Protected: QCMD – Molecular External Quality Control (NEW)
Protected: QCMD – Molecular External Quality Control (NEW)
RX series (Concept 3)
The RX series range of clinical chemistry analysers includes both semi-automated and fully automated testing for a range of clinical settings. With a world leading test menu comprising of routine chemistries, specific proteins, lipids, therapeutic drugs, drugs of abuse, antioxidants and diabetes testing, the RX series offers laboratories the complete clinical chemistry package and results you can trust. The RX series was built with three core values in mind – Reliability, Accuracy and Precision.
Consolidation of Routine & Specialised Testing on One Single Platform
With an extensive product portfolio covering over 100 disease markers within routine and nice testing, the RX series removes the need for a separate nephelometry system for specific proteins and allows laboratories to bring all testing in-house; thus ensuring minimal downtime and providing real cost savings through consolidation.
Low Reagents & Sample Volumes
Built with excellence in mind, the RX series range of analsyers require a low sample volume to deliver consistent high quality results which is beneficial when working with paediatric patients and animals. Combined with our high quality reagents, the RX series reduce the possibility of misdiagnoses, offering accurate, reliable and precise results each time, every time.
Unrivalled Customer Support
Our team of trained engineers are on hand to work with you in preserving the continuity of your operations while maximising the potential of your RX series instrument. We know time is critical in any laboratory and our global network means we are uniquely positioned to meet your needs with local service and support whenever you need it.
Fully Automated
Test Menu
Semi-Automated
Test Menu
Niche
Test Menu
QCMD – Molecular External Quality Control
QCMD is a world leading External Quality Assessment (EQA) / Proficiency Testing (PT) scheme, dedicated to improving the quality of molecular diagnostic assays used in the detection of infectious diseases.
With an extensive database of over 15,000 participants in over 100 countries, QCMD is one of the largest providers of molecular EQA in the field of molecular diagnostics.
Blood Borne Viruses
Central Nervous System Diseases
Drug Resistance
Exotic / Emerging Diseases
Gastrointestinal Diseases
Immunocompromised Associated Diseases
Multiple Pathogen / Syndromic Infections
Respiratory Diseases
Serology
Sexually Transmitted Infections
Transplant Associated diseases
Typing
New Pilot Studies
After the close of the results return phase, EQA participants will receive an individual report outlining their performance relative to their method and technology groups. A supplementary report may be commissioned – this includes any additional relevant information regarding the annual EQA distribution, as well as scientific expert commentary and feedback on the overall results within that distribution.
*Randox are authorised by QCMD to provide the QCMD EQA schemes under a strategic global partnership. The EQA design, composition, data analysis & reporting remain the responsibility of QCMD. Please refer to specific geographical regions for further details on availability.
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QCMD Website
RIQAS EQA
Protected: RX series (Concept)
Get your teeth into a Randox commutable control this Halloween
Get your teeth into a Randox commutable control this Halloween
It is that time of year again – when people dress up, children trick-or-treat and many a scary story is told in households around the world. An age-old tradition celebrated globally by millions of people – it can only be Halloween.
Last year Randox QC brought you the truly scary story about a laboratory who chose not to use a third party control, but eventually “treated their laboratory to a true third party control”. This year, we have another scary story for you about a lab manager in Transylvania, Dr. Acula.
It was a normal, busy day in the lab for Dr. Acula. That was until it was time to change reagent batch, after changing batch of reagent Dr. Acula was shocked to find his QC results had shifted by over 20%. This left Dr. Acula very frustrated, having to spend precious time troubleshooting and reassigning QC targets. After troubleshooting showed no apparent root cause, Dr. Acula searched the internet for an answer finally stumbling upon an educational guide from Randox Quality Control on commutability and its many benefits to the lab.
Grinning from ear-to-ear with excitement, Dr. Acula began to read the guide in the hope of finding a solution to his problem – and solutions he found. While reading the guide, Dr. Acula came across a quote from ISO 15189:2012. It read that laboratories “must use quality control materials that react to the examining system in a manner as close as possible to the patient sample”.
Dr. Acula made a decision to look for a commutable control material that met all of his requirements and he didn’t have to search very far. Randox Quality Control were able to supply Dr. Acula and his laboratory with a QC material to meet all his needs – true third party, excellent stability, consistency and consolidation but most importantly of all commutable controls. The fact all Randox immunoassay and immunology controls are manufactured from 100% human material appealed to Dr. Acula a lot. After trialing the Randox control material alongside patient samples and comparing results between reagent batches, Dr. Acula was thrilled with the results.
Labs rely heavily on quality control to detect errors in their test system and to ultimately make critical decisions regarding the accuracy and reliability of patient test results, the use of a control that reacts to the test system in the same manner as a patient sample is therefore essential.
At Randox Quality Control we take quality seriously. All our QC products are manufactured to the highest possible standard ensuring controls of unrivalled quality time and time again. Designed to be commutable, the Acusera range will ensure accurate and reliable instrument performance while simultaneously helping laboratories meet ISO 15189:2012 requirements.
Just ask Dr. Acula, who likes our 100% human controls so much he has started to drink them himself!
RIQAS Frequently Asked Questions (FAQ’s)
- How do I register for RIQAS?
Complete the RIQAS method questionnaire and enrolment document for the programmes you wish to participate in. RIQAS will then issue you with a unique laboratory reference number. The enrolment document should be returned to RIQAS before the start of the cycle. These documents can be easily downloaded from the RIQAS website. Simply click on the programme of interest and download the relevant documentation.
- What if my current method is not listed in the method questionnaire or enrolment document?
Use the method questionnaire to help you complete the registration of methods section on the enrolment document. If a code is not available for your method/assay please state the details of your method clearly in the appropriate section at the end of the enrolment document.
- How do I enter my EQA results?
Participants may conveniently enter their results online via RIQAS.Net. Alternatively results can be entered via the manual return sheet and submitted by fax or post before the final submission deadline.
- How do I know when to submit my EQA results?
Each RIQAS pack will contain a multi-lingual product insert containing instructions for use. The product insert also highlights the recommended date of analysis and more importantly the final date by which the results must reach Randox. The final date for submission of results can also be found on the RIQAS calendar. All results should reach RIQAS before 5pm GMT on the final submission date.
- How and when are RIQAS reports issued?
For most programmes reports are available within 72 hours of the final submission date (for RIQAS Serology Programmes, reports are sent via email within 7-10 days of the final submission date). The reports may be accessed online via RIQAS.Net or alternatively may be sent by email or post. Individual reports may be emailed to up to three addresses.
- Can I register multiple instruments for a single EQA programme?
Yes, laboratories can register up to five instruments per programme at no extra cost. Individual reports for each instrument plus a unique multi-instrument report are provided. The multi-instrument report allows for comparative performance assessment of each instrument. Additional sample packs may be ordered as required.
- What is the summary CSV file?
Laboratories can register to receive a CSV file containing a summary of their report statistics, acceptable limits and performance indicators for every sample. The file mirrors the information found on the quantitative report summary page but will also include the calculated SD and SDPA. If you wish to receive a summary CSV file, please indicate this by ticking the box on the enrolment document and include the email addresses to which the reports should be sent.
- Is RIQAS accredited to ISO/IEC 17043:2010?
Yes, in 2012 RIQAS celebrated gaining accreditation to ISO/IEC 17043:2010. This standard outlines general requirements for proficiency testing and demonstrates our commitment to quality whilst providing both participants and accrediting bodies with confidence in the schemes operation. Our accreditation to ISO/IEC 17043:2010 highlights the superior quality and excellence of RIQAS. **Please be aware that not all RIQAS programmes are accredited. Programmes marked with a “+” highlight the programmes not accredited.**
9. What if I don’t need all the parameters in a particular EQA programme?
Reduced parameter options are available for selected EQA programmes offering greater flexibility, whilst ensuring suitability for laboratories of all sizes and budgets.
10. How does the group reporting facility work?
The Group Reporting facility enables group co-ordinators to monitor the performance of satellite sites. Each individual laboratory in the group will receive an individual report, the group supervisor will receive a unique instrument group report comparing each laboratory’s performance within the group.
11. Will I receive a certification of participation?
Yes, RIQAS provides certificates as proof of EQA participation and performance for laboratory accreditation purposes. A complimentary certificate of participation for each RIQAS programme is available to participants at the end of each cycle, provided at least 50% of results have been returned. A certificate of performance is also supplied with the end-of-cycle report. Certificates will specify the cycle number, programme name and the LABORATORY / HOSPITAL NAME specified in the enrolment document.
12. Can you offer technical support and advice?
Unrivalled technical support is available through our team of RIQAS scientists and experts who are on hand to offer advice and to help you troubleshoot technical issues relating to our RIQAS programmes.
13. I have found a transcription error on my report. Can I submit the revised result?
Participants are permitted to submit corrected results up to 4 weeks after the final date of the sample. Although a new report will not be issued, results can be viewed on the charts of subsequent reports, showing “C” in place of the sample number. If a result is corrected and resubmitted to RIQAS before the final date for the current sample, it will be entered as a current result.
14. How do I notify a change of method if the cycle is already underway?
It is possible to change your units, method, instrument or reagent classification during a cycle. For participants using RIQAS.Net changes can be made in the method changes section of the data entry menu. Each RIQAS return sheet also has a section for method changes.
15. How do I add extra parameters to my registration?
Extra parameters can be added to a registration via RIQAS.Net using the method changes section on the data entry menu. A list of your registered laboratory reference numbers will appear on screen. Select the laboratory reference number for which you would like to add the assay details and select ‘Add Parameter’. A list of parameters you are not registered for will appear. Select the parameters you wish to add and complete the assay details. Parameters cannot be deleted on RIQAS.Net. If you wish to delete a parameter please contact RIQAS directly on mail@riqas.com.
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.
Celebrate Christmas with Randox Quality Control
T’was the week before Christmas and all through the lab not a thing could be heard not even a sound. The analyser lay silent asleep in the corner, the lab staff at home dreaming of a few days’ rest, only a few more days to go before the big day!
The big man in red, what will he bring those who already have everything? Peace, happiness and health for their loved ones throughout the festive break, that would be the wish for everyone to make. And what better way to ensure they stay healthy, well it all begins in the laboratory…
An important consideration to remember when choosing your lab Quality Control (QC) is that approximately 70% of clinical decisions are based on laboratory test results. It is therefore essential that the results gained from laboratory testing are accurate and reliable in order to provide the appropriate treatment and avoid or prevent potential misdiagnosis.
Patient results are of the utmost importance for a laboratory and therefore running the best Quality Control material should be at the top of their agenda. QC material should have a number of features that allow a lab to judge the overall quality of their output. These features include the controls ability to be commutable (which means how well it reacts as a replicate of a patient sample), is it a true third party control that has been manufactured to provide an independent and unbiased assessment of performance, does your control come with clinically relevant levels and does it have a long shelf life as well as a good open vial or reconstituted stability? These are the questions lab staff will be asking themselves when deciding on what QC is the right QC.
So stay off Santa’s naughty list by providing accurate and reliable patient test results, do this by employing Randox QC in your laboratory. Our controls have been designed to deliver significant cost savings without sacrificing on quality. With consolidated controls (combining up to 100 analytes in a single vial) your lab can reduce QC costs and preparation time, the inclusion of analytes present at clinical decision levels will eradicate the need for additional controls and because of our long shelf life (2 years for liquid controls, 4 years for lyophilised) and excellent stability claims your laboratory can be sure that expensive lot changes will be a thing of the past! Our controls can be described as true third party and this, combined with the commutable nature of the controls, leads to us being able to claim that we have the best Quality Control material around.
So this Christmas when deciding what QC to choose – make sure you look no further than Randox Quality Control. Our QC family is known as Acusera and our product offering includes QC and calibrator material, Interlaboratory Data Management Program (Acusera 24.7), the world’s largest international EQA/PT scheme better known as RIQAS and the newest addition to the family, Linearity or Calibration Verification material.
We have packages for every lab regardless of size and budget and we guarantee you will become ho-ho-hooked on Randox QC.
Wishing you all season’s greetings and a prosperous New Year from everyone at Randox QC.
Don’t Get Tricked This Halloween
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.
