What is Six Sigma?
Six Sigma is a method of process improvement which focuses on minimizing variability in process outputs. The Six Sigma model was developed by Motorola in 1986, and Motorola have reportedly saved over $17 Billion due to its successful implementation.
The model looks at the number of standard deviations (SD) or ‘sigmas’ that fit within the quality specifications of the process. In the laboratory, the quality specifications relate to the Total Allowable Error (TEa). The higher the number of standard deviations that fit between these limits, the higher the sigma score and the more robust the process or method is. As sources of error or variation are removed from a process, the SD becomes smaller and therefore the number of deviations that can fit between the allowable limits is greater; ultimately resulting in a higher sigma score.
A process with a sigma score of six is considered to be a high quality process, making six the target for many industries including the clinical laboratory.
In order to achieve Six Sigma, a process must not produce more than 3.4 defects per million opportunities. In a Laboratory context, this would equate to 3.4 failed QC results per million QC runs.
Sigma is calculated using the following equation:
Sigma = (TEa – %Bias) / %CV
TEa – Total Allowable Error
%Bias – Deviation from the target or peer group mean
%CV – Imprecision of the data
Why is Six Sigma useful in the laboratory?
Six Sigma can be used to help answer one of the most commonly asked questions in laboratory quality control. How often should I run QC?
The Six Sigma model allows laboratories to evaluate the effectiveness of their current QC processes. Its most common use is to help implement a risk-based approach to QC, where an optimum QC frequency and multi-rule procedure can be based on the sigma score of the test in question. The performance of tests or methods with a high sigma score of six or more may be evaluated with one QC run (of each level) and a single 1:3s warning rule. On the other hand, tests or methods with a lower sigma score should be evaluated more frequently with multiple levels of QC and a multi-rule strategy designed to increase identification of errors and reduce false rejections.
The below table shows how multi-rules and QC frequency can be applied according to Sigma Metrics:
| Sigma Score | QC Frequency | Number of QC Samples | QC Rules |
| 6 or more | Once per day | Each level of QC | 1:3s |
| 5 | Once per day | Each level of QC | Multi-rule strategy |
| 4 | At least twice per day | Each level of QC | Multi-rule strategy |
| < 4 | At least four times per day | Each level of QC | Multi-rule strategy |
It is important to note that this is just an example and it may be necessary to run QC samples more often than three times per day. Some high throughput laboratories prefer to run QC samples before and after a set number of patient samples, while others opt to run QC samples after a set period of time. Whatever frequency you choose it is vital that the frequency is appropriate for the test in use. Download our guide ‘How often is right for QC’ to find out more.
What can Randox offer?
Randox’s Acusera 24.7 Live Online is a peer group reporting software application designed to complement the Acusera QC range. The intuitive and user-friendly software boasts some of the most advanced features on the market, and Version 1.6 provides automatic calculation of sigma scores for individual assays, giving the user an at-a-glance overview of assay performance.
Peer group reporting software is an integral part of any modern laboratory seeking to streamline their QC processes and reduce costs. With Acusera 24.7 Live Online, there has never been a better time to implement, save and succeed.
Contact us today to find out how Randox can help your laboratory achieve its goals.
Randox and Chan Zuckerberg Initiative share common goal
You may have read in the news this week that the Chan Zuckerberg Initiative co-founded by Mark Zuckerberg has pledged to invest $3 billion over the next decade to help further and advance medical research. Investments will go towards a research facility, named the Biohub, which will focus on developing new tools to research, understand and treat diseases, and of particular interest to us here at Randox, on creating a chip to diagnose disease.
Here at Randox we fully support this drive to further research that is devoted to revolutionising healthcare. We commit up to 16% of turnover to research and development each year and currently over 20% of the world’s major laboratories are using Randox products.
In particular, we invested £220 million into the development of our Biochip Array Technology (BAT). The Randox biochip has revolutionised the diagnostics industry by facilitating the detection of a wide range of markers of disease from a single undivided sample. This not only enhances patient diagnosis but reduces the amount of time spent on individual tests and associated laboratory costs.
Our expertise, highly specialised scientists and world-class ISO accredited manufacturing facilities enables early, accurate, informed clinical decisions in the areas of veterinary testing, molecular research and diagnostics, drug development, food safety and forensic and clinical toxicology.
Our Randox Health clinics use our Biochip to allow people to avail of the complete portfolio of Randox routine and novel tests to empower their health decisions. This new and exciting service provides personalised and preventive health profiling for each individual.
Speaking about the biochip Dr. Peter FitzGerald, Founder and Managing Director of Randox said,
“Many years of development and the expertise of our highly qualified scientists have gone into the creation of Randox Biochip Array Technology. This scientific development will facilitate the simultaneous quantitative or qualitative detection of a wide range of analytes from a single undivided sample. This approach both proteomic and genomic enables an enhanced patient diagnosis, optimum efficiency and consolidation of cost. Our arrays are suitable for use in a wide range of settings including clinical and research laboratories, biopharmaceutical organisations, forensic and clinical toxicology, hospital laboratories, food testing and veterinary laboratories.”
We are delighted that Chan Zuckerberg’s interest in this area brings to the forefront the importance of improving healthcare through innovative diagnostics. It is clear that Randox and the Chan Zuckerberg Initiative share a common goal to revolutionise healthcare worldwide and we believe that the Randox Biochip can play an important role in realising this vision.
For further information please contact our Randox Comms Team on 028 9445 1016 or email amy.mcilwaine@randox.com
Liquid Controls vs Lyophilised Controls
Results of our Liquid vs Lyophilised Poll
Having conducted a recent poll on our Social Media platforms (Facebook, LinkedIn & Twitter) asking our customers what format they preferred their quality control material in – liquid or lyophilised – we saw a large preference for liquid controls.
What does this poll result really tell us?
That most people prefer Liquid controls? Yes.
Lyophilised controls are not as popular amongst our social following? Yes.
However, it also tells us that even though most people chose a liquid format there was still almost a quarter of people who prefer to use lyophilised controls. Liquid and lyophilised controls both have their advantages and disadvantages, this blog is designed to help you decide which is the best fit for your lab.
Liquid Controls
Firstly, it is important to note that there are two distinct types of liquid control available on the market;Liquid ready-to-use and Liquid for ease-of-use, better known as Liquid Frozen. Both types of liquid controls reduce the potential for reconstitution errors and prevent contamination from poor quality water.
Liquid frozen controls must be thawed in a refrigerator before use, making them a little less convenient than the liquid ready-to-use alternative. They require no reconstitution so associated errors are removed. Due to the frozen nature of these controls, they are often shipped on dry ice to prevent thawing in transit, as such transportation costs can be significant.
Liquid ready-to-use controls are arguably the most favoured of the three formats and it is easy to understand why. The controls are simple to use, they require no preparation and there is no need to thaw before use.– With zero preparation required, these controls can be removed from the packaging and used right away! What’s more, they can be conveniently stored at 2-8oC minimising expensive shipping costs.
Another major benefit of using a liquid ready-to-use control is the fact that they are ideal for POCT (Point of Care Testing). The ability to use these controls on the spot is extremely beneficial to POC providers.
Lyophilised Controls
Lastly, the choice of 22% of respondents – lyophilised. This is freeze dried material which requires the laboratory professional to reconstitute the sample using sterilised water and mixing before use. Although this format is not as easy to use as either liquid control it does come with benefits. The enhanced stability of this control sees a shelf life of almost double the two years that is normal with a liquid control, however, the potential for reconstitution errors and the fact it is not as simple to use lead to the majority of people opting for a more convenient liquid control.
Randox Quality Control Range
With Randox QC there are a vast array of controls available in liquid ready-to-use and liquid frozen formats. Areas we have liquid frozen formats available in, include; Clinical Chemistry and Immunoassay.
Liquid ready-to-use controls can be found in the following; Liquid Cardiac, Blood Gas, Liquid Urine, Urinalysis, Specific Protein, Ammonia Ethanol, Haematology, Liquid HbA1c and Liquid Tumour Markers.
Lyophilised controls available with Randox QC can be found within; Chemistry, Immunoassay, Cardiac, Coagulation, HbA1c, Lipids and Therapeutic Drug Monitoring.
To register an interest in any of our controls simply contact us at acusera@Randox.com and let us know how we can help and support you or alternatively click here – where you will be redirected to our contact page.
Grand National sponsor Randox hosts Polo event in Bushmills, Northern Ireland
New Grand National sponsor, Randox hosted a unique event in Bushmills this weekend – an International Polo tournament with teams taking part from Northern Ireland, the Republic of Ireland, Scotland, and South Africa.
Guests from around the world who made the journey to Northern Ireland for the Polo event were given a warm welcome – they were treated to an intimate performance from world renowned concert pianist Barry Douglas on the evening of Friday 16th September, in the recently acquired Dundarave Estate.
The Randox NI Polo was the first of its kind and over 500 guests made their way to the North Coast town to attend the inaugural event. The day kicked off with the Police Service Northern Ireland pipe band who entertained the crowds before the tournament began. Guests included Pamela Ballantine and the Lord-Lieutenant of County Antrim, Mrs. Joan Christie OBE who delivered the match ball of the opening game.
It was a victory for Scotland during the first nail-biting game of the tournament, as they went head to head with the team from Northern Ireland. But it was South Africa who emerged the winners of the 2016 tournament, after beating the team from the Republic of Ireland and scoring more goals than any other team. The weekend’s events ended with a Gala Ball and dinner, followed by a breath-taking firework display which was also enjoyed by members of the Bushmills community.
Randox Founder and Managing Director, Dr. Peter FitzGerald, a keen horseman and horse sports enthusiast, said he is looking forward to the highly anticipated Polo event;
“We’ve been engaged on the Point-to-Point scene in Northern Ireland for many years, close to our Randox headquarters in County Antrim, but up until now have never had the opportunity to also host a Polo tournament in Northern Ireland. We’re delighted to be able to now hold the event in the beautiful scenery of the North Coast and to bring the Randox Health message to our Polo guests. By taking care of your wellbeing you can ensure that you enjoy days out in Northern Ireland – such as the Randox Polo event – to the fullest.”
Earlier this year, it was announced that Randox Health will sponsor the Grand National, in a five year deal which starts in 2017.
At the time of the sponsorship announcement earlier this year, FitzGerald commented;
“We see this partnership as a natural fit, as both organisations invest heavily in the future and we aim to use our partnership to promote a positive lifestyle and to bring enjoyment to millions of people. We care about people’s health and this is the people’s race.”
As the company expands and develops – more than 370 million people across 145 countries now receive medical diagnosis via Randox products – it seems fitting that Randox would move from the local horse sports scene to the world’s greatest race.
But the global healthcare company is remaining true to its roots, continuing to host the Point-to-Point events that have been synonymous with the company for so long. And by bringing the Polo event to Bushmills, and opening its doors to the public, Randox is saying ‘we haven’t forgotten where we come from.’
Randox unveils Future of Diagnostics Technology at Annual Global Distributorsā Conference
The future of diagnostic healthcare has been unveiled at the Randox Science Park in Antrim, as the company’s annual global distributors’ conference gets underway. Delegates from more than 90 countries are taking part in the world-leading healthcare firm’s three-day event at the Hilton Hotel in Templepatrick.
As well as discussions about developments in reagents and quality control products, participants enjoyed demonstrations of Randox’s patented Biochip Array Technology and its extensive range of analysers from the RX Series.
Melansha Fernando from Alpha and Omega Diagnostics in Sri Lanka said,
“Randox has released so many new products recently that laboratories in my country are increasingly interested in what it can offer. As a result I felt it important to come here to learn more about the new technologies. The truly global nature of the company has been impressed upon me after meeting colleagues from so many different countries – I’m delighted to have been able to take part.”
Speaking at the conference, Dr. Peter Fitzgerald said,
“All exporters are aware of the considerable challenges we must overcome in order to do business in the global market but year on year our teams across the world have helped to drive our success. One of the biggest challenges Randox faces is the one we put to ourselves, to deliver truly transformative technologies and improve health worldwide. We recently celebrated our £1 billionth sale and we now look to build on that achievement and accelerate our rate of growth. All of our profits go straight to either R&D, or the development of our infrastructure, so strong growth is key to our goal of revolutionising diagnostics and saving lives across the world.”
Susan Hammond, Global Reagents Sales Manager said,
“It is a pleasure to see the diversity of our distributors gathered together in one room, and recognize how far we have come as an international company. We dedicated Thursday to focusing on building relationships with our worldwide distributors to ensure that they attain the best product knowledge available. Over 100,000 end users employ Randox products and every second of every day 80 Randox tests are used across the world, and it is vital our distributors are kept up to date with every new development.”
For more information on the Distributors’ Conference contact Amy in our PR Team by calling 028 9445 1016 or email amy.mcilwaine@randox.com
Randox hosts Polo Weekend 2016 in Scotland
Piano, polo and cardiac risk profiles were part of the mix enjoyed by more than a hundred guests from around the world at the annual Randox Laboratories’ weekend in Scotland.
World-renowned concert pianist Barry Douglas launched the event at Gleneagles Hotel with an intimate recital of his new music, as well as performing O’Carolan’s “Farewell to Music” and Tchaikovsky’s “Autumn Song.” The evening concluded with dinner and a talk from Manufacturing Manager David Martin who presented Randox’s innovative plans for the future which included our new state of the art Science Park.
A range of impressive seminars were held on Saturday morning, many of which were live-streamed for the first time on our social media channels to international followers. Guests were shown ground-breaking studies completed using Randox products, with the potential to truly transform the way healthcare is delivered. Highlights included a talk by Professor Ray Sherwood from Kings College London who studied “Cytokines for Diagnosis of POEMS syndrome and Castleman Disease” and research by Dr Ibrahim Mansoor from the International Medical Centre in Jeddah on “Extended Lipid Profile, Roles of sLDL”.
The polo match ball was hand delivered to Dr Peter FitzGerald by the Red Devils Parachute Regiment who impressed the crowds by jumping from thousands of feet up in the air to land squarely on the field at Errol Park. Some of the world’s best players took part including Sébastien Pailloncy (3-goals) who wore the England jersey. After three games, England were crowned the 2016 winners, South Africa followed closely behind as the runner up while Scotland came in at third place.
As well as the action on the polo field, guests enjoyed browsing a selection of stalls assembled by the Prince’s Trust (Randox official corporate charity) which included businesses such as “Maddy Burrows Illustrations,” “My Fantasy Bouquet” and “The Family Tree”.
The weekend’s events concluded that evening with the Highland Ball and dinner, followed by a breath-taking firework display – which was also enjoyed by members of the Errol community!
Plans are already underway for our next Polo Weekend – held this weekend for the first time at Dundarave House in Bushmills, Northern Ireland.
Randox welcomes record number of people to its student placement and graduate programme
71 people including scientists, engineers and IT specialists, from across the UK and Europe are taking the first steps in their Randox careers this week, as the company celebrates a record intake to its student placements and graduate programmes.
Now in its 26th year of providing student placements and 6th year for graduate programmes, Randox is recognised internationally for providing world-class opportunities for students and graduates – one of the core reasons that the global diagnostics company was established in 1982. Thirty years on, its founder Dr Peter FitzGerald remains as committed as ever to championing new talent and driving innovation.
Nadine McKerrow, who graduated this summer with a 2.1 in Biomedical Science from Ulster University, said,
“It’s always been my ambition to work for Randox because of the value it puts into R&D which is my speciality. Not only does it invest 16% of turnover into it – which is something very few companies do, but it’s also building the Randox Science Park which will house pioneering R&D labs. The research we do is going to make an incredible difference to saving lives and improving health, and I’m very proud to be part of the team.”
One of a number of people who have moved to Northern Ireland to take up a placement post is Ross Moir, a Chemistry student from the University of Edinburgh. He said,
“When I go into the lab, I am working beside people who came up with the test that detects Alzheimer’s – it’s incredibly inspirational. I’m not standing on the side-lines either – I’m getting right into the nitty-gritty of the work here. On-the-job experience with a company that is right now developing more new tests than any other diagnostics company in the world is an amazing opportunity.”
Randox founder Dr Peter FitzGerald said,
“I am pleased to welcome these ambitious and bright young people from across the UK and Europe to join the Randox team; they are key to continuing our success. It is no exaggeration to say that during the course of their careers many of them, through their innovative work in diagnostics within the labs at Randox, will save lives. The importance of supporting STEM students has never been so important, a fact recognised by business and political leaders across the world, and here at Randox we are delighted to be playing a significant part in that.”
University students across a range of disciplines take part in a 50-week placement with Randox. They gain invaluable experience in fields ranging from Business and Marketing to Biological and Life Sciences, Graphic Design to Mathematics and Physics, and Engineering to Computer Technology. At the end of their placements, subject to attaining a 2.1 degree or above, students are offered a full-time position in their chosen field.
Graduates enter a two-year programme, which is divided into a series of six-month placements, designed to provide a valuable insight into a variety of roles and departments. Many of the successful graduates who join Randox in full-time positions after this have progressed to attain senior positions within the Company.
Randox Reagents: Solving the Problem of Heart Attack Misdiagnosis
A report has today revealed that almost a third of patients in England and Wales are being given a misdiagnosis following a heart attack, following a study of 243 NHS hospitals, conducted by researchers at Leeds University.
Timely evaluation of patients with chest pain and subsequently suspected heart attack is a major challenge for hospitals around the world, with chest pain typically representing around 5% of all visits to the Emergency Department (ED) and 25% of ED admissions. One of the biggest challenges facing emergency doctors now is how to prioritise people presenting with chest pain – to primarily deal with those suffering from a heart attack, and to be able to move those who are not, to a different ward, to alleviate the pressures of the overrun A&E departments.
Responding to the escalating misdiagnosis crisis in emergency hospitals across the globe, scientists at Randox Laboratories in the UK have developed a test which could help clinicians rule out heart attacks in patients immediately upon arrival at hospital; allowing clinicians to accurately prioritise those who have truly suffered heart attacks.
This Randox test, for Heart-type fatty acid-binding protein (H-FABP), is a highly sensitive biomarker for use in the earlier diagnosis of patients with suspected Acute Myocardial Infarction (AMI), enabling faster “rule-in” and “rule-out”. H-FABP is detectable as early as 30 minutes after chest pain onset, significantly earlier than traditionally used biomarkers such as Troponin or CK-MB , which typically require 6-12 hours to reach detectable concentrations.
Put simply, given that H-FABP is released earlier than traditional biomarkers used in diagnosing a heart attack, an earlier diagnosis is achievable.
A succession of recent international clinical trials have demonstrated that by combining H-FABP, via this new laboratory assay, with the existing tests already used in hospitals for for Troponin I or Troponin T, the sensitivity and negative predictive value for ruling out AMIs is significantly improved.
Growing evidence indicates that even when one of the newer generation of “highly sensitive” Troponin assays is used, utilising the combination of Troponin and H-FABP is superior to Troponin alone.
The value of H-FABP is not just in positive diagnosis – but doctors are beginning to see it as a means of ‘ruling out heart attack’ when a patient presents at A&E with chest pain.
Please do get in touch if you would like to find out more about our H-FABP test, and how this can go a long way in solving the heart attack misdiagnosis crisis, by emailing reagents@randox.com
We Are Randox | Randox Rugby Team Promote Healthy Work-Life Balance at Randox
As a global healthcare diagnostics company, we know a thing or two about health. And we know that taking time out from our busy lives to relax and unwind is important to stay healthy. Whether that’s taking your dog for a walk, meeting up with friends, getting lost in a good book, or playing your favourite sport.
Playing a competitive sport brings a wealth of benefits – it’s the perfect way to socialise and look after your health at the same time! Not only is it good for your physical health, but can go a long way in maintaining your mental wellbeing too.
There is great value in exercise and fresh air. However, it’s an unfortunate fact of life that most 9-5ers just don’t have the opportunity to indulge in this pleasure very often.
Randox, being a company serious about health and wellbeing, like to know we’re giving our employees the best opportunities to be as healthy as they can, and live their lives as fulfilled as possible.
Amongst many sports in which Randox encourages employees to take part, we encourage our employees to regularly take the time to engage in some friendly competition of 5-a-side rugby against each other. The County Antrim countryside, in which our Randox headquarters are located, is the perfect setting for an informal game of rugby – our rugby players can let off some steam and take in the scenery at the same time!
The team was banded together by Randox Founder and Managing Director, Dr. Peter FitzGerald, who occasionally joins in on the games himself! Dr. FitzGerald is a strong advocate of teamwork and camaraderie in the workplace.
Jonathan Acheson, Randox Health Sales Executive, who plays for our Randox Rugby Team, commented;
“At Randox we work hard but we play hard too! Our work can often be very fast-paced and Randox is expanding phenomenally – for example we’re all working towards our 5 year sponsorship of the Randox Health Grand National, beginning in 2017, which is keeping us all very busy. So it’s important that we take time to unwind and recharge our batteries. We’re lucky that we’re able to take advantage of being in such a lovely area of Northern Ireland – right beside Lough Neagh – and so we can get outside after work and have a good run-about!”
Follow Randox Careers on Facebook, Twitter and Instagram to stay up-to-date with the hashtag #WeAreRandox
We Are Randox | Randox employees put the ‘fun’ in fundraising!
Randox employees put the ‘fun’ in fundraising last Friday with a water balloon fundraiser in aid of Macmillan Cancer Support!
Randox employee, Gary Laverty, initiated this fantastic fundraising event and allowed colleagues to throw water balloons at him in efforts to raise money for this worthy charity. Raising an impressive £409.38 for the charity, Gary spoke of great admiration for Macmillan;
“When my father was ill last year, Macmillan offered tremendous support to both him and my family. Their commitment to helping cancer patients is incredible, really life-changing. I debated a few fundraising ideas but thought that the water balloon idea was something unusual so I hoped people would see it as a really fun event. The fundraiser went really well and I am delighted at the amount we raised for such an amazing charity! My colleagues got really involved and it was a really fun event, thankfully it wasn’t too cold on the day!”
The Macmillan Cancer Support charity aim to improve the lives of everyone living with cancer. They are committed to ensuring no one faces cancer alone by offering support and assistance right from the beginning of a diagnosis, through treatment and beyond, including support to the wider family circle.
We were delighted to welcome Margaret Young from Macmillan to Randox HQ in Crumlin yesterday to present a cheque from Gary’s tremendous fundraising efforts;
“We were absolutely delighted to hear of the water balloon fundraiser and hope that Gary and all the staff at Randox enjoyed themselves. Thank you to all those who took part and donated, especially to Gary!”
Well done Gary!
