Jaffe Creatinine Assay

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Jaffe Creatinine Assay

Reagent | 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

Cat NoSize    
CR5101 x 200ml (S)EnquireKit Insert RequestMSDSBuy Online
CR3814R1 6 x 51ml
R2 3 x 28ml
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.

More useful information

  • Physiological Significance
  • Renal Function
  • Diabetes
  • COVID-19

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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Enzymatic Creatinine Assay

Reagent | Creatinine (Enzymatic)

A Highly Sensitive And Reproducible Method

Benefits 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 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.

More Information

  • Methodology
  • Physiological Significance
  • Renal Function
  • Diabetes
  • COVID-19

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.

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Cystatin C Assay

Reagent | Cystatin C

An Indispensable 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.

Stability

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.

Logos-07

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 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.

Diagnostic Uses

  • TRADITIONAL CKD BIOMARKERS
  • PHYSIOLOGICAL SIGNIFICANCE
  • CLINICAL SIGNIFICANCE
  • COVID-19

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.

Useful Links

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The RX series – Raising Awareness of Urology Week

This week marks Urology Week, an important week in the annual health calendar. Urology Week is an initiative of the European Association of Urology (EAU) that aims to raise awareness of urological conditions among the general public and provide knowledge into how vital urology is to your standard of life.

What is Urology?

Urology is a surgical speciality which involves the diagnosis and treatment of disorders of the kidneys, ureters, bladder, prostate and male reproductive organs. It is an extremely varied branch of medicine and caters for patients of both genders and all ages, from infants to elderly pensioners. (1)

Did you know?

There are 25 million or 16% of Europeans above 40 years of age who experience some symptoms of urinary incontinence, with costs of this condition totalling approximately €7 billion in just 6 countries? Currently, 10% of all medical care involves Urology which is a large proportion of the annual healthcare spend. (2)

The RX series Clinical Chemistry Analysers offer a comprehensive renal testing panel which allows for a quick and accurate diagnosis to combat urological diseases.

The RX series Renal Function Test Panel is aimed to help diagnose and manage conditions affecting kidney function; these tests may be used as part of general health screening or to screen someone who is at risk of developing kidney disease.

Why choose the RX series analysers to test Renal Function?

  • Extremely low patient sample volumes are required ensuring the upmost in patient comfort
  • Accurate testing ensures patients can receive correct treatment as early as possible
  • STAT functionality allows for the addition of emergency samples when required
  • Advanced QC capabilities insuring your results are both accurate and reliable.

View the Full RX series Test Menu Here

For more information please visit www.randox.com/clinical-chemistry-analysers or contact therxseries@randox.com to speak with your local Randox Representative.

 

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(1) The British Association of Urological Surgeons Limited. (2017). What Is Urology? Available: https://www.baus.org.uk/patients/information/default.aspx. Last accessed 26th Sept 2017.

(2) European Association of Urology. (2017). Urology Statistics.Available: http://www.urologyweek.org/what_is_urology/statistics/. Last accessed 26th Sept 2017.


Randox Reagents celebrate World Kidney Day 2017

On 9 March 2017, Randox Reagents are celebrating World Kidney Day!  World Kidney Day is a global campaign aimed at raising awareness of the importance of our kidneys to our overall health. It aims to reduce the frequency and impact of kidney disease and its associated health problems worldwide.

This year, the World Kidney Day promotes education on the harmful consequences of obesity and its association with kidney disease, advocating healthy lifestyle and health policy measures that make preventive behaviours an affordable option.

With this in mind, throughout the week we have been sharing on social media some interesting facts on diagnostic tests which can help aid an early risk assessment of kidney disease in obese patients, allowing preventative action to be taken before any serious damage occurs.  The tests of focus this week included cystatin C, adiponectin and microalbumin

Cystatin C

The creatinine test is routinely run for patients who are suspected for deteriorating kidney function, however this test has limitations.  Cystatin C is an alternative test, and is particularly useful in patients where creatinine measurements are not suitable e.g. individuals who are obese, malnourished, have liver cirrhosis or reduced muscle mass. Importantly, unlike creatinine, cystatin C does not have a ‘blind area’ – up to 50% of kidney function can be lost before significant creatinine elevation occurs. Cystatin C is extremely sensitive to very small changes in kidney function and is therefore capable of detecting early stage kidney dysfunction.  The cystatin C test therefore allows preventative measures to be taken much earlier and before significant kidney function decline.

Adiponectin

There is substantial evidence that excess visceral fat is the main driving force for almost all of the disorders associated with the metabolic syndrome, including CKD.1,2 The adiponectin test from Randox can accurately assess levels of abdominal visceral fat, independent of age, race or fitness level.3,4  Assessing adiponectin, and therefore visceral fat levels, can help assess risk of CKD, as well as a range of other illnesses such as pre-diabetes, CVD and various cancers.

 

Microalbumin

The microalbumin test detects very low levels of a blood protein called albumin, in urine. The detection of albumin in urine can be an indicator of kidney injury and can result in irreversible damage if left untreated. Low albumin concentrations in the urine are the earliest marker of kidney damage and therefore enable preventative measures to be taken.  Microalbumin testing can identify individuals with diabetic nephropathy approximately 5-10 years earlier than proteinuria tests helping reduce the frequency of end stage renal disease.

Both World Kidney Day and Randox are working towards improving healthcare worldwide. With continuous investment in R&D, Randox are helping with the risk assessment and earliest detection of renal function problems. By assessing one’s risk of kidney problems (with the adiponectin test), it can give patients (obese and other) the tools to prevent kidney problems further on down the line.  With early diagnosis (through the cystatin C and microalbumin tests) it will be possible to keep kidney problems from getting worse, therefore lowering the number of those diagnosed with CKD worldwide.

For health professionals

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

For more information, download our Diabetes Brochure or email reagents@randox.com.

References

  1. Hall JE, Henegar JR, Dwyer TM, et al. Is obesity a major cause of chronic renal disease?Adv Ren Replace Ther. 2004;11(1):41–54. [PubMed]
  2. Tchernof A, Després JP. Pathophysiology of human visceral obesity: an update.Physiol Rev. 2013;93(1):359–404. [PubMed]
  3. Matsuzawa, Y. The role of fat topology in the risk of disease.  Int J Obes.  2008;32:s83-s92.
  4. Frederiksen, L., Nielsen, T. L., Wraae, K., Hagen, C., Frystyk, J., Flyvbjerg, A., Brixen, K. and Andersen, M. Subcutaneous Rather than Visceral Adipose Tissue Is Associated with Adiponectin Levels and Insulin Resistance in Young Men.  JCEM, (2009) 94 (10): 4010-4015.

 

Further reading:


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