Acusera 24•7 Live Online – Speeding up the Review of QC Data

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Acusera 24•7 Live Online – Speeding up the Review of QC Data

Reviewing QC data can be an extremely time consuming and costly process. With manual statistical calculation laboratories risk missing or ignoring significant trends in QC data which could potentially put patients at risk. So how does a laboratory combat this? Simple; participate in an interlaboratory data management program that provides a quick, effective, accurate and detailed analysis of QC results. The answer to this program is Acusera 24•7 Live Online.

Acusera 24•7 Live Online

With the launch of Acusera 24•7 Live Online version 2.0, QC data review is now faster and simpler than ever before. Our program aims to save the laboratory precious time and money by instantly flagging any QC failures, ultimately ensuring accurate test system performance.

Designed to complement and be used primarily with our Acusera range of true third party controls, Acusera 24•7 Live Online has two primary functions; 1) management and interpretation of IQC data and 2) rapid and effective troubleshooting of QC failures via access to instantly updated worldwide peer group statistics.

These two functions have one common goal – being an effective tool for evaluating laboratory performance. With the launch of version 2.0 the software boasts even more functionality than before, ensuring any laboratory employing Randox Quality Control coupled with Acusera 24•7 Live Online will see benefits from the get-go.

Why should you use Acusera 24•7 Live Online?

Using Acusera 24•7 to help speed up the review process in your laboratory can reap dividends. The program has been designed for this specific reason and the features are geared towards helping the laboratory review, interpret, and analyse QC data quickly, effectively and accurately. One such example of this is the unique dashboard function which instantly flags any alerted or rejected results from the past 7 days, significantly reducing the time spent analysing reports and charts whilst simultaneously allowing any corrective action to be taken immediately with minimum disruption to the lab’s output.

Previously, peer group statistics would have been updated every 24 hours with Acusera 24•7 Live Online version 1.6, however, with the new release, peer data is about to get a unique upgrade. Gone are the days when you will have to wait 24 hours to get updated stats – Acusera 24•7 Live Online now has the ability to generate peer data live in real-time, thereby enhancing the laboratory’s troubleshooting capabilities and allowing labs to compare their data with others around the globe.  What’s more there is no deadline for submission of results meaning labs can get a true reflection of performance at any time. Ultimately, laboratories will be able to easily identify if an issue is unique to them or a widespread issue amongst their peers. Such information will allow them establish a root cause quicker and spend less time troubleshooting.

The capacity to generate interactive charts and comprehensive reports automatically is a feature included in Acusera 24•7 that will aid quick review of QC data. Reports can be generated for a user-defined date range and provide a wealth of information. Reports include statistical analysis, statistical metrics, measurement uncertainty, exception and audit trail reports. Reports coupled with Levey-Jennings, Histogram and Performance Summary charts enable rapid and stress-free performance monitoring. The ability to add multiple instruments, QC lots and analytes to a single chart allows for comparative performance assessment and immediate identification of any trends.

We must not forget that Acusera 24•7 Live Online has already had a modernisation in the past few months. In November 2016 we announced the automatic calculation of Measurement of Uncertainty, Total Error and Sigma Metrics. These new features are also included in the version 2.0 launch of our Live Online program.

Our software is highly flexible with custom configurations of performance limits, multi-rules and target values designed to meet and exceed every laboratory’s needs.

With the ability to identify trends, system errors, minimise false rejections and bridge the gap between IQC and EQA, there really is no reason to look elsewhere for your analytical performance of QC.

For more information on Acusera 24•7 Live Online or our Acusera third party controls, click here.


Celebrate Christmas with Randox Quality Control

T’was the week before Christmas and all through the lab not a thing could be heard not even a sound. The analyser lay silent asleep in the corner, the lab staff at home dreaming of a few days’ rest, only a few more days to go before the big day!

The big man in red, what will he bring those who already have everything? Peace, happiness and health for their loved ones throughout the festive break, that would be the wish for everyone to make. And what better way to ensure they stay healthy, well it all begins in the laboratory…

An important consideration to remember when choosing your lab Quality Control (QC) is that approximately 70% of clinical decisions are based on laboratory test results. It is therefore essential that the results gained from laboratory testing are accurate and reliable in order to provide the appropriate treatment and avoid or prevent potential misdiagnosis.

Patient results are of the utmost importance for a laboratory and therefore running the best Quality Control material should be at the top of their agenda. QC material should have a number of features that allow a lab to judge the overall quality of their output. These features include the controls ability to be commutable (which means how well it reacts as a replicate of a patient sample), is it a true third party control that has been manufactured to provide an independent and unbiased assessment of performance, does your control come with clinically relevant levels and does it have a long shelf life as well as a good open vial or reconstituted stability? These are the questions lab staff will be asking themselves when deciding on what QC is the right QC.

So stay off Santa’s naughty list by providing accurate and reliable patient test results, do this by employing Randox QC in your laboratory. Our controls have been designed to deliver significant cost savings without sacrificing on quality. With consolidated controls (combining up to 100 analytes in a single vial) your lab can reduce QC costs and preparation time, the inclusion of analytes present at clinical decision levels will eradicate the need for additional controls and because of our long shelf life (2 years for liquid controls, 4 years for lyophilised) and excellent stability claims your laboratory can be sure that expensive lot changes will be a thing of the past! Our controls can be described as true third party and this, combined with the commutable nature of the controls, leads to us being able to claim that we have the best Quality Control material around.

So this Christmas when deciding what QC to choose – make sure you look no further than Randox Quality Control. Our QC family is known as Acusera and our product offering includes QC and calibrator material, Interlaboratory Data Management Program (Acusera 24.7), the world’s largest international EQA/PT scheme better known as RIQAS and the newest addition to the family, Linearity or Calibration Verification material.

We have packages for every lab regardless of size and budget and we guarantee you will become ho-ho-hooked on Randox QC.

Wishing you all season’s greetings and a prosperous New Year from everyone at Randox QC.


Liquid HbA1c Quality Control

Therapeutic Drug Quality Control

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

DescriptionSizeAnalytesCat No
Liquid HbA1c Control2 x 2 x 0.5 ml1HA10155
Liquid HbA1c Control Level 16 x 1 ml1HA10224
Liquid HbA1c Control Level 26 x 1 ml1HA10225

Analytes

HbA1c (Haemoglobin A1c)


What is Six Sigma?

Six Sigma is a method of process improvement which focuses on minimizing variability in process outputs. The Six Sigma model was developed by Motorola in 1986, and Motorola have reportedly saved over $17 Billion due to its successful implementation.

The model looks at the number of standard deviations (SD) or ‘sigmas’ that fit within the quality specifications of the process. In the laboratory, the quality specifications relate to the Total Allowable Error (TEa).  The higher the number of standard deviations that fit between these limits, the higher the sigma score and the more robust the process or method is. As sources of error or variation are removed from a process, the SD becomes smaller and therefore the number of deviations that can fit between the allowable limits is greater; ultimately resulting in a higher sigma score.

A process with a sigma score of six is considered to be a high quality process, making six the target for many industries including the clinical laboratory.

In order to achieve Six Sigma, a process must not produce more than 3.4 defects per million opportunities. In a Laboratory context, this would equate to 3.4 failed QC results per million QC runs.

Sigma is calculated using the following equation:

Sigma = (TEa – %Bias) / %CV

TEa – Total Allowable Error

%Bias – Deviation from the target or peer group mean

%CV – Imprecision of the data

Acusera 24.7 now featuring

Why is Six Sigma useful in the laboratory?

Six Sigma can be used to help answer one of the most commonly asked questions in laboratory quality control. How often should I run QC?

The Six Sigma model allows laboratories to evaluate the effectiveness of their current QC processes. Its most common use is to help implement a risk-based approach to QC, where an optimum QC frequency and multi-rule procedure can be based on the sigma score of the test in question. The performance of tests or methods with a high sigma score of six or more may be evaluated with one QC run (of each level) and a single 1:3s warning rule. On the other hand, tests or methods with a lower sigma score should be evaluated more frequently with multiple levels of QC and a multi-rule strategy designed to increase identification of errors and reduce false rejections.

The below table shows how multi-rules and QC frequency can be applied according to Sigma Metrics:

Sigma Score QC Frequency Number of QC Samples QC Rules
6 or more Once per day Each level of QC 1:3s
5 Once per day Each level of QC Multi-rule strategy
4 At least twice per day Each level of QC Multi-rule strategy
< 4 At least four times per day Each level of QC Multi-rule strategy

 

It is important to note that this is just an example and it may be necessary to run QC samples more often than three times per day.  Some high throughput laboratories prefer to run QC samples before and after a set number of patient samples, while others opt to run QC samples after a set period of time.  Whatever frequency you choose it is vital that the frequency is appropriate for the test in use.  Download our guide ‘How often is right for QC’ to find out more.

What can Randox offer?

Randox’s Acusera 24.7 Live Online is a peer group reporting software application designed to complement the Acusera QC range. The intuitive and user-friendly software boasts some of the most advanced features on the market, and Version 1.6 provides automatic calculation of sigma scores for individual assays, giving the user an at-a-glance overview of assay performance.

Peer group reporting software is an integral part of any modern laboratory seeking to streamline their QC processes and reduce costs. With Acusera 24.7 Live Online, there has never been a better time to implement, save and succeed.

Contact us today to find out how Randox can help your laboratory achieve its goals.


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


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!


Liquid CSF Quality Control

Therapeutic Drug Quality Control

Providing a true third party solution for the measurement of Cerebrospinal Fluid (CSF), the Acusera Liquid CSF Control is designed to deliver an unbiased, independent assessment of analytical performance for 14 analytes, helping to ensure the results clinical laboratories release are accurate and reliable.

With an extended open vial stability of 30 days at 2oC – 8oC, the Acusera Liquid CSF Control will reduce waste, while remaining easy and convenient to use.

Features & Benefits

  • Liquid ready-to-use samples requiring no preparation
  • Human based material
  • True third party control providing unbiased performance assessment
  • Assayed target values available
  • Shelf life of 2 years from the date of manufacture
  • Open vial stability of 30 days for all analytes when stored at 2oC to 8oC
DescriptionSizeAnalytesCat No
Liquid CSF Control Level 110 x 3ml14CF10138
Liquid CSF Control Level 210 x 3ml14CF10139

Analytes

  • Albumin
  • Albumin (electrophoresis)*
  • Alpha – 1- globulin (electrophoresis)*
  • Alpha – 2- globulin (electrophoresis)*
  • Beta- globulin (electrophoresis)*
  • Chloride
  • Gamma – globulin (electrophoresis)*
  • Glucose
  • hsIgA*
  • hsIgG
  • hsIgM*
  • Lactate
  • Protein (Total)
  • Sodium

*No claims are made regarding values and stability.


PTH Quality Control

Therapeutic Drug Quality Control

Providing a true third party solution for the measurement of Intact PTH, the new Acusera PTH Control will deliver an unbiased,
independent assessment of analytical performance with any instrument or method.

This notoriously unstable marker, present in a number of immunoassay controls, is now available in a liquid frozen format with an impressive 30 day open vial stability, reducing waste while remaining easy-to-use.

Features & Benefits

  • Liquid Frozen
  • 100% human serum
  • Assayed target values available for many immunoassay platforms
  • Stable to expiry date at -20°C to 70°C
  • Open vial stability of 30 days at 2°C to 8°C
DescriptionSizeAnalytesCat No
PTH Control Level 13 x 3 ml1PTH10110
PTH Control Level 23 x 3 ml1PTH10111
PTH Control Level 33 x 3 ml1PTH10112

Analytes

  • Intact PTH (Parathyroid Hormone)

Related Products


Evidence Immunoassay Control

Therapeutic Drug Quality Control

Multi-analyte immunoassay control designed for use in the routine monitoring of the Randox Fertility, Thyroid and Tumour Marker Arrays.

Features & Benefits

  • Lyophilised for enhanced stability
  • Assayed values available for Randox Biochip systems
  • 100% human serum
  • Stable to expiry date at 2oC – 8oC
  • Reconstituted stability of 7 days at 2oC – 8oC or 4 weeks at -20oC
DescriptionSizeAnalytesCat No
Evidence Immunoassay Control 4 x 3 x 5ml14EV3570

Analytes

  • CEA
  • Estradiol
  • FSH
  • Free T4
  • Free T3
  • Leutinising Hormone
  • Prolactin
  • Progesterone
  • PSA (Total)
  • PSA (Free)
  • Testosterone
  • Total T4
  • Total T3
  • TSH