Superior Performance & Unique Tests
Superior Performance & Unique Tests – Innovating clinical diagnostics and enhancing laboratory testing!
In vitro diagnostics is the heart and soul of the healthcare system as healthcare professionals not only rely on diagnostic tests to diagnose and treat patients, but also to rule out the different contributing causes of a disease state. The implementation of superior performance & unique tests can aid in the early and accurate diagnosis of disease states, enabling the appropriate and effective implementation of a personalised treatment plan 1.
Benefits of the Randox Superior Performance & Unique Tests
Superior Performance Offering
Offering a range of assays with superior methodologies, delivering more accurate and specific results compared to traditional methods.
Offering a range of unique assays meaning that Randox are one of the only manufacturers to offer these tests in an automated biochemistry format.
Reduce time spent running tests with liquid ready-to-use formats, automated methods and our easy-fit options.
Creating cost-savings for your laboratory through excellent reagent stability; by eliminating costly re-runs, as a result of high quality of products and the availability of a range of kit sizes (including smaller kits for unique tests, reducing wastage).
Confidence in Patient Results
All our superior performance & unique diagnostic reagents are validated against gold-standard methods, offering low CV’s and excellent precision giving you the confidence that you are sending out accurate patient results.
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.
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.
Adiponectin has been identified as having pleiotropic functions widely associated with anti-atherogenic, anti-diabetic, cardioprotective and anti-inflammatory effects. Adiponectin levels inversely correlate with insulin levels, BMI, triglyceride levels, insulin resistance (IR), glucose, and most importantly, visceral fat accumulation.
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.
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.
Cardiovascular Disease (CVD)
CVD accounts for 45% of all deaths in europe and 37% of all deaths in the EU. Atherogenesis is a circulatory disease whereby atheromas are formed (plaque build-up) within the artery. Plaque is a combination of cholesterol, fat, calcium, lipids and other substances within the blood stream. As time progresses, the plaque hardens, narrowing the arteries. This is known as atherosclerosis. Consequently, blood flow through the narrowed artery is reduced, limiting the supply of blood to vital organs and bodily tissues. As atherogenesis can affect any artery within the body, different diseases may develop based on the artery that is affected. Such diseases include: coronary heart/artery disease, carotid artery disease, peripheral artery disease and chronic kidney disease 2, 3, 4.
Type 2 Diabetes Mellitus
425 million people are living with type 2 diabetes mellitus (T2DM) and 352 million are at risk of developing T2DM. T2DM is a serious condition whereby blood glucose levels are elevated (hyperglycaemia). T2DM is characterised by insulin resistance or insulin deficiency. T2DM is the most common form of diabetes, accounting for 90% of cases. The key to T2DM is control. Implementing lifestyle changes, oral medication and in more severe cases, insulin, a diabetic can take control of their disease, keeping glucose levels stable. When glucose levels are not monitored and controlled, associated complications may arise including: diabetic nephropathy, CVD and renal impairment 5, 6.
Chronic Kidney Disease (CKD)
Worldwide 1/5 of men and 1/4 of women between 65 and 74 years of age have Chronic kidney disease (CKD). CKD is an umbrella term encompassing a wide range of renal conditions from commonly prevalent sub-clinical, asymptomatic to rare end-stage renal disease requiring dialysis or a transplant to sustain life. Kidney disease is ranked in stages from stage 1 (very mild damage) through to stage 5 (kidney failure) 7. Symptoms are commonly expressed in the later stages of renal impairment, however, at this point dangerous levels of fluid, electrolytes and waste products can build up inside the body. The aim of CKD treatment is to slow the progression of the disease, thus early intervention is vital 8.
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 Williams DA. Increased funding is not enough to sustain the NHS. We need to make better use of in vitro diagnostics to ensure a successful future. https://www.bivda.org.uk/News-Events/Blog/ArticleID/155/Increased-funding-is-not-enough-to-sustain-the-NHS-We-need-to-make-better-use-of-in-vitro-diagnostics-to-ensure-a-successful-future (accessed 16 April 2019).
 National Heart, Lung, and Blood Institute (NIH). https://www.nhlbi.nih.gov/health-topics/atherosclerosis (accessed 16 April 2019).
 Diabetes UK. What is Type 2 diabetes? https://www.diabetes.org.uk/diabetes-the-basics/what-is-type-2-diabetes (accessed 16 April 2019).
 American Diabetes Association. Type 2 Diabetes. https://www.diabetes.org/diabetes/type-2 (accessed 16 April 2019).
Approximately 400,000 people in the UK are living with type 1 diabetes, with over 29,000 being children and young people . Type 1 diabetes affects 96% of all children with diabetes in England and Wales, with incidences increasing by approximately 4% each year.
Globally, the UK has the fifth highest rate of type 1 diabetes diagnosis in children (aged up to 14) with 85% of these children having no family history of the condition. Whilst the condition isn’t fatal and can be managed, it cannot be cured. Type 1 diabetes increases the risk of developing other health problems such as heart disease, stroke, foot and circulation problems, sight problems including blindness, nerve damage and kidney problems. However, many of these related conditions are preventable and it is recommended to stabilise blood sugar levels, attend diabetes appointments regularly and complete a diabetes course to educate patients and family members and prevent the risk of further help complications.
Diabetes in children
Children under five are at the highest risk of developing diabetic ketoacidosis due to a late diagnosis and it is also thought to be due to of lack of public knowledge of the signs and symptoms attributed to type 1 diabetes. Such symptoms include:
- Frequent urination as the kidneys are trying to expel excess sugar in the blood, resulting in dehydration which leads to extreme thirst.
- Increased hunger or unexpected weight loss because the body is unable to attain enough energy from food
- Slow healing cuts as high blood sugar levels can affect blood flow which can cause nerve damage.
- Fatigue as the body is unable to convert sugar into energy
- Irritable behaviour combined with other symptoms can be a means of concern
Diabetes and the NHS
Diabetes costs the NHS approximately £9.8 billion per year, an estimate of 10% of total expenditures. Hospital admissions of children and young people with diabetes presents a considerable burden on themselves, their families and the NHS. It is estimated that approximately 80% of these cases are potentially avoidable.
A report produced by the National Paediatric Diabetes Audit found that although the numbers of admissions didn’t significantly differ year to year, it highlighted differences in terms of socio-economic risk factors:
- Living in a deprived area increases the risk of hospital admissions which can be attributed to lack of education in the community about diabetic symptoms and the management of diabetes.
- Children below 5 years of age have a 35% increased risk of hospitalisation compared to those aged 5-9
- Females have a 33% increased risk of developing type 1 diabetes compared to males.
- Children with poor diabetes control have a twelve-fold increased risk of hospital admission
- Insulin pump users have a 27% increased risk of hospital admission compared to those who use insulin injections.
Figure A. Number of preventable paediatric diabetes admissions 
There are campaigns in place to aid in the early diagnosis of type 1 diabetes which mainly focus on raising awareness of the signs and symptoms of diabetes. On this World Diabetes Day, it is important to know that it is not just simply the responsibility of the diabetic patient to prevent admission but the main responsibility lies with the diabetic teams that inform the families with children who are diagnosed with type 1 diabetes.
Paediatric diabetes teams should ensure that the families and the children receive structured education for self-management when diagnosed and throughout the illness. In doing so, the diabetic teams should implement blood ketone testing from diagnosis and utilise the nationally agreed hypoglycaemia management guidelines. It is also important that diabetic teams are fully aware of the patient characteristics associated with a greater risk of admission and that they use this knowledge to develop anti-admission strategies specifically tailored to the needs of each individual group.
Primary care practitioners should seek access to a specialist diabetic team who they can refer to when deciding if a patient requires admission to hospital. Furthermore, they should access blood glucose and ketone testing to identify patients at risk of diabetic ketoacidosis that require hospital admission.
How Randox can Help
Randox offer a range of assays to diagnosis and monitor diabetes and to monitor associated complications. Some of these tests are unique to Randox, including:
The Randox fructosamine assay employs 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.
The Randox D-3-Hydroxybutyrate (Ranbut) assay detects the most abundant and sensitive ketone in the body, D-3-Hydroxybutyrate. The Randox Ranbut assay is used for the diagnosis of ketosis, more specifically diabetic ketoacidosis. Other commercially available tests, such as the nitroprusside method, are less sensitive as they only detect acetone and acetoacetate, not D-3-Hydroxybutyrate.
The Randox adiponectin assay is a biomarker in diabetes testing as adiponectin is a protein hormone responsible for regulating the metabolism of lipids and glucose and influences the body’s response to insulin. Adiponectin levels inversely correlates with abdominal visceral fat levels.
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Contact us or visit our Diabetes panel page to learn more.
 National Paediatric Diabetes Audit and Royal College of Paediatrics and Child Health, National Paediatric Diabetes Audit Report 2012-15: Part 2, 2017
 NHS, “Avoiding Complications” – Type 1 Diabetes, Available at: https://www.nhs.uk/conditions/type-1-diabetes/avoiding-complications/ [Accessed on 24th October 2018].
 “Potentially Preventable Pediatric Hospital Inpatient Stays for Asthma and Diabetes, 2003-2012”, www.hcup-us.ahrq.gov, 2015. [Online] Available: https://www.hcup-us.ahrq.gov/reports/statbriefs/sb192-Pediatric-Preventable-Hospitalizations-Asthma-Diabetes.jsp [Accessed 08-Nov-18]
Diet trends have continued to evolve throughout the years with a strong influence from celebrities. Beginning in the 1930s the grapefruit diet aka the “Hollywood diet” started which encouraged eating a grapefruit with every meal. More recently an increasing amount of extreme diet trends have emerged. In 2004, Beyoncé started the master cleanse involving a concoction of hot water, lemon juice, maple syrup and cayenne pepper and even crazier was Reese Witherspoon’s “baby food diet”. The newest trend to materialise is the keto diet favoured by celebrities including Halle Berry and the Kardashians. However, the results for long term weight loss and the safety of the diet is still questioned.
What is the ketogenic diet?
The ketogenic diet is a low carb diet which involves drastically reducing carbohydrate intake and replacing it with fat. Initially, the purpose of the ketogenic diet was not to aid weight loss but was prescribed to aid in the treatment of tough-to-control epileptic seizures that were unresponsive to drugs. In the 1920s the diet was found to significantly reduce the frequency of seizures in children. However, the benefits for weight loss have also been realised as the carbohydrate reduction kicks the body into a natural fat burning state called ketosis. By starving the body of carbohydrates and sugars, the first fuel the body burns, the body looks for another source of fuel to retrieve its energy. The body becomes efficient at burning fat for energy whilst also turning fat into ketones in the liver which can supply the brain with energy.
The metabolism of fatty acids in the liver results in the production of ketone bodies. These comprise of three chemicals consisting of acetone (2%), acetoacetate (20%) and D-3-Hydroxybutyrate (78%) and this production is called ketogenesis. The ketone bodies are produced by the chemical acetyl-CoA predominantly in the mitochondrial matrix of liver cells. This process is necessary in small amounts particularly when carbohydrates are scarce, and glucose is not available as a fuel source.
The ketone bodies are water soluble allowing for the transportation across the inner mitochondrial membrane as well as across the blood brain barrier and cell membranes. This allows them to source the brain, heart and muscle with fuel. Interestingly, during starvation they are the major energy source for the brain, providing up to 75%.
The excess production of ketones can accumulate in the body creating a state of ketosis. This stage, although abnormal, is not considered harmful, which is why it is being promoted as a diet craze. However, due to the acidic nature of the ketone bodies, particularly D-3-Hydroxybutyrate, larger amounts of ketone bodies can cause the pH levels in the body to drop to dangerously acidic levels creating a state of ketoacidosis.
The benefits of the keto diet have been well advertised and received a lot of celebrity support. With powerful celebrities such as Halle berry ‘swearing by it’ as it allows her to manage her diabetes, it is easy to see why so many are keen to try it. However, with little to no information about the long-term effects, should we be finding out more before trying it ourselves?
In 2006, a study was conducted reviewing the influence of a low-carbohydrate diet can have on ketoacidosis. In this study the patient who had no history of diabetes was placed on a strict low carbohydrate diet for four years. Although the patient showed a significant decrease in weight on the diet, they also experienced four episodes of ketoacidosis. Each time an episode occurred the patient was administered intravenous fluids and insulin which lead to their recovery, however each time they returned to the diet it wasn’t long before another ketoacidosis episode occurred. When the patient was placed on a diet containing normal amounts of carbohydrates their glucose levels returned to normal, preventing a ketoacidosis episode from occurring again. The more ketones in the blood, the more ill a person with ketoacidosis will become. Left untreated ketoacidosis can cause potentially fatal complications such as severe dehydration, coma and swelling of the brain.
Randox D-3-Hydroxybutyrate (Ranbut) Reagent
Randox Reagents offer a D-3-Hydrobutyrate assay designed to measure the major ketone lvels in the body, D-3-Hydroxybutyrate, allowing for an efficient diagnosis to be implemented. The superior methodology provides more accurate, reliable and specific results compared to the traditional dipstick method of ketone body measurement.
The benefits of the Randox D-3-Hydroxybutyrate (Ranbut) assay include:
- Excellent precision of less than 3.5% CV
- Exceptional correlation coefficient of r=0.9954 when compared against other commercially available methods.
- A wide measuring range of 0.100 – 5.75mmol/l, comfortably detecting levels outside of the healthy range, 0.4 – 0.5mmol/l.
- Enzymatic method for accurate and reliable results
- Reconstituted stability of 7 days when stored between +2 to +8⁰C
- Ketoacidosis during a low-carbohydrate diet. Shah, Panjak and Isley, William. s.l. : The new england journal of medicine, 2006, Vol. 354.