RCLS: Flexibility and Quality at the Core of Service

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RCLS: Flexibility and Quality at the Core of Service

Randox Clinical Laboratory Services is a dedicated group of laboratories across the United Kingdom with plans to expand across the world. All of the clinical laboratories are purpose built to deal with the bespoke needs of research and clinical projects. Currently we have laboratories situated in Antrim, Holywood, Liverpool and London.

Flexibility and quality are at the core of our service offering and our experienced team are available to support and advise at each step of a project to ensure deadlines are met and high quality data is delivered in the most cost efficient manner.

Specialising in biomarker and multiplex testing in addition to standard safety and clinical testing, RCLS provides a full laboratory service to accelerate your project to completion. Our patented and globally recognised Biochip Array Technology (BAT), provides multiplex testing solutions in an accurate and precise format. Vast expertise in in-house antibody and assay development also allows for customised assays to be incorporated into your testing.

A key focus for RCLS, utilising this technology (BAT) and the ability to customise, is esoteric/niche biomarker analysis within clinical trials. Randox has been providing custom assay design, development and manufacturing services to the diagnostic, pharmaceutical, contract research and biotech industries for many years. This also includes fully customised human and animal quality control sera. We have the facilities to design a novel multiplex biochip tailored to each customer’s requirements taking into account sample types, available sample volumes and expected ranges for various analytes of interest.

Our assay development specialists will endeavour to work with you to ensure your needs are constantly met and provide a smooth process from the time of your first enquiry through to final delivery.

If you would like more information on RCLS please contact info@rcls.com


Randox Clinical Laboratory Services: Accelerating Your Clinical Trial

Randox Clinical Laboratory Services is built upon Randox’s 35 years as an invitro diagnostics company, and is on hand to assist your drug discovery ensuring the toxicity and efficacy of your drug before proceeding to Phase 1 of your clinical trial.

RCLS currently has four state of the art, fully functional ISO12025 accredited laboratories across the UK. They are situated in Liverpool, London and two in Northern Ireland, Hollywood and Randox Science Park in Antrim.

RCLS looks to expand their team of experienced scientists, working towards further accreditations and furthermore setting up two additional labs in Dubai and Los Angeles. The addition of these purpose-built labs will give RCLS the ability to increase output to both the pharmaceutical, health and research market.

The RCLS laboratories offer unrivalled sample management and workflow with a unique identifier and sample traceability allowing patient history to be 100% accurate and guaranteed. The storage locations of sample are located separately with a duration of 15-25 years in fire proof cabinets. The sample rejection criteria and sample destruction processes are different from diagnostics standards as we offer multiple bar coding, sample manifests dictated by LIMS and double blinding of samples undergoing genomic testing.

A variety of analysers are situated across all RCLS laboratories not only including our RX Series and Evidence Series of multiplex immunoassay analysers but also third party analysers ensuring the testing abilities are diverse. The equipment covers chemistry, haematology, urinalysis and immunoassay testing capabilities.

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 the market quicker.

If you would like more information on RCLS please contact info@rcls.com


Reconstituting Lyophilised Controls

What is Lyophilisation?

Lyophilisation or ‘freeze drying’ is the process by which water is removed from a product after it is frozen and placed under a vacuum, allowing the ice to change directly from solid to vapor without passing through a liquid phase. The process consists of three separate processes:

  1. Freezing
  2. Primary Drying (Sublimation)
  3. Secondary Drying (Desorption)

There are many benefits to using a lyophilised control including; improved product shelf-life and enhanced stability of volatile analytes. For example, many lyophilised controls have a shelf life of up to four years from the date of manufacture resulting in a reduction of costly new lot validation studies. Furthermore, lyophilised controls can be aliquoted and refrozen to extend the working stability of the product.

Reconstituting Lyophilised QC Material

The process of reconstitution involves adding a specified volume of distilled water to lyophilised QC material. The water should completely dissolve the lyophilised contents, giving a liquid solution, which is ready for analysis.

Reconstitution is a straightforward process, but requires a high level of precision. Small errors can have serious implications to the reconstituted material:

  • If too much water is pipetted during reconstitution, the material will be heavily diluted and results will be lower than expected
  • If too little water is pipetted during reconstitution, the material will not be sufficiently diluted, and results will be higher than expected
  • If the correct volume of water is pipetted, but a small amount of water gets stuck in the pipette tip due to poor pipetting technique, results will be higher than expected

If a lyophilised control has been reconstituted incorrectly the contents of the vial will be wasted. It is therefore vitally important that controls are reconstituted with care.

Materials and Methods Required

The list of requirements for an accurate and consistent reconstitution technique is not extensive, but each requirement is vital. Labs should have:

  • Calibrated volumetric pipettes
  • Sterile, appropriately sized pipette tips
  • Distilled water, or other reconstitution fluid as specified
  • Technician with good pipetting technique
  • Lyophilised QC stored according to manufacturer’s specifications

How to Reconstitute Lyophilised QC Material

Each different lyophilised control may require slightly different preparation, always refer to the instructions for use before reconstituting control material. The below guide provides a general overview of the reconstitution process, using the Randox Human Assayed Chemistry Premium Plus control (HN1530) as an example

  1. Place the vial of lyophilised QC on a flat surface, carefully remove the lid and the rubber stopper making sure not to spill any material
  2. Using a calibrated pipette and sterilised pipette tip, add exactly 5ml of distilled water directly into the QC vial, ensuring no water is left in the pipette tip, or on the rim/side of the vial
  3. Place the rubber stopper and lid firmly back onto the QC vial, and leave to stand for 30 minutes
  4. After 30 minutes, gently invert the QC vial 10-15 times to ensure the contents is completely dissolved, making sure to avoid the formation of foam. It is important that you DO NOT SHAKE the vial. Alternatively place the vial on a roller for 30 minutes to ensure the contents is thoroughly mixed
  5. Once satisfied all material has been completely dissolved, proceed to use the QC product in accordance with the ‘Control’ section of the individual analyser application
  6. Once finished, refrigerate any unused material. It is good practice to label the vial with the date of reconstitution to prevent the use of material outside of the recommended stability period
  7. Prior to reusing lyophilised material, mix the contents thoroughly by gentle inversion, as highlighted in Step 4

Additional Considerations

It is important to remember that there may be slightly different reconstitution requirements for different QC material. For this reason, it is vital that the instructions provided on the QC Kit Inserts are closely followed.

Reconstituting lyophilised QC can be time-consuming. Therefore, Randox Acusera offer convenient 5ml distilled water serum diluent to assist laboratories with reconstitution of lyophilised controls. These user-friendly pour over vials streamline the reconstitution process and eliminate the risk of pipetting errors.

If you have any further questions regarding lyophilised controls or would like to contact us, please do so by emailing us at acusera@randox.com or use the contact us button provided.


This Christmas, treat your laboratory to the “gift” of Randox Quality Control

At Christmas time all around the globe, people search for the best gift for their loved ones, something they will really like. At Randox Quality Control, we understand you care for your patients, and your laboratory. This year, show how much you care by treating your lab to a Randox Quality Control.

With over 35 years’ experience in the market, Quality Control is our passion and streamlining QC practice is our forte! Our extensive product offering comprises true third party controls, interlaboratory data management, external quality assessment and calibration verification.

Last year we looked in depth at Acusera – our range of true third party controls. This year, lets add another product to the Christmas wish list in the form of RIQAS, the world’s largest EQA scheme. Don’t wait until Christmas to wake up to a RIQAS programme under your tree – enrol in one of our comprehensive programmes today.

With over 45,000 laboratory participants across 133 countries, our RIQAS portfolio spans 32 comprehensive programmes ranging from Chemistry to Immunoassay, Lipids to Cardiac, Drugs to Serology and much more!

User-friendly, one page per parameter reports are available within 72 hours of the submission deadline.  These reports enable at-a-glance performance assessment, ultimately allowing your laboratory to save valuable time. You will also gain access to complimentary multi-instrument and inter-laboratory reports as well as an end-of-cycle report  summarising laboratory performance for each cycle and helping to identify progress over time.

Consolidation is key – and with an extensive parameter index available (up to 360 parameters) RIQAS will help you to significantly reduce costs, time and the number of individual programmes required to cover your test menu.

All RIQAS samples are free from interfering preservatives ensuring a commutable matrix that reacts to the test system in the same manner as a patient sample.

Additionally, enrolling in RIQAS isn’t just enrolling in an EQA scheme. Our programmes are accepted by National and International accreditation bodies worldwide and at the end of each cycle, participation in the scheme results in a certificate that can be used to decorate your laboratory all year around – not just at Christmas!

So this Christmas don’t give your laboratory second best, choose RIQAS, and reap the rewards.

To find out more on any of our RIQAS programmes visit our website – https://www.randox.com/riqas-external-quality-assessment/ or email us at acusera@randox.com

Randox Quality Control wish you all Season’s Greetings & a Prosperous New Year!


RCLS – at the cutting edge of laboratory innovation

Randox Clinical laboratory Services (RCLS) is the latest offering from Randox, Built over 35 years of experience producing high quality IVD products, Randox Clinical Laboratory Services (RCLS), is dedicated to providing a clinical laboratory service designed to meet the time sensitive, bespoke requirements of research and clinical projects globally.

RCLS currently has four state of the art, fully functional ISO12025 accredited laboratories across the UK. They are situated in Liverpool, London and two in Northern Ireland, Hollywood and Randox Science Park in Antrim. RCLS looks to expand their team of experienced scientists, working towards further accreditations and furthermore setting up two additional labs in Dubai and Los Angeles. The addition of these purpose built labs will give RCLS the ability to increase output to both the health and research market.

Ann-Marie Jennings, Laboratory Manager for Randox Clinical Laboratory Services, discusses the Randox Biochip Array, RCLS’ abilities and confidence in testing;

“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.”

Thanks to these state of art laboratories, RCLS will now be able to provide an increasingly wide range of testing services to Biotechnology, research and pharmaceutical companies delivering the testing services required to support their research and drug development projects.

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.

If you would like more information on Randox Clinical Laboratory Services, please contact us by emailing us at info@rcls.com

 


Mythbusting: ‘Using IQC and EQA From the Same Provider Leads to QC Bias’

Some laboratory professionals believe that using Internal Quality Control (IQC) and External Quality Assurance (EQA, also known as Proficiency Testing) material from the same provider can lead to increased levels of qc bias, or that their test system will not be appropriately challenged. It is important to address these concerns, because some labs may in fact be hindering their own performance by using IQC and EQA material from different sources.

It is important to first understand how IQC and EQA work together to help form a complete Laboratory Quality Management System.

IQC and EQA in Laboratory Quality Management

IQC is a means of monitoring test system precision on a daily basis. IQC effectively evaluates test system performance over time, so that any sudden or gradual shifts in performance can be detected. However, while IQC is an effective performance monitor, it cannot detect more intricate problems like calibration errors or wide acceptable limits provided by some QC manufacturers.

EQA is essential for challenging test system accuracy, and is carried out less frequently than IQC testing. EQA samples are tested ‘blind’ and the results are returned to the scheme organiser. As EQA testing compares an individual lab’s performance to other labs using the same method and instrument, it is a very effective tool for identification of potential issues.

Is there any disadvantage to using IQC and EQA material from the same provider?

The answer to this question depends primarily on the source material of the IQC and EQA. If an IQC provider manufactures their material using artificial additives or components of animal origin, then it will not be suitable to use EQA material from the same provider. Westgard (2011) maintains that using non-commutable IQC or EQA material can lead to results becoming compromised due to matrix effects – something which would not happen using commutable controls.

For example, with Immunoassay testing, non-human components of IQC material interact with antibodies in the reagent in a different way to fully human patient samples – ultimately giving unpredictable shifts, and not adhering to the ISO 15189 requirement to: “use quality control materials that react to the examining system in a manner as close as possible to patient samples”.

However, if the IQC and EQA material is manufactured using a source material which is similar in composition to patient samples (100% human), this commutable control will adequately mimic patient sample performance; meaning labs can use EQA and IQC material from the same provider with confidence that the integrity of their results is maintained.

Conclusion

ISO 15189 also states: “Use of independent third party control materials should be considered…”. In this instance, ‘Independent’ does not mean from a separate provider. It means that the QC material should not be optimized for use on one specific instrument (i.e. not dependent on a single instrument/method type).

No regulatory body states a requirement to use different providers for IQC and EQA material. Indeed, using IQC from one provider and EQA from another provider could increase the risk of labs using non-commutable material.

Labs should use commutable IQC and EQA material for a true assessment of their test system. Randox QC and RIQAS EQA are specifically designed with commutability in mind, giving labs a control which reflects patient sample performance and ensures excellent performance.

How can we help?

To learn how Randox can offer a complete solution for your laboratory, follow the links below or submit a question using the form above.

References

Westgard, S. (2011). Is QC Quality Compromised?. Available: https://www.westgard.com/qc-quality-compromised.htm. Last accessed 31st October 2017.

Mythbusting QC Bias
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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!


Randox and partners announce opening of £7m Advanced Biomedical Devices laboratory

Randox Laboratories is pleased to announce the opening of a state-of-the-art Advanced Biomedical Engineering Laboratory today, the result of an innovative partnership with some of Northern Ireland’s leading business and education stakeholders.

The strategic collaboration with Invest Northern Ireland, Ulster University and Heartsine Technologies to develop the £7 million laboratory aims to transform the future of healthcare. The lab, which is based at Ulster University, will offer expertise and state of the art equipment to assist companies to develop prototypes for the biomedical, engineering, electronic device and aerospace sectors.

Welcoming the new lab, Dr Peter FitzGerald from Randox Laboratories said: “As one of the UK’s leading life sciences companies, we are delighted to be a partner in this innovative collaboration and to promote Northern Ireland as a global life sciences hub. We believe the greatest improvements to patients’ lives are possible through the continuous development of new technologies.

“This unique laboratory will facilitate that, as it will allow the rapid development of test prototype devices and also assist us to expand our unique range of high-calibre analyser systems.”

Tracey Meharg, Invest NI’s Executive Director of Business Solutions said: “The new Bio Devices Lab is a welcome and exciting development for Northern Ireland’s Health & Life Sciences sector. The facility will open up opportunities for stronger innovation by hosting a suite of equipment which will allow companies to quickly develop prototypes and medical devices for testing.

“It is a great example of how partnerships between government, industry and academia can enhance Northern Ireland as a knowledge economy and boost the credibility and visibility of Northern Ireland as a global leader in connected health.”  

Prof Jim McLaughlin from Ulster University said: Developing technology platforms to help translate our world class science and discovery to a device format as promptly as possible is essential for the very best design and performance.

“In healthcare technology, Ulster University leads the way in the development of new patient monitoring systems, stimulation devices, wearable solutions and diagnostic sensing.

“The lab will enable our researchers to develop the strong leadership and innovation skills so critical to future industry growth, working in collaboration with our industry partners.”

The total investment is £7.4m. Invest NI has offered assistance of £3.7m through a Grant for R&D, with Ulster University contributing £2.9m and £716,000 invested through industry collaborations with Randox Laboratories and Heartsine Technologies. Invest NI’s R&D support is part funded by ERDF under the EU Investment for Growth and Jobs Programme 2014-2020.

Celebrating the opening of the Advanced Biomedical Engineering Laboratory are (from left) Professor Brian Meenan, Ulster University; Tracy Meharg, Invest NI; Professor Jim McLaughlin, Ulster University; and Stuart McGregor, Randox Laboratories


Committed to meeting customers’ needs

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.

Customer support

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.

Customer Reviews

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 acusera@randox.com.


Centralised QC Data Management Platform

Busy laboratories are not uncommon, in fact, many laboratories are expanding and their workload is increasing as a result. In labs like this, time is limited therefore ease of use and accessibility are valuable traits when it comes to the technology used to monitor daily QC activities.

With this in mind, Randox Quality Control are pleased to announce the launch of a new centralised platform for the management of both daily QC activities and calibration verification.

Convenience is key and that is what we have aimed for with the launch of this new platform. With laboratory professionals at the front of our minds, the platform delivers access to QC data at the click of a button ensuring the review process is as simple as possible.

What is available on the new QC platform?

With the new QC platform users have access to both;

By encompassing these two programs onto one easy to use platform, laboratories can save precious time allowing them to focus on other important tasks with the reassurance that their data is easily accessible.

Further information on Acusera 24.7 Live Online and Acusera Verify can be seen below;

Keep your instrument in check with Acusera Verify

Designed with convenience in mind the Acusera Verify range of linearity sets will help you to easily meet CLIA requirements for calibration verification. The availability of instrument dedicated, liquid ready-to-use materials covering a wide range of cardiac markers, specific proteins and therapeutic drugs enables specific instrument requirements to be met, while challenging the complete reportable range. Complimentary data reduction software is provided with all linearity sets delivering access to:

  • Easy-to-interpret charts for at-a-glance performance assessment
  • Unique traffic light system indicating pass or fail
  • Automatically generated statistics
  • Peer group data updated live in real-time

Stress free QC analysis with Acusera 24.7

Acusera 24.7 Live Online is an interlaboratory data management package complementing our Acusera range of true third party controls. With the recent launch of version 2.0, the software is smarter, faster and more powerful than ever before.

Designed to help laboratories efficiently review QC data from all of their laboratory instruments, the software generates a wide range of charts and reports enabling quick & easy identification of QC failures and emerging trends.  Unique access to peer group data updated instantly in real-time facilitates comparative performance assessment and helps speed up the troubleshooting process, easily identifying if a problem is unique to your lab or a widespread issue.

Contact us today and register your interest in Acusera Verify & Acusera 24.7 Live Online.


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