With more than 30 years’ experience developing pioneering high quality, cost effective Quality Control solutions for the IVD market Randox has designed their Acusera range of third party controls to simplify QC practice for labs of all sizes. The following outlines frequent complaints that arise in the lab & solutions we can offer to ensure you no longer quietly complain about your QC.
High volumes of controls needed to assess your test menu?
Acusera controls can contain a unique combination of up to 100 analytes in a single vial. This consolidation will permit you to reduce costs by removing the need to purchase extra controls to cover your complete test menu. As fewer controls are required the amount of time spent preparing controls is reduced, freeing staff to complete other tasks.
QC does not contain clinically relevant levels?
The analytes present in our Acusera controls have been included at clinical decision levels. The importance of employing controls that cover clinically relevant concentrations is highlighted by ISO 15189 & its significance is demonstrated in the following example. When measuring Troponin T the cut off value is 14 ng/l. Patients who present to the hospital with a concentration higher than 14 ng/l in their blood are said to have had a cardiac event. Test results lower than 14 ng/l would indicate that the patient is healthy or it is too early to tell if a cardiac event has occurred. As such it is imperative that analysers can accurately measure to this level and that performance at this level is assessed. QC material with similar cut off levels should therefore be used. Acusera meets these requirements, reducing the number of controls you need to cover both your complete test menu & the necessary clinical decision range for specific tests.
Frequent expensive lot changes?
With a shelf life of up to 2 years for liquid & 4 years for lyophilised controls, Acusera can help minimise costly lot changes. Furthermore each control has their own target values & extended open vial stability claims, which do not differ from lot to lot due to our unrivalled consistency. Both features will ultimately help reduce waste, minimise costs & limit the time spent reassigning values after each lot change.
When using controls with non-human components you are likely to experience shifts in QC values when changing reagent batch. Our controls are 100% commutable, reacting to the test system in the same manner as a patient sample, helping you to not only meet ISO requirements but reduce costly QC shifts.
Need to improve confidence in QC results?
Acusera 24.7 is an interlaboratory data management designed for use with Randox true third party controls. The software has been created to help monitor and interpret QC data, providing access to; QC multi-rules, interactive charts, real-time peer group data and our unique dashboard interface for at-a-glance performance assessment.
With Acusera you will no longer quietly complain about your QC!
With features such as our test menu consolidation, clinically relevant levels, commutability & unrivalled stability, partnered with Acusera 24.7 can help you reduce waste and costs while improving performance in your lab. Simply contact us today for more information or request a consultation from one of our QC consultants via firstname.lastname@example.org
What does the future of Medical Technology and Healthcare look like? How big of an impact does technology have on health?
Let’s start with a few fun facts: more people on this planet own a smart phone than a toothbrush, Google handles an estimated 1 billion search queries every day, every minute 20.8 million+ WhatsApp messages are sent, and you can probably check if all of those facts are correct in about 0.70 seconds.
If one thing is clear, it’s this: technology has made the world a different place. We live in a digital world where we rely on technology to make friends, to keep friends, to track progress, to prompt us, to wake us up, to motivate us and, most importantly, to keep us healthy.
When considering the future of technology, we may picture crisp-white rooms, voice-activated coffee machines and holograms… at one time it was a common idea that the future would hold flying cars! There is, however, one thing we can all agree on. In the “future”, however advanced technology may be and however far we may have come: whatever technology is created will be created to aid human life, as tech-innovation has always been. Inventors have striven to simplify and solve life’s little problems for centuries. Holistically speaking, most products and services with vigorous research and development programs are devoted to searching for new ways to fulfill human lives. We, at the RX series team, are based within a marriage of sectors that are more human-focused and yet forward facing in terms of development of new and exciting ideas than any others; health, medicine and technology.
“We take our commitment to research and development very seriously” comments Peter FitzGerald, founder of Randox and the RX series on the company’s R&D department, “Randox is at the forefront of life-changing research and development in the diagnostics industry.” Jason Silva, an American public speaker pondered, “In symbiosis with our technology, our powers are expanding exponentially and so, too, our possibilities” and just as Silva stated, advanced technology can greaten human abilities and opportunities vastly when dedication to healthcare is combined with advanced knowledge in technology and innovation. Diagnostics and medical technology are at the forefront of life changing innovation. RX series scientist, David Brown, pondered advances in Medical Technology, “There is constant progress being made in the range of diagnostic tests across every aspect of healthcare. Medical technology needs to meet the demand of these tests along with the expectation of patients for fast results. “
Today, only the smartest minds are dedicated to tackling the many issues within the industry. Many sectors play a part in innovation in healthcare; reagents production broadening test menus and researching new assays for a wide variety of human conditions, quality control bringing confidence in laboratory results for organisations and patients, health services giving complete diagnostic reports for preventative health, medical devices pushing the boundaries for automation, software design, reliability and precision, bio-sciences, toxicology, food testing, and so forth. Randox have played a large role in innovating all of these sectors. We do this, because we are confident that complete consolidation is the future of healthcare. The RX series team run on the belief that our machines function as the high-tech heartbeat of the laboratory and and our quality control and reagents function as the lifeblood, working in harmony to deliver effective results, and advancing in synch with each other.
When the RX series sees the future, we see test menus expanded to cover all ranges of analytes for earlier diagnosis, we see high class automation and longer walkaway times to make laboratories more efficient in time and money, and finally, we see those who rely on our medical technology for accurate results living happy, healthy lives, having trust in doctors and medical professionals worldwide.
It is widely recognised that high homocysteine levels in the blood (hyperhomocysteinemia) can cause inflammation in the blood vessels, which in turn may lead to atherogenesis and ischemic injury. High homocysteine levels are therefore a possible risk factor for coronary artery disease (CAD), or heart disease.
However a new study published in the Journal of Thrombosis and Haemostasis in April 2016 (conducted by Young Cheul Chung and colleagues, from Rockefeller University in New York City) has looked into the growing evidence to suggest that hyperhomocysteinemia is also correlated with Alzheimer’s disease and vascular dementia. This study was undertaken to clarify the specific role of elevated homocysteine levels in Alzheimer’s disease pathophysiology.
The study was carried out on mice, and showed a promising link between high levels of homocysteine and Alzheimer’s disease. It showed that diet-induced hyperhomocysteinemia in an Alzheimer’s disease mouse model leads to severe cerebral amyloid angiopathy and parenchymal amyloid-β deposition, as well as significant impairments in learning and memory, suggesting that elevated levels of plasma homocysteine and its metabolite, homocysteine thiolactone, contribute to Alzheimer’s disease pathology.
Commenting on an earlier study, Dr Susanne Sorensen, Head of Research at Alzheimer’s Society UK said that the molecule [homocysteine] is carried by everyone, but those who go on to develop some dementias appear to have higher levels of the compound. She also stressed that research is needed to establish just what role if any homocysteine plays in the development of dementia and how best to keep levels of the molecule low.
Alzheimer’s disease is a progressive mental decline that can occur in middle to old age, due to a degeneration of the brain. It is the most common cause of premature senility, and is also the most common form of dementia, affecting 62% of those diagnosed. Vascular dementia is another form, affecting 17% of those diagnosed.
Paul McGivern, Clinical Chemistry R&D Manager at global healthcare company Randox Laboratories, has commented
“Dementia is a terminal condition and with 850,000 people living with dementia in the UK, there is an urgent need for further research into the link between Alzheimer’s disease and homocysteine levels. If we can better establish this link, it may give future researchers the tools necessary to find a prevention, or even a cure to this condition.”
With the number of dementia sufferers set to rise to over 1 million by 2025, soaring to 2 million by 2051, the need for further research into the link between homocysteine levels and Alzheimer’s disease has never been more pressing.
For health professionals
Randox Laboratories offer an automated test for the biochemistry measurement of homocysteine. This is available for use on a wide range of manufacturer’s analysers. Please contact email@example.com for further information, or to request a kit insert or application.
Randox employees enjoyed a bake sale yesterday at our headquarters in Crumlin. The bake sale was hosted by Randox employee Rachel Walls on behalf of her sister, Ursula McKenna, who will be running both the Dublin Marathon and Manchester half Marathon later this year in aid of the Cystic Fibrosis Trust.
Ursula McKenna has raised an impressive £3000 for the Cystic Fibrosis Trust and is set to continue her efforts in raising money for this great cause. Having run the London Marathon twice, with the last one completed on Sunday 24th April, her motivation stems from personal empathy of the condition;
‘Our cousin suffers from Cystic Fibrosis, and running a few marathons is easy compared to what he has to deal with on a daily basis’
Cystic Fibrosis is a genetic condition caused by a faulty gene that controls the movement of salt and water across the cell wall. This causes mucus to build up in the lungs and digestive tract, causing problems with breathing and digestion. An estimated 1 in 2,500 babies born in the UK have Cystic Fibrosis, with more than 2.5 million people in the UK carrying the faulty gene. Currently there is no cure for Cystic Fibrosis, however there are treatments to help manage the symptoms.
Ursula’s dedication to the cause is evident and this extends to her family through their help and support. The bake sale hosted by Rachel yesterday at Randox included scrumptious treats made by the family, and helped raise £308! In addition to hosting fundraising events, her brother also ran the New York Marathon in 2014 and will be joining Ursula in running the Dublin Marathon in October. Hoping to beat her previous completion times of 4:27 in her first marathon and 4:07 in her second marathon, Ursula aims to complete the Dublin Marathon in less than 4 hours. Good luck!
A lot happens between giving a patient sample and getting your results. Although you may never meet face-to-face, laboratory professionals play a very important role in health care. These professionals are ultimately responsible for conducting tests that provide results and information for detecting, diagnosing, treating and monitoring disease.
With the aim of celebrating and honouring medical laboratory professionals around the world who perform and interpret billions of laboratory tests every year, Lab Week has been taking place at the end of April each year for over 40 years.
Randox Quality Control would like to thank both the laboratory professionals who utilise our products and our own research & development laboratory staff who make our QC and EQA range the highest quality and most reliable available worldwide.
We are committed to revolutionising healthcare on a global scale.
This week, Randox Testing Services opened the doors of its laboratory to BBC Newsline, and Donna Traynor, to offer an expert opinion on legal highs. Legal highs are mood-altering or stimulant substances whose sale is not banned by current legislation. They are made up of various chemical ingredients and replicate a similar user experience of illegal drugs such as cannabis, ecstasy and cocaine. They are extremely addictive and can have fatal side effects.
April 2016 marks the anniversary of one such case. The tragic passing of Adam Owens, a 17 year old boy who died after taking a legal high known as Sky brought this issue to the spotlight, and now one year on, the BBC want to know what is being done to tackle this issue.
The most difficult issue to combat with legal highs is that their chemical make-up is constantly being altered in order to get around legislation. As they keep changing it is difficult to create tests for these substances as they constantly evolve. Addressing this issue, Dr Mark Piper, Head of Toxicology at Randox Testing Services explained what is currently being done to try and counter this problem:
“We counter it here at Randox by continually developing new tests. In the past 12 months, Randox has developed over 115 new tests for new types of psychoactive substances.
These drugs are continually being developed and evolving into new types of substances which have previously fallen outside of the legislation, so it is a challenge for the likes of ourselves as drug testing laboratories to continually develop new tests to detect these substances.”
The prevalence of legal high use makes this an issue that cannot be avoided. Randox Testing Services are dedicated in their commitment to continually develop new tests in the fight against legal highs.
More and more women in the United States are waiting until they’re older to start having children.
The number of births to women aged 45–49 rose 14% in 2013 from 2012, according to the Centers for Disease Control and Prevention’s National Vital Statistics Report. With this comes the responsibility by clinicians and laboratories to better assess those at risk of gestational diabetes and to aid better control of the condition for those who already have it. Quick and precise detection of risk of gestational diabetes and associated complications by clinical labs will provide women with the autonomy to take control of their maternal health.
Innovations in maternal health testing have meant that analysis such as adiponectin and enzymatic fructosamine are now available in automated biochemistry formats and with more accurate methodologies; allowing laboratories to assess gestational diabetes risk, and evaluate control of the condition with ease, speed and accuracy. Testing of such analytes have historically been non-routine and not easily accessible for clinical laboratories, and now with little adjustment within the laboratory, these can be added to the test menu allowing for detailed patient testing profiles.
Current innovations in the area of gestational diabetes testing will ultimately secure the health, both during and post-pregnancy, of mother and baby.
A shocking 7 million people worldwide are diagnosed with diabetes each year! As such, it is one of the biggest challenges to healthcare today. Help raise awareness of diabetes by sharing our infographic:
Year upon year, WHO (World Health Organisation) have set a date to raise awareness of various health issues from Food Safety, to Hypertension to Vector-Borne diseases. This year, WHO are setting their goals in raising awareness on Diabetes; those with family and friends affected and those diagnosed. The RX series take a closer look at a type of Diabetes we don’t often talk about to raise awareness for the #BeatDiabetes campaign by the World Health Organisation (WHO).
Diabetes is a life-long condition, featuring in the top 10 causes of death globally, responsible for approximately 1,497,371 deaths worldwide and 6,088 in the UK alone yearly. As a major non-communicable disease, diabetes claims on average around 8% of total health budgets in developed countries.
As many know, diabetes can come in 2 common forms: Types I Diabetes; where the pancreas does not produce insulin and Type II Diabetes; where the pancreas doesn’t produce enough insulin/the body’s cells do not react to insulin. Not very often, however, do we hear the term Gestational Diabetes.
Gestational Diabetes is a type of diabetes that affects pregnant women, usually in their third trimester. The good news is, the condition usually disappears soon after the baby is born, but what are the risks, how serious is it really and what are the chances you may find yourself dealing with the condition?
Pregnancy puts extra demands on the body, as it demands higher level of nutrition, and energy. Gestational Diabetes (GDM) occurs when the body can’t produce enough extra insulin to meet these demands.
The condition is surprisingly common, with 15% of all pregnancies resulting in the mother suffering from GDM. Whilst it only occurs in pregnancy; it is estimated that over 50% of women who have had gestational diabetes will go on to develop type II diabetes within 5-10 years of delivery which is a startling statistic.
A study carried out at JSS Medical College aimed to investigate the biochemical parameters that could be used to diagnose GDM. Levels of serum creatinine, uric acid and the albumin were studied in GDM patients and unaffected pregnant women to consider any correlation between these biochemical markers and certain clinical parameters. The RX daytona, a clinical chemistry analyser from Randox’s RX series range was used to analyse the samples. The conclusion was that biochemical parameters such as serum creatinine, uric acid and albumin, can help in predicting the early onset and progression of GDM.
The study also stated that early diagnosis was paramount as it could help in the proper treatment of gestational diabetes and its associated complications for mother and baby, thus helping to improve the quality of life of the GDM patients and their offspring.
There are measures women can take before and during pregnancy to prevent the likelihood of Gestational Diabetes occurring. One study shows that increasing fibre intake to 10g per day reduces the risk by 26%. Also, women who exercise before pregnancy have a lower risk of gestational diabetes, the more intense the exercise, the lower the risk. However, this doesn’t have to mean extremely strenuous exercise, anything as simple as walking at a brisk pace, rather than at a leisurely pace will reduce your risks.
This year on World Health Day, we urge you to share your stories and give support for those affected by diabetes and use the hashtag #BeatDiabetes to get involved with the conversation.
Randox offers high quality tests for the diagnosis of diabetes and the monitoring of its complications.
To find out more about the RX series range of clinical chemistry analysers and how we tackle Diabetes with accurate and early diagnosis, take a look at our brochures below.
Questions? Speak to the RX team: theRXseries@Randox.com
The use of ELISAs for clinical testing within a laboratory is notably time and personnel consuming, with heavy resources used on manual interaction. Moving from ELISA technique to an automated biochemistry method for detection of the same analyte increases time and personnel efficiency considerably – time and management efficiencies equal cost effectiveness. The significance of ensuring quality in testing practices, and as such confidence in clinical results, is also a key consideration for running automated biochemistry tests over manual ELISA testing techniques. The risk of error, contamination and therefore compromising clinical results (which is higher when running ELISA methods) will be greatly reduced through the alternative biochemistry automation.
By transitioning analytes historically only available on ELISA to automated biochemistry methods, laboratories are able to expand their test offerings to patients and clinicians. As an example within key cardiovascular testing, analysis such as H-FABP, 11dhTxB₂, adiponectin and sPLA₂ being available in an automated biochemistry format allows laboratories to expand their testing and test menu with ease. Automated biochemistry analytes increase testing range, with little adjustment within the laboratory, allowing for detailed patient testing profiles, without the manual restrictions placed by running ELISA techniques.