November focus: Drugs of Abuse
November focus: Drugs of Abuse
Throughout November, the Randox clinical teams – Randox Reagents, Randox Rx series and Randox QC – will be highlighting how the Randox product range can be utilised to allow for the most accurate analysis of Drugs of Abuse, with a particular focus placed with the Evidence MultiSTAT. The Evidence MultiSTAT is a fast, fully automated and versatile immunoanalyser that enables on-site detection of up to 21 Drugs of Abuse from a single sample of oral fluid, urine or blood.
Drugs of Abuse are a growing problem worldwide and represent a significant burden to healthcare systems as well as creating problems in an individual’s lifestyle. It has been estimated by the WHO (World Health Organisation) that 31 million people globally suffer from drug use disorders and 3.3 million deaths each year are linked to the abuse of both drugs and alcohol.
Randox have reacted to this growing concern and are now a world leader in the Drugs of Abuse testing field. Our product range currently comprises classical, prescription and synthetic drugs.
The Evidence MultiSTAT offers a simple drug screening solution to those who have little or no knowledge of laboratory procedures. As an extremely versatile desktop analyser, it is ideally suited to a variety of settings including both the clinical laboratory and the emergency room.
Randox Reagents – Drugs of Abuse Assays
In order to assist in dealing with the ongoing burden of substance abuse, Randox Reagents offer a comprehensive range of ten assays to test for some of the top most commonly-abused substances including alcohol, methamphetamines, cocaine, methadone, cannabis, benzodiazepines, barbiturates, EDDP and ecstasy and opiates. The Randox Drugs of Abuse assays are liquid, ready-to-use for increased efficiency and applications are available for over 30 different analysers.
RX Series – Toxicology testing
Renowned for quality and reliability, the RX series range of clinical chemistry analysers boasts a world-leading test menu comprising of both therapeutic drugs and Drugs of Abuse. Our toxicology range comprises amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolite, ecstasy, EDDP, ethanol, methadone and opiates. The RX series range of clinical chemistry analysers ensures a high degree of accuracy with a wide range of testing throughputs to suit all laboratories, big or small.
RIQAS Urine Toxicology Programme
Designed to monitor the performance of 20 Drugs of Abuse tests in urine, our RIQAS urine toxicology EQA program is suitable for both qualitative and quantitative methods of analysis. As the largest EQA scheme in the world, access to large peer groups is guaranteed. Additional benefits include; monthly analysis, user-friendly reports allowing at-a-glance performance assessment, ability to register up to five instruments per programme and cost savings via our unrivalled consolidation.
For more information about Randox RX, Randox Reagents or Randox QC, please email marketing@randox.com.
Iron Deficiency Anaemia during Pregnancy
On a global scale, 1.62 billion people are affected by anaemia which is equivalent to 24.8% of the population ₁. According to a review carried out by WHO of various national surveys, anaemia affects approximately 42% of pregnant women worldwide and it is also estimated that at least 50% of all anaemia cases are due to iron deficiency.
Anaemia caused by iron deficiency is usually expected during pregnancy. This is due to several reasons: the increased demand for iron by a pregnant woman’s body from increased total blood cell volume, requirements of the foetus and placenta as well as mass blood loss during labour₂. Although iron cost is unbalanced by the lack of loss of menstrual blood during pregnancy, the net cost is still high enough that iron recommendations are higher than in non-pregnant women. Also, iron is critical during pregnancy considering its involvement in foetal growth: 600-800mg of iron is required during pregnancy with around 300mg needed just for the foetus, a minimum of 25mg for the placenta and almost 500mg due to the increase in volume of red blood cells. ₃
Iron deficiency is the most common micronutrient deficiency in pregnant women leading to iron deficiency anaemia if left untreated. However, iron deficiency can be difficult to measure in some populations due to the lack of availability of field-specific biomarkers. For example, anaemia can affect up to 56% of pregnant women in developing countries, which suggests a high prevalence of iron deficiency anaemia: around 25%. In settings with endemic malaria, such as certain countries in Africa, the number of pregnant women with anaemia is much higher: around 65%.
There are various factors that may increase the risks of iron deficiency anaemia. For example, a diet influenced by religious beliefs can cause a lack of iron in the diet, such as vegetarianism which is common in countries such as India where religious beliefs dictate this. Iron levels can also be affected by consumption of nutrients which inhibit proper absorption of iron, such as calcium or ones that promote iron absorption, such as vitamin C. Other circumstantial risks include infections, multiple pregnancies and adolescent pregnancy while socioeconomic factors and access to healthcare mean some women won’t have access to anaemia control programs, iron supplements or even access to information about iron deficiency anaemia during pregnancy.
To prevent iron deficiency, international guidelines state that iron supplementation to manage iron deficiency is recommended during pregnancy. ₄ However, this is not always available, especially in developing countries.
Iron deficiency anaemia during pregnancy can cause several complications for the mother including:
- Increased fatigue
- Short-term memory loss
- Decreased attention span
- Increased pressure on the cardiovascular system due to insufficient haemoglobin and blood oxygen levels
- Lower resistance to infections
- Reduced tolerance to significant blood loss and surgical implications during labour.
As expected, neonates with mothers who suffered from iron deficiency anaemia during pregnancy will also be confronted with risks and, even if iron deficiency is only mild to moderate, can result in a premature birth, complications with foetal brain development, low birth weight and even foetal death. Additionally, it has been proven that cognitive and behavioural abnormalities can be seen in children for up to ten years after iron insufficiency in the womb.
Randox Soluble Transferrin Receptor (sTfR) Reagent
Randox Reagents offer a Soluble Transferrin Receptor assay to expand upon our current iron testing offering.
In iron deficiency anaemia, soluble transferrin receptor levels are significantly increased, however, remain normal in acute phase conditions including: chronic diseases and inflammation. As such, sTfR measurements are useful in the differential diagnosis of anaemia: anaemia of chronic disease or iron deficiency anaemia.
In iron deficiency anaemia, increased sTfR levels have also been observed in haemolytic anaemia, sickle cell anaemia and B12 deficiency.
The benefits of the Randox Soluble Transferrin Receptor (sTfR) Reagent include:
- Latex enhanced immunoturbidimetric method facilitating testing on biochemistry analysers and eliminating the need for dedicated equipment.
- Liquid ready-to-use reagents for convenience and ease-of-use
- Stable to expiry date when stored at +2 to +8 °C
- Excellent measuring range of 0.5 – 11.77mg/L, comfortably detecting levels outside of the normal health range of 0.65 – 1.88mg/L
- Excellent correlation coefficient of r=0.977 when compared against other commercially available methods
- Applications available detailing instrument-specific settings for a wide range of clinical chemistry analysers
Find out more at: https://www.randox.com/stfr/
References:
- de Benoist B et al., eds.Worldwide prevalence of anaemia 1993-2005. WHO Global Database on Anaemia Geneva, World Health Organization, 2008.
- Harvey et al, Assessment of Iron Deficiency and Anemia in Pregnant Women: An Observational French Study, Women’s Health, Vol 12 Issue 1, 2016
- Burke et al, Identification, Prevention and Treatment of Iron Deficiency during the First 1000 Days, Nutrients, Vol 6 Issue 10, 2014
- Guideline: Daily Iron and Folic Acid Supplementation in Pregnant Women. World Health Organization; Geneva, Switzerland: 2012
If you are a clinician or laboratory who are interested in running assays to test iron status, Randox offer a range of assays, including: Iron, Total Iron-Binding Capacity (TIBC), Transferrin and Ferritin . These assays can be run on most automated biochemistry analysers.
Instrument Specific Applications (ISA’s) are available for a wide range of biochemistry analysers. Contact us to enquire about your specific analyser.
For more information, visit: https://www.randox.com/stfr / or email: reagents@randox.com
The Keto Diet: Are the risks worth the benefits?
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.
Ketosis
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.
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
References
- Ketoacidosis during a low-carbohydrate diet. Shah, Panjak and Isley, William. s.l. : The new england journal of medicine, 2006, Vol. 354.
Instrument Specific Applications (ISA’s) are available for a wide range of biochemistry analysers. Contact us to enquire about your specific analyser.
For more information, visit: https://www.randox.com/homocysteine or email: reagents@randox.com
The Correlation Between Liver Cirrhosis and Lactic Acidosis
Lactic acid is an organic compound which produces the conjugate base lactate through a dissociation reaction. Due to it being a chiral compound, two optical isomers of lactate exist; D-Lactate and L-Lactate. The lactate dehydrogenase (LDH) enzyme can produce and metabolise both isomer forms to pyruvate, however due to the isomer-specific nature of LDH different forms of the enzyme are required. D-Lactate requires a D-LDH form whereas L-Lactate requires L-LDH. As a result of this requirement, combined with the fact that mammalian cells only contain L-LDH, the lactate produced in humans is almost exclusively L-Lactate.
One of the roles of L-Lactate is its involvement in the Cori Cycle, a metabolic pathway involved in the production of glucose. The cycle involves the rotatory transportation of lactate and glucose from the liver and the muscle. Lactate is produced in the muscle through glycolysis which is then transported to the liver through the blood stream. In the liver, the lactate is oxidised to pyruvate and then converted to glucose by gluconeogenesis, which is then transported back to the muscle for the process to start again. 1500 mmol of lactate is produced daily by the body and is cleared at a constant rate via the liver.
Problems can arise if the liver fails to regulate the lactate produced. Hyperlactamia is the name given to elevated levels of lactate in the body, as a result of the rate of production exceeding the rate of disposal. This is due to a lack of oxygen that reduces blood flow to the tissues. If levels continue to rise a patient is at risk of lactic acidosis.
The liver is an important tissue in the regulation of lactate, it is therefore no surprise that liver damage can prevent this process resulting in a further diagnosis of lactic acidosis. A healthy liver is a vital part of lactate regulation as it acts as the main consumer of lactate and contributes to 30-40% of lactate metabolism. Potential victims are patients who suffer with cirrhosis, a complication of liver disease, which is commonly caused by alcohol abuse and viral Hepatitis B and C.
Patients with liver cirrhosis have a higher risk of increased lactate levels. Increased levels of the lactate ions disturbs the acid-base equilibrium, causing a tilt towards lactic acidosis. The mortality rate of patients who develop lactic acidosis is high, prompt recognition and treatment of the underlying cause remain the only realistic hope for improving survival.
The Randox L-Lactate reagent allows for a prompt and accurate diagnosis of lactic acidosis.
Randox L-Lactate Reagent
The Randox L-Lactate key benefits include:
- Excellent working reagent stability of two weeks when stored at + 15 – +25°C
- Exceptional correlation of r = 0.99 when compared against other commercially available methods
- A wide measuring range of 0.100 – 19.7 mmol/l and so is capable of detecting abnormal levels in a sample
Other features:
- Colorimetric method
- Lyophilised reagents for enhanced stability
If you are a clinician or laboratory who are interested in running assays for Lactic Acidosis or Liver Disease, Randox offer a range of high-quality routine and niche assays including:L- Lactate, Ethanol, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Albumin which can be used to diagnose conditions commonly affecting the liver. These assays can be run on most automated biochemistry analysers.
Instrument Specific Applications (ISA’s) are available for a wide range of biochemistry analysers. Contact us to enquire about your specific analyser.
For more information, visit: https://www.randox.com/lactate/ or email: reagents@randox.com
Securing the future with in vitro diagnostic tests
The aim of Biomedical Science Day is to raise the public’s awareness of the importance of biomedical science and the vital role it plays in the world. Randox are dedicated to improving healthcare worldwide through placing a major focus on research and development. The Randox scientists work in pioneering research into a range of common illnesses such as cancer, cardiovascular disease and Alzheimer’s disease.
A recent blog from Doris-Ann Williams, the Chief Executive at BIVDA, explains how “increased funding is not enough to sustain the NHS” and how “we need to make better use of in vitro diagnostics to ensure a successful future”.
The National Health Service (NHS) is a publicly funded, primarily taxation, national healthcare system in the United Kingdom. It was first set-up on July 5th, 1948 by Aneurin Bevan as he believed that everyone, regardless of wealth, should have access to good healthcare. Whilst the NHS is an extremely important aspect of healthcare in the UK, in vitro diagnostics are the heart and soul of the healthcare system as healthcare professionals not only rely on blood tests to diagnose and treat patients, but also to rule out the different contributing causes to a disease state. In vitro diagnostics also plays a key role in monitoring chronic disease states. In vitro diagnostics can also aid in reducing hospital stays, reduce misdiagnosis and support patients in looking after their own health and to deliver personalised treatment plans.
The Randox scientists have developed several niche assays to improve patient diagnosis, monitor treatment and eliminate misdiagnosis.
Adiponectin
Adiponectin is a protein hormone secreted by adipocytes with anti-inflammatory and insulin-sensitising properties. It plays an important role in a number of metabolic processes including glucose regulation and fatty acid oxidation. Adiponectin levels are inversely correlated with abdominal visceral fat which have proven to be a strong predictor of several pathologies, including: metabolic syndrome, type 2 diabetes mellitus (T2DM), cancers and cardiovascular disease (CVD). For more information on the importance of testing Adiponectin levels, check out our Adiponectin Whitepaper.
Cystatin C
Cystatin C is an early risk marker for renal impairment. The most commonly run test for renal impairment is Creatinine. Creatinine measurements have proven to be inadequate as certain factors must be taken into consideration, including age, gender, ethnicity etc. The National Institute for Health and Care Excellence (NICE) have updated their guidelines, which now recommends Cystatin C as a more superior test for renal impairment due to its higher specificity for significant disease outcomes than those based on Creatinine. For more information on the importance of testing Cystatin C levels, check out our Cystatin C Whitepaper.
Small-dense LDL Cholesterol (sdLDL-C)
LDL Cholesterol (LDL-C) consists of two parts: the large and buoyant LDL Cholesterol and the small and dense LDL Cholesterol. Whilst all LDL-C transports triglycerides and cholesterol to bodily tissues, their atherogensis varies according to their size. As sdLDL-C is small and dense, they can more readily permeate the arterial wall and are more susceptible to oxidation. Research indicates that individuals with a predominance of sdLDL-C have a 3-fold increased risk of myocardial infarction. It has been noted that sdLDL-C carries less Cholesterol than large LDL, therefore a patient with predominately sdLDL-C particle may require nearly 70% more sdLDL-C particles to carry the same amount of cholesterol as the patient with predominately LDL-C particles. For more information on the importance of testing sdLDL-C levels, check out our sdLDL-C Whitepaper.
These three niche in vitro diagnostics tests developed by Randox scientists can aid in reducing NHS costs due to their higher performance compared to the traditional tests. Randox are constantly striving to improve healthcare worldwide.
For more information on the extensive range of Randox third-party in vitro diagnostic reagents, visit: https://www.randox.com/diagnostic-reagents/ or contact reagents@randox.com.
Homocysteine & Womenās Health
Homocysteine is a thio-containing amino acid produced by the intracellular demethylation of methionine. Elevated levels of homocysteine (hyperhomocysteinemia) is more common in women than in men and is associated with a wide array of illnesses. It has also been proven to cause several problems in women including: cardiovascular disease (CVD), colon cancer, pregnancy complications, and birth defects.
Cardiovascular Disease
Elevated levels of circulating homocysteine correlates with an increased risk of vascular occlusion (blockage of a blood vessel). Hyperhomocysteinemia can cause inflammation of the endothelium (thin layer of cells linking the interior blood vessels). Failure to lower homocysteine levels can cause further inflammation of the arteries, veins, and capillaries causing atherosclerosis. Consequently, blood and oxygen supply to tissues is reduced, increasing the risk of cardiovascular disease. Elevated levels correlates with higher diastolic and systolic blood pressure, hypertension. However, this correlation is stronger in women than in men. Women with elevated levels of homocysteine have a 3-fold increased risk of CVD, whereas men have a 2-fold increased risk.
Colon Cancer
Women with hyperhomocysteinemia have an increased risk of colorectal cancer than women with lower levels. Women who present with the highest levels of homocysteine have more than a 70% increased colorectal cancer risk. A correlation between reduced levels of folate and increased levels of homocysteine have been found in women with colorectal adenoma. It is recommended that women with hyperhomocysteinemia and reduced levels of folate should increase their intake of fruit and vegetables to reduce their levels of homocysteine and increase their levels of folate.
Pregnancy Complications and Birth Defects
Homocysteine levels should decline during pregnancy, however, in some cases, levels increase. Hyperhomocysteinemia is associated with foetal neural tube defects which causes various conditions, characterised by placental vasculopathy, including pre-eclampsia, abruption, and recurrent pregnancy loss. It has been identified that folate supplementation can half the risk of foetal neural tube defects. One study found that hyperhomocysteinemia was associated with a 2-fold to 3-fold increased risk for pregnancy-induced hypertension, abrupyio placentae, and intrauterine growth restriction.
Randox Homocysteine Reagent
The Randox Homocysteine assay offers a few unique features:
- Limited interference from Bilirubin, Haemoglobin, Triglycerides, and Intralipid, producing more accurate and precise results.
- Two-reagent format for convenience and ease of use
- Calibrator provided with kit, simplifying the ordering process
Other features include:
- Liquid ready-to-use reagents – for optimum user experience
- Excellent linearity – 47. 9 μmol/L, ensuring abnormally high levels of homocysteine are detected.
- Enzymatic method
- Tri-level cardiac control available
If you are a clinician or laboratory who are interested in running assays for women’s health, Randox offer a range of high-quality routine and niche assays including: Adiponectin, Cystatin C, Lipoprotein (a), and Zinc which can be used to diagnose conditions commonly affecting women. These assays can be run on most automated biochemistry analysers.
Instrument Specific Applications (ISA’s) are available for a wide range of biochemistry analysers. Contact us to enquire about your specific analyser.
For more information, visit: https://www.randox.com/homocysteine or email: reagents@randox.com
Rheumatoid Arthritis and Women’s Health
Rheumatoid Arthritis (RA) is a chronic autoimmune disease characterised by pain, swelling and stiffness in joints which commonly affects the hands, wrists and feet. Whilst both men and women can suffer from rheumatoid arthritis, it is more commonly seen in women than men.
Rheumatoid arthritis is the most common autoimmune disease with a higher prevalence rate compared to lupus, multiple sclerosis, type 1 diabetes, Crohn’s disease and psoriasis.
(Simmons, 2013)
The incidence rates of rheumatoid arthritis differ between men and women. The onset of RA occurs much earlier for women, for most, during their 30’s and 40’s. In an American study, it was noted that the incidence rates peak for women around the ages of 55 to 64, compared to 75 to 84 years of age for men.
(Simmons, 2013)
As most women are diagnosed with rheumatoid arthritis in their 30’s and 40’s, a study found that the diagnosis negatively impacts both the body and mind of women, as indicated in their pain, disease activity, and quality of life scores. This is due to women being diagnosed at a time when their burdens are the heaviest as this is the time when women are most likely to have children or are raising children combined with work and socialising.
Changes in hormone levels also impacts women. It has been noted that before a menstrual period, women find the symptoms of rheumatoid arthritis to be more severe, but settles during their cycle. Also, due to the changes in hormone levels during pregnancy, 50 – 60% of women with rheumatoid arthritis noticed that their symptoms improved.
The key to managing rheumatoid arthritis is to start the treatment as early as possible as it can halt or slow the disease, preventing joint damage and complications, including: osteoporosis and cardiovascular disease. Rheumatoid arthritis increases the risk of heart attack by 60%. To start treatment as early as possible, it is important that it is diagnosed as early as possible.
Randox offer a number of key assays for the diagnosis of rheumatoid arthritis.
Rheumatoid factor is the most routinely run test to diagnose rheumatoid arthritis as 80% of rheumatoid arthritis patients test positive for rheumatoid factor. The Randox Rheumatoid Factor reagent offers the following benefits:
- Wide measuring range of 6.72 – 104lU/ml for the accurate measurement of clinically important results
- Accurate assessment of rheumatoid factor titre (calibrant standardised against primary WHO material; 1st British Standard 64/2)
- No interference from complement C1q
- Automated immunoturbidimetric assay
- Applications available for a wide range of biochemistry analysers, detailing instrument-specific settings
It has been found that complement C4 and CRP upregulation indicates the middle to late stages of rheumatoid arthritis.
The Randox Complement C4 reagent offers the following benefits:
- Wide measuring of 3.41 – 152mg/dl for the accurate measurement of clinically significant results
- Limited interferences from Bilirubin, Haemoglobin, Intralipids, and Triglycerides, producing more accurate results
- Automated immunoturbidimetric assay
- Applications available for a wide range of biochemistry analysers, detailing instrument-specific settings
The Randox High-Sensitivity CRP reagent offers the following benefits:
- Wide measuring of 0.477 – 10mg/l fir the accurate measurement of clinically significant results
- Liquid ready-to-use reagents for convenience and ease of use
- Applications available for a wide range of biochemistry analysers, detailing instrument-specific settings
Lp(a): For the Accurate Detection of CVD Risk
Lp(a) is an independent risk factor for cardiovascular disease (CVD), even when classical risk factors such as hypertension, elevated cholesterol, and diabetes have been taken into consideration. High levels of Lp(a) is a heredity condition, associated with complex mechanisms involving the proatherogenic and prothrombotic pathways (1).
Traditional CVD testing panel
According to the World Health Organisation (WHO), CVD is the leading cause of death globally, accounting for 31 percent of deaths, totalling 17.7 million deaths per year. 80 percent of all CVD deaths are attributed to heart attacks and strokes, equivalent to 1 in 4. Identifying those who are at a high risk of developing CVD and ensuring that they are receiving the appropriate treatment can prevent premature deaths (2).
The lipid profile is frequently used to assess an individual’s risk of CVD developing later in life. Routine tests to assess CVD risk include: triglycerides, high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C). LDL-C has been found to strongly correlate with CVD risk (3). NICE recommend measuring total cholesterol, HDL cholesterol, non-HDL cholesterol and triglycerides as the full lipid profile and then review other risk factors, including: age, diet, smoking, QRISK, co-morbidities to view risk and the management of risk (4). However, the current lipid panel needs to be adjusted to ensure that its utilisation is effective in meeting clinician and patient needs.
Lipoprotein(a)
Lipoprotein (a) or Lp(a) consists of two protein molecules, apolipoprotein (a) or apo(a) is covalently linked by a disulphide bond to the apolipoprotein B-100 or apoB-100 of a cholesterol-rich low-density lipoprotein or LDL like particle. Lp(a) is synthesised in the liver and is detectable in the bloodstream (5).
The structure of Lp(a) resembles that of the proteins involved in the breakdown of blood clots, plasminogen and tissue plasminogen activator (TPA). As a result, the biggest concern with Lp(a) is that it prohibits the ability of these proteins to break down blood clots by competing for the ‘binding to fibrin’, boosting the blood’s clotting ability within arteries, thus heightening the risk of heart attacks and strokes. Consequently, high levels of Lp(a) is characterised by atherosclerosis including coronary heart disease, peripheral vascular disease, aortic stenosis, thrombosis and stroke (6).
The Journal of the American Medical Association reviewed 36 studies in 2009 which assessed ‘the role of Lp(a) and vascular disease’ in 126,634 individuals. The study found that a 3.5-fold increase in Lp(a) levels was accompanied with a 13 percent higher risk of coronary heart events and a 10 percent higher risk of stroke (7).
Later, an Italian population study carried out on 826 individuals in 2014 found that elevated levels of Lp(a) is due to two different variations of the apo(a) gene which is determined by the kringle sequence differences at the apo(a) locus. The study found that individuals with one variation had a 50 percent greater risk of CVD, while individuals with both variations had 2.5 times greater risk (7).
According to the Lipoprotein Foundation (2015), based on genetic factors, from birth, one in five or 20% of individuals have high Lp(a) levels greater than 50mg/dL, with most blissfully unaware they have it. Overtime, high levels of Lp(a) gradually narrow the arteries, limiting blood supply to the brain, heart, kidneys and legs, increasing the risk of heart attacks and strokes (5).
Testing for high Lp(a) levels
The Lipoprotein (a) Foundation (2015) recommends that Lp(a) levels should be tested if:
- There is a family history of cardiovascular disease including stroke, heart attack, circulation problems in the legs and/or narrowing of the aorta, at a young age
- Stroke or heart attack if classical risk factors including high LDL-cholesterol, obesity, diabetes and smoking have been eliminated
- High levels of LDL-cholesterol following treatment with statins or other LDL lowering medications(5)
When selecting a Lp(a) assay, the Internal Federation of Clinical Chemistry (IFCC) (2004) Working Group on Lp(a) recommends that laboratories use assays that do not suffer from apo(a) size-related bias to minimise the potential risk of misclassification of patients for coronary heart disease (8).
The Lp(a) Foundation reference Marcovina and Albers (2016) in their recommendations for the best Lp(a) test. The study came to the following conclusions:
- Robust assays based on the Denka method, reportable in nanomoles per litre (nmol/L) are traceable to WHO/IFCC reference material
- Five-point calibrators with accuracy-based assigned target values will minimise the sensitivity of to the size of apo(a)
- Upon request, manufacturers should provide the certificate of evaluation of the calibrator and reagent lots with the relative expiration dates (9)
Benefits of the Randox Lp(a) assay
The Randox Lp(a) assay is one of the only methodologies on the market that detects the non-variable part of the Lp(a) molecule and so suffers minimal size related bias providing more accurate and consistent results. This methodology allows for the detection of Lp(a) in serum and plasma. The Randox Lp(a) kit is standardized to the WHO/IFCC reference material, SRM 2B, and is the closest in terms of agreement to the ELISA reference method.
A five-point calibrator is provided with accuracy-based assigned target values which accurately reflects the heterogeneity of isoforms present in the general population.
Liquid ready-to-use reagents are more convenient as the reagent does not need to be reconstituted, reducing the risk of errors.
Applications are available for a wide range of biochemistry analysers which details instrument-specific settings for the convenient use of the Randox Lp(a) assay on a variety of systems. Measuring units in nmol/L are available upon request.
References
- Li, Yonghong, et al. Genetic Variants in the Apolipoprotein(a) Gene and Coronary Heart Disease. Circulation: Genomic and Precision Medicine. [Online] October 2011. [Cited: April 24, 2018.] http://circgenetics.ahajournals.org/content/4/5/565.
- World Health Organisation. Cardiovascular Disease. [Online] 2017. [Cited: April 30, 2018.] http://www.who.int/cardiovascular_diseases/en/.
- Doc’s Opinion. Lipoprotein (a). [Online] 2013. [Cited: April 30, 2018.] https://www.docsopinion.com/health-and-nutrition/lipids/lipoprotein-a/.
- National Institutional for Health and Care Excellence. Cardiovascular disease: risk assessment and reduction, including lipid modification. [Online] July 2014. [Cited: April 30, 2018.] https://www.nice.org.uk/guidance/cg181/chapter/1-recommendations#lipid-modification-therapy-for-the-primary-and-secondary-prevention-of-cvd-2.
- Lipoprotein(a) Foundation. Understand Inherited Lipoprotein(a). [Online] 2015. [Cited: April 24, 2018.] http://www.lipoproteinafoundation.org/?page=UnderstandLpa.
- Heart UK. Lipoprotein (a). [Online] June 23, 2014. [Cited: April 24, 2018.] https://heartuk.org.uk/files/uploads/huk_fs_mfss_lipoprotein_02.pdf.
- Ashley, Robert. High lipoprotein(a) levels may indicate heart disease in some. The Brunswick News. [Online] March 05, 2018. [Cited: April 24, 2018.] https://thebrunswicknews.com/opinion/advice_columns/high-lipoprotein-a-levels-may-indicate-heart-disease-in-some/article_16ab1049-7a6f-5da0-8966-59e94ae31b6d.html.
- Dati, F; Tate, J R; Marcovina, S M; Steinmetz, A; International Federation of Clinical Chemistry and Laboratory Medicine; IFCC Working Group for Lipoprotein(a) Assay Standardization. First WHO/IFCC International Reference Reagent for Lipoprotein(a) for Immunoassay–Lp(a) SRM 2B. NCBI. [Online] 2004. [Cited: April 30, 2018.] https://www.ncbi.nlm.nih.gov/pubmed/15259385.
- Tsimikas, Sotirios. A Test in Context: Lipoprotein(a) – Diagnosis, Prognosis, Controversies, and Emergining Therapies. 6, s.l. : Elsevier, 2017, Vol. 69. 0735-1097.
If you are a cardiologist or a laboratory who are interested in running cardiology and lipid assays, Randox offer a wide range of high-quality, routine and niche assays including: adiponectin, H-FABP, sLDL, TxBCardio, HDL2/3-C, Homocysteine, Apo C-II, Apo C-III and Apo E. These can be run on most automated biochemistry analysers.
Instrument Specific Applications (ISA’s) are available for a wide range of biochemistry analysers.
For more information, visit: https://www.randox.com/lipoprotein-a or email: reagents@randox.com
Metabolism: how Randox is helping to diagnose metabolic conditions
Many people talk about their metabolism as if it is a muscle or organ they can somehow control. In reality, your metabolism refers to a series of chemical processes in each cell that turn the calories you eat into fuel to keep you alive.
Metabolism is the biochemical process of combining nutrients with oxygen to release the energy our bodies need to function. Your resting metabolic rate (RMR) is the number of calories your body burns to maintain vital body functions such as heart rate, brain function and breathing. RMR accounts for up to 75 percent of the calories you burn each day. Knowledge of your individual RMR is a critical piece of information to appropriately establish daily calorie needs.
The body’s major organs — the brain, liver, kidneys, and heart — account for about half of the energy burned at rest, while fat, the digestive system, and especially the body’s muscles account for the rest.
Did you know?
Approximately 20-25% of the world’s adult population have metabolic syndrome?
A common misconception surrounding metabolic health is that it refers solely to your weight, and if you are overweight you are considered to be unhealthy. But in actual fact this may not be entirely true. Good metabolism means that your body is in good overall health, which doesn’t account for just your weight! Common metabolic disorders include genetic metabolic disorders, diabetes and metabolic syndrome. Understanding and testing to see how well your metabolism is functioning is key to ensuring long lasting health.
Genetics
There are a number of genetic metabolic disorders caused by mutations of single genes. Examples of common disordersinclude Gaucher’s disease, hemochromatosis and cystic fibrosis. Gaucher’s disease is a genetic disorder that affects the body’s ability to break down fat that can accumulate in the liver/spleen and bone marrow. Hemochromatosis is a condition that is caused by the over-absorption and build-up of iron while cystic fibrosis is a metabolic disorder that appears as a result of a build-up of mucus in lungs/liver and intestines. Each of these metabolic disorders affect certain organs from functioning properly and therefore your overall healthiness.
Diabetes
Type 2 diabetes is one of the most common types of metabolic disorders in the world that is expected to affect 592 million people by 2035. It is characterised by high blood sugar, insulin resistance or a lack of insulin being produced by the pancreas. Insulin resistance occurs when the body isn’t able to use insulin the right way which increases blood glucose levels. Insulin is needed for cells to take in glucose (sugar) from the bloodstream and convert it into energy. Over time this lack of insulin can damage the organs in your body.
Metabolic Syndrome
Metabolic syndrome (also known as syndrome X, Reaven’s syndrome, and CHAOS) is not a disease but a collection of risk factors that affect your health; these include high blood pressure, high blood sugar/cholesterol and abdominal fat. Left untreated, these risk factors, together, can lead to long term serious problems including an increased risk of heart disease, stroke and developing type 2 diabetes.
Can you improve your metabolic health?
Yes! The good news is that if you discover that your metabolic health is not up to scratch you can improve it through a combination of diet, exercise and lifestyle adjustments such as:
- 30 minutes of moderate to intense exercise 5-7 times a week
- Low-dose aspirin to reduce your risk of stroke or heart attack
- Quit smoking
- Medication for blood pressure/cholesterol/ blood sugar
- Limit alcohol intake
- Eat a healthy balanced diet
Related Products
Randox has developed the RX series of clinical chemistry analysers for superior semi-automated and fully automated testing. The RX series extensive dedicated test menu goes beyond routine testing and has many unique and high-performance tests available. Our range of tests covers several parameters to assess your overall metabolic health.
Metabolic Health Profile
| Albumin | Chloride | Potassium |
| Alkaline Phosphatase | C02 Total | Sodium |
| ALT | Creatinine | Total Bilirubin |
| AST (GOT) | Glucose | Total Protein |
| Direct Bilirubin | Lactate | Urea |
| Calcium |
The RX series clinical chemistry analysers provide laboratories with a robust and smart solution ensuring you maintain a consistent workflow and can provide accurate results first time, every time. Offering excellent customer support services, our trained engineers are on hand to work with you in preserving the continuity of your operations while maximising the potential of your RX series instrument.Our world-famous test menu of high quality reagents ensures excellence in patient care, guaranteeing unrivalled precision and accuracy reducing costly test re-runs or misdiagnosis and offering complete confidence in results.
For more information visit: https://www.randox.com/clinical-chemistry-analysers/
Could there be 5 types of diabetes?
A peer-reviewed study, published in The Lancet Medical Journal suggests there are five types of diabetes. Could diabetes be more complex than we once thought? Could diabetes be segmented into five separate diseases?
What is diabetes?
Diabetes is an incurable disease which prohibits the body’s ability to produce and respond to insulin. Currently, diabetes is classified into two main forms, type 1 and type 2.
Type 1 diabetes is an autoimmune disease which manifests in childhood. In type 1 diabetes, the body’s white blood cells attack the insulin-producing cells in the pancreas. As a result, individuals with Type 1 diabetes rely on the injection of insulin for the remainder of their lives.
Type 1 diabetes affects 10 percent of individuals with diabetes. 96 percent of children diagnosed with diabetes have type 1. Type 1 diabetes in children is commonly diagnosed between the ages of 10 and 14. The prevalence of type 1 diabetes in children and young people (under the age of 19) is 1 in every 430-530 and the incidence of type 1 in children under 14 years of age is 24.5/100,000 (Diabetes UK, 2014).
Type 2 diabetes is the result of insulin resistance, meaning that the pancreas does not produce enough insulin or the body’s cells do not respond to the insulin produced. As type 2 diabetes is a mixed condition, with varying degrees of severity, there are a few methods to manage the disease, including dietary control, medication and insulin injections.
Type 2 diabetes is the most common form of diabetes, affecting 90 percent of individuals with diabetes, and has now become a global burden. The global prevalence of diabetes has almost doubled from 4.7 percent in 1980 to 8.5 percent in 2014, with a total of 422 million adults living with diabetes in 2014. It is expected to rise to 592 million by 2035. In 2012, diabetes accounted for 1.5 million deaths globally with hypertension causing a further 2.2 million deaths. 43 percent of these deaths occurred before 70 years of age. Previously type 2 diabetes was commonly seen in young adults but is now commonly seen in children as well. In 2017, 14% more children and teenagers in the UK were treated for diabetes compared to the year before (World Health Organization, 2016).
In both forms of diabetes, hyperglycemia can occur which can lead to number of associated complications including renal disease, cardiovascular disease, nerve damage and retinopathy.
The novel subgroups of adult-onset diabetes and their association with outcomes: a data-driven cluster analysis of six variables – peer-review study
This new research studied 13,270 individuals from different demographic cohorts with newly diagnosed diabetes, taking into consideration body weight, blood sugar control and the presence of antibodies, in Sweden and Finland.
This peer-reviewed study identified 5 disease clusters of diabetes, which have significantly different patient characteristics and risk of diabetic complications. The researchers also noted that the genetic associations in the clusters differed from those seen in traditional type 2 diabetes.
Cluster One – Severe autoimmune diabetes (SAID)
SAID is similar to type 1 diabetes. SAID manifests in childhood, in patients with a low BMI, have poor blood sugar and metabolic control due to insulin deficiency and GADA. 6% of individuals studied in the ANDIS study were identified with having SAID.
Cluster Two – Severe insulin-deficient diabetes (SIDD)
SIDD is similar to SAID, however, GADA is negative. This means that the characteristics of SIDD are the same as SAID, young, of a healthy weight and struggled to make insulin, however, SIDD is not the result of an autoimmune disorder as no autoantibodies are present. Patients have a higher risk of diabetic retinopathy. 18% of subjects in the ANDIS study were identified with having SIDD.
Cluster Three – Severe insulin-resistant diabetes (SIRD)
SIRD is similar to that of type 2 diabetes and is characterised by insulin-resistance and a high BMI. Patients with SIRD are the most insulin resistant and have a significantly higher risk of kidney disease, and microalbuminuria, and non-alcoholic fatty liver disease. 15% of subjects in the ANDIS study were identified as having SIRD.
Cluster Four – Mild obesity-related diabetes (MOD)
MOD is a mild form of diabetes which generally affects a younger age group. This is not characterised by insulin resistance but by obesity as their metabolic rates are close to normal. 22% of subjects in the ANDIS study were identified as having MOD.
Cluster Five – Mild age-related diabetes (MARD)
MARD is the most common form of diabetes manifesting later in life compared to the previous four clusters. Patients with MARD have mild problems with glucose regulation, similar to MOD. 39% of subjects in the ANDIS study were identified with having MARD.
This new sub-classification of diabetes could potentially enable doctors to effectively diagnose diabetes earlier, through the characterisation of each cluster, including: BMI measurements, age, presence of autoantibodies, measuring HbA1c levels, ketoacidosis, and measuring fasting blood glucose levels. This will enable a reduction in the incidence of diabetes complications and the early identification of associated complications, and so patient care can be tailored, thus improving healthcare (NHS, 2018) (The Week, 2018) (Ahlqvist, et al., 2018) (Collier, 2018) (Gallagher, 2018).
The Randox diabetes reagents cover the full spectrum of laboratory testing requirements from risk assessment, using our Adiponectin assay, to disease diagnosis and monitoring, using our HbA1c, glucose and fructosamine assays, to the monitoring of associated complications, using our albumin, beta-2 microglobulin, creatinine, cystatin c, d-3-hydroxybutyrate, microalbumin and NEFA assays.
Whilst this study is valuable, alone it is not sufficient for changes in the diabetes treatment guidelines to be implemented, as the study only represents a small proportion of those with diabetes. For this study to lead the way, the clusters and associated complications will need to be verified in ethnicities and geographical locations to determine whether this new sub-stratification is scientifically relevant.
References
Ahlqvist, E. et al., 2018. Novel subgroups of adult-onset diabetes and their association with outcomes: a data-driven cluster analysis of six variables. [Online]
Available at: http://www.thelancet.com/journals/landia/article/PIIS2213-8587(18)30051-2/fulltext?elsca1=tlpr
[Accessed 16 April 2018].
Collier, J., 2018. Diabetes: Study proposes five types, not two. [Online]
Available at: https://www.medicalnewstoday.com/articles/321097.php
[Accessed 16 April 2018].
Diabetes UK, 2014. Diabetes: Facts and Stats. [Online]
Available at: https://www.diabetes.org.uk/resources-s3/2017-11/diabetes-key-stats-guidelines-april2014.pdf
[Accessed 16 April 2018].
Gallagher, J., 2018. Diabetes is actually five seperate diseases, research suggests. [Online]
Available at: http://www.bbc.co.uk/news/health-43246261
[Accessed 16 April 2018].
NHS, 2018. Are there actually 5 types of diabetes?. [Online]
Available at: https://www.nhs.uk/news/diabetes/are-there-actually-5-types-diabetes/
[Accessed 16 April 2018].
The Week, 2018. What are the five types of diabetes?. [Online]
Available at: http://www.theweek.co.uk/health/92048/what-are-the-five-types-of-diabetes
[Accessed 16 April 2018].
World Health Organization, 2016. Global Report on Diabetes, Geneva: World Health Organization.
If you are a clinician, dietitian or laboratory who are interested in running diabetes assays, Randox offer a wide range of high-quality routine and niche assays including: fructosamine, glucose, HbA1c for diagnosing and monitoring diabetes, albumin, beta-2 microglobulin, creatinine, cystatin c, NEFA, microalbumin, and d-3-hydroxybutyrate to monitor associated complications, and adiponectin as a biomarker for diabetes risk assessment. These assays can be run on most automated biochemistry analysers.
Instrument Specific Applications (ISA’s) are available for a wide range of biochemistry analysers. Contact us to enquire about your specific analyser.
For more information, visit: https://www.randox.com/diabetes-reagents or email: reagents@randox.com