Get your teeth into a Randox commutable control this Halloween
Get your teeth into a Randox commutable control this Halloween
It is that time of year again – when people dress up, children trick-or-treat and many a scary story is told in households around the world. An age-old tradition celebrated globally by millions of people – it can only be Halloween.
Last year Randox QC brought you the truly scary story about a laboratory who chose not to use a third party control, but eventually “treated their laboratory to a true third party control”. This year, we have another scary story for you about a lab manager in Transylvania, Dr. Acula.
It was a normal, busy day in the lab for Dr. Acula. That was until it was time to change reagent batch, after changing batch of reagent Dr. Acula was shocked to find his QC results had shifted by over 20%. This left Dr. Acula very frustrated, having to spend precious time troubleshooting and reassigning QC targets. After troubleshooting showed no apparent root cause, Dr. Acula searched the internet for an answer finally stumbling upon an educational guide from Randox Quality Control on commutability and its many benefits to the lab.
Grinning from ear-to-ear with excitement, Dr. Acula began to read the guide in the hope of finding a solution to his problem – and solutions he found. While reading the guide, Dr. Acula came across a quote from ISO 15189:2012. It read that laboratories “must use quality control materials that react to the examining system in a manner as close as possible to the patient sample”.
Dr. Acula made a decision to look for a commutable control material that met all of his requirements and he didn’t have to search very far. Randox Quality Control were able to supply Dr. Acula and his laboratory with a QC material to meet all his needs – true third party, excellent stability, consistency and consolidation but most importantly of all commutable controls. The fact all Randox immunoassay and immunology controls are manufactured from 100% human material appealed to Dr. Acula a lot. After trialing the Randox control material alongside patient samples and comparing results between reagent batches, Dr. Acula was thrilled with the results.
Labs rely heavily on quality control to detect errors in their test system and to ultimately make critical decisions regarding the accuracy and reliability of patient test results, the use of a control that reacts to the test system in the same manner as a patient sample is therefore essential.
At Randox Quality Control we take quality seriously. All our QC products are manufactured to the highest possible standard ensuring controls of unrivalled quality time and time again. Designed to be commutable, the Acusera range will ensure accurate and reliable instrument performance while simultaneously helping laboratories meet ISO 15189:2012 requirements.
Just ask Dr. Acula, who likes our 100% human controls so much he has started to drink them himself!
QC Material Stability
Stability has a number of different definitions, however, the most relevant to clinical diagnostics, and indeed quality control sera, is the “resistance to chemical change or physical disintegration”. Much like a chain, your quality control system is only as strong as its weakest link, or in this case analyte.
Whilst we appear to be stating the obvious here, this might not be as straightforward as it first appears. The product literature you peruse will help you decide what control best suits your needs, whilst many companies will state their control stability in the literature there are some instances where all may not be as it first appears. It is also important to note that some manufacturers may not make stability claims for some of the analytes listed in their control material. In such instances, you are required to validate these in-house, taking up precious time and resources.
Dig a Little Deeper
Whilst we understand that some analytes do have limitations due to their inherent nature, misleading analyte claims can cost the laboratory both time and money. In a recent survey conducted by Randox, 65.5% of respondents indicated that they felt stability was a ‘Very Important’ QC feature. As such it’s important that you look beyond the sales literature when it comes to control stability. Look out for exceptions in the small print of the control kit inserts. For example, if a control has a stability claim of 7 days at 2-8oC and a routine analyte like Cholesterol has a stability claim of just 2 days at 2-8oC then the true stability of the control is only 2 days. In such instances, there is a lot of potential for waste, as laboratories will be required to prepare a new vial of QC material every 2 days leading to increased costs and time. However, if you dig a little deeper into the controls and always read the small print, you could avoid such issues.
How can Randox Acusera benefit you?
For more than 30 years Randox has been shaping the future of clinical diagnostics with our pioneering high quality, cost effective laboratory solutions. Quality Control is our passion, we believe in producing high-quality material that can help streamline procedures, whilst saving money for laboratories of all sizes and budgets. We pride ourselves in not misleading our customers with false stability claims for our controls. With controls such as our Liquid Cardiac and Specific Proteins Controls, you could benefit from a 30-day open vial stability for all analytes, without exception.
By employing our Randox Acusera quality control materials you could benefit from;
Commutable controls, ensuring a matrix that reacts to the test system in the same manner as a patient sample, enabling an accurate and reliable assessment of instrument performance.
Accurate target values that won’t shift throughout the shelf life of the controls, eliminating the need to spend valuable time and money assigning values in-house.
Consolidation of test menu with controls comprising up to 100 analytes, reducing preparation time and storage space required.
Analytes present at clinically relevant levels ensuring accurate test system performance across the clinical range, maximising laboratory efficiency by eliminating the need to purchase additional high or low-level controls at extra expense.
True third party controls designed to provide an unbiased assessment of performance, our Acusera controls have not been manufactured in line with or optimised for use with any particular reagent, method or instrument.
For more information on any of our products, or to request a consultation from one of our QC Consultants, contact us via firstname.lastname@example.org.
According to the NHS Litigation Authority; in 2015 within the UK alone, £193,680,744.30 was spent on ‘wrong diagnosis’ or ‘failed/delayed diagnosis’ causing huge financial strain and impact on labs.
With approximately 75% of clinical decisions and diagnosis based on laboratory test results. The only way to guarantee a high degree of accuracy is to implement a good Quality Control plan. The importance of this is recognised globally, several bodies exist internationally including ISO (International organisation for standardisation) who have developed a set of guidelines and quality systems to ensure the reliability of laboratory test results.
So what can you do to improve accuracy and reliability?
Choose a third party QC
ISO 151589:2012 Section 18.104.22.168 states that “the use of third party control materials should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer”.
First Party Controls are those manufactured by the instrument/reagent manufacturer. These controls are optimised specifically for use with the manufacturers test system and therefore will mask a multitude of weaknesses. First Party Controls tend to result in perceived accuracy and a biased assessment of performance.
Third Party Controls on the other hand are designed to be completely independent and are not optimised for use with a specific test or system. Leading manufacturers of third party controls will assign target values based on data collected from thousands of independent laboratories, ensuring the availability of statistically robust multi-method, multi-analyser data. Therefore laboratories using Third Party Controls can be assured of unbiased error detection across multiple platforms.
Randox Acusera is a world leading manufacturer of true third party controls providing a cost effective, high quality solution for any laboratory-regardless of size or budget.
Look out for QC samples with clinically relevant concentrations
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’.
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 performing accurately across the full clinical range and in particular at the medical decision level, QC materials that cover low, normal and elevated concentrations should be used.
Due to the superior manufacturing process used by Randox, QC target values consistently cover the MDL of tests. By ensuring the controls in use cover clinical decision levels laboratories can be confident of the reliability and accuracy of the patient results they release.
Opt for a commutable control material
A good QC material has many essential properties but above all, controls must perform consistently and reflect the performance of patient samples – if a control meets these requirements then we can say it is commutable. Having a commutable control would aid in the prevention of incorrect patient results because they replicate the performance of a patient sample and react to the test system in a similar manner. Use of a commutable control will also reduce costly shifts in QC target values when reagent batch is changed.
At Randox we take quality seriously, that’s why all QC products are manufactured to the highest possible standard, delivering controls of unrivalled quality. Designed to be commutable, the Acusera range will ensure accurate and reliable instrument performance while simultaneously helping laboratories to meet ISO 15189:2012 requirements. A good QC process will include the use of Third Party Controls, Clinically Relevant Concentrations and controls which can be described as commutable. By employing Quality Control’s that encompass these traits, a laboratory professional can be certain that they have taken the necessary steps to decrease incorrect results and therefore potential misdiagnosis.