In celebration of British Science Week 2017, we will be giving you an introduction to diagnostics, and exploring how Randox Scientists are helping to change healthcare.
You may or may not already know that Randox are one of the leading diagnostics companies globally. But what exactly does clinical diagnostics involve? It is one of the fundamental steps of finding out what is wrong with a person when they are ill. Read on to find out a bit more about diagnostics, and how the Randox Reagents R&D Scientists are helping to change healthcare globally!
What is a diagnostic test?
A diagnostic test is any kind of analysis performed on a patient sample (a sample is typically blood, urine or cerebrospinal fluid (CSF)), to aid in the diagnosis or detection of disease. The information found from a test can be used to:
- Diagnose disease
- Assess the extent of damage
- Monitor the effectiveness of treatment
- Confirm a person to be free from disease
Examples of substances that may be tested for the blood include proteins, nutrients, waste products, antibodies, hormones, salts, trace elements or vitamins. These are sometimes referred to as ‘analytes’, ‘markers’ or ‘biomarkers’.
This is where reagents come in…
A reagent is a substance which is mixed with the patient sample to create a chemical reaction to detect the biomarker. These reactions are analysed by machines known as analysers.
Using data gathered from both clinical symptoms and laboratory tests, the doctor will follow a sometimes painstaking process of analysis and elimination to perform a successful diagnosis!
We’re looking forward to meeting you at CLMA Knowledgelab, booth #338!
Stop by our booth for your chance to check out our Acusera 24.7 Live Online version 2.0. It’s smarter, faster and more powerful than ever before, with unique access to live peer data, accelerating troubleshooting processes and pinpointing the cause of any QC failures. Additional features include the automatic calculation of Measurement Uncertainty & Sigma Metrics, comprehensive charts, bi-directional LIMS connectivity and a complete make-over of our dashboard. Don’t miss your opportunity to see this software live.
Our Randox Consultants will also be on hand to discuss our other products available, which will help you ensure your laboratory produces results you can trust.
Acusera true third party quality controls
As a world leading manufacturer of multi-analyte, true third party controls, thousands of laboratories rely on Randox to accurately assess test system performance and ultimately empower them with the confidence required to release patient test results. With more than 390 analytes available across the Acusera range we can uniquely reduce the number of individual controls required while simultaneously reducing costs, time and storage space. A choice of formats is available ensuring flexibility and suitability for laboratories of all sizes and budgets.
Acusera Calibration Verification
Our Acusera Linearity range has been specifically designed with convenience in mind, helping you to easily meet accreditation requirements. Our liquid ready-to-use verifiers are supplied in varying levels and are available in multiple configurations to meet the specific requirements of individual analysers while challenging the complete reportable range; ultimately ensuring accurate patient testing. All linearity sets are supplied with complimentary data reduction software, providing instant access to reports and real-time peer group data.
On 9 March 2017, Randox Reagents are celebrating World Kidney Day! World Kidney Day is a global campaign aimed at raising awareness of the importance of our kidneys to our overall health. It aims to reduce the frequency and impact of kidney disease and its associated health problems worldwide.
This year, the World Kidney Day promotes education on the harmful consequences of obesity and its association with kidney disease, advocating healthy lifestyle and health policy measures that make preventive behaviours an affordable option.
With this in mind, throughout the week we have been sharing on social media some interesting facts on diagnostic tests which can help aid an early risk assessment of kidney disease in obese patients, allowing preventative action to be taken before any serious damage occurs. The tests of focus this week included cystatin C, adiponectin and microalbumin…
The creatinine test is routinely run for patients who are suspected for deteriorating kidney function, however this test has limitations. Cystatin C is an alternative test, and is particularly useful in patients where creatinine measurements are not suitable e.g. individuals who are obese, malnourished, have liver cirrhosis or reduced muscle mass. Importantly, unlike creatinine, cystatin C does not have a ‘blind area’ – up to 50% of kidney function can be lost before significant creatinine elevation occurs. Cystatin C is extremely sensitive to very small changes in kidney function and is therefore capable of detecting early stage kidney dysfunction. The cystatin C test therefore allows preventative measures to be taken much earlier and before significant kidney function decline.
There is substantial evidence that excess visceral fat is the main driving force for almost all of the disorders associated with the metabolic syndrome, including CKD.1,2 The adiponectin test from Randox can accurately assess levels of abdominal visceral fat, independent of age, race or fitness level.3,4 Assessing adiponectin, and therefore visceral fat levels, can help assess risk of CKD, as well as a range of other illnesses such as pre-diabetes, CVD and various cancers.
The microalbumin test detects very low levels of a blood protein called albumin, in urine. The detection of albumin in urine can be an indicator of kidney injury and can result in irreversible damage if left untreated. Low albumin concentrations in the urine are the earliest marker of kidney damage and therefore enable preventative measures to be taken. Microalbumin testing can identify individuals with diabetic nephropathy approximately 5-10 years earlier than proteinuria tests helping reduce the frequency of end stage renal disease.
Both World Kidney Day and Randox are working towards improving healthcare worldwide. With continuous investment in R&D, Randox are helping with the risk assessment and earliest detection of renal function problems. By assessing one’s risk of kidney problems (with the adiponectin test), it can give patients (obese and other) the tools to prevent kidney problems further on down the line. With early diagnosis (through the cystatin C and microalbumin tests) it will be possible to keep kidney problems from getting worse, therefore lowering the number of those diagnosed with CKD worldwide.
Ubicados en Europa, la misión de Randox Control de Calidad es la producción de materiales de alta calidad que ayuden a racionalizar los procesos de control de calidad, además de ayudar a ahorrar tiempo y dinero a cualquier laboratorio, independientemente de su tamaño y presupuesto. Gracias a nuestra extensa oferta de productos, en los que se incluyen controles internos de tercera opinión, un software para la gestión de datos inter laboratorios y una amplísima variedad de Programas de Evaluación Externa de Calidad (PEEC), podrá obtener una visión completa del rendimiento de su laboratorio.
Al ser uno de los mayores fabricantes de controles auténticamente conmutables, ofrecemos soluciones para el control de calidad económicas, de la más alta calidad y diseñadas para la evaluación de los resultados de las pruebas de los pacientes. Con nuestra gama de controles Acusera podrá controlar lo que hasta ahora le supondría hasta 4 controles diferentes con un único vial Acusera, que junto con nuestra estabilidad sin igual y la elevada vida útil, le ayudarán a ahorrar tiempo y dinero. Además, las concentraciones son clínicamente relevantes, garantizando la precisión y fiabilidad de los instrumentos a lo largo de toda la variabilidad clínica.
Acusera 24.7 le permitirá obtener resultados más precisos y reducir el tiempo que implica la supervisión e interpretación de los datos del control de calidad. Además, tendrá acceso a una gran variedad de funciones como a los datos del grupo par actualizados en tiempo real y el cálculo automático de la Incertidumbre, el Error Total y las Métricas Sigma. Con Acusera 24.7 podrá asegurar la calidad de sus análisis a través de la resolución más rápida de los problemas mediante esta plataforma centralizada.
RIQAS es el Programa de Evaluación Externa de Calidad (PEEC) de preferencia, empleado por más de 45.000 participantes en 124 países. Gracias a la frecuencia de los informes, podrá identificar los errores rápidamente, reduciendo la necesidad de realizar repeticiones innecesarias y costosas, haciendo que su laboratorio ahorre tiempo y recursos valiosos.
Is it possible to compare multiple instruments on a single Levey-Jennings Chart?
With Acusera 24•7 users can combine multiple instruments, as well as analytes and QC lots on a single chart. This will enable comparative performance assessment and facilitate immediate visualisation of any ongoing or emerging trends. It may also be useful for troubleshooting out of control QC events.
Is it possible to compare different levels of control on a single Levey-Jennings Chart for identification of concentration related bias?
Yes data for multiple QC lots can be displayed on a single, convenient Levey-Jennings chart allowing any concentration related problems to be identified quickly.
How often is peer group data updated?
With Acusera 24•7 Live Online, peer group data is uniquely updated live in real-time. The instant nature of the peer data will help reduce time and money spent troubleshooting, re-running QC samples and performing any instrument maintenance. With real-time peer group data you can compare to other laboratories around the globe using the same lot of QC material and identify if there are any issues and whether they are unique to your lab or a widespread issue.
Is there a limit to the number of users?
There is no limit to the number of concurrent users – you can have as many as you want. There are 5 different levels of user access – Admin, Group Co-Ordinator, Manager, User and Technical Support. It is worth noting that User access can be customised per user to ensure access to only the required functionality
How can the software help me to meet ISO 15189:2012 requirements?
Unique to Acusera 24.7 Live Online, our software will automatically calculate Measurement Uncertainty (UM) and provide your laboratory with a printable report that can be used to help meet ISO 15189:2012 accreditation requirements. In addition to this the software can help to prevent the release of patient results in the event of a QC failure for example when the Quality Control rules are violated.
Is it possible to use RiliBAK as my allowable limits?
QC data can indeed be rejected or alerted based on RiliBAK guidelines. Other options are also available, including, CLIA, Biological Variation, RIQAS TDPA and user defined performance limits.
Can I purchase Acusera 24.7 Connect without Live Online?
This is unfortunately not possible. Acusera 24.7 Connect is an additional add-on to Acusera 24.7 Live Online that will facilitate automated entry of QC data. To get the benefits of Acusera 24.7 Connect you will be required to participate in the Acusera 24.7 Live Online interlaboratory program.
Is Acusera 24.7 Live Online secure?
To authenticate users, a number of security measures are used, including; participant number, username and a password combination (for individual role-based accounts). Password complexity standards are enforced on user account setup. CAPTCHA is enforced after several failed login attempts to prevent or guard against automated attacks. HTTPS and X509 certificate authentication is in place meeting industry security standards.
I have never used interlaboratory software before, is there training provided with my purchase of 247?
There are a number of different options available in terms of training. The easiest, most convenient and accessible form of training is through the use of our walk through demo that has voice-over and text so everyone can follow. With our software comes a user guide, this is a walk through that laboratories can use to guide them through the usage of the software. Additionally, there is also the possibility of a live demo from the sales consultant in your area who will be able to run through the software with you.
Can I create unique login credentials for each user?
Yes, each user will have their own personal log-in. If a lower level user, e.g. user, technical support or manager forgets their password they can have it reset by the administrator. However, if a group co-ordinator or admin forgets their password they should contact Randox directly who will be able to reset their credentials and resend to the administrator’s email address.
I currently use non-Randox Quality Controls, does this affect the ability of the software?
Not at all, our software is so flexible that it can be used with any other manufacturers Quality Control material. However, you will only have access to the internal functions of the software and will not have access to peer group statistics. For this reason we recommend the software is used alongside our Acusera true third party Quality Control solutions.
Is Acusera 24.7 Live Online the only software option available?
Yes this is the only option available – Unlike other manufacturers there is no need for any additional software packages or options. All functionality is available in the one software package.
My computer is very old, do I need a new, modern and up-to-date operating system to run the software?
Not necessarily. As long as you have stable access to the internet you can access Acusera 24.7 Live Online as it is a cloud based software.
My patient data is confidential. Will the software need access to this data?
Acusera 24.7 will not require access to your patient data. This is important for a laboratory but less for the software. Acusera 24.7 will only need access to the results of your Quality Control to ensure that your instrument/s are performing to standard and therefore ensuring that your patient results will be reliable and accurate.
I have forgotten my username and password – what do I do now?
If an individual with user level or manager level access forgets their username and password, they should contact the laboratory administrator. If an administrator or group co-ordinator forgets their username or password they should contact Randox who will verify the administrator and send new login details for the account.
Is Acusera 24.7 Connect required to import QC data?
Acusera 24.7 Connect is only required if you wish to import QC data automatically. Data can also be entered manually using the data entry screen or in a semi-automated manner using the EDI function.
I need to renew my license, is this done automatically?
If your licence has expired and you would like to renew you should get in touch with your local Sales Consultant.
My internet connection isn’t great. Will this affect the running of the software? What happens if the signal drops when entering results?
If connection is lost from the laboratory’s side, all data will be transferred to the web and once reconnected, the previous session will also be remembered. Emergency power generators and fall over servers are in place to ensure 99.8% uptime is guaranteed.
Are there any additional software requirements?
You must have access to a Java applet. This software is available as standard on almost all modern computers, laptops and notebooks.
Acusera 24•7 Live Online – Version 2.0
Randox Quality Control are pleased to announce the launch of our brand new version 2.0 of our interlaboratory data management program – Acusera 24•7 Live Online Version 2.0.
The launch of this new version has seen major updates and improvements to the software and gives Acusera 24•7 Live Online the edge over many other competitors.
Updates to the software include real-time updates of peer data, more comprehensive charts and reports, bi-directional connectivity, speed improvements and a complete make over to the dashboard. Below, some of these updates are broken down and outlined as to why they are important for a laboratory.
Peer Group Statistics
The biggest update to Version 2.0 is definitely the ability to review peer data in real time. Previously, peer group statistics would have been updated every 24 hours, however, with this new update, data will be available to review instantly! The ability to generate peer data live in real-time will enhance the laboratory’s troubleshooting capabilities and allow labs to compare their data with others around the world. On top of this, there is no deadline for submission like some of our competitors, meaning labs can get a true reflection of performance at any time. Ultimately, labs will have the ability to identify if an issue is unique to them or if there is a widespread issue amongst their peers. Information such as this will allow laboratories to establish a root cause much quicker and therefore spend less time troubleshooting poor performance.
Reports & Charts
With version 2.0 reports and charts are more flexible than ever before. All reports can be generated for a user defined data range and will provide the lab with a whole wealth of information. Reports available on Acusera 24.7 Live Online can include; Statistical Analysis, Statistical Metrics, Audit Trail Reports and the new Exception Report. These reports, coupled with user-friendly and easy to interpret charts, such as Levey-Jennings, Histograms and Performance Summary Charts, enable rapid and stress-free performance monitoring. The ability to add multiple instruments, QC lots, analytes and events such as calibration and reagent lot changes to a single chart allows for comparative performance assessment and immediate identification of any trends.
Communication & Flexibility
The new software is now also capable of bi-directional communication with LIMS. This is a benefit to any laboratory, in the event of a QC failure or rule violation the 24.7 software send a message or alert back to the LIMS. Acusera 24.7 is designed primarily for use with our Acusera range of true third party controls, however, our software is flexible and can therefore be used with any QC material. Performance limits, QC multi-rules and peer groups can now be customised to suit each individual laboratory depending on user preferences for each different analyte, instrument or lot of control. Alternatively, users can also create custom configurations that are able to be shared across other instruments in their labs and within their groups.
Sigma Metrics & Uncertainty of Measurement (UM)
Version 2.0 of Acusera 24•7 Live Online comes with the automatic calculation of Sigma Metrics and Uncertainty of Measurement (UM). The benefit of automatic UM calculation is that it will help laboratories meet ISO 15189 requirements. Automatic Sigma Metrics calculation is included and is designed to help improve QC strategy design.
For further information on Acusera 24•7 Live Online click here. Alternatively you can request a demo by completing the adjacent form.
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.
Conveniently supplied liquid ready-to-use the Liquid HbA1c control is ideally suited to both clinical laboratories and POCT helping to significantly reduce preparation time. With a stability of 30 days waste and costs are also kept to a minimum.
Features & Benefits
- Liquid ready-to-use
- Human based whole blood
- Assayed target values
- Convenient bi-level pack covering clinically relevant decision levels
- Stable to expiry date at 2°C – 8°C
- Open vial stability of 30 days at 2°C – 8°C
HbA1c (Haemoglobin A1c)
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.