Fabricado en Europa – Randox Control de Calidad
Fabricado en Europa – Randox Control de Calidad
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 gestión de datos interlaboratorios
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.
Acusera 24•7 Frequently Asked Questions (FAQ’s)
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, 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 , 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.
Is Acusera 24.7 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 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 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.
Pancake Tuesday 2017
As it’s Pancake Tuesday, we at Randox QC wanted to share one of our recipes with you for the perfect pancake. What better way to do this than to create our very own IFU especially for today! Click the link below to download the IFU and celebrate Pancake Tuesday with us.
*Note: this IFU was created with humour in mind. Please ensure you follow the correct procedures in place in case of a fire or other emergencies.*
Randox Quality Control – More than EQA
Did you know that Randox is the company behind the RIQAS EQA scheme? RIQAS (Randox International Quality Assessment Scheme) is just one area of our comprehensive Quality Control portfolio. As such it is our resolution this New Year to introduce Randox as the brains behind RIQAS and show you that we are more than just an EQA provider by sharing our passion for laboratory QC.
Who are Randox Quality Control?
At Randox we believe in producing high quality material that can help streamline procedures, whilst saving time and money for laboratories of all sizes and budgets. With our extensive product offering comprising third party QC sera, interlaboratory data management software and calibration verification products, you can be sure that our complete QC solutions will provide you with a comprehensive overview of laboratory performance.
Seeing the complete picture with Randox QC
Acusera QC sera
As one of the largest manufacturers of true third party, commutable controls we deliver high quality, cost effective quality control solutions designed to accurately assess instrument performance and provide confidence in patient test results.
Acusera 24.7 interlaboratory data management
Acusera 24.7 enables you to drive for more accurate results by helping you to monitor and interpret QC data. With access to an impressive range of features, including the automatic calculation of Measurement Uncertainty, Total Error and Sigma Metrics, Acusera 24.7 ensures analytical quality.
RIQAS EQA Scheme
RIQAS is employed by more than 45,000 laboratory participants in 124 countries. With frequent reporting you will identify errors sooner ultimately reducing the need to carry out preventable, expensive retests on a large volume of patient samples.
Acusera Calibration Verification sera and software
The Acusera linearity sets cover a wide range of clinical testing including; cardiac markers, therapeutic drugs and proteins. Designed with convenience in mind, the range ultimately helps you to meet CLIA requirements for calibration verification and the assessment of linearity.
Randox QC Resources Hub
Beyond selling laboratory QC we are also passionate about education, offering a range of educational guides, seminars and webinars, with more to come throughout 2017. Check out our QC resources hub for our current educational material and let us know what educational material you would like to see.
For more information, or to request a visit from one of our QC Consultants, contact us via acusera@randox.com.
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
Microalbumin shifts when changing reagent batch
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 | ||
| Reagent Batch |
QC Level One |
QC Level Two |
| 1 | 19.9 | 81.0 |
| 2 | 29.7 | 90.5 |
| 3 | 50.4 | 122.4 |
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 | ||
| Reagent Batch |
QC Level One |
QC Level Two |
| 1 | 33.5 | 158.8 |
| 2 | 34.9 | 164.9 |
| 3 | 34.8 | 168.0 |
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.
Serving Up Accurate Test Results
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 acusera@randox.com. We guarantee you will love us!
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
