Reconstituting Lyophilised Controls

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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 – http://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!


Mythbusting: Frequency of EQA Reports

External Quality Assessment (EQA) is a vital aspect of laboratory testing and is often a regulatory requirement. The primary function of EQA is to provide the laboratory with an indication of test system accuracy through interlaboratory comparison. Ultimately participation in an EQA programme will give the laboratory greater confidence in the accuracy and reliability of the results they release.

When choosing an EQA scheme there are a variety of different options.  It is important that laboratories weigh up the pros and cons of each option in order to choose the scheme that best suits their needs.

Many EQA schemes promote the distribution of multiple EQA samples per challenge or testing event as a benefit to the laboratory.  By analysing multiple samples at each testing event, laboratories believe they are challenging their test system across a wider range of concentrations than would be possible if they were to analyse just one sample. However, this is not always the case as in many instances the levels can be very similar.  Another consideration is the EQA report received by the laboratory.  EQA reports are used to assess analytical performance and identify any test system failures, such reports can take more than one month to receive.  In such instances it would be more beneficial if the laboratory tested just one sample at each bi-weekly/monthly challenge and received their report faster.

Report frequency should be priority for any laboratory when choosing an EQA scheme. A fast turnaround time will allow any test system errors to be identified sooner and necessary corrective actions to be taken immediately with minimum disruption to the lab. Perhaps the most important benefits of a rapid report turnaround is cost and time savings as it will significantly reduce the time and money spent re-running patient samples.

If the time between sending EQA results back to the organizer and receiving an EQA report is too long, it becomes more difficult to pin-point exactly when an error was encountered thus increasing the possibility of incorrect test results and possible misdiagnosis. While this would be considered the worst-case scenario, it is still a possibility.

Choosing an EQA provider that delivers both frequent analysis and a quick report turnaround will give the laboratories the confidence they need to report patient test results.

With the Randox International Quality Assessment Scheme (RIQAS), comprehensive reports are available within 72-hours of the submission deadline. Furthermore both bi-weekly and monthly analysis options are available.

To find out more on RIQAS and our extensive product portfolio, comprising 32 programmes, visit our page – http://www.randox.com/riqas-external-quality-assessment/ or alternatively contact us using the button provided.


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!


World Heart Day – 29th September 2017

World Heart Day – 29th September – Introduction

This year (29th September 2017) join us as we help to raise awareness for World Heart Day! The theme for this year’s World Heart Day is to share the power – and you know what they say… “Knowledge is Power” so throughout this blog we will be providing vital knowledge as well as tips to having a healthy heart!

The heart is a muscular organ that pumps blood around the body and is indeed central to your circulatory system. The system consists of a network of blood vessels, including, veins, arteries and capillaries. These vessels transport blood – as well as carrying oxygen and other important nutrients – to every part of the body. Ensuring a healthy heart is therefore vital.

What is CVD?

When too much pressure is put on our hearts we start to run into some issues – the general term for conditions affecting the heart is Cardiovascular Disease – better known as CVD. The exact cause of CVD is far from clear, with many factors increasing your chances of developing CVD. These risk factors can include, but are not limited to, high blood pressure, smoking, high cholesterol, being overweight or in many cases, can be hereditary.

It is important to note that Cardiovascular Disease is accountable for nearly half of all non-communicable disease (NCD) deaths, therefore making it the number one killer across the globe! Scary thought considering there are a whopping 17.3 million CVD related deaths per year – including stroke and heart disease. Understanding CVD in today’s society is more important than ever before, we need to know the truth about CVD and be able to decipher the facts from the fiction. Below you can see a few examples of common misconceptions regarding CVD and also some that are indeed true.

Only older men can get heart disease/CVD

False

Cardiovascular Disease can develop before birth

True

Exercising won’t help if you’re genetically predisposed to CVD

False

Low and middle-income countries are the most susceptible to CVD

True

It is estimated that by 2030 the number of deaths, due to CVD, will rise to an enormous 23 million globally! However, by raising awareness of the critical numbers and facts we can all help prevent CVD by making small, simple lifestyle changes.

Tips for a Healthy Heart

Using our “art into heart” graphic below, we decided to outline some of our Randox QC top tips for staying healthy! Why not try some of them and feel the effects of having a happy, healthy heart!

This World Heart Day, join us and many more around the world, to raise awareness for this great cause and unite together to “Share the Power”.


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.


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