50th Brazilian Pathology Congress Clinical / Laboratory Medicine (CBP/ML)

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Liquid Controls vs Lyophilised Controls

Results of our Liquid vs Lyophilised Poll

Having conducted a recent poll on our Social Media platforms (Facebook, LinkedIn & Twitter) asking our customers what format they preferred their quality control material in – liquid or lyophilised – we saw a large preference for liquid controls.

What does this poll result really tell us?

That most people prefer Liquid controls? Yes.

Lyophilised controls are not as popular amongst our social following? Yes.

However, it also tells us that even though most people chose a liquid format there was still almost a quarter of people who prefer to use lyophilised controls. Liquid and lyophilised controls both have their advantages and disadvantages, this blog is designed to help you decide which is the best fit for your lab.

Liquid Controls

Firstly, it is important to note that there are two distinct types of liquid control available on the market;Liquid ready-to-use and Liquid for ease-of-use, better known as Liquid Frozen. Both types of liquid controls reduce the potential for reconstitution errors and prevent contamination from poor quality water.

Liquid frozen controls must be thawed in a refrigerator before use, making them a little less convenient than the liquid ready-to-use alternative. They require no reconstitution so associated errors are removed. Due to the frozen nature of these controls, they are often shipped on dry ice to prevent thawing in transit, as such transportation costs can be significant.

Liquid ready-to-use controls are arguably the most favoured of the three formats and it is easy to understand why. The controls are simple to use, they require no preparation and there is no need to thaw before use.– With zero preparation required, these controls can be removed from the packaging and used right away! What’s more, they can be conveniently stored at 2-8oC minimising expensive shipping costs.

Another major benefit of using a liquid ready-to-use control is the fact that they are ideal for POCT (Point of Care Testing). The ability to use these controls on the spot is extremely beneficial to POC providers.

Lyophilised Controls

Lastly, the choice of 22% of respondents – lyophilised. This is freeze dried material which requires the laboratory professional to reconstitute the sample using sterilised water and mixing before use. Although this format is not as easy to use as either liquid control it does come with benefits. The enhanced stability of this control sees a shelf life of almost double the two years that is normal with a liquid control, however, the potential for reconstitution errors and the fact it is not as simple to use lead to the majority of people opting for a more convenient liquid control.

Randox Quality Control Range

With Randox QC there are a vast array of controls available in liquid ready-to-use and liquid frozen formats. Areas we have liquid frozen formats available in, include; Clinical Chemistry and Immunoassay.

Liquid ready-to-use controls can be found in the following; Liquid Cardiac, Blood Gas, Liquid Urine, Urinalysis, Specific Protein, Ammonia Ethanol, Haematology, Liquid HbA1c and Liquid Tumour Markers.

Lyophilised controls available with Randox QC can be found within; Chemistry, Immunoassay, Cardiac, Coagulation, HbA1c, Lipids and Therapeutic Drug Monitoring.

To register an interest in any of our controls simply contact us at acusera@Randox.com and let us know how we can help and support you or alternatively click here – where you will be redirected to our contact page.


ISO 22870:2006 in the Point-of-Care Testing (POCT) Market

Point-of-Care Testing (POCT)

The Point-of-Care testing market, better known as POCT, is growing rapidly as the demand for faster patient testing increases. This point is fully backed up through the results of the recent BIVDA (British IN-Vitro Diagnostics Association) survey of 2016. This survey focuses primarily on Point-of-Care Testing and there were a few questions asked that sparked an interest amongst us. The questions can be seen below;

“What are the challenges you face regarding POCT?”

“What do you see in the future for POCT?” (BIVDA, 2016)

Although many answers were put forward there was one (answer) that appeared for both questions. Accreditation. We found this intriguing yet far from surprising. POCT and accreditation go hand-in-hand, with laboratories striving to achieve ISO accreditation with the ultimate aim of allowing patients to have peace of mind that they are being tested properly and effectively.

ISO 22870:2006

The ISO standard that relates to POCT is ISO 22870:2006 Point of Care Testing- Requirements for quality and competence. This standard gives specific requirements applicable to POCT testing and apply when POCT is carried out in a hospital, clinic or a healthcare organisation providing ambulatory care. However, it is important to note and remember that ISO 22870 is not to be seen as a separate, standalone document, in fact, it is to be used in conjunction with ISO 15189:2012 (medical laboratories – particular requirements for quality & competence).

With accreditation in POCT becoming a major factor to laboratories, it is no surprise to see accreditation as one of the top answers to the two questions asked in the survey.

For laboratories looking to participate in point-of-care testing there are other factors of ISO 22870 that they must be aware of, one of the major factors is as follows;

“ISO 22870:2006 advises that where available, Internal Quality Control and participation in an External Quality Assessment (EQA) scheme is required in the point-of-care setting.”

How can Randox help?

Fortunately for laboratories, Randox are able to help out here. With a vast range of true third party controls and 32 comprehensive RIQAS (EQA) programmes, Randox can aid laboratories as they aim for ISO accreditation.

We have multiple products particularly suited to the POCT market including, Liquid Cardiac, Blood Gas and Urinalysis. These products are available both as internal quality controls and as EQA programmes.

Our Acusera range of true third party controls are conveniently supplied liquid ready-to-use, therefore requiring no preparation. This is a particular advantage in the POC environment were test results are required quickly and also were testing is not always performed by laboratory personnel.  Supplied with assayed target values and manufactured from 100% human material, ensuring they act in the same manner as a patient sample, our Acusera controls are ideal for use at the point of care and will therefore aid a laboratory in gaining ISO accreditation.

Similarly, participation in our RIQAS EQA programme will also assist laboratories to meet regulatory requirements and achieve ISO accreditation.  With over 40,000 laboratory participants in 123 countries, RIQAS is the largest international EQA scheme worldwide! Our Liquid Cardiac, Blood Gas and Urinalysis programmes are all supplied liquid ready-to-use, complementing their Acusera counterparts perfectly!

By using our Acusera controls and RIQAS EQA programmes side by side, a laboratory can confidently aim for ISO accreditation in the knowledge that they are meeting criteria.

For more information

Acusera Quality Controls & RIQAS

Click for more information on our range of Acusera Quality Controls or RIQAS EQA Programmes


Microalbumin shifts when changing reagent batch

A laboratory running a competitors 3rd party Microalbumin QC noticed shifts in their QC values whenever they changed reagent batch.

They tested two levels of quality control over three different batches of reagent the results can be seen in the table below.

Competitor Control – Microalbumin
Reagent
Batch
QC
Level One
QC
Level Two
1 19.9 81.0
2 29.7 90.5
3 50.4 122.4

 

As can be seen from the findings above, Microalbumin results shifted significantly each time they changed reagent batch. This was the case for both the level one and level two control however when the lab tested the same set of patient samples across the three reagent batches results were consistent and did not show the same shifts.

The laboratory decided to contact Randox and ask about our Microalbumin controls. They were concerned about the shifts seen with their current supplier and highlighted the fact they were no longer confident in the results they were releasing. This led to them trialling the Randox liquid ready-to-use Microalbumin control with the same three reagent batches they tested previously.

Having tested two levels of the Randox quality control over the same three reagent batches the laboratory reported to us that their results were back on track and they were delighted with the outcome! The results of the Randox control can be seen in the table below.

Randox Control – Microalbumin
Reagent
Batch
QC
Level One
QC
Level Two
1 33.5 158.8
2 34.9 164.9
3 34.8 168.0

 

The difference seen with the Randox control across the three reagent batches was much smaller than that of their previous control and was in line with the changes seen with their patient samples.

This case study highlights the commutability of the Randox QC range. By using a control with a matrix that reacts to the test system in the same manner as the patient sample the laboratory was confident in the patient test results produced and were able to meet ISO 15189:2012 requirements.

REQUEST A FREE QC CONSULTATION TODAY!

Request a free QC consultation today and find out how Randox Quality Control can help your laboratory consolidate and save with our extensive range of true third party, commutable controls – designed to give you the confidence needed to report accurate and reliable QC results.


Serving Up Accurate Test Results

Today, June 27th, sees the beginning of one of the four tennis majors – Wimbledon. Basking in the summer sun while lying on ‘Henman Hill’, this yearly tournament attracts spectators from all over the globe who want to watch the world’s best tennis players ply their skills on the revered centre court over the course of a two week period. But what exactly is the most important skill a tennis player can utilise? Well, many players have different strengths but the one skill that all of them must possess is the ability to serve – and accurately.

The ability to serve is vitally important as it allows the point to begin, serving accurately however allows the player to set the pace and ensure they are on the front foot. By making sure they serve more accurately, the player can be confident in their ability to win the point and the match.

Just like tennis, laboratories will aim to be accurate when ‘serving’ up their test results. Achieving accurate test results is what every lab strives for. With patient results on the line it is important for labs to use QC material that will assist them in obtaining the correct results, therefore keeping them clear of causing a ‘racquet’.

Randox Acusera is world renowned for delivering unbiased performance assessment. Our range of true third party controls are manufactured to the highest standard ensuring commutable samples that react to the test system in the same manner as a patient sample, ultimately allowing labs to be confident in the results they produce. Much like the serve in tennis that needs to fall within a target area, QC results should be as close as possible to the target and ideally should fall within +/- 2 SD from the mean. By falling within these limits a lab can be sure of accurate results and an acceptable performance.

Employ Acusera quality controls in your laboratory today and experience unrivaled confidence in your test results.

Get your slice of our control range here by contacting us at acusera@randox.com. We guarantee you will love us!


JIB, Paris 2016

This year, we’re inviting you to visit Randox as we attend JIB, Paris 2016!

Talk to an expert from one of our many Randox Laboratories teams, as they visit the heart of France for JIB, such as Randox Quality Control, The RX series range of Clinical Chemistry Analysers, Randox Reagents, and specialists of Randox’s famous Biochip Array TechnologyAll of these teams will be available between the 22nd and 24th of June 2016 in the Paris Expo Porte de Versailles (Paris, France) at stand C022.

Don’t miss the team! Join the conversation on the future of diagnostics and medical technology, visit Randox!


Randox launches White Paper on Quality Control in POCT

Randox has launched the first in a series of White Papers, focusing on the importance of quality control in point-of-care testing (POCT). The White Paper is free to download and will help laboratories define an appropriate QC procedure for all POCT devices.

Patient testing at the point-of-care has increased dramatically in recent years, as technology makes it more convenient to test patient samples at the bedside producing rapid results and allowing immediate action. However, the benefits of this are only true if the results are both accurate and reliable, making quality control vitally important in the POC setting, just as it is in the laboratory.

A recent survey* identified that POCT is the largest source of error when compared to other sources of laboratory testing errors. Furthermore, the most common phase for errors in POCT is in the analytical stage, whereas in laboratory-based testing this is the least common source for errors. This highlights how vital it is to have a robust QC procedure in place for POCT as the potential risk of harm to a patient appears to be far greater for POC tests compared to those performed in a laboratory.

The White Paper from Randox covers the fundamentals of developing a POCT QC strategy in line with ISO15189 requirements, looking at who is responsible for QC, what QC is appropriate for different types of POC devices and tips for choosing IQC material and an EQA scheme.

The Paper can be downloaded from the Randox website here.

Randox second White Paper, which studies the importance of using 100% human serum controls to avoid lot-to-lot variations in immunoassay testing, will be available in December.


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