Key Benefits of the Randox Lipase Assay
The Randox lipase assay displayed a precision of <5% CV.
The Randox lipase assay displayed an exceptional correlation coefficient of r=1.00 when compared against other commercially available methods.
Fully automated protocols
Fully automated protocols are available for a variety of clinical chemistry analysers.
Further Benefits of the Randox Lipase Assay
Liquid ready-to-use format for convenience and ease-of-use.
Measuring range of 2.0 – 744U/l for the comfortable detection of abnormal levels.
Applications available detailing instrument-specific settings for the convenient use of the Randox lipase assay on a wide range of clinical chemistry analysers.
Instrument Specific Applications (ISA’s) are available for a wide range of biochemistry analysers. Contact us to enquire about your specific analyser.
About Lipase Testing
Elevated lipase concentrations 3-to-4-fold greater than the upper normal limit is indicative of pancreatitis, however, the degree of elevations does not correlate with the severity of the disease 2, 3.
In pancreatic dysfunction, lipase concentrations rise between 4 and 6 hours, peaking at 48 hours and returning to baseline within 8 to 14 days. It has a half-life of 6.7 to 13.7 hours in plasma. The half-life of amylase (another assay utilised in the diagnosis of pancreatic dysfunction) is less, however, lipase is filtered by the glomerulus and reabsorbed by the tubules which may contribute towards the longer half-life of lipase.
Lipase offers a few advantages over amylase including: a slightly better specificity, greater sensitivity for patients presenting late, due to the longer half-life, and greater sensitivity in alcoholic pancreatitis 4.
Furthermore, for prolonged longitudinal injuries, lipase activity tends to be more sensitive compared to amylase as lipase concentrations within the zymogen granules are approximately 4.5 times than those of amylase. Consequently, recurring injuries are more likely to be recognised due to the leakage of lipase into the bloodstream. Moreover, lipase concentrations are less affected by intestinal injury or renal dysfunction compared to amylase 2.
Derived from zymogen granules of pancreatic acinar cells, lipase is involved in the digestion of lipids for the subsequent absorption in the small intestine 1, 2. The pancreas is located in the anterior abdominal cavity adjacent to the liver, duodenum and stomach to allow the secretion of digestive enzymes into the small intestine, and to convert ingesta into absorbable lipids, carbohydrates and proteins. The exocrine pancreas provides a microenvironment for pancreatic islet cells. The pancreatic islet cells provide the embedded endocrine function of the pancreas which in turn enables the hepatic and peripheral tissues to modulate blood glucose levels and other functions 2.
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Diabetes Week is an annual week to raise awareness of diabetes. This year, the aim is to increase the public’s understanding of diabetes 1. Diabetes mellitus (DM) is a global epidemic, increasing at an alarming rate and burdening healthcare systems 2. DM is a life-long condition characterised by the body’s inability to produce / respond to insulin resulting in the abnormal metabolism of carbohydrates and elevated blood glucose levels.
Whilst it is important to increase the public’s understanding of DM, it is imperative that clinicians and physicians are aware of the different in vitro diagnostic tests to diagnose and monitor DM. Not only is this vital, but is also important that clinicians and physicians also understand the different methodologies available when choosing the diagnostic test.
It has been highlighted in numerous clinical studies that diabetic complications may be reduced through the long-term monitoring and tight control of blood glucose levels. Both fasting plasma glucose (FPG) and glycated haemoglobin A1c (HbA1c) tests are universally accepted as reliable measurements of diabetic control. However, studies have emerged highlighting the role of fructosamine in diabetes monitoring. Whilst HbA1c provides an index of glycaemia over 2 to 3 months, fructosamine provides this index over the course of 2 to 3 weeks, enabling closer monitoring of diabetic control 1.
Drawbacks of Traditional Diabetes Tests
The FPG test measures the level of blood sugars which is used to diagnose and monitor diabetes based on insulin function. The main drawback of this test is that a hormone called glucagon, produced in the pancreas, is triggered during prolonged fasting, signalling the liver to release glucose into the bloodstream. In diabetic conditions, either the body is unable to generate enough insulin or cannot appropriately respond to insulin. Consequently, FPG levels remain high 4.
In the 1980’s, HbA1c was incorporated into clinical practice as HbA1c levels correlated well with glycaemic control over a 2 to 3-month period. The main drawback of this test is that any condition that reduces the survival rate of erythrocytes such as haemolytic anaemia will falsely lower the HbA1c test results, regardless of the assay method utilised 5.
In a diabetic patient where blood glucose levels are abnormally elevated, the concentration levels of fructosamine also increase as fructosamine is formed by a non-enzymatic Maillard reaction between glucose and amino acid residues of proteins. During this glycation process, an intermediate labile Schiff base is produced which is converted to a more stable ketoamine (fructosamine) via an Amadori rearrangement 2.
Fructosamine has been identified as an early indicator of diabetic control compared to other markers such as HbA1c. Red blood cells live for approximately 120 days, HbA1c represents the average blood glucose levels for the previous 2 to 3 months. Conversely fructosamine has a shorter lifespan, about 14 to 21 days, reflecting average blood glucose levels from the previous 2 to 3 weeks. Due to the shorter time span of fructosamine, it is also used to evaluate the effectiveness of medication changes and to monitor the treatment of gestational diabetes. The test is also particularly useful in situations where HbA1c cannot be reliably measured e.g. haemolytic anaemia, thalassemia or with genetic haemoglobin variants 5.
Fructosamine Assay Methodology
The most commonly utilised method for fructosamine testing is the colorimetric method. Whilst widely available, automated and inexpensive, the main drawback is the lack of standardisation across the different fructosamine assays 4.
Randox, on the other hand, utilise an enzymatic method, offering improved specificity and reliability compared to conventional NBT-based methods. The Randox enzymatic method does not suffer from non-specific interferences unlike existing methods which can also be time consuming and difficult to automate.
The Randox fructosamine assay is also standardised to the highest level as the Randox fructosamine calibrator and control is assigned relative to human serum glycated with 14C-glucose, which directly reflects the nature of the patient sample.
With an excellent stability of 28 days on-board the analyser, the Randox fructosamine assay is developed in a liquid ready-to-use format for convenience and ease-of-use.
Randox offer fully automated applications detailing instrument-specific settings for the convenient use of the Randox fructosamine assay on a wide range of clinical chemistry analysers.
Want to know more?
Contact us or download our diabetes brochure
Reagents Resource Hub
 Diabetes UK. Diabetes Week. [Online] 2019. [Cited: May 31, 2019.] https://www.diabetes.org.uk/get_involved/diabetes-week.
 Gounden, Verena and Jialal, Ishwarlal. Fructosamine. [Online] January 23, 2019. [Cited: April 11, 2019.] https://www.ncbi.nlm.nih.gov/books/NBK470185/.
 World Health Organization (WHO). Diabetes. [Online] October 30, 2018. [Cited: May 2, 2019.] https://www.who.int/news-room/fact-sheets/detail/diabetes.
 Manzella, Debra. The Fasting Plasma Glucose Test. very well health. [Online] November 16, 2018. [Cited: April 11, 2019.] https://www.verywellhealth.com/understanding-the-fasting-plasma-glucose-test-1087680.
 BMJ. Using haemoglobin A1c to diagnose type 2 diabetes or to identify people at high risk of diabetes. [Online] 2014. [Cited: April 11, 2019.] https://www.bmj.com/content/348/bmj.g2867/rr/695927.