At Randox Quality Control, we strive to meet and exceed customer expectations ensuring high quality products and superior customer service are at the top of our priority list.
How can Randox Quality Control help you?
High Quality QC
The Acusera range of true third party controls boasts an impressive range of benefits ultimately designed to help laboratories reduce costs and time while also ensuring an accurate and reliable test system.
The extended shelf life of our controls allows the same lot of control to be used for a period of up to 2 years keeping costly new lot validation studies to a minimum. We may also be able to sequester lots on your behalf.
The availability of commutable controls designed to react to the test system in the same manner as a patient sample and controls targeted at clinical decision levels will not only help you to meet ISO 15189:2012 requirements but will effectively challenge instrument performance.
Click here to find out more about our QC range.
The Randox global support network are on hand with expert advice to ensure timely, accurate and helpful resolution of any issues or queries you may have. The added benefit of quick delivery of product orders further highlights how we work with and for our customers to provide the best service available.
Don’t believe us? Read a few of the reviews we have received from laboratories around the world;
“I would like to thank the Randox team for the excellent service when helping to reserve and manage our IQC orders, lot numbers and stock.” – Chief Biomedical Scientist, London, 2017.
Request your free QC consultation by contacting us today! Get in touch and we can arrange for your laboratory to have a consultation with one of our Randox QC specialists. Alternatively, if you would like to leave us a review you can do so by emailing email@example.com.
- 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 firstname.lastname@example.org.
From April 23rd to April 29th we are celebrating Medical Laboratory Professionals Week! This is a week dedicated to raising awareness for those who work in a laboratory & the hard work that goes unnoticed every day in laboratories around the world.
Have you ever wondered what happens between submitting your patient sample and receiving your results? Have you ever wondered who conducts the detailed laboratory testing for your annual check-up such as cholesterol and glucose levels? Or who analyses these results? The answer, a Medical Laboratory Professional (MLP). MLP’s provide up to 70% of the medical laboratory results for physicians and others to make informed decisions about a patient’s diagnosis and aftercare treatment plan. The work that laboratory professionals do each and every day is integral to providing excellent patient care. They perform and interpret billions of laboratory tests every year.
Providing accurate and reliable test results is of the utmost importance for laboratory professionals and also for us at Randox. With a passion for Quality Control, and with more than 30 years’ experience developing Laboratory QC for the in vitro diagnostics market, we believe in producing high quality material designed to streamline procedures, whilst reducing costs in laboratories of all sizes and budgets. These qualities have been reflected in our Acusera true third party quality controls, Acusera 24.7 interlaboratory data management software, Acusera Verify Calibration Verification material and RIQAS, the largest international EQA scheme.
Randox Quality Control would like to take this opportunity to thank all the laboratory professionals around the world and especially our own laboratory staff – you truly are the “Unsung Heroes of Healthcare”.
Following the success of the first ever Randox Health Grand National, global health diagnostics company Randox has today announced the official opening of its new central laboratory, Randox Clinical Laboratory Services (RCLS), at the recently acquired Randox Science Park in Antrim, Northern Ireland.
Situated at this new state of the art biohub, the RCLS accredited lab now houses Randox’s latest blood screening equipment – the pioneering Evolution machine. This new technology enables the labs to conduct a full range of niche and standard research testing, as well as current health testing for the company’s Randox Health division, which offers the world’s most comprehensive full body health analysis.
Research areas at the newly accredited laboratory include but are not exclusive to cancer, fertility, heart, inflammation, stroke and kidney health, both in-house and collaboratively with external organisations. Current and past collaborations include an Acute Kidney Injury Study with the Royal Victoria Hospital, a Bladder Cancer Study in partnership with Queen’s University Belfast and The Belfast Trust, a Stroke and Brain Injury study with Cambridge University, and key partnerships with a number of major pharmaceutical companies.
A staggering 222 clinical diagnostic tests are currently run routinely with the lab, with more tests pending accreditation in the coming months.
Ann-Marie Jennings, Laboratory Manager for Randox Clinical Laboratory Services, explained that the new facilities will allow RCLS to increase their output and enter new markets;
“Randox Clinical Laboratory Services has been operational for a number of years in our headquarters in Crumlin, near the Belfast International Airport. Now that we have moved to our new, purpose-built labs in the Randox Science Park, we have the ability to increase the output of both our health testing and our research testing. This involves expanding our team of experienced scientists, working towards further accreditations and furthermore setting up independent labs in Dubai, LA, Holywood and Liverpool in addition to our current labs in Antrim and London.”
Thanks to the new Randox Science Park facilities, the company will now be able to provide an increasingly wide range of testing services to Biotechnology and In Vitro Diagnostic companies, and will deliver to pharmaceutical companies the testing services required to support their drug development projects, in addition to the testing provided to research organisations,
With the ability to conduct an unrivalled range of health testing – haematology, biochemistry and immunoassay – all under one roof, the laboratory offers unparalleled support services to the dynamic and growing healthcare industry. With a greater understanding of human complexity, pharmaceutical companies are now focusing on developing safer drugs tailored to specific patient groups or sub-groups and the expansion plans in motion at RCLS will help these organisations bring new drugs to market faster.
“On our patented Randox Biochip Array Technology we can customize bespoke testing platforms based on the requirements of each drug development project, which can be a challenging process. From initial product development to clinical trial stages there can be a number of barriers and time constraints before drugs are successfully released to the public. We’re confident that our newly enhanced capabilities will benefit patients suffering from conditions in most need of research by offering pharmaceutical companies at the forefront of pioneering research, with the latest technological developments.”
For more information about RCLS please contact Randox PR on 028 9442 2413 or email RandoxPR@randox.com
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!
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, 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.
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)