soluble Tumour Necrosis Factor Receptor I – sTNFR I
  • Soluble Tumour Necrosis Factor Receptor II – sTNFR II
  • Macrophage Inflammatory Protein Iα – MIP-Iα
  • Interleukin-8 – IL-8
  • Epidermal Growth Factor – EGF
  • D-Dimer

Chronic Kidney Disease II:

  • Complement C3a Des Arginine – C3a des Arg
  • C-Reactive Protein – CRP
  • Neutrophil Gelatinase Associated Lipocalin – NGAL
  • Cystatin C

Acute Kidney Injury (AKI) is when your kidneys stop working properly. This is caused by reduced blood flow to the kidneys, which often happens as a complication of another serious disease.3 AKI affects one in five people admitted to hospital as an emergency, and is considered deadlier than a heart attack 2.

AKI can be reversible if found and treated quickly. Therefore, it is important, if someone has signs of having AKI, to get it treated promptly. Abnormal levels of salt and chemicals can build up in our bodies which causes organs to fail, resulting in the need for dialysis, or can even cause death. 3

  • Osteopontin – OPN
  • Serum creatinine – Creatinine
  • Serum cystatin-C – Cystatin-C
  • Kidney injury Molecule-I – KIM-I
  • Urinary neutrophil gelatinase associated lipocalin – NGAL

The Evidence Series of Immunoassay analysers contains four revolutionary Biochip Array Technology platforms including the Evidence, Evolution, MultiSTAT and the Investigator.

Randox’s renal panel is available on our Evidence Investigator Immunoassay Analyser, which is a multiplex testing platform allowing for the simultaneous quantitative or qualitative detection of a wide range of analytes from a single sample. It provides a unique platform for assessment of biological samples in a rapid, accurate and easy-to-use format.

For more information on any of the Evidence Series analysers, please visit https://www.randoxbiosciences.com/  or contact us at info@randoxbiosciences.com

  1. https://www.kidneycareuk.org/news-and-campaigns/facts-and-stats/
  2. https://www.niddk.nih.gov/health-information/kidney-disease/kidneys-how-they-work
  3. https://www.nhs.uk/conditions/acute-kidney-injury/

 

 

 

 

 

 

 


Is Biomarker Multiplexing the future of kidney disease screening?

Chronic Kidney Disease (CKD) is both a cause and a consequence of cardiovascular diseases, and is an increasing burden on global health. As diabetes, obesity and hypertension incidences continue to rise and the world’s population steadily ages, CKD’s prevalence is already estimated to be between 11% and 13% globally for all five KDOQI stages, with a majority in Stage 3 (about 90% of all stages).

With early stages of CKD being asymptomatic and current diagnostic tools (proteinuria determined by albumin to creatinine ratio and decreased renal function estimated from GFR using the CKD-EPI equation) are insufficiently sensitive to detect most cases up to stage 3, it is likely that the true prevalence of CKD is still underestimated. Therefore the need to improve both early diagnostics and overall CKD outcome is all the more critical.

Accordingly, biomarker research has been intense in the field of renal disease for at least 10 years with a number of promising candidates emerging, some now well-known by specialists: Cystatin C, NGAL or KIM-1 for example.

However, further novel biomarkers, assessed in combination using a properly developed multiplex assays can allow superior insight into CKD than what their individual performance could achieve.  This also largely stems from selecting the markers that are indicative of complementary mechanisms that contribute to the development of CKD.

When assayed together from a single serum sample and after combinatorial analysis has been applied, these biomarkers can open new avenues in the management of CKD, such as proper diagnosis of the condition from Stage 1, clear differentiation between stages and monitoring of the progression pace of the disease. Early screening of patients at risk of CKD is now within reach and it is expected that its systematic use will have a profound impact on health system economics.

Another area of interest in renal research is Acute Kidney Injury (AKI) which may arise as a result of cardiac surgery and can subsequently lead to CKD. AKI detection is also of significant interest in the field of drug development, where early stage toxicity is still a large cause of new drug marketing withdrawal. Hence selecting and qualifying kidney tissue damage biomarkers, and assembling them into a multiplex panel is a key priority to those involved in early stage clinical trials.

An AKI panel has been worked out using the same principles as those used in the development of the CKD panel: high individual diagnostic value and multiple, independent cellular targets. This panel is now ready for final clinical qualification and will be one of the first of several organ-targeted safety panels aiming to become standard for drug induced toxicity screening.

It is key to the adoption of multiplex testing that proper validation guidelines be published and that careful, matrix-based validation data is made available to potential users. It is essential that multiplexed testing comes to the front line of testing in the field, so it can deliver to its full potential and start translating into public health improvement and cost savings. Technology is ready, let’s make a start!

Dr Claire Huguet

Randox Biosciences – Head of Biomarkers

 

For further information about kidney disease screening from Randox Biosciences, please contact randoxpr@randox.com

 

 

 


Looking after your kidney health during your pregnancy

With this year’s World Kidney Day theme focusing on women’s health and in particular, their kidney health, the campaign is drawing attention to the need for a higher awareness, timely diagnosis and proper follow-up of kidney issues amongst women.

One key area being highlighted by the campaign is the close links between pregnancy and kidney health problems.  The two are intrinsically connected – with CKD considered a high-risk factor for problematic pregnancies and reduced fertility, and in turn, pregnancy-related complications, including preeclampsia, can increase the risk of kidney disease.

Although not commonly known, women who have Chronic Kidney Disease are at increased risk of hypertensive disorders and premature births – which can be devastating for all involved.

Women with Chronic Kidney Disease who become pregnant also usually have mild kidney dysfunction, the severity of which will depend on the stage the CKD is at.

It is clear therefore that there is a need for increased awareness of Chronic Kidney Disease in pregnancy, to timely identify its existence before conception, and to monitor its progress before, during and after birth.

With a comprehensive panel of kidney health tests, Randox are working to ensure timely diagnosis of kidney function problems, to ensure that necessary treatment is administered at the earliest possible stage, when it is most likely to be successful.

Pregnant women, or women hoping to get pregnant in the future, can therefore determine their kidney health and be empowered to embark upon the necessary lifestyle changes or treatment required to ensure a safe and healthy pregnancy.

For example, the Randox test for albumin, low concentrations of which are the earliest marker of kidney damage, can identify individuals with diabetic nephropathy (damage to the kidneys caused by diabetes) around 10 years earlier than standard protein tests. The Randox albumin test can therefore enable preventative measures to be taken to reduce your risk of developing kidney disease.

In addition to albumin, there are a number of other highly specific and sensitive tests for kidney health, which are available as part of a Randox Health Check at our Randox Health Clinics. These include;

  • Estimated Glomerular Filtration Rate, which is an equation that considers age, gender, blood and protein levels to determine how well the kidneys are functioning.
  • Creatinine, which is a waste product produced by muscle tissue, and removed by the kidneys. When kidney function is diminished, creatinine levels increase.
  • Other proteins within the body which should be filtered by the kidneys, and are therefore measured to determine kidney function, include;

–              Cystatin C

–              Beta-2-Microglobulin

–              Microalbumin, which is not usually found in urine, but can appear when normal kidney function is impaired.

  • Minerals processed by the kidneys and analysed by Randox Health include;

–              Magnesium

–              Calcium

–              Phosphate

–              Potassium

–              Sodium

Both World Kidney Day and Randox are working towards improving healthcare worldwide. With access to these high-performance kidney health tests, expectant mothers with kidney problems can be diagnosed early, before the condition develops into something more serious – keeping both you, and your baby healthy.

With early diagnosis we can improve patient treatment outcomes and reduce the number of people across the world suffering with kidney health problems.

 

If you are a clinician or lab interested in running renal function assays, download our Reagents Brochure or email reagents@randox.com

If you want to find out the status of your own Kidney Health, book a health check with Randox Health today. Speak to our team by phoning 0800 2545 130.

 

 

 


Randox Testing Services: Customer Testimonials from Ireland

At Randox Testing Services (RTS), we pride ourselves on helping our customers improve the health and safety of their working environment. Using our accurate and reliable testing methods and a range of additional services including training and policy reviews, we create tailored packages to meet the needs of our customers. We work with customers all over the world, but this month are highlighting the work we are doing across Ireland.

This month RTS will be attending the Northern Ireland Occupational Health, Hygiene and Wellbeing Conference at Titanic Belfast. This conference brings together companies from a range of industries all across Ireland to discuss the importance of employee health and wellbeing. As a company that began in Northern Ireland, RTS have always had strong connections with local businesses and are continually expanding our reach across Ireland.

Some of the companies with which we currently work, like GRAHAM construction, have recently provided feedback on our services. GRAHAM is based in Hillsborough, Co. Down and is a national construction, asset management and project investment business. They deliver services to a diverse range of clients from a network of regional offices, throughout the UK and Ireland.

GRAHAM Construction are proud to be partnered with Randox as their main Drug & Alcohol Service Provider. Over the years they have given a consistent, prompt, efficient, and professional service that delivered what was promised, when promised, to the proper agreed standards, which assists us in managing our relevant responsibilities with ease and confidence. I would have no hesitation in recommending them to others.”

This is great feedback to receive from such a reputable company who have a range of different testing needs. The construction industry is becoming more and more proactive when it comes to drug and alcohol testing. At RTS our experience working with GRAHAM and other major construction firms across the UK and Ireland means we are extremely well equipped to deal with the changing needs of this industry.

Another industry which requires a flexible and reliable drug and alcohol testing services provider is the aviation industry, especially when it comes to recruitment. We have been working with CAE Parc Aviation Services, the global leader in the provision of aviation personnel and support services to conduct pre-employment testing.

“We use Randox for Pre-Employment and Random Drug & Alcohol testing for select clients. We would happily recommend their services.”

Again, through working with various industries, the experience our staff possess is second to none. By qualifying the exact needs of our customers we create customised, cost-effective packages to ensure all testing needs are met.

As well as offering drug and alcohol testing services, our complete solution also includes a host of training, educational and consultancy services to equip our customers in tackling drug and alcohol misuse. Including comprehensive chain of custody training programs, which enables employers to conduct on-site collections to the same standard as a Randox Testing Services collection specialist.

The Henderson Group in Newtownabbey are another large company that has availed of the services offered by Randox Testing Services. The Henderson Group are the owners of the SPAR, EUROSPAR, ViVO, ViVOXTRA and ViVO Essentials franchises in Northern Ireland and have been distributing food and grocery-related products to the convenience retail sector for over 100 years.

“We switched provider for our Drug and Alcohol policy almost two years ago, moving to Randox.  The switchover was relatively seamless and the impact on our business has been positive.  Our tests are now all completed within target and we have realised a saving to boot.  We are glad we made the switch.”

 

 

Randox Testing Services is committed to tailoring our service to the needs of customers all over the world, and across the island of Ireland.

If your company would like to speak to us, please contact testingservices@randox.com

Alternatively you can contact David O’Regan, the Business Development Executive for Ireland directly: David.O’Regan@randox.com.

 

 


Randox Reagents are Supporting World Kidney Day 2018

On 8th March 2018, Randox Reagents are supporting World Kidney Day!  World Kidney Day is an annual campaign and partnership to raise awareness of the importance of our kidneys to our overall health and to reduce the frequency and impact of kidney disease and its associated health problems worldwide.

 

This year, the World Kidney Day theme is: “Kidney Disease and Women’s Health: Include, Value, Empower”.  Chronic kidney disease affects approximately 195 million women worldwide and it is currently the 8th leading cause of death in women, with close to 600,000 deaths per year.

 

Chronic kidney disease in women has increased over the years.  Women over the age of 50 and African American women have seen the highest rise of kidney failure.  This has been attributed to obesity, diabetes and high blood pressure.  It is important that women are screened for renal impairment as although treatment of kidney disease in men and women are the same, the complications associated with renal impairment in women is greater than in men.  The complications women are faced with due to renal impairment include: irregular periods, diminished sex drive and difficulties conceiving.  Whilst it is difficult for a woman with renal impairment to conceive, it is not impossible, however, 50% of babies born to women on dialysis survived with most being born prematurely due to high blood pressure.  There are several measures that women can take to reduce their likelihood of developing renal impairment or manage their symptoms including; lifestyle changes, medication to control associated problems, dialysis and kidney transplant.

 

The standard marker for renal functional is creatinine as creatinine clearance gives a measure of the glomerular filtration rate (GFR), however, creatinine levels are unreliable in individuals who are obese, malnourished, have liver cirrhosis or reduced muscle mass.  Due to this, Randox developed an automated test for Cystatin C, a superior marker of kidney dysfunction.

 

The Randox Cystatin C assay

Cystatin C is a small (13kDa) cysteine proteinase inhibitor that is produced at a constant rate by all nucleated cells.  The small molecular weight of cystatin C allows it to be completely removed and broken down by the kidneys.  Therefore, levels remain steady if the kidneys are working efficiently and the Glomerular Filtration Rate (GFR) is normal.

There are several studies that have documented the superiority of cystatin C compared to creatinine as a marker of GFR function.  Unlike creatinine, cystatin C does not have a ‘blind area’ meaning it is extremely sensitive to very small changes in GFR and therefore capable of detecting early reductions in GFR.  Up to 50% of renal function can be lost before significant creatinine levels are detected.  GFR estimates based on cystatin C are less influenced by diet or muscle mass compared to GFR estimates based on creatinine, therefore, Cystatin C is also beneficial if the patient is overweight, elderly or has a lot of muscle mass. Cystatin C is also beneficial if previous kidney function tests were inconclusive.

World Kidney Day and Randox are working towards improving healthcare globally.  With continuous investment into R&D, Randox are striving to develop the earliest biomarker for renal function to prevent serious complications.

 

For more information, download our High Performance & Unique Tests Brochure or email reagents@randox.com.

Cystatin C

 

 

For health professionals

If you are a clinician or laboratory who are interested in running renal function assays, Randox offer a wide range of high-quality routine and niche assays including:  Albumin, Ammonia, β2- Microglobulin, Calcium, Chloride, Creatinine Enzymatic and Jaffe, Cystatin C, Glucose, HbA1c, IgG, LDH, Magnesium, Microalbumin, Phosphorus (Inorganic), Potassium, Sodium, Urea, Uric Acid, and Urinary Protein. These can be run on most automated biochemistry analysers.

For more information, download our High Performance & Unique Tests Brochure or email reagents@randox.com.


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