The Evidence Evolution – The newest member of the Evidence series
The Evidence Evolution – The newest member of the Evidence series
Launched in 2016, the Evidence Evolution has set new standards in the world of clinical, forensic and food testing.
With the most extensive test menu on offer, we can provide more tests than any other supplier and we are continually investing in R&D to keep up with industry developments and challenges, such as our extensive clinical test menu with a range of routine and novel tests including our CKD panel which detects the early stages of Chronic Kidney Disease.
The Evidence Evolution utilises Randox’s cutting-edge Biochip Array Technology, offering diagnostic testing from a single sample. The Evidence Evolution boasts 2640 tests per hour and when put to the test against our competitor machines, the Evidence Evolution gives a true walk away time of up to 2 hours, meaning staff can fully load the machine and get up to 44 results from each sample every minute, while they get on with important laboratory tasks.
The Evidence Evolution has been designed to meet the needs of a variety of laboratories. Delivering quality results, efficiently and economically in forensic and clinical immunoassay locations.
The Evidence Evolution is the latest development in our Evidence Series range, which was first launched in 2002. This trusted technology is powered by Biochip and is used throughout the world in a range of different sites for clinical, toxicology and food testing. The Evidence Series has a range of analysers that can meet the need of any laboratory.
For more information on any of the Evidence Series analysers, please visit https://www.randox.com/evidence-series/ or contact us evidenceseries@randox.com.
Biochip vs ELISA: Which testing platform is right for me?
Biochip Vs ELISA
Randox Toxicology’s latest video series, ‘Biochip Vs ELISA’, highlights our routine and novel ELISA products and how they differ from Biochip Array Technology.
Showcasing the journey and ongoing brand evolution of Randox Toxicology, these videos will help you to discover which method is right for you!
Episode 1: Meet ELISA
Episode 1 “Meet ELISA” uses speed reading to showcase Randox Toxicology’s extensive and ever-expanding ELISA test menu, including our range of New Psychoactive Substances, drugs of abuse, stimulants, analgesics and sedatives. Manufactured in the United Kingdom, our continuous reinvestment in research and development has enabled us to develop a range of exclusive ELISA kits such as, Mitragynine, MT-45, and U-47700 which was involved in the death of the famous singer Prince.
Our cost effective ELISA kits are the highest quality on the market and results provide excellent correlation with confirmatory methods, typically <10% CV.
Episode 2: Meet Biochip
Based on ELISA principles, Episode 2 “Meet Biochip” illustrates Biochip Array Technology as a solid-state device with discrete test sites onto which antibodies specific to different drug compounds are immobilised and stabilised. Moving away from traditional single analyte assays, Biochip Array Technology boasts cutting-edge multiplex testing capabilities for rapid and accurate drug detection from a single sample.
As the primary manufacturers of Biochip Array Technology, Randox Toxicology offer the most advanced screening technology on the market. With the world’s largest test menu capable of detecting over 500 drugs, Randox Toxicology are changing the landscape of drugs of abuse testing.
Episode 3: Biochip Vs ELISA
Episode 3 “Biochip Vs ELISA” gives you the opportunity to hear from a professional! Laura Keery our Senior Research and Development Team Leader gives you a behind the scenes look at our Biochip Array Technology and ELISA products in action at our new Science Park, answering some of those must know questions.
Episode 4: Biochip Vs ELISA 360-Degrees
If you missed it at SOFT-TIAFT 2017, our Biochip Vs ELISA 360-degree video allows you to experience Biochip and ELISA in action.
Discover which method is right for you! #biochipvselisa
For more information about our revolutionary Biochip Array Technology and ELISA kits, email info@randoxtoxicology.com or visit www.randoxtoxicology.com
Contaminated Cereal Products Rejected at EU Borders
In the month of May alone, over 20 cases of feed and cereal based products have been rejected at EU borders after testing positive for aflatoxins with a risk decision level marking of ‘serious’, countries of origin include; Turkey, Egypt, Gambia, U.S, Indonesia, India, Azerbaijan and Spain.
The European Union have set tolerance levels for Aflatoxin B1 at 2 parts per billion (ppb) and total aflatoxins at 4ppb for nuts, cereals and dried fruits.
Aflatoxins are a mycotoxin produced by a fungus and thrive in hot and humid climates. Aflatoxin B1 is the most prevalent among food products and commonly occur among cereals (including wheat, barley, rice and corn) oilseeds (peanuts, almonds, pistachios and other nuts) spices, fruits, vegetables, milk and dairy products.
Screening for Mycotoxins
There are various screening methods available for mycotoxins in food, but few offer the choice of screening for multiple mycotoxins from one sample. Randox Food Diagnostics has created patented Biochip Array Technology (BAT), an immunoassay ELISA based method, to save the feed and cereal industry time and money on testing.
The Myco Array kit range can screen for 3-10 mycotoxins simultaneously from a single sample and depending on the users testing requirements, customisable kits are available.
For more information on mycotoxin screening with Randox Food Diagnostics contact info@randoxfooddiagnostics.com
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Neonatal health testing from Randox: what to expect after birth
It’s been almost a month since the Duke and Duchess of Cambridge welcomed Prince Louis into the Royal Family, and as reported it was a natural birth with no complications.
But caring for a newborn baby in the first few hours of its life isn’t quite as simple as it may have seemed in the picture-perfect media coverage of Kate and William introducing their third child to the world for the first time.
Behind the doors of the hospital maternity ward, doctors and nurses are busy carrying out a wealth of tests to ensure the health of the neonates in their care. Because the time immediately following a baby’s birth is crucial for their development in the coming months.
Newborn babies are particularly at risk for some diseases because their immune systems aren’t yet developed enough to fight bacteria, viruses and parasites. Just a few minutes after a baby’s arrival, they will be poked, pricked, measured, tested, examined, cleaned and swaddled – all in the name of making sure they are – and importantly, remain – healthy.
The first test to be conducted is usually an Apgar score – a simple assessment of how a baby is doing at birth, to help determine whether they are ready to meet the world without additional medical assistance. Based on heart rate, colour, reflex response, activity, muscle tone and breathing, the Apgar score ranges from zero to ten, with anything above seven or above being considered a healthy score. Babies with a score below seven will have their issues addressed – it could be something as simple as moving them to a warmer room until they are able to maintain their own body temperature, or clearing their nose and mouth for more efficient breathing.
The baby is then weighed and measured, and may be given antibiotic eye ointment to prevent infections, and vitamin K to prevent clotting problems.
They will also have their pulse, abdomen, genitals, fingers and toes examined, and their Ballard score taken. This takes into account head circumference, chest circumference and length, to confirm gestational age.
A paediatrician will then assess risk factors for infection and ensure that the baby is feeding well. They will also check for jaundice, which causes yellowish skin when bilirubin, a compound formed by the liver, isn’t being broken down properly.
Neonatal jaundice is extremely common, because during the first week of their life nearly every newborn develops a somewhat elevated bilirubin level, which could potentially lead to jaundice. And the good news is, that if diagnosed early, jaundice can easily be eradicated, by exposure to a specialist light that can help break down bilirubin.
At Randox, we offer a test for bilirubin to diagnose and monitor newborn jaundice, which, in rare cases if left untreated, can lead to brain damage. Early, accurate diagnosis is therefore imperative and so to ensure the precision of the bilirubin tests, Randox also offers Acusera Bilirubin Elevated Quality Control.
The baby will also have their heel pricked for a variety of metabolic conditions including sickle cell anaemia, which causes red blood cell destruction. The Randox test for haptoglobin, a protein found in blood plasma, can help to diagnose sickle cell anaemia.
Or if the baby is premature, they will remain in the hospital nursery. Depending on how premature the baby is there will be different types of tests and treatment given, but they will have their temperature, heart rate and respiratory rate closely monitored. These vital signs will be checked regularly for the first few hours of the baby’s life.
So as you can see, within just a few short hours newborn babies are kept incredibly busy. Procedures may vary from one hospital to the other, but one thing is for sure: neonatal tests are vital in determining and protecting the health of babies.
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, please email randoxpr@randox.com or phone 028 9442 2413
Randox Testing Services | How can a policy form the basis of workplace drug & alcohol testing?
If you work in a company with safety-critical roles it is more than likely that you have some sort of workplace drug and alcohol testing policy in place. Even companies without safety-critical roles are implementing these policies to further ensure the health, safety and wellbeing of their staff.
Employers hold the responsibility to ensure employees are fully aware of the company’s rules, regulations, testing and disciplinary procedures.
The policy itself holds vital importance, providing employees with the knowledge of the standards expected of them, whilst educating themselves with information provided in a written comprehensive manner.
The importance of implementing a policy
The most important element of a workplace drug and alcohol testing policy is SAFETY. Drug and alcohol use increases the probability of workplace accidents occurring. Studies have found that employees who have alcohol problems are 2.7 times more likely to have an accident whilst at work. The main issues associated with substance misuse relate to:
- Absenteeism – it’s estimated that 17 million days of work are lost per year due to substance misuse.
- Low productivity levels – employees may reduce output in different tasks and become de-motivated.
- Inappropriate behaviour – some cases of substance abuse may lead to crime.
- Aggressive behaviour towards others – resulting in loss of employment / convictions
It’s evident that many who suffer from drug & alcohol abuse are in employment. Studies show 25% of those in employment were registered drug addicts with 3.3% of all adults aged 16-59 classified as frequent users.
Significant issues such as these provide growing concerns for employers to implement a workplace drug and alcohol policy, to ensure the welfare of each member of staff is considered. Under the Health & Safety Act 1874, employers have a responsibility to ensure the safety of their employees is fully met in order to maintain standards.
The importance of a workplace policy for drugs and alcohol can benefit employers by:
- Building relationships with employees by showing there is help and support available.
- Policies can raise awareness of issues in the business and can encourage staff members to take action if needed.
- It can reduce the number of sick employees, reduce staff turnover and increase productivity levels.
Speak with us directly
We understand that the importance of having a policy that suits the specific needs of your company. In order to fully achieve this, we offer a free policy review service, where we will review your company’s existing documentation to gain an understanding of how we can help going forward.
We are delighted to announce we will be attending the Safety & Health Expo 2018. The annual event, running from 19th – 21st June and held at the Excel London, is the UK’s largest health and safety event with over 13,500 national and international key industry professionals across construction, manufacturing, government and consulting.
By attending this prestigious event we hope to engage with a range of stakeholders to discuss how our drug & alcohol testing services can have a positive impact on your employees and business.
If you are attending this event and would like to speak with us, please stop by our stand M410 to speak with one of our experts.
Alternatively, if you would like to arrange a meeting with us prior to the event, please email us: testingservices@randox.com, and quote Safety & Health Expo 2018 at the beginning of your message.
For more information on workplace drug & alcohol testing, visit www.randoxtestingservices.com.
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
Is Biomarker Multiplexing the future of kidney disease screening?
Chronic Kidney Disease (CKD) is both a cause and a consequence of cardiovascular diseases, and is an increasing burden on global health. As diabetes, obesity and hypertension incidences continue to rise and the world’s population steadily ages, CKD’s prevalence is already estimated to be between 11% and 13% globally for all five KDOQI stages, with a majority in Stage 3 (about 90% of all stages).
With early stages of CKD being asymptomatic and current diagnostic tools (proteinuria determined by albumin to creatinine ratio and decreased renal function estimated from GFR using the CKD-EPI equation) are insufficiently sensitive to detect most cases up to stage 3, it is likely that the true prevalence of CKD is still underestimated. Therefore the need to improve both early diagnostics and overall CKD outcome is all the more critical.
Accordingly, biomarker research has been intense in the field of renal disease for at least 10 years with a number of promising candidates emerging, some now well-known by specialists: Cystatin C, NGAL or KIM-1 for example.
However, further novel biomarkers, assessed in combination using a properly developed multiplex assays can allow superior insight into CKD than what their individual performance could achieve. This also largely stems from selecting the markers that are indicative of complementary mechanisms that contribute to the development of CKD.
When assayed together from a single serum sample and after combinatorial analysis has been applied, these biomarkers can open new avenues in the management of CKD, such as proper diagnosis of the condition from Stage 1, clear differentiation between stages and monitoring of the progression pace of the disease. Early screening of patients at risk of CKD is now within reach and it is expected that its systematic use will have a profound impact on health system economics.
Another area of interest in renal research is Acute Kidney Injury (AKI) which may arise as a result of cardiac surgery and can subsequently lead to CKD. AKI detection is also of significant interest in the field of drug development, where early stage toxicity is still a large cause of new drug marketing withdrawal. Hence selecting and qualifying kidney tissue damage biomarkers, and assembling them into a multiplex panel is a key priority to those involved in early stage clinical trials.
An AKI panel has been worked out using the same principles as those used in the development of the CKD panel: high individual diagnostic value and multiple, independent cellular targets. This panel is now ready for final clinical qualification and will be one of the first of several organ-targeted safety panels aiming to become standard for drug induced toxicity screening.
It is key to the adoption of multiplex testing that proper validation guidelines be published and that careful, matrix-based validation data is made available to potential users. It is essential that multiplexed testing comes to the front line of testing in the field, so it can deliver to its full potential and start translating into public health improvement and cost savings. Technology is ready, let’s make a start!
Dr Claire Huguet
Randox Biosciences – Head of Biomarkers
For further information about kidney disease screening from Randox Biosciences, please contact randoxpr@randox.com
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