Dementia is now āour greatest medical challengeā
It has been announced today by the Office of National Statistics that dementia is the leading cause of death in the UK. Last year alone more than 61,000 people died of dementia and this figure is set to rise along with the ageing population. Currently, there are over 850,000 people with dementia in the UK- 40,000 of which are under the age of 65. This number is expected to reach over 1 million by 2025.
The majority of the dementia deaths were among women – 41,283 deaths in 2015 compared to 20,403 dementia deaths in men. For men it seems the leading cause of death is related to heart disease.
Hilary Evans, Chief Executive of Alzheimer’s Research UK, said, “These figures once again call attention to the uncomfortable reality that currently no-one survives a diagnosis of dementia.
“Dementia is not an inevitable part of ageing, it’s caused by diseases that can be fought through research, and we must bring all our efforts to bear on what is now our greatest medical challenge.”
Dementia describes the different brain disorders that trigger a loss of brain function. These conditions are all usually progressive and eventually severe. Alzheimer’s Disease is the most common type of dementia, affecting 62% of those diagnosed. Other types of dementia include; vascular dementia affecting 17% of those diagnosed and mixed dementia affecting 10%.
The most common symptoms of dementia include memory loss, confusion and problems with speech. However it is important to spot the early warning signs. These include finding it hard to follow conversations or programs on TV, forgetting names of friends or everyday objects and feeling confused even in a familiar environment.
Here at Randox we recognise the importance diagnosing dementia early and we worked with the Medical University of Vienna to develop the Randox ApoE4 Biochip Array which can identify the risk of developing Alzheimer’s within three hours. When we presented it earlier this year, it won the prestigious NACB/ AACC Distinguished Abstract Award.
The Biochip analyses Apolipoprotein E (ApoE), a gene which is recognised as one of the most significant genetic risk factors for dementia and other neurodegenerative diseases. There are three versions of the ApoE gene: E2, E3 and E4. The E4 version increases a person’s risk of developing late-onset Alzheimer’s disease, though it may also be associated with an earlier onset of memory loss. Everyone carries two copies of the ApoE gene but 25% of the population carry one copy of the ApoE4. Inheriting two copies of the E4 variant increases a person’s disease risk by 10 times or more.
The Biochip was developed at our state of the art site in Dungloe, ‘Teoranta’. R&D scientists Emma Harte said, “This type of testing is important in our quest to understand and diagnose Alzheimer’s, and empower patients to understand risks, consider medication and even make early lifestyle changes.
“Pairing this test with medical and family history for risk of Alzheimer’s disease has the real potential to advance personalised medicine. This fast, accurate testing will allow doctors and patients to make more informed choices earlier to potentially slow the possible progress of Alzheimer’s.”
If you would like to find out more information about our Alzheimer’s test contact us at randoxPR@randox.com
We Are Randox | Life in Austin, Texas with Andrew Dunlop
As a global diagnostic company with employees situated in 145 different countries across the globe, working with Randox offers amazing opportunities for international travel, and even for relocating half way across the world!
Our aim is to revolutionise healthcare through innovative diagnostics and save lives, and we can’t achieve this aim without the support of each and every one of our employees who are situated throughout the world.
Recently we took the time to catch up with Andrew Dunlop, who relocated from our Headquarters in Crumlin to Austin, Texas, USA.
Hi Andrew, what’s your current job title at Randox?
Currently my job title is National Sales Manager for the RX Sales department at Randox. I have been working for Randox for over four years now and I am really enjoying my role. My main job responsibilities include selling RX instrumentation to clinical labs, research sites and education facilities while also managing staff who do the same.
Was relocating something that you imagined doing when you first started your career with Randox?
Relocating was always something that I thought may have been an option but wasn’t sure how realistic it would be. I was always encouraged to pursue international travel and I loved the idea of seeing how business was done in other parts of the world. Having previously lived in the USA for two years through an internship with another company before I started working for Randox, I loved the idea of returning someday but didn’t know if it would be possible. I didn’t know anyone who already lived in Texas but because I had travelled to Austin on so many occasions for business I knew it was a great city. As I was travelling quite frequently to the USA I brought up the possibility of relocating there which was fully supported by the company.
What happened in the first few weeks of your relocation? Did you face any challenges?
The first few weeks were fairly hectic: I had to source getting a new car, a driver’s licence and finding an apartment and furniture. Randox helped me settle in by putting me up in a hotel initially and they also bring me home at least once per year which is something that I always look forward to.
How are you finding living in a new culture?
I love the culture in the USA and I have got used to pronouncing words a certain way so people can understand me such as two, eight, hour and even Andrew. The American’s use different terms such as Cell Phone, trunk, Gas etc too. The weather is also great, blue skies and sun is the norm for me now. I am able to live an outdoor lifestyle in my spare time, go hiking, mountain biking, BBQs etc, the list could go on and on!
How are you coping living so far from home?
I miss family and friends a lot, but as time passes it becomes normal. But the company does fly me home once per year which is something I always look forward to. I will have been home three times in 2016, but I wasn’t home at all in 2015.
Are you doing the same job in your new role?
My job role didn’t change significantly, I do a very similar job that I did before when I was located in Ardmore. Previously I managed staff who sold RX equipment in Brazil, Spain, UK and USA but now I purely focus on the US market. Plus being in the market has allowed me to understand it so much more and sales have really grown as a result which is a big plus!
What’s been the highlight of your move so far?
The highlight for me is being in a city that I truly love.
If you are interested in joining an international company that can offer you the chance to relocate to some of the biggest cities in the world, make sure that you check out our website for any current opportunities. We also offer a student placement program and graduate development program to help students and recent grads build the necessary experience needed to work within a global company.
Make sure to follow Randox Careers on Facebook, Twitter and Instagram to stay up-to-date with the hashtag #WeAreRandox
IQCP: Where Are We Now?
What is IQCP?
IQCP stands for Individualized Quality Control Plan, and it is an all-inclusive approach to creating a customized quality control plan for a laboratory.
IQCP focuses on assuring quality in the lab using more in-depth means than simply carrying out a certain number of QC tests at a specific frequency. Many different aspects of laboratory operations will be evaluated, such as the test system, reagents, environment, testing personnel etc.
Where are we now?
As of January 2016, many labs in and outside the USA have implemented their IQCP’s, but what impact has this had on day-to-day operations?
In order to gauge the overall effectiveness and user-experience of implementing IQCP, Westgard QC1 conducted a survey for all IQCP participants both in the USA and globally.
Opinions were mixed regarding the effectiveness of IQCP:
Positive Opinions of IQCP
- Some users found that IQCP decreased the number of QC materials required
- There is a greater emphasis on the pre and post-analytic phases of testing, thus improving process error identification
- Over half of global survey participants revealed that their IQCP identified unacceptable risk(s) in their test system, thereby creating a more robust process
- Of the labs whose IQCP’s were inspected in the USA, 96.3% were deemed adequate by the relevant regulatory bodyies
- Identification of errors can lead to additional personnel training, thereby increasing the knowledge and expertise of laboratory staff
Negative Opinions of IQCP
- Due to the length of time taken to create a single IQCP, coupled with the additional expense, several survey participants found that the benefits of IQCP did not justify using so many resources in its implementation
- Many labs raised concerns regarding the availability of guidance in developing an IQCP. Participants complained that useful guidelines were not provided quickly enough, and labs had to rush their IQCP implementation.
- Several survey participants felt as though there was widespread confusion over IQCP. Participants highlighted that the volume of questions from laboratory professionals proves that IQCP was not introduced by regulatory bodies in an organized or effective manner
- Some labs surveyed voiced the opinion that IQCP evaluation needs to be more standardized, and that inspections can either be too lenient or too stringent.
ISO 15189:2012 requirements
As with any new system, feedback is important for further refinement. IQCP appears to be a step in the right direction for the advancement of laboratory QC. According to Westgard’s survey1, only around 30% of US respondents were satisfied, showing that labs still feel improvements need to be made. Inspectoral standardization, or more concise, straightforward guidelines on IQCP implementation could be potential improvements for regulatory bodies to consider.
We would love to know your thoughts on the subject. Send us an email at acusera@randox.com.
References:
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Westgard QC. (2016).2016 IQCP Users Survey. Available: https://www.westgard.com/iqcp-user-survey-comments.htm. Last accessed 25-Oct-16.
Ballymacrickett Primary School pupils visit Randox as part of a new collaboration to enhance pupil knowledge of STEM based work.
As an international organisation that aims to deliver world class pioneering research that will revolutionise healthcare worldwide, we are always pleased when the next generation of scientists want to come and visit us. So we were delighted when Ballymacrickett Primary School got in touch with us to organise a visit.
Last week Randox welcomed primary 7 pupils from Ballymacricket Primary School to our Randox labs to gain a first class insight into the work that we carry out here. As part of the collaboration Randox is sponsoring Ballymacrickett Primary School to conduct their very own STEM project that will allow primary 7 pupils to take part in the Junior Innovators project. This project is run alongside Sentinus, a non-profit educational charity that works with schools throughout Northern Ireland to deliver programs to promote engagement in STEM subjects.
As part of the project the primary 7 pupils will conduct cross circular project work which can include workbooks, exhibition materials, models of products and even the development of a mini enterprise and their very own products. The aim of this project is to support the development of links between primary schools and local business and industry and to give classroom learning relevance to the world of work through a structured program of activity.
The first step in the project involves a visit to a local company, and we were thrilled to welcome over 50 pupils to our headquarters here in Crumlin from the 24th-27th October. The tour included a visit around our different departments and behind the scenes access to our science labs to gain a better insight into the work that we pioneer which was especially interesting.
At the end of the tour each pupil received a goodie bag filled with plenty of Randox stationery to take back to school with them.
We are delighted that the tour was both enjoyable and informative and sparked an interest in many more pupils to enter the world of science!
Good luck Ballymacrickett Primary School- We can’t wait to see your final project!
Make sure to follow Randox Careers on Facebook, Twitter and Instagram to stay up-to-date with the hashtag #WeAreRandox
We Are Randox | Behind the scenes of Randox Engineering with Maryrose McLoone
Randox is an international company renowned for our innovative medical diagnostics but did you know we also have a dedicated engineering team with over 30 years’ experience in the design, prototyping, testing and manufacturing of diagnostic analysers?
Maryrose McLoone, from our Randox Teoranta site, gave us an insight into her role as a mechanical design engineer and told us what she enjoys the most about engineering.
Hi Maryrose, tell me a little about your position and what you do on a day-to-day basis?
I work as a Mechanical Design Engineer in Randox Teoranta where my main role is to aid in the design and development of clinical chemistry analysers. My day-to-day work can vary depending on what stage of a project we’re on. At the minute I’m working on developing concepts for our new project. This involves working with other members of the Engineering team to come up with ideas and designs and develop them into working prototypes. Engineers have many roles including creating designs using 3D modelling software, carrying out testing and analysis, as well as verifying and validating our designs. We work with Manufacturing and also with Quality Assurance to ensure we meet all of the relevant standards which are applicable for the Medical Device Industry.
Are there any challenges in your job? If so, how do you handle them?
When working in R&D, the main challenges we face are in ensuring we develop analysers of the highest quality, which will perform accurate diagnoses, and also are competitive in their market. It is always important that we consider the end user of our devices as the patient is of the upmost importance. Quality is an integral part in all stages of the project from the early design stages right through to product release. We must ensure that we will continually deliver quality in every aspect of our work. This is achieved by conducting thorough testing on all of our designs as well as remaining up-to-date with all of the latest technologies which are available to us.
What is your proudest accomplishment at the job?
As a team, we recently completed the design and development of a semi-automated clinical chemistry analyser, the RX misano, which has been released to market. This is a big accomplishment for our team as it is the result of our combined hard work and efforts. This was the first engineering project to be completed solely in Randox Teoranta, which is why it is such a big achievement for us.
What do you enjoy the most about your job?
As a Mechanical Design Engineer, there is a wide variety in the work that I do. Every day is different and each brings its own challenges. I particularly enjoy working with medical devices as I find that is a very rewarding job. Randox analysers are used worldwide to conduct a wide variety diagnostic tests. By working in the development of clinical chemistry analysers I am part of a team which create devices that improve the healthcare of patients all over the world.
As a Mechanical Design Engineer, I also have the opportunity to work with an interdisciplinary team of Engineers including Mechanical, Electrical, and Embedded Systems Engineers, as well as Software Developers. We also work closely with Manufacturing and Quality Assurance which has allowed me to gain an insight into various aspects of design and development which I would not have previously experienced.
What advice would you give someone who is seeking the same line of work?
Design Engineering involves creating innovative solutions and improving on current designs; therefore problem solving is a key skill in this line of work. The design and development stages involve a lot of creativity, whereas the testing stages of a project require meticulous attention to detail. As an Engineer you work autonomously as well as part of a team. You also work alongside Engineers of different disciplines and other departments within the plant. The design and development of a product can be a lengthy and sometimes challenging process but it is also very rewarding when you see a project through to completion.
If you are interested in joining our Engineering team make sure that you check our our careers website for all our current opportunities.
Make sure to follow Randox Careers on Facebook, Twitter and Instagram to stay up-to-date with the hashtag #WeAreRandox
The RX misano is currently unavailable to purchase in Germany
NI business leaders and MLAs take a trip to Randox China
A number of business leaders and MLAs from Northern Ireland took time to meet with members of our Randox team based in China this week.
The group visited China in a bid to develop and nurture business relationships between the two countries, during a trip organised by the Northern Ireland Assembly Business Trust.
The Trust works to forge business relationships between local businesses and parliamentarians in Northern Ireland, offering a unique opportunity for each to better understand the industry in which they operate. The Trust organises educational visits, fellowships, seminars and trips for local businesses and MLAs to encourage participation on issues of mutual interest.
David Hu and Karen Li, members of Team Randox based in China, met with the group made up of MLAs Colin McGrath, Conor Murphy, Danny Kennedy, Clare Bailey, Kellie Armstrong, and Joanne Dobson, Stephen Kelly, Chief Executive of Manufacturing NI, Colin Neill, the head of Pubs of Ulster, and representatives from the Confucius Institute at Ulster University, an organisation which aims to develop academic, cultural, economic and social ties between Northern Ireland and China.
The group’s trip also involved a visit to the Shenyang Party Congress and Department for Commerce, and to the Irish Embassy in Beijing.
Susan Hammond, Randox China Sales Manager, commented;
“As a key market we have for the past 20 years exported to and worked across China, where Randox is a well-known and respected brand within the healthcare landscape. It is our dedication and hard work within this dynamic market, through both our HQ based team in Northern Ireland and our dedicated local team spread across China, that has enabled this. Our success so far drives us in our continued efforts in growth in this market, and our continued investment in introducing new and innovative products to the market.”
David Hu, Business Development Executive at Randox China, commented;
“It was a fantastic occasion meeting with the delegation from Northern Ireland. We work very closely with the team at Randox HQ in County Antrim, and so we relish the opportunity to engage and develop relationships with relevant representatives from Northern Ireland, whether in the political or business sphere. We’re delighted to be able to gain further insight into the relationships that exist between our two prosperous nations and look forward to nurturing these relationships in the future.”
For further information about our team in China, please contact our Randox PR Team.
E: nicola.mchugh@randox.com or amy.mcilwaine@randox.com
T: 028 9445 1016
Pictured left to right are:
Stephen Kelly, Manufacturing NI; Jill Xie, David Hu and Karen Li, Randox China.
Don’t Get Tricked This Halloween
Don’t Get Tricked This Halloween – Treat Your Lab to Randox True Third Party Controls Today!
Halloween – a celebration observed by many countries around the world on a yearly basis. Falling on October 31st this holiday is a chance for people to dress up, carve pumpkins, bob for apples, attend costume parties, trick-or-treat and tell scary stories.
It just so happens that we have a scary story for you – and what makes this story even scarier is that it’s a true story!
Our story starts off in a medical laboratory. This laboratory was running QC on their machine as they would do every day. Getting accurate results with no faults or problems arising from their machine, this laboratory was happy with how things were going – until one day when it all went wrong!
Having run their EQA/PT samples, the laboratory found themselves reviewing their report with shock –they noticed a large negative bias. To their horror the perceived ‘accuracy’ they had once achieved was now no longer the case. Right away the laboratory professional’s thoughts turned to the fact that approx. 70% of all clinical decisions are based on laboratory test results, meaning it is essential that the results provided are accurate and reliable in order to prevent potential misdiagnosis or inappropriate treatment. Had they sent incorrect patient results to the clinicians? Had a patient been misdiagnosed? Many thoughts fluttered around in their heads.
The laboratory repeated their QC and found that the results obtained were almost identical to the previous run. The laboratory knew there must be a problem with their QC or their instrument, so they began the troubleshooting process. Nothing. Nada. Zilch. “What was going on?” was the question on the lips of the laboratory professionals.
One of the laboratory professionals then stumbled across a case study that took place in the University of Verona and Academic Hospital of Parma, Italy. The study was related to a field recall of Intact PTH, the reagent was recalled after falsely elevated patient results were discovered. The alarming thing was that the same elevated performance was not identified by the instrument manufacturer’s control. The study reported that due to this issue there was potential for 40,000 inaccurate patient results from just 18 labs in the Lombardy region of Italy. The study also concluded that the issue could have been prevented if a third-party control, independent from calibrator materials had been used.
This PTH case study got the laboratory thinking that maybe they should source a true third party manufacturer… Having sampled a third party QC, the lab found their results now mirrored that of their EQA and patient samples and as such proceeded to make the switch from first party to third party.
The moral of this story is that first party controls can sometimes “trick” the lab into thinking their performance is acceptable. Quite often target values provided with first party quality controls are in the middle of the analytical range thus masking the issues at the low and high ends of the assay range. Laboratory professionals should “treat” their labs to the best QC material. ISO 15189 highlights that the “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”. So this Halloween don’t randomly choose your QC supplier, treat your laboratory to the best, Randox QC.
All Randox controls are manufactured independently of any instrument or reagent, and designed for use with multiple instruments and methods ensuring, unbiased performance assessment.
Heart disease study suggests benefits of testing toddlers
Heart disease experts have suggested today that toddlers get tested for an inherited form of the condition, from as early as twelve months old.
Familial hypercholesterolemia (FH) is a genetic disorder characterised by very high cholesterol levels, specifically very high levels of low-density lipoprotein (LDL – so-called ‘bad’ cholesterol). FH is the main cause of heart disease and increases by 10-fold the chance of someone having a heart attack under the age of 40. However people who have been diagnosed can control their cholesterol levels by taking a daily dose of statins.
Currently testing is carried out when an adult who had has heart problems is found to be FH positive. Doctors then recommend testing for others in the family. It’s estimated that currently between 80-90% of FH cases remain undiagnosed.
However a new study led by a team from Queen Mary University of London took a different approach. They tested a group of one-year-old children for known genetic mutations which are linked to FH. Out of 10,000, 40 were found to be FH positive. Not only has this group of children been identified early, but because the condition is genetic, one or both of their parents must have it too. For every one positive FH test, at least two people were diagnosed.
According to the lead researcher Dr David Wald, preventive diagnostic testing for FH could prevent up to 600 heart attacks a year among the under-40s in England and Wales. He told the BBC,
“This is the only screening method that stands a reasonable chance of covering the whole population and identifying those at highest risk of an early heart attack.”
The broadcaster also spoke to the British Heart Foundation’s Medical Director Professor Sir Nilesh Samani who said,
“Early diagnosis in children is likely to substantially improve treatment of their condition and will help find other family members with FH. But before nationwide screening is adopted by the NHS, more work needs to be done to show it’s a cost-effective way for picking up individuals with FH which will be acceptable to families.”
Randox Biosciences have developed a FH test in partnership with the Belfast Health and Social Care Trust to proactively diagnose FH. Utilised on our patented Biochip Array Technology, our FH arrays simultaneously detect 40 of the most common FH-causing mutations within the LDLR, ApoB and PCSK9 genes, with results available in just three hours.
The test, which is available through Randox Health Clinics, has also been adopted by medical professionals within the NHS including Dr. Colin Graham, recently retired Consultant Clinical Scientist and former Head of the Regional Genetics Lab in the Belfast Health and Social Care Trust, who introduced the test within his Belfast Laboratory screen for suspected cases of FH.
He said the availability of this test marked a key milestone in the detection of the condition,
“Current FH diagnostic tests require a large volume of samples to be batched, leading to lengthy turnaround times of two to three months. With the new test, the turnaround time is dramatically reduced, enabling more rapid patient diagnosis. This new test has the potential to enable FH screening to become routine in the clinical setting for improved detection and earlier identification of familial cases.”
Dr. Peter FitzGerald, Managing Director of Randox Laboratories said,
“In the battle against cardiovascular disease, people with FH are on the front line. It is important to raise awareness of FH as many people do not even know that they and their family members have this life-threatening condition. There is so much that can be done to support families with FH and with this readily available and much-needed test, detecting and treating entire families with FH is now possible.”
We Are Randox | De Bordeaux Ć Belfastā¦Anthony Borsato passe 15 semaines en Irlande du Nord!
We Are Randox | De Bordeaux à Belfast…Anthony Borsato passe 15 semaines en Irlande du Nord!
As a global diagnostics company, with distributions and offices in 145 countries across the globe, Randox has plenty to offer students who are interested in understanding how an international organisation operates. Whether you are a placement student or a graduate you will be sure to gain great experiences, make new lifelong friends and broaden your employability skill set for the future.
Anthony Borsato, a French placement student currently working in the Finance Department here at Randox, told us about his experience living and working in Northern Ireland. Following his 15 week placement, today is Anthony’s last day and we are interested to hear what he has learnt from his time spent in our global organisation.
“I arrived in Crumlin at the end of July having travelled over from Bordeaux which is in southwestern France. I am studying continuous improvement engineering at Cesi School of Engineering, and as part of the apprenticeship programme I have to undertake a 15 week placement in an English country to help not only improve my English but to gain an international experience working abroad.”
After hearing good reviews from a previous placement student Anthony decided to come to Randox
“Last year another placement student who was on the same course as me came here. So I thought it would be a good idea to meet up with her to hear how she got on, find out what she did during her placement and hear more about Northern Ireland. She was extremely positive about Randox and really recommended coming over. I was reassured when she explained how much consideration Randox put into placements for international students – my mentor would speak French and be able to help with any issue to do with my placement. She also said that the people I’d be working with were very friendly and helpful. Knowing this made me feel much more comfortable about the move and I could see why she had been able to enjoy her time with the company. All in all, the feedback she gave me was really encouraging so that’s what enticed me to come.”
Anthony went on to discuss what his placement involved and how he enjoys having a varied range of tasks to complete each day.
“I like being challenged and learning new things on a daily basis. My responsibilities include updating the software with any new records and checking financial records and any recent transactions.”
Anthony’s team leader quickly identified his ability to develop strong customer relations and his bi-lingual talent was particularly useful with customers who speak French.
“As a global business there are many customers who speak languages other than English so being able to converse in another language is a real advantage in every department here. I was able to work on a number of occasions with our French customers and help to resolve any issues they had. When I go back to France I will have to conduct a presentation on what I did during my placement with Randox so I will have a lot to talk about.”
Anthony continued to tell us what he’s done during his free time and what he will miss the most when he returns home.
“I live in Belfast with six other people, my roommates are from Spain, Poland and even India so I have made some good friends from different nationalities. There is a good atmosphere here and there is a lot to do. I enjoy seeing the sights and experiencing all that the Belfast nightlife has to offer. I brought my own car over when I travelled across France from Bordeaux to Cherbourg. From Cherbourg I got the ferry which docked in Rosslare and I travelled up from there. It was an 18 hour journey but it was worth it as I wanted to be able to travel around Northern Ireland and see as much as I could. At first it was a little tricky getting used to driving on the other side of the road but now I’m used to it. When I go back home I will have to remember to drive on the right hand side again.”
“I live near Queen’s University which is a beautiful historical building that is a must see -especially at night. I also experienced my first traditional Irish fry which was very tasty. During my holidays in August I took a trip to the North Coast and the Giant’s Causeway which was great. I have also explored Derry, Sligo and Donegal, visited friends in Omagh and Enniskillen and took a day trip to discover the Mourne Mountains. I even spent a weekend in Dublin so I have managed to squeeze in a good bit of sightseeing since being here.”
“I have made some good lifelong friends during my time at Randox. So I think that is what I will miss the most when I leave along with the great work atmosphere. Randox is a fast paced environment and you are able to meet a range of people, not just those who work in the same department as you. I learnt a lot from my co-workers who were very welcoming from the moment I started. They taught me the phrase “on it like a car bonnet” which I will be introducing my family to when I return to France! In the future I hope to be able to come back and visit the friends I’ve made here and discover more of Northern Ireland.”
We’ve thoroughly enjoyed having Anthony as part of our team during 2016 and wish him the best for the future.
Au Revoir Anthony.
A la prochaine!
If you are interested in working with a global company and completing your placement with Randox make sure that you check out our careers website for all our current opportunities.
Make sure to follow Randox Careers on Facebook, Twitter and Instagram to stay up-to-date with the hashtag #WeAreRandox
Does Your QC Cover Clinically Relevant Ranges?
Following recommendations from recognized institutions such as ISO and CLIA, more laboratories are using third party controls than ever before. However, great care should be taken when choosing which third party control to use. A number of factors should be considered, and primarily among these is whether the control challenges the complete Clinical Range and the Medical Decision Levels. ISO 15189:2012 states that ‘The laboratory should choose concentrations of control materials wherever possible, especially at or near clinical decision values, which ensure the validity of decisions made’.
Measuring the Complete Clinical Range
It is important to assess the full clinical range of an assay i.e. the range between the lowest and highest results which can be reliably reported. In order to make sure a laboratory instrument is working across the full clinical range, a QC which covers low, normal and elevated concentrations must be used.
Question: “If the full clinical range isn’t covered by QC, how will we know whether patient results which fall outside the range of quality controls are accurately reported?”
What are Medical Decision Levels?
Medical Decision Levels (MDL) are the analyte values at which medical professionals can determine whether a patient may be suffering from a certain condition. The MDL is determined by a consensus of medical professionals and clinical research. Patients’ test results are compared to the MDL and appropriate diagnoses or medical interventions can be made.
For example, the MDL of Glucose can indicate a certain diabetic status:
| Analyte | Medical Decision Level | Diagnostic Status |
| Glucose (fasting) | <100 mg/dL | Non-Diabetic |
| 100–125 mg/dL | Pre-Diabetic | |
| >125 mg/dL | Diabetic |
Competitor QC
Many QC manufacturers ‘cut corners’ in an attempt to keep costs down, which often results in the sale of controls which do not cover the complete clinical range or vital medical decision levels. Below is an example of the Glucose concentrations present in a competitor control:
Competitor Chemistry Control Level 1 – 68 mg/dL
Competitor Chemistry Control Level 2 – 134 mg/dL
Competitor Chemistry Control Level 3 – 386 mg/dL
In the examples above, the competitor’s level 1 control covers the non-diabetic MDL, but the level 2 control is not within the ‘Pre-Diabetic’ decision range. The level 3 control is also much higher than can be expected for an elevated diabetic patient result (200 mg/dL or more).
Randox QC
Due to the superior manufacturing process used by Randox, QC target values are consistently within the MDL of tests. For example, the Glucose concentrations present in our Liquid Assayed Chemistry Premium Plus control are:
Level 1 – 57 mg/dL
Level 2 – 114 mg/dL
Level 3 – 236 mg/dL
The MDL for Glucose is covered by the Randox control, meaning laboratory professionals can be confident that patient results will be accurately interpreted.
Immunoassay Medical Decision Levels
Controls which cover the MDL can reduce the number of Quality Controls required by laboratories. For example, Randox Acusera Lyophilised Immunoassay Controls contain particularly low levels of TSH, Ferritin and Vitamin B12 in the Level 1 control, eliminating the need for an additional control at extra expense:
| Analyte | Medical Decision Level | Randox Level 1 IA Control | Competitor Level 1 IA Control |
| TSH | 0.1 or 0.27 uU/mL | 0.15uU/mL | 0.37 uU/mL |
| Vitamin B12 | 190 pmol/L | 174 pmol/L | 327 pmol/L |
| Ferritin | 12 ng/mL | 11.1 ng/mL | 49.6 ng/mL |
In this example the competitor offers an anaemia control with lower levels of TSH, Vitamin B12 and Ferritin at an additional cost. With Randox Acusera QC, only one control is required for anemia monitoring and detection.
