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
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.
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.
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 email@example.com
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 firstname.lastname@example.org
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.
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 email@example.com
A lot happens between giving a patient sample and getting your results. Although you may never meet face-to-face, laboratory professionals play a very important role in health care. These professionals are ultimately responsible for conducting tests that provide results and information for detecting, diagnosing, treating and monitoring disease.
With the aim of celebrating and honouring medical laboratory professionals around the world who perform and interpret billions of laboratory tests every year, Lab Week has been taking place at the end of April each year for over 40 years.
Randox Quality Control would like to thank both the laboratory professionals who utilise our products and our own research & development laboratory staff who make our QC and EQA range the highest quality and most reliable available worldwide.
We are committed to revolutionising healthcare on a global scale.
Parathyroid Hormone (PTH) is a hormone released by the parathyroid glands. It is often referred to as the parathormone and is often requested to help determine the cause of a low or high calcium concentration, helping to distinguish between parathyroid related and non-parathyroid related causes.
For health professionals
The new PTH Control has been designed with convenience in mind, providing laboratories with a true third party solution for the measurement of PTH. Our assayed liquid control has been developed with an extended open vial stability of 30 days and 2 year shelf life, reducing waste and ensuring consistency for this notoriously unstable assay.
Is your laboratory currently running PTH? Are you seeing shifts in QC results when you change reagent batch? If so, visit the new Acusera PTH Control product page for more information or register your interest.
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