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.
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.
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.
Demand for external support driving growth of EQA
“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 acusera@randox.com
One RIQAS Haematology Sample
With over 40,000 laboratory participants in 124 countries, RIQAS is truly the largest international External Quality Assessment (EQA) scheme. The large volume of participants is testament to the quality of our material and highlights further the trust and confidence laboratories have in RIQAS to help them accurately report their patient results.
RIQAS is world renowned for delivering flexible EQA solutions to help laboratories reduce the number of programmes required. Our RIQAS portfolio covers most areas of clinical testing including Haematology.
Our RIQAS Haematology programme combines 11 parameters in total and comprises the full blood count into a single sample. Designed with user convenience in mind, samples are supplied in a liquid ready-to-use format in primary tubes. Coupled with user-friendly reports, enabling at-a-glance performance assessment, preparation and evaluation time will be dramatically reduced in even the most demanding of laboratories.
Errors will be identified early thanks to the bi-weekly analysis of the Haematology programme, while reports are ready within a maximum of 72 hours from the date of submission and accreditation to ISO 17043:2010 allows the laboratory to take any necessary corrective actions.
Cat No. Kit Size Frequency Parameters
RQ9118 6 x 2ml Bi-weekly Eleven (11)
Parameters
- Haemoglobin (Hb)
- Mean Cell Volume (MCV)
- Mean Cell Haemoglobin Concentration (MCHC)
- Red Blood Cell Count (RBC)
- Mean Platelet Volume
- Plateletcrit
- Haematocrit (HCT)
- Mean Cell Haemoglobin (MCH)
- Platelets (PLT)
- Total White Blood Cell Count (WBC)
- Red Cell Dist. Width
Request your FREE RIQAS consultation
Allow our RIQAS consultants to provide your laboratory with a free consultation to demonstrate how RIQAS can consolidate the number of EQA programmes required to cover your test menu, saving your laboratory precious time and money.
Simply fill out the form below to request a consultation today!
Measurement of Uncertainty Educational Guide
Measurement of Uncertainty relates to the doubt that exists for the result of any measurement. For every measurement there is always a margin of doubt and therefore we need to ask ‘How big is the margin?’ and ‘How significant is the doubt?’.
In a hospital or healthcare environment, the clinician must be certain that any change identified in a patient’s test results is not a change to the laboratory test system but a change to the patient’s status. This is especially critical at clinical decision levels. Randox Quality Control has developed a guide to Measurement of Uncertainty in response to the demand for more information on the topic within the industry. This guide outlines what Measurement of Uncertainty is, how to measure uncertainty, factors which affect uncertainty and it’s sources.
Request your copy today!
Importance of Using Third Party Controls
Importance of using third party controls
The importance of using third party controls cannot be overlooked. Using these controls can help to identify instrument, reagent and procedural errors which, if undetected could lead to the reporting of incorrect patient results!
What is a third party control?
ISO 15189:2012 states “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.” True third party controls are not optimised for use with a specific reagent or test system and therefore are renowned for delivering unbiased performance assessment with any instrument/method. The manufacturers of third party controls will usually assign values based on data collected from thousands of independent reference labs – thus ensuring the availability of statistically valid data for a wide range of platforms. Due to their independent nature and objectively assigned values you can be sure that third party controls will provide unbiased error detection across multiples platforms and methods.
First party control
Conversely, first party controls are analyser dependent controls that are supplied by the instrument/reagent manufacturer and are optimised specifically for use with the manufacturers test system and therefore will often mask weaknesses which could lead to the release of incorrect patient test results. These dependent controls are considered to lead to perceived accuracy and a biased assessment of performance.
Acusera third party controls
The Randox Acusera range of multi-analyte controls are true third party. Our controls have been designed to deliver an independent, unbiased assessment of performance with instrument or method. Our unique value assignment process employs thousands of independent laboratories ensuring statistically valid targets are available for most laboratory instruments. The availability of multi-analyte, multi-instrument controls with a shelf life of up to 4 years not only ensures continuity of lot supply but will significantly reduce costs and preparation time by reducing the need for multiple instrument specific controls.
Case Study 1
A laboratory running Acusera Immunoassay Premium Plus Control reported their QC results for Thyroglobulin were four times higher on the their main analyser compared to other systems.
They ran the instrument manufacturer’s control alongside the Acusera control but it did not show the same problem.
After reviewing EQA data, the Randox Technical Services team confirmed there was a significant difference in results compared to other instruments.
The customer contacted their instrument manufacturer, who advised of a positive bias with several batches of reagent.
In summary, the Randox Immunoassay Control detected a shift in results that the instrument dedicated control did not.
Case Study 2
A laboratory noticed an increase in native patient sample result recovery of around 15-20%. The lab were running their Gentamicin reagent along with a TDM calibrator. Over recovery was also noted for EQA samples however, the issue had not been detected with their current control set.
The laboratory got in touch with Randox about the use of our controls and if they would experience the same problems with our controls as they are with their current provider. We assured the laboratory that our controls were true third party and the unique 100% human serum matrix would provide a sample as close as possible to that of the patient.
The laboratory decided to test a sample of Acusera TDM control and were delighted with the results. They purchased some of our therapeutic drug controls and have yet to experience any increase in the result recovery of patient samples highlighting the need to use true third party controls.
Summary
This case study once again highlights how important running true third party controls is to a laboratory. It can be the difference between them reporting accurate and reliable patient test results and reporting incorrect results that could lead to a misdiagnosis which could be fatal to the patient on the receiving end.
Ensure your laboratory is using true third party controls by contacting Randox today. Request a quote from one of our QC consultants at acusera@randox.com
Manage Your Laboratory Effectively with Randox Quality Control
Manage Your Laboratory Effectively with Randox Quality Control
With Euro 2016 starting today the final squads for each country participating have been carefully selected. Confirming those players who made the squad were the managers – managing their team effectively is a tough job but when done right it can be rewarding. However, getting the squad and team wrong can have major repercussions.
Linking Football to your Laboratory
Is the idea of managing a “team” effectively sounding familiar? You could be forgiven for not seeing the link between a football team and laboratory in this scenario. By managing your laboratory effectively you can be sure that accurate and reliable results are being reported whilst keeping your costs at a minimum and reducing the time spent preparing your controls. The same can be said for a football team – if you get the squad right then the players perform well and therefore produce better results and performances.
In terms of managing your laboratory effectively the best option is to ensure you have all areas of clinical testing covered, internal quality control, an inter-laboratory data management programme and also external quality assessment.
What can Randox Quality Control offer?
With an extensive portfolio combining true third party controls (Acusera Quality Control), inter-laboratory data management (Acusera Live Online 24.7) and the world’s largest EQA scheme (RIQAS), Randox can uniquely provide a complete Quality Control package to help “manage laboratories effectively”. Unrivaled confidence in patient results comes from using our complete package, our IQC and EQA will also deliver effective consolidation and significant cost savings, while implementation of Acusera 24.7 Live Online will allow at-a-glance performance assessment.
Appoint Randox to help you manage your laboratory and ensure accurate and reliable results enabling you to sit back, watch Euro 2016 and roar your country to victory.
To request a visit from a QC consultant contact us via acusera@randox.com
Laboratory Accreditation sees rise in the use of Third Party Quality Controls
A recent report published by Markets and Markets called “In Vitro Diagnostics (IVD) Quality Controls Market” has highlighted the significant growth within the Quality Control market, with further growth expected within the next 4 years, estimating that the IVD QC market will be worth $979 million. The report is crediting this growth to “the increasing number of accredited clinical laboratories and growing adoption of third-party quality controls”. It also indicates an anticipated growth of 4.7% CAGR between 2015 -2020 for third party quality controls. The adoption of third party controls is particularly interesting, as a survey conducted by Randox in 2015 found that only 35% of respondents felt that the most important feature when selecting quality controls for the laboratory was that they were third party, with stability being the top choice. This highlights the influence accreditation is having within the IVD market.
Why have these been influential?
Accreditation to ISO 15189:2012, and other similar standards, is becoming mandatory in many countries. Laboratories are becoming accredited to highlight the accuracy and reliability of the patient results they are releasing. Furthermore such accreditation standards and the industry regulatory bodies, like CAP, CLSI and so on, are recommending the use of third party controls. This is supported by ISO 15189:2012 which states, “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”. The report states that third party controls “offer various advantages over other types” of quality controls, this includes a longer shelf life and long term quality monitoring.
What can Randox Quality Control Offer?
The Acusera range of quality controls can be described as true third party or independent controls. Unlike first party controls or semi dependent controls they are manufactured independently of any instrument or reagent and thus are designed to deliver an unbiased assessment of analytical performance across all platforms while also meeting ISO 15189:2012 recommendations. To assist with the other requirements of ISO 15189:2012 each control is 100% commutable, ensuring a matrix that will react to the test system in the same manner as a patient sample. It should also be noted that the entire Acusera quality control range has been manufactured in line with clinically relevant decision levels. Employing controls that cover the entire clinical range will eliminate the need for separate low/high controls ultimately reducing costs while also ensuring accurate instrument performance. By employing any one of our Acusera Controls in your laboratory you could minimise costs & limit the time spent reassigning values after each lot change, highlighting just some of the additional benefits of employing a third party control.
To request a visit from a QC consultant contact us via acusera@randox.com
Quietly complaining about your current QC?
With more than 30 years’ experience developing pioneering high quality, cost effective Quality Control solutions for the IVD market Randox has designed their Acusera range of third party controls to simplify QC practice for labs of all sizes. The following outlines frequent complaints that arise in the lab & solutions we can offer to ensure you no longer quietly complain about your QC.
High volumes of controls needed to assess your test menu?
Acusera controls can contain a unique combination of up to 100 analytes in a single vial. This consolidation will permit you to reduce costs by removing the need to purchase extra controls to cover your complete test menu. As fewer controls are required the amount of time spent preparing controls is reduced, freeing staff to complete other tasks.
QC does not contain clinically relevant levels?
The analytes present in our Acusera controls have been included at clinical decision levels. The importance of employing controls that cover clinically relevant concentrations is highlighted by ISO 15189 & its significance is demonstrated in the following example. When measuring Troponin T the cut off value is 14 ng/l. Patients who present to the hospital with a concentration higher than 14 ng/l in their blood are said to have had a cardiac event. Test results lower than 14 ng/l would indicate that the patient is healthy or it is too early to tell if a cardiac event has occurred. As such it is imperative that analysers can accurately measure to this level and that performance at this level is assessed. QC material with similar cut off levels should therefore be used. Acusera meets these requirements, reducing the number of controls you need to cover both your complete test menu & the necessary clinical decision range for specific tests.
Frequent expensive lot changes?
With a shelf life of up to 2 years for liquid & 4 years for lyophilised controls, Acusera can help minimise costly lot changes. Furthermore each control has their own target values & extended open vial stability claims, which do not differ from lot to lot due to our unrivalled consistency. Both features will ultimately help reduce waste, minimise costs & limit the time spent reassigning values after each lot change.
Inconvenient shifts?
When using controls with non-human components you are likely to experience shifts in QC values when changing reagent batch. Our controls are 100% commutable, reacting to the test system in the same manner as a patient sample, helping you to not only meet ISO requirements but reduce costly QC shifts.
Need to improve confidence in QC results?
Acusera 24.7 is an interlaboratory data management designed for use with Randox true third party controls. The software has been created to help monitor and interpret QC data, providing access to; QC multi-rules, interactive charts, real-time peer group data and our unique dashboard interface for at-a-glance performance assessment.
With Acusera you will no longer quietly complain about your QC!
With features such as our test menu consolidation, clinically relevant levels, commutability & unrivalled stability, partnered with Acusera 24.7 can help you reduce waste and costs while improving performance in your lab. Simply contact us today for more information or request a consultation from one of our QC consultants via acusera@randox.com
