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.
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|
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).
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.
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.
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.
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.
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.
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.
Point-of-Care Testing (POCT)
The Point-of-Care testing market, better known as POCT, is growing rapidly as the demand for faster patient testing increases. This point is fully backed up through the results of the recent BIVDA (British IN-Vitro Diagnostics Association) survey of 2016. This survey focuses primarily on Point-of-Care Testing and there were a few questions asked that sparked an interest amongst us. The questions can be seen below;
“What are the challenges you face regarding POCT?”
“What do you see in the future for POCT?” (BIVDA, 2016)
Although many answers were put forward there was one (answer) that appeared for both questions. Accreditation. We found this intriguing yet far from surprising. POCT and accreditation go hand-in-hand, with laboratories striving to achieve ISO accreditation with the ultimate aim of allowing patients to have peace of mind that they are being tested properly and effectively.
The ISO standard that relates to POCT is ISO 22870:2006 Point of Care Testing- Requirements for quality and competence. This standard gives specific requirements applicable to POCT testing and apply when POCT is carried out in a hospital, clinic or a healthcare organisation providing ambulatory care. However, it is important to note and remember that ISO 22870 is not to be seen as a separate, standalone document, in fact, it is to be used in conjunction with ISO 15189:2012 (medical laboratories – particular requirements for quality & competence).
With accreditation in POCT becoming a major factor to laboratories, it is no surprise to see accreditation as one of the top answers to the two questions asked in the survey.
For laboratories looking to participate in point-of-care testing there are other factors of ISO 22870 that they must be aware of, one of the major factors is as follows;
“ISO 22870:2006 advises that where available, Internal Quality Control and participation in an External Quality Assessment (EQA) scheme is required in the point-of-care setting.”
How can Randox help?
Fortunately for laboratories, Randox are able to help out here. With a vast range of true third party controls and 32 comprehensive RIQAS (EQA) programmes, Randox can aid laboratories as they aim for ISO accreditation.
We have multiple products particularly suited to the POCT market including, Liquid Cardiac, Blood Gas and Urinalysis. These products are available both as internal quality controls and as EQA programmes.
Our Acusera range of true third party controls are conveniently supplied liquid ready-to-use, therefore requiring no preparation. This is a particular advantage in the POC environment were test results are required quickly and also were testing is not always performed by laboratory personnel. Supplied with assayed target values and manufactured from 100% human material, ensuring they act in the same manner as a patient sample, our Acusera controls are ideal for use at the point of care and will therefore aid a laboratory in gaining ISO accreditation.
Similarly, participation in our RIQAS EQA programme will also assist laboratories to meet regulatory requirements and achieve ISO accreditation. With over 40,000 laboratory participants in 123 countries, RIQAS is the largest international EQA scheme worldwide! Our Liquid Cardiac, Blood Gas and Urinalysis programmes are all supplied liquid ready-to-use, complementing their Acusera counterparts perfectly!
There is much debate among clinical laboratories when discussing this common question. With some schemes offering testing as little as 2 times per year, it raises the question, is this really enough?
How frequently an EQA scheme is run will often be dependent on several aspects. Factors such as the diagnostic error rate, number of tests undertaken, experience and turnover of technical staff, and the known stability/instability of the analyte in question should be considered and will all contribute to determine the desired frequency of EQA.
Each EQA programme will vary, where one area, for instance Chemistry, may require bi-weekly testing, another, such as Serology, may only need to be tested every 3 months. Although there is variation between schemes, the benefits of testing more frequently unquestionably outweighs the costs of not testing frequently enough.
Issues with infrequent testing?
If your EQA provider offers infrequent testing, there is likely to be a lengthy period of uncertainty where errors could be happening in the laboratory and consequently incorrect results being released. The outcome of this could be damaging to both patients and laboratories, with credibility and trust in results likely to come under scrutiny. For these reasons, having an infrequent EQA scheme could cause harm to your laboratory and reduce confidence in your test results.
Why should you use a frequent EQA scheme?
To ensure the previously mentioned errors do not occur, laboratories should participate in frequent EQA schemes to guarantee that if incorrect test results do arise, then they will be detected and rectified immediately.
As preventative/corrective actions can be taken sooner through frequent EQA schemes, you will have increased confidence in your test systems performance and may reduce the need for expensive retests. Being able to pinpoint when an error occurred will be much simpler if you are only looking back a matter of weeks or a couple months, as opposed to if you are looking back over a longer period such as 4 to 6 months.
The ability to implement corrective actions sooner and with less disruptions to the lab will help lead to both time and cost savings in the future.
What can Randox Quality Control offer?
Randox International Quality Assessment Scheme (RIQAS), offers bi-weekly, monthly and quarterly reporting options* designed to assist with the early identification of laboratory errors. Not only will RIQAS provide you with extra confidence in test system accuracy, but with 32 flexible programmes you could also make significant cost and time savings through consolidation.
With more than 40,000 participants in 124 countries, RIQAS is the largest international EQA scheme on the market and offers laboratories around the world assurances that the results they are releasing are accurate and reliable. Our many features include; the ability to register up to 5 instruments per programme at no extra cost, easy to read reports, internationally accredited programmes and rapid report turnaround. Why don’t you contact us today and find out how we can support you in maintaining quality control in your laboratory?
“In Vitro Diagnostics (IVD) Quality Controls Market” recently published by Markets and Markets has highlighted an overall significant growth within the Quality Control Market. Further growth is anticipated in the coming years with the Markets and Markets report estimating that the IVD QC market will be worth $979 million.
One area that is currently experiencing growth within this sector is the EQA segment, which Markets and Markets estimates to command a 6.6% share of the overall IVD market. The report is crediting growth within this segment to you, the customer, stating “…various end users or customers of IVD quality control products mostly prefer external support to run their quality control activities. For this, market players are largely focusing on providing external quality assurance (EQA) support”. As such companies such as Randox are being approached to provide EQA for a range of small, independent laboratories and large laboratory chains alike.
What other factors have contributed to this growth?
The adoption of ISO15189 and other similar standards is becoming mandatory in many countries, as discussed in a previous blog post. Accreditation highlights the accuracy and reliability of the patient results being released. ISO15189 states that “The laboratory shall participate in interlaboratory comparisons such as those organised by external quality assessment or proficiency testing schemes”. Therefore laboratory managers are employing EQA programmes in their laboratory to meet such requirements. EQA also enables laboratories to meet other accreditation requirements such as peer comparison and clinically relevant testing.
Selecting the right EQA for you
When selecting the right EQA scheme for your laboratory there are a number of considerations to be made; sample frequency, peer group numbers, report format, report turnaround and so on. According to a survey conducted by Randox Quality Control 55% of respondents listed sample frequency as the most important feature to be considered when selecting an EQA scheme. Sample frequency is an ongoing debate regarding EQA. However, schemes with frequent reporting will allow you to easily pinpoint when an error occurred and implement corrective actions with minimal disruption. Also making the top three key factors in this survey were; quality samples and peer group numbers.
What can Randox Quality Control offer?
As the largest international EQA scheme available on the market RIQAS offers laboratories around the world assurance that the results they are releasing are accurate and reliable. With more than 40,000 participant in 124 countries and 32 flexible programmes we are certain that the external support we offer for your quality control activities will provide you with the upmost confidence in your laboratory’s performance. Furthermore with our programmes accepted by national and international accreditation bodies worldwide employing RIQAS can help you gain accredited status providing your end users with peace of mind. With other benefits such as programme consolidation, rapid report turnaround, easy to read at-a-glance reporting and the ability to register up to 5 instruments per programme at no extra cost why don’t you contact us today and find out how we can support your quality control activity?
To request a visit from a QC consultant contact us via firstname.lastname@example.org
A laboratory running a competitors 3rd party Microalbumin QC noticed shifts in their QC values whenever they changed reagent batch.
They tested two levels of quality control over three different batches of reagent the results can be seen in the table below.
|Competitor Control – Microalbumin|
As can be seen from the findings above, Microalbumin results shifted significantly each time they changed reagent batch. This was the case for both the level one and level two control however when the lab tested the same set of patient samples across the three reagent batches results were consistent and did not show the same shifts.
The laboratory decided to contact Randox and ask about our Microalbumin controls. They were concerned about the shifts seen with their current supplier and highlighted the fact they were no longer confident in the results they were releasing. This led to them trialling the Randox liquid ready-to-use Microalbumin control with the same three reagent batches they tested previously.
Having tested two levels of the Randox quality control over the same three reagent batches the laboratory reported to us that their results were back on track and they were delighted with the outcome! The results of the Randox control can be seen in the table below.
|Randox Control – Microalbumin|
The difference seen with the Randox control across the three reagent batches was much smaller than that of their previous control and was in line with the changes seen with their patient samples.
This case study highlights the commutability of the Randox QC range. By using a control with a matrix that reacts to the test system in the same manner as the patient sample the laboratory was confident in the patient test results produced and were able to meet ISO 15189:2012 requirements.
Today, June 27th, sees the beginning of one of the four tennis majors – Wimbledon. Basking in the summer sun while lying on ‘Henman Hill’, this yearly tournament attracts spectators from all over the globe who want to watch the world’s best tennis players ply their skills on the revered centre court over the course of a two week period. But what exactly is the most important skill a tennis player can utilise? Well, many players have different strengths but the one skill that all of them must possess is the ability to serve – and accurately.
The ability to serve is vitally important as it allows the point to begin, serving accurately however allows the player to set the pace and ensure they are on the front foot. By making sure they serve more accurately, the player can be confident in their ability to win the point and the match.
Just like tennis, laboratories will aim to be accurate when ‘serving’ up their test results. Achieving accurate test results is what every lab strives for. With patient results on the line it is important for labs to use QC material that will assist them in obtaining the correct results, therefore keeping them clear of causing a ‘racquet’.
Randox Acusera is world renowned for delivering unbiased performance assessment. Our range of true third party controls are manufactured to the highest standard ensuring commutable samples that react to the test system in the same manner as a patient sample, ultimately allowing labs to be confident in the results they produce. Much like the serve in tennis that needs to fall within a target area, QC results should be as close as possible to the target and ideally should fall within +/- 2 SD from the mean. By falling within these limits a lab can be sure of accurate results and an acceptable performance.
Employ Acusera quality controls in your laboratory today and experience unrivaled confidence in your test results.
Get your slice of our control range here by contacting us at email@example.com. We guarantee you will love us!
World leader in preventive healthcare, Randox Health, is announced as the title sponsor of the 150th Anniversary celebrations for Royal Ulster Yacht Club at Bangor on Belfast Lough.
The fortnight of celebrations began on Friday 17th June with The Sigma 33 UK & Irish National Championships which attracted twenty boats from throughout the UK and Ireland. The 150th Keelboat event begins on Saturday 25th June until Sunday 26th June. This event has attracted not only local modern yachts but also some of the classics of the sport. The 150th Anniversary celebrations will conclude on Friday 1st July with a Gala Dinner.
Stuart Penrose, Global Marketing Manager of Randox Health is eagerly anticipating the 150th Keelboat event this weekend, and commented;
“We are proud to sponsor the Royal Ulster Yacht Club in its 150th year. As an innovative healthcare company committed to improving people’s health and wellbeing, we value the opportunity for people to get involved in competitive sport, that the RUYC offers. Sailing simultaneously brings benefits to your physical health, but getting out on the sea and taking in fresh air can contribute to your wellbeing too.”
The Randox Health team will also be in attendance at the event, where you can find information on the latest technology to better understand your current and future health.
Randox Health is committed to changing the landscape of preventative health care through a steadfast commitment to developing the most comprehensive and personalised health checks possible.
To find out more, contact the Randox Health team today:
0800 2545 130
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