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

Related Products

Clinical Chemistry Calibrator

Clinical Chemistry Controls

Clinical Chemistry EQA

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H-FABP (Cardiac) Assay

H-FABP (Cardiac)

A Superior Marker of Acute Coronary Syndrome

Benefits of the Randox H-FABP (Cardiac) Assay

Superior Performance

Superior method

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

Excellent Correlation

Excellent correlation

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

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

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H-FABP Calibrator

H-FABP Controls

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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

Reagents Resource Hub


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