Neonatal health testing from Randox: keeping your baby healthy now and into the future
Neonatal health testing from Randox: keeping your baby healthy now and into the future
Most newborns enter the world healthy. But sometimes, infants develop conditions that require medical tests and treatment. Newborns are particularly at risk for some diseases, and in particular infections, because their immune systems aren’t developed enough to fight bacteria, viruses, and parasites.
At Randox we offer a number of accurate and reliable tests capable of detecting illnesses in newborn babies, enabling early medical intervention to allow for the best possible outcome for the baby.
Testing for Jaundice with Randox Bilirubin
In the routine care of newborns, a test for bilirubin is commonly conducted.
Bilirubin is formed by the breakdown of haemoglobin in the spleen, liver and bone marrow. It travels to the liver where it is secreted into the bile ducts as bile, and stored in the gallbladder where it is later released into the small intestines for digestion.
Increased levels of bilirubin within the body are associated with a condition called jaundice, which occurs in toxic or infectious diseases of the liver. The most common symptom of jaundice is a yellow pigmentation of the skin.
Elevated levels of bilirubin may also arise as a result of an obstruction in the bile duct or gall bladder, as a result of haemolysis (the destruction of red blood cells), or by the liver not actively treating the haemoglobin it is receiving.
Therefore the Randox Bilirubin test is essential in the screening, monitoring and diagnosis of hepatic (liver function) disorders and jaundice in newborn babies.
Neonatal jaundice, otherwise known as hyperbilirubinemia, is extremely common in babies, because nearly every newborn develops a somewhat elevated bilirubin level during the first week of life.
Side effects may include excess sleepiness or poor feeding, but in some more extreme cases babies may experience seizures, cerebral palsy, delayed intellectual development, or physical abnormalities.
Early and accurate detection is therefore extremely important – making bilirubin testing fundamental. To ensure the precision of the bilirubin tests conducted in paediatric testing, Randox also offers Acusera Bilirubin Elevated Quality Control.
Monitoring the destruction of red blood cells with Randox G-6-PDH
Glucose-6-Phosphate Dehydrogenase (G-6-PDH) is an enzyme located on the X-chromosome, and so is found in every bodily cell as soon as a baby is born.
G-6-PDH is involved in the normal processing of carbohydrates and plays a critical role in red blood cells, protecting them from damage and destruction. Depleted levels of G-6-PDH can therefore cause red blood cells to become particularly vulnerable to haemolysis. G-6-PDH deficiency, which causes rapid heart rate, shortness of breath, excess tiredness, and mild to severe jaundice in new-borns, affects more than 400 million people globally.
During a baby’s new-born screening, a test for the G-6-PDH enzyme will be conducted to check for this deficiency disorder. Early diagnosis is imperative, as untreated haemolysis can result in haemolytic anaemia.
Genetic Disease Screening with Randox Copper
Copper is an essential mineral in human nutrition, and is mainly found in the brain, liver, kidneys, heart and skeletal muscle.
It aids in some of the key bodily functions including the production of red blood cells, the maintenance of nerve cells and the immune system, and the formation of bone and connective tissue. A deficiency in this mineral can therefore result in bone abnormalities or fractures in premature babies.
Copper deficiency can also be caused by an inherited disorder called Menkes Disease. Affecting approximately 1 in 100,000 children worldwide, this condition is characterised by sparse, kinky hair; failure to gain weight and grow at the expected rate, and deterioration of the nervous system.
The first signs of Menkes Disease – curly, sparse, coarse, dull, and discoloured hair – usually first develop at 2-3 months of age and therefore monitoring copper levels in babies is a way to catch this rare condition at the earliest possible opportunity.
Testing for Lupus with Randox Complement C4 and Complement C3
Another condition which can affect newborn babies is neonatal lupus, which occurs when the mother’s antibodies affect the foetus. A rare condition, it is an autoimmune disease caused by the body’s immune system attacking its own tissues and organs.
The Complement C4 and Complement C3 proteins, which play an important role in eliminating certain infections, can be used as biomarkers in the diagnosis and monitoring of lupus. Complement C4 deficiency is commonly associated with lupus, as the protein is required to clear damaged cells, promote inflammation, and attack pathogens.
Although there is no cure for lupus at present, the condition is very treatable and usually responds well to a number of different types of medication – especially when treatment is started in the early stages of the disease.
Early diagnosis is therefore imperative, and the Randox Complement C4 and Complement C3 tests can help to diagnose babies with lupus at the earliest possible stage. Randox also offer Acusera Immunology controls.
Monitoring a baby’s anti-infection defences with Randox IgA
IgA (immunoglobulin A) is an antibody present in the cells of the immune system, and plays a crucial role in the immune function of mucous membranes including tears, saliva, and sweat. It is also present in colostrum, often referred to as ‘liquid gold’, which is the first secretion from the mammary glands after giving birth.
It’s the IgA in colostrum and milk that is important in neonatal protection against infection and it is therefore imperative to monitor the levels of this antibody to make sure your baby is receiving the anti-infection defences he or she requires.
Testing for allergic reactions with Randox IgE
IgE (immunoglobulin E) is an antibody released by the immune system as a defence mechanism when it believes the body is at risk. IgE determinations are therefore used as an aid in the diagnosis of allergic diseases.
In babies, an allergen-specific IgE test may be done to look for some kinds of allergies, including food, animal dander, pollen, mould, medicine, dust mites, or insect venom.
Increased concentrations of IgE will confirm that an allergic response has occurred, facilitating further investigation as to the specific allergy present.
Testing for bacterial infection with Randox CRP
C-reactive protein (CRP) is an acute phase protein found in blood plasma and produced by the liver. The concentration levels of CRP increase in response to cytokines which are produced by white blood cells during inflammation, infection and tissue injury.
Testing for this protein can therefore be used in the detection of bacterial infections in neonates – enabling antibiotic prescription and a speedy recovery. If infection is identified, CRP can also be used to monitor treatment response or identify neonatal septicaemia.
Randox is committed to saving and improving lives – at any age and any stage of life.
Our innovative diagnostic technologies are versatile and easily adapted for use in the paediatric setting – keeping your baby healthy now and into the future.
For more information on neonatal health tests available from Randox click here or email randoxpr@randox.com or phone 028 9442 2413
Measurement Uncertainty Vs Total Error
In a recent article, Error Methods Are More Practical, But Uncertainty Methods May Still Be Preferred, James Westgard comments on the latest developments in the debate on the use of analytical total error (TE) and measurement uncertainty (MU), a debate which has been regularly revisited for the last twenty years. This blog aims to briefly explore the benefits of MU and TE and attempt to draw a conclusion on which is most beneficial in the clinical laboratory.
Many things can undermine a measurement. Measurements are never made under perfect conditions and in a laboratory, errors and uncertainties can come from (Good Practice Guide No. 11, 2012):
- The measuring instrument – instruments can suffer from errors including bias, changes due to ageing, wear, poor readability, and noise.
- The item being measured – the sample may be unstable.
- The measurement process – the analyte may be difficult to measure
- ‘Imported’ uncertainties – calibration of the instrument.
- User error – skill and judgement of the operator can affect the accuracy of a measurement.
- Sampling issues – the measurements you make must be properly representative of the process you are trying to assess. I.e. not using fully commutable controls will mean your quality control process is not reflective of a true patient sample.
Random and systematic errors
The effects that give rise to uncertainty in a measurement can be either random or systematic, below are some examples of these in a laboratory.
- Random – bubbles in reagent, temperature fluctuation, poor operator technique.
- Systematic – sample handling, reagent change, instrument calibration (bias), inappropriate method.
Total Error (TE) or Total Analytical Error (TAE) represents the overall error in a test result that is attributed to imprecision (%CV) and inaccuracy (%Bias), it is the combination of both random and systematic errors. The concept of error assumes that the difference between the measured result and the ‘true value’, or reference quantity value, can be calculated (Oosterhuis et al., 2017).
TE is calculated using the below formula:
TE = %BIAS + (1.96 * %CV)
Measurement Uncertainty is the margin of uncertainty, or doubt, that exists about the result of any measurement.
There is always margin of doubt associated with any measurement as well as the confidence in that doubt, which states how sure we are that the ‘true value’ is within that margin. Both the significance, or interval, and the confidence level are needed to quantify an uncertainty.
For example, a piece of string may measure 20 cm plus or minus 1 cm with a 95% confidence level, so we are 95% sure that the piece of string is between 19 cm and 21 cm in length (Good Practice Guide No. 11, 2012).
Standards such as ISO 15189 require that laboratories must determine uncertainty for each test. Measurement Uncertainty is specifically mentioned in section 5.5.8.3:
“The laboratory shall determine measurement uncertainty for each measurement procedure in the examination phases used to report measured quantity values on patients’ samples. The laboratory shall define the performance requirements for the measurement uncertainty of each measurement procedure and regularly review estimates of measurement uncertainty.”
Uncertainty is calculated using the below formula:
u = √A2+B2
U = 2 x u
Where:
A = SD of the Intra-assay precision
B = SD of the Inter-assay precision
u = Standard Uncertainty
U = Uncertainty of Measurement
Error methods, compared with uncertainty methods, offer simpler, more intuitive and practical procedures for calculating measurement uncertainty and conducting quality assurance in laboratory medicine (Oosterhuis et al., 2018).
It is important not to confuse the terms ‘error’ and ‘uncertainty’.
- Error is the difference between the measured value and the ‘true value’.
- Uncertainty is a quantification of the doubt about the measurement result.
Whenever possible we try to correct for any known errors: for example, by applying corrections from calibration certificates. But any error whose value we do not know is a source of uncertainty (Good Practice Guide No. 11, 2012).
While Total Error methods are firmly rooted in laboratory medicine, a transition to the Measurement Uncertainty methods has taken place in other fields of metrology. TE methods are commonly intertwined with quality assurance, analytical performance specifications and Six Sigma methods. However, Total Error and Measurement Uncertainty are different but very closely related and can be complementary when evaluating measurement data.
Whether you prefer Measurement Uncertainty, Total Error, or believe that they should be used together, Randox can help. Our interlaboratory QC data management software, Acusera 24•7, automatically calculates both Total Error and Measurement Uncertainty. This makes it easier for you to meet the requirements of ISO:15189 and other regulatory bodies.
This is an example of the type of report generated by the 247 software. MU is displayed for each test and each lot of control in use therefore eliminating the need for manual calculation and multiple spreadsheets.
Fig. A
Fig. B
Fig. A and Fig. B above are examples of report generated by the 24•7 software. Fig.A shows how MU is displayed for each test and each lot of control in use therefore eliminating the need for manual calculation and multiple spreadsheets. Fig. B shows TE displayed for each test.
Acusera Third Party Controls
The Importance of ISO 15189
Good Practice Guide No. 11. (2012). Retrieved from http://publications.npl.co.uk/npl_web/pdf/mgpg11.pdf
Hill, E. (2017). Improving Laboratory Performance Through Quality Control.
Oosterhuis, W., Bayat, H., Armbruster, D., Coskun, A., Freeman, K., & Kallner, A. et al. (2017). The use of error and uncertainty methods in the medical laboratory. Clinical Chemistry and Laboratory Medicine (CCLM), 56(2). http://dx.doi.org/10.1515/cclm-2017-0341
Westgard, J. (2018). Error Methods Are More Practical, But Uncertainty Methods May Still Be Preferred. Clinical Chemistry, 64(4), 636-638. http://dx.doi.org/10.1373/clinchem.2017.284406
Randox Food Diagnostics offers innovative multiplex technology for mycotoxin screening within varieties of farmed crops
Mycotoxins are poisonous chemical compounds produced by certain fungi. There are many such compounds, but only a few of them are regularly found in food, farmed crops and end product animal feeds. Since they are produced by fungi, mycotoxins are associated with diseased or mouldy crops. Those that do occur in food may have an impact on livestock and the health of humans and have been associated with conditions such as asthma, respiratory infections and chronic fatigue. The main causes of mycotoxins within stored grains are when the grain is damp, damaged or cracked and kept in insufficient storage conditions.
The formation of mycotoxins is climate-dependent, with temperature and moisture levels directly impacting fungal growth. Evidence shows that climate change is causing increasing temperatures and altered rainfall patterns. Additionally, extreme weather incidents have increased. As a consequence of these changes, increased levels of mycotoxins have been observed in some European crops.
Mycotoxins occur, and exert their toxic effects, in extremely small quantities in foodstuffs. Their identification and quantitative assessment therefore generally require sophisticated sampling, sample preparation, extraction, and analytical techniques. Under practical storage conditions, the aim should be to monitor for the occurrence of fungi. If fungi cannot be detected then there is unlikely to be any mycotoxin contamination. The presence of fungi indicates the potential for mycotoxin production, and the need to consider the fate of the batch of commodity affected.
In order to help the industry Randox Food Diagnostics developed the Evidence Investigator analyser. The Investigator uses Biochip Array Technology (BAT), a technology that was developed by Randox, to detect multiple residues (up to 45) from a single sample. Within farmed crops Randox Food Diagnostics provide testing for different matrices such as: Maize silage, maize, Barley, grass seed, rice, wheat, oats, soya, DDGS, rapeseed as well as livestock and pet foods including premixed feed.
Randox Food Diagnostics offer a mycotoxin screening array on Biochip called Myco 10 which can detect 10 mycotoxins per sample including aflatoxins G1/G2 & B1/B2, ergot alkaloids, fumonisins, paxilline, ochratoxin A, diacetoxyscirpenol, deoxynivalenol (DON), T2 toxin & zeralenone. Also offered is a range of ELISA test kits including ergot alkaloids.
Randox Food Diagnostics is a regular participant in the FAPAS proficiency testing scheme which provides an independent check of a laboratory’s procedures to ensure the delivery of quality results. To read our study on: Biochip Array Technology for the reliable performance of multi-mycotoxin determination in animal feed materials” click here: http://www.randoxfooddiagnostics.com/docs/default-source/randox-fd/posters/bat-mycotoxins-in-animal-feed-materials.pdf?sfvrsn=4
For more information on our arrays for mycotoxins please visit the website: http://www.randoxfood.com/matrices/mycotoxins or contact us via email at: info@randoxfooddiagnostics.com
The RX series celebrate Medical Laboratory Professionals Week
Medical Laboratory Professionals Week is taking place this year from 22nd– 28th April 2018. This is an annual celebration of professionals working in the laboratory, highlighting and recognising their contributions to medicine and healthcare.
To celebrate Medical Laboratory Professionals Week the RX series interviewed Aidan Murphy, one of our laboratory analysts at Randox to find out more about what his job in the lab entails day-to-day. Aidan works with the RX series of clinical chemistry analysers and Randox QC on a daily basis.
We asked Aidan a few questions about his life as a scientist. See what he gets up to in Randox on a daily basis …
1. What attracted you to a career in laboratory science?
Science has always interested me in both my academic and personal life, I always aspired to get a science based degree and after achieving this I now hope to improve my laboratory skills to increase my employability.
2. What were your stronger subjects at school?
My strongest subjects in school were biology, chemistry, music and politics. Some of which are more applicable to my current role than others.
3. What does your job in Randox entail?
My job entails a variety of roles ranging from testing Randox diagnostic kits before they’re released to customers as well as maintenance and precision checks of the machines in our lab.
4. What aspects of your job do you enjoy the most?
The independence in my job is great. Knowing what I have to do at the start of each week and the deadlines to do these jobs requires me to organise and prioritise my work accordingly.
5. What are some common preconceived ideas the public have about what laboratory staff do?
From my friends’ ideas of what I do in the lab I have found that a stereotypical image of a lab is one of a dark quiet lab full of strange equipment and even stranger people. However fortunately my lab is a lively one and thankfully with normal people.
6. In your opinion, what are the most important aspects of laboratory work?
Following correct protocols and procedures are imperative in an efficient laboratory. As well as this, good lab practice and good hygiene can have a massive effect on the accuracy of our results.
7. What’s in your lab coat pocket?
My lab coat pockets are quite boring. I have a pair of safety goggles, some post-its and some pens and markers.
8. In what ways does your work make a difference to people’s lives?
Randox is dedicated to improving the quality of diagnostics globally, so knowing that the kits that I have tested are then sent to customers to be used in patient diagnosis gives me a level of job satisfaction that I haven’t got from previous jobs.
Aidan is a fundamental member of the Randox team and plays an essential role in the diagnosis and prevention of disease through his work. Without our valuable laboratory team working extremely hard behind the scenes the lifesaving work we do here at Randox would not be possible.
To find out more about Randox products contact us at theRXseries@randox.com.
Check out our social media sites for more on Medical Laboratory Professionals Week.
The Evidence Series: What is it and how is it changing the diagnostic landscape forever?
Having developed the patented Biochip Array Technology following £250 million investment in diagnostic research and development, we needed a platform that allowed Biochip Array Technology capabilities to be showcased. Step forward the Evidence Series.
The series includes the Evidence, the Evidence Evolution, the Evidence Investigator and the Evidence MultiSTAT. Each analyser has been designed and built with boundary pushing engineering, to ensure financial, labour and time savings for the end user.
Have a read below of the overview of each analyser in the Evidence Series
Evidence Evolution
The world’s first fully automated random-access biochip testing platform, the Evidence Evolution is the world’s most advanced immunoanalyser. With the capability to process up to 2,640 tests per hour, the Evidence Evolution offers complete system integration, as well as the most comprehensive test menu on the market.
Evidence
As the world’s first Biochip Array Technology system, the Evidence immunoanalyser has revolutionised laboratory screening worldwide. With the capability to process 3,960 tests per hour and a sample capacity of 360, the Evidence is ideal for use in a high throughput laboratory.
Evidence Investigator
The Evidence Investigator is a compact, semi-automated benchtop immunoanalyser that offers efficient and comprehensive testing across a range of applications including clinical diagnostics, molecular, toxicology and food diagnostics. The Evidence Investigator boasts a throughput of up to 2,376 tests per hour, offering efficiency without compromising on accuracy.
Evidence MultiSTAT
The Evidence MultiSTAT is a fully automated immunoanalyser that enables on-site simultaneous detection of up to 44 analytes from a single sample of oral fluid, urine or blood. With a three-step process and results generated in less than 20 minutes, the Evidence MultiSTAT is an ideal solution for those with no knowledge of laboratory procedures and offers a throughput of up to 132 tests per hour.
About the Randox Evidence Series
The Evidence Series is set to revolutionise diagnostic testing forever. Offering unrivalled capabilities across all analysers, we truly believe that the Evidence Series range of immunoassay analysers can meet your diagnostic testing capabilities.
For more information on any of the Evidence Series analysers, please visit https://www.randox.com/evidence-series/ or contact us evidenceseries@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
The Importance of Meeting ISO 15189 Requirements
Laboratory accreditation provides formal recognition to competent laboratories, providing a means for customers to identify and select reliable services (CALA, n.d.). Use of accreditation standards by clinical laboratories enables them to drive gains in quality, customer satisfaction, and financial performance. This is essential at a time when laboratory budgets are shrinking.
Some key benefits include:
- Recognition of testing competence – as mentioned above, customers can recognise the competence of a lab with an internationally recognised standard.
- Marketing advantage – accreditation can be an effective marketing tool as labs can demonstrate their quality and overall competence.
- Benchmark for performance – laboratories can determine whether they are performing to the appropriate standards and provides them with a benchmark to maintain that standard.
To maintain the global recognition gained from accreditation, labs are evaluated regularly by an accreditation body to ensure their continued compliance with requirements, and to check that standards are being maintained. (CALA, n.d.).
In a comprehensive study conducted by Rohr et al. (2016) it was found that, while accounting for as little as 2% of total healthcare expenditure, in vitro diagnostics (IVD) account for 66% (two thirds) of clinical decisions. Despite such a small percentage of budget dedicated to it, IVD plays a huge role in patient care so it is vital that there is guidance in place to ensure quality standards are met. Poor performance of tests at any stage of care and treatment can reduce the effectiveness of treatment and deny appropriate care to patients in need (Peter et al., 2010).
ISO 15189 is an international accreditation standard that specifies the quality management system requirements particular to medical laboratories and exists to encourage interlaboratory standardisation, it is recognised globally.
Meeting ISO Requirements
Scroll through below to learn how ISO 15189 regulates aspects of a clinical laboratory and how Randox can help you meet these suggestions.
Review of QC data
“The laboratory shall have a procedure to prevent the release of patient results in the event of quality control failure. When the QC rules are violated and indicate that examination results are likely to contain clinically significant errors, the results shall be rejected…QC data shall be reviewed at regular intervals to detect trends in examination performance”
– ISO 15189:2012
Acusera 24∙7 will automatically apply QC multi-rules, alert you to or reject any results that violate the QC multi-rules or performance limits, generate a variety of charts allowing visual identification of trends and provide access to real-time peer group data to assist with the troubleshooting process.
Calculation of MU
“The laboratory shall determine measurement uncertainty for each measurement procedure in the examination phases used to report measured quantity values on patients’ samples. The laboratory shall define the performance requirements for the measurement uncertainty of each measurement procedure and regularly review estimates of measurement uncertainty.”
– ISO 15189:2012
Acusera 24∙7 is the only QC data management platform that incorporates the automatic calculation of Measurement Uncertainty (MU) as well as other performance metrics, including Total Error.
More about Measurement Uncertainty and how Acusera 24∙7 can help
Commutability
“The laboratory shall use quality control materials that react to the examining system in a manner as close as possible to patient samples”
– ISO 15189:2012
Acusera True Third Party Controls are fully commutable, behaving like a real patient sample, reducing the need to re-assign QC target values when the reagent batch is changed, reducing labour and costs.
Medical decision levels
“The laboratory should choose concentrations of control materials, wherever possible, especially at or near clinical decision values, which ensure the validity of decisions made”
– ISO 15189:2012
Acusera True Third Party Controls are designed to challenge instruments across the entire clinical reporting range.
Comparison of results across instruments
“Laboratories with two or more analysers for examinations, should have a defined mechanism for comparison of results across analysers”
– ISO 15189:2012
Acusera 24∙7 is capable of combining multiple data sets on a single Levey-Jennings, Histogram of Performance Summary chart, enabling at-a-glance performance review and comparative performance assessment. A unique multi-instrument report is also available via our RIQAS EQA programme allowing performance of each instrument to be compared.
Third Party Control
“Use of independent third party control materials should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer”
– ISO 15189:2012
Acusera True Third Party Controls are manufactured completely independently of and calibrators and assigned values through a pool of instruments across the world, making them true third party controls.
At a conference in Belgium in 2016, data, which highlighted the most common areas of non-conformance in laboratories, showed that nonconformities were most prevalent in sections 5.5 and 5.6 of ISO 15189. This data is visualised in fig. A below. Furthermore, a study by Munene et al. (2017) has had similar findings, as visualised in fig. B. The greatest number of nonconformities occur in the sections that are concerned with insufficient assay validation and quality of examination procedures. These studies specifically identified the lack of independent controls, QC not at clinically relevant levels, commutability issues, and a lack of interlaboratory comparison as major issues.
Randox Quality Control products are designed to target these areas, making it easier to conform to ISO 15189 standards.
Fig. A
Fig. B
Acusera Third Party Controls
Interlaboratory Data Management
CALA. The Advantages of Being an Accredited Laboratory. Canadian Association for Laboratory Accreditation. Retrieved from http://www.cala.ca/ilac_the_advantages_of_being.pdf
Munene, S., Songok, J., Munene, D., & Carter, J. (2017). Implementing a regional integrated laboratory proficiency testing scheme for peripheral health facilities in East Africa. Biochemia Medica, 110-113. http://dx.doi.org/10.11613/bm.2017.014
Peter, T., Rotz, P., Blair, D., Khine, A., Freeman, R., & Murtagh, M. (2010). Impact of Laboratory Accreditation on Patient Care and the Health System. American Journal Of Clinical Pathology, 134(4), 550-555. http://dx.doi.org/10.1309/ajcph1skq1hnwghf
Rohr, U., Binder, C., Dieterle, T., Giusti, F., Messina, C., & Toerien, E. et al. (2016). The Value of In Vitro Diagnostic Testing in Medical Practice: A Status Report. PLOS ONE, 11(3), e0149856. http://dx.doi.org/10.1371/journal.pone.0149856
The rise of drug abuse in India – Randox Toxicology
A recent study completed by the Narcotics Control Bureau (NCB) reported an all-time high of 3.6 lakh kg narcotic drugs seized in India in 2017, this was an increase of over 300 percent in the last five years. Known as ganja, cannabis is the most widely abused drug in India, increasing from 40,113 in 1999 to 352,379 by 2017, according to The Times of India.
(Sourced: The Times of India: Drug abuse on the rise in India, Ganja most in demand)
A prevalent issue in the north of India is pharmaceutical drug abuse, both over the counter and prescription drugs. The Times of India reported that 566,450 bottles of cough syrup, 58,463 injections and more than 6,300,000 tablets were recovered across India in 2017. Among the drugs being smuggled out of India and into countries such as America and Canada is the opioid painkiller Tramadol, which is not covered under the Narcotic Drugs and Psychotropic Substances Act.
With daily drug seizures across the country, the situation in India has been described as akin to the US national opioid emergency. Therefore, it has been suggested that a harm-reduction approach be taken to educate the young and tackling substance abuse.
Using our revolutionary Biochip Array Technology, the Evidence MultiSTAT is a fully automated analyser that enables on-site simultaneous detection of up to 21 classical, prescription and synthetic drugs from a single sample. Designed to work across a variety of matrices and generate results in under 20 minutes, Randox Toxicology have changed the landscape of drug detection forever.
For further information about the Evidence MultiSTAT and our cutting-edge multiplex testing capabilities, contact info@randoxtoxicology.com to be put in touch with a sales member or visit www.randoxtoxicology.com
Vivalytic: The all-in-one solution for Molecular Diagnostics
A game-changing partnership between Randox Laboratories and Bosch is changing the accessibility to molecular diagnostics with the launch of a revolutionary product – the innovative platform Vivalytic.
Using Randox-patented Biochip Array Technology, it is the easiest-to-use and most-comprehensive multiplex PCR platform on the market. It provides the broadest range of test options ever seen for an analyser of its size, and also supports single-plex and low-plex testing, simplifying the processes for otherwise-complex laboratory test procedures. Depending on the test application, results will be delivered from 30 minutes.
Biochip Array Technology, developed by Randox Laboratories, is the innovative multiplexing technology which is utilised within the cartridge aspect of the platform. The Biochip allows for the simultaneous detection of multiple analytes from a single sample.
The new platform will be initially released with two molecular arrays available including Respiratory Tract Infection and Sexually Transmitted Infection with other tests to follow.
The Vivalytic is the perfect fit for any laboratory with numerous benefits to enhance your laboratories testing capabilities.
Hygienic and space saving
No other peripherals such as laptop, keyboard, barcode scanner or filling stations are required. This makes Vivalytic a hygienic and space-saving all-in-one solution.
Direct and clear results
The test result is presented clearly in a summary, but also details on the raw data of each individual measurement can be displayed.
Protected system
The Vivalytic integrates the software with the instrument to ensure a safe and reliable run. This is the ultimate protection of the data and the valuable sample material.
Networked and combinable
Easy integration with popular standard IT systems makes test results instantly available. An analyser device can be networked and combined with several other devices so that multiple series of tests can be performed simultaneously. All devices are based on the same hardware and software, so that the product family can be expanded quickly and without major development effort.
28th European Congress of Clinical Microbiology and Infectious Diseases
Randox Laboratories will be attending the 28th European Congress of Clinical Microbiology and Infections from the 21st – 24th April 2018.
Our innovative diagnostic solutions have been developed with consolidation and economy in mind, providing cost savings whilst using pioneering technology.
Diagnostics is our passion. We are dedicated to developing solutions that not only meet your needs, but are of the highest quality, the most reliable and the most cost-effective. We look forward to meeting you in Madrid at IFEMA – Feria de Madrid to launch the Vivalytic at our stand 55A.
For further information, visit https://goo.gl/S2Yj2c or email info@randoxbiosciences.com
