Product Focus: Urology

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Product Focus: Urology

Did you know?”

The month of September is Urology Awareness Month in 2017.

Focus On - Urology

This month our Randox QC Product Spotlight focuses on urology and our extensive range of urine chemistry controls and EQA programmes.

During the month of September, there is a particular focus placed on helping to raise awareness for Urology and the effects that urological diseases can have on a person’s life.

It is estimated that 1 in 2 people will be affected by a urological condition at some point in their lifetime. Conditions and diseases related to kidneys, bladder and prostate, among others, are commonplace and can be devastating for millions of men, women and children across the globe.

Urological conditions can be common, such as a urinary tract infections, or they can be much more serious, for example, prostate or testicular cancer.

Throughout September the aim is to make people more aware of these urological conditions and reduce the stigma attached by encouraging people to be more open when talking about their conditions.

So where do Randox Quality Control fit into this?

It is accepted that over 70% of medical decisions are based on laboratory test results with Quality Control playing an often behind the scenes but vital role in ensuring both accuracy and reliability.

Our range of Urine Chemistry and Urinalysis quality controls are designed primarily to ensure accurate test system performance however offer the laboratory additional benefits that will help them to meet regulatory requirements whilst also reducing costs and time.  Manufactured from 100% human urine each control will react to the test system in the same manner as a patient sample reducing inconvenient shifts in QC results when reagent batch is changed.  As true third party controls you can be sure of unbiased performance assessment with any instrument or method.

Introducing Acusera Urine Controls

With a choice of liquid or lyophilised and assayed or unassayed controls there is a cost effective option to suit any laboratory. Read on to find out more information on the range – each week of Urology month we will add additional products so make sure you come back every week to find out more!

Week One (1) - Acusera Assayed Urine Control

The Randox Acusera Assayed Urine Quality Control is designed for use in the routine monitoring of urine chemistry tests. Assayed, method specific target values and ranges are provided for 24 analytes including kidney function parameters, catecholamines and urinary proteins.

 

Features & Benefits

  • Lyophilised for enhanced stability
  • 100% human urine
  • Assayed target values provided for 24 parameters
  • Stable to expiry date at 2 – 8℃
  • Reconstituted stability of 5 days at 2 – 8℃ or 14 days at -20℃

Week Two (2) - Acusera Liquid Urine Control

The Randox Acusera Liquid Urine quality control is designed to be both convenient and easy to use. The liquid ready-to-use format eliminates issues with pipetting and allows convenient storage at 2 – 8℃. Assayed instrument and method specific target values and ranges are provided for 18 commonly tested urine chemistry parameters.

Features & Benefits

  • Liquid ready-to-use
  • 100% Human Urine
  • Assayed target values provided for 18 parameters
  • Stable to expiry date at 2oC – 8oC
  • Open vial stability of 30 days at 2oC – 8oC

Week Three (3) - Acusera Unassayed Urine Control

The Randox Acusera Unassayed Urine Quality Control is designed for use in the routine monitoring of 12 common urine chemistry parameters.

Features & Benefits

  • Lyophilised for enhanced stability
  • 100% human urine
  • Approximate target values available
  • Stable to expiry date at 2 – 8℃
  • Reconstituted stability of 5 days at 2 – 8℃or 14 days at -20℃

Week Four (4) - Acusera Liquid Urinalysis Control

The Randox Acusera Urinalysis quality control is specifically designed for use with both manual and automated method of urine test strip analysis. The control is available in convenient 12ml vials with assayed ranges provided for 13 parameters covering the chemical examination of urine strips.

Features & Benefits

  • Liquid ready-to-use
  • 100% human urine
  • Assayed ranges provided for 13 parameters
  • Suitable for use in POC testing
  • Stable to expiry date at 2 – 8℃
  • Open vial stability of 30 days at 2oC – 25oC (20 immersions for UC5033/5034)

Introducing RIQAS Urine Programmes

It is important to note that Randox QC don’t just supply top quality Urine Controls, we also have a number of RIQAS EQA programmes that go hand-in-hand perfectly. RIQAS is the largest, international EQA scheme in the world with over 45,000 laboratory participants spanning 133 countries, as such peer groups are maximised ensuring data for a wide range of instruments.

Week One (1) - RIQAS Human Urine Programme

The RIQAS Human Urine EQA programme is designed to monitor the performance of 25 routine chemistry assays in urine.

  • Accredited to ISO/IEC 17043
  • Lyophilised for enhanced stability
  • 100% human urine
  • Bi-weekly reporting
  • 24 x 10ml samples provided
  • Submit results and view reports online via RIQAS.Net
  • Register up to five instruments at no extra cost

Week Two (2) - RIQAS Urinalysis Programme

The RIQAS Urinalysis EQA programme is designed to monitor the performance of urine dipstick test using both manual and automated methods. All samples are supplied in a liquid ready-to-use format ideal for both clinical and point-of-care testing (POCT).

  • Liquid ready-to-use
  • 100% human urine
  • Bi-monthly reporting
  • Submit results and view reports online via RIQAS.Net
  • Suitable for POCT

The RIQAS Urine Toxicology EQA programme is designed to monitor the performance of 20 drugs of abuse tests in urine. Suitable for both qualitative and semi-quantitative methods of analysis.

  • Liquid ready-to-use
  • 100% human urine
  • Monthly reporting
  • Submit results and view reports online via RIQAS.Net
  • Suitable for use with both quantitative and screening methods
  • Report results for drug group or individual metabolite

Product Spotlight Archive

Don’t forget to visit our Product Spotlight Archive and see spotlights from different months


Product Focus: Randox HbA1c

This month’s product spotlight is our new Liquid HbA1c Control. Over the next few weeks, we will be taking a look at some of the QC solutions available from Randox for HbA1c.

Haemoglobin is an oxygen-transporting protein found inside Red Blood Cells (RBC). Glycated Haemoglobin is simply a haemoglobin with a glucose molecule attached. The higher the level of glucose in the blood the more glycated haemoglobin is formed. Red Blood Cells live for around 2-3 months, because of this the HbA1c test is used by clinicians to get an overall picture of average blood sugar levels for the last 2-3 months. For people with diabetes this is important as the higher the HbA1c, the greater the risk of developing diabetes-related complications. It is suggested that an individual’s HbA1c target should be under 48mmol/mol or below 6.5%. By lowering your HbA1c, you help reduce the risk of long-term health problems.

HbA1c is used to monitor patients with diabetes providing an indication of how well the condition is controlled. A measurement of less than 6% of HbA1c in the sample indicates good glucose control and a lower risk of diabetic complications for the majority of diabetics.

Week 1: HbA1C Quality Control

The Randox Acusera HbA1c control is designed for use in the quality control of both HbA1c and Total Haemoglobin assays. Assayed instrument and method specific target values and ranges are provided for all major systems and methods including HPLC. A reconstituted stability of 4 weeks keeps waste to a minimum and helps to reduce costs.

Main Features and Benefits:

Lyophilised for enhanced stability
100% human whole blood
Assayed target values provided for 2 parameters
Convenient bi-level pack containing two clinically significant levels of control
Stable to expiry date at 2°C – 8°C
Reconstituted stability of 4 weeks at 2°C – 8°C

Week 2: Liquid HbA1C Quality Control

The Randox Acusera Liquid HbA1C control is conveniently supplied in a liquid ready-to-use format and 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.

Main Features and Benefits:

Liquid ready-to-use
Human based whole blood
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

Week 3: RIQAS HbA1C Programme

RIQAS is the largest international External Quality Assessment Scheme, with more than 40,000 participants in over 124 countries. World renowned for reducing the number of individual programmes required by even the most demanding laboratories, RIQAS covers 360 parameters across 32 flexible multi-parameter programmes.  Effective consolidation in this way will not only deliver real cost savings but free up storage space and ultimately reduce the time spent preparing multiple samples at each survey.

The RIQAS Glycated Haemoglobin (HbA1c) EQA programme is designed to monitor the performance of HbA1c and Total Haemoglobin assays.

Main Features and Benefits:

Accredited to ISO/IEC 17043 designed to meet ISO 15189 requirements
Lyophilised for enhanced stability
100% whole blood ensuring a matrix similar to the patient sample
Monthly reporting allowing identification of any system errors sooner
Submit results and view reports online via RIQAS.Net
Register up to five instruments at no extra cost


Product Focus: Calibrators

Calibrators

The importance of accurate instrument calibration in the laboratory is often overlooked. At Randox Quality Control we believe that accurate calibration is the foundation for producing reliable patient results. In fact, we believe that this should be your first step in ensuring accurate instrument performance and something you should consider carefully.

Effective instrument calibration will provide you with a baseline for your analysers from which accurate results can be produced. This baseline is then used to adjust readings to match the computed value and ensure accurate patient results are reported.

Calibrator features you should consider;

As well as frequent recalibration, according to the instructions provided by the instrument / reagent manufacturer, Randox Quality Control recommends;

  • Utilising a third party calibrator, such as those available from our Acusera range, which have independently assigned values and have not been optimized for use with any specific instrument or reagent system
  • Ensuring the calibrator you employ has the same matrix as a patient sample
  • Choosing a calibrator that is 100% commutable, ensuring it mimics the behaviour of a patient sample
  • multi-analyte calibrator with a long shelf life

Clinical Chemistry Calibration Serum

Third party calibrator covering 42 commonly used clinical chemistry tests. Method and instrument specific target values and ranges are provided for most chemistry analysers. Two clinically significant levels are available.

Features & Benefits

  • Lyophilised for enhanced stability
  • Human based serum
  • Instrument specific target values provided for 42 parameters
  • Stable to expiry date at 2°C – 8°C
  • Reconstituted stability of 7 days at 2°C – 8°C or 4 weeks at -20°C

Product Spotlight Archive

Don’t forget to visit our Product Spotlight Archive and see spotlights from different months


Product Focus: Randox Cardiac

With World Heart Month running throughout February, we have decided to focus this month on Cardiac Markers. Over the next few weeks, we will be taking a look at some of the QC solutions available from Randox.

The accurate diagnosis of a potentially life threatening cardiac event is essential in order to avoid misdiagnosis and/or incorrect treatment. Acusera True Third Party Cardiac Controls have been designed to cover a wide range of cardiac markers at clinical decision levels eliminating the need for additional low level controls at extra expense. Available in a choice of liquid ready-to-use and lyophilised formats, they are ideal for use at the point-of-care and in the lab. Manufactured from 100% human serum, a matrix similar to that of the patient is guaranteed.

Week 1- Acusera Tri-Level Cardiac Control

The Randox Acusera Tri-Level Cardiac control is designed for use in the routine monitoring of both accuracy and precision. Assayed instrument and method specific target values are provided for 7 cardiac markers along with temperature specific target values for CK and CK-MB.

Features & Benefits

  • Lyophilised for enhanced stability
  • 100% human serum
  • Assayed target values provided for 7 cardiac markers
  • Cut off levels for Troponin I and T in line with internationally recommended levels
  • Stable to expiry date at 2°C – 8°C
  • Reconstituted stability of 5 days at 2°C – 8°C or 4 weeks at -20°C

Week 2- Acusera Liquid Cardiac Control

The Randox Acusera Liquid Cardiac control is designed to be both convenient and easy to use. The liquid ready-to-use format makes it ideal for both clinical laboratories and point-of-care testing. Assayed, instrument specific values are provided for an impressive 8 cardiac markers including, NT-ProBNP, D-dimer and Troponin ensuring consolidation and flexibility. Furthermore an open vial stability of 30 days for all analytes helps to keep waste and costs to a minimum.

Features & Benefits

  • Liquid ready-to-use
  • 100% human serum
  • Assayed target values provided for 8 cardiac markers
  • Cut off levels for Troponin I and T in line with internationally recommended levels
  • Stable to expiry date at 2°C – 8°C
  • Open vial stability of 30 days at 2°C – 8°C for all analytes

Week 3 – RIQAS Cardiac Programme

RIQAS is the largest international External Quality Assessment Scheme, with more than 40,000 participants in over 124 countries. World renowned for reducing the number of individual programmes required by even the most demanding laboratories, RIQAS covers 360 parameters across 32 flexible multi-parameter programmes.  Effective consolidation in this way will not only deliver real cost savings but free up storage space and ultimately reduce the time spent preparing multiple samples at each survey.

The RIQAS Cardiac EQA programme is designed to monitor the performance of up to 7 clinically significant cardiac markers. Two flexible reporting options are available to suit the needs of all laboratory sizes.

Features & Benefits

  • Accredited to ISO/IEC 17043
  • Lyophilised for enhanced stability
  • 100% human serum
  • Bi-weekly reporting
  • Submit results and view reports online via RIQAS.Net
  • Register up to five instruments at no extra cost

Week 4 – Acusera 24.7 Live Online Version 2.0

Acusera 24•7 Live Online is an interlaboratory data management and peer group reporting package complementing the Acusera range of true third party quality controls. Designed to assist in the management of daily QC activities, Acusera 24•7 Live Online will help to meet regulatory requirements, improve error detection, reduce false rejections and ensure accurate patient results.

Delivering an online platform for effective QC data management, our software provides unique access to instantly updated real-time peer group data, automatically generated QC statistics, QC multi-rules, interactive charts and comprehensive reports.

Acusera 24•7 Live Online is an essential QC tool for laboratories of all sizes. By participating and implementing our software your laboratory will be able to do the following;

  • Quickly identify trends, system errors and reagent issues, minimising expensive repeat tests
  • Automatically calculate Measurement Uncertainty, Total Error and Sigma Metrics
  • Bridge the gap between daily quality control and external quality assessment
  • Improve EQA performance by eliminating any undetected bias
  • Facilitate regulatory compliance
  • Reduce false rejections through the use of QC multi-rules
  • Increase confidence in assigned QC target values
  • Speed up troubleshooting processes, shortening delays in reporting

QC Shelf Life – Why is it Important?

An important consideration when choosing your Quality Control material that is often overlooked is the shelf life of the control. With every new lot of control extensive validation studies must be performed. Regulatory bodies such as CLIA require new lot numbers to be evaluated before routine use in the laboratory. For example, CLIA has instructed that any new control lot to be run alongside patient samples will need to be verified alongside the old lot of control. The process is designed to give laboratory professionals confidence in the new material and ensure it is fit for purpose before implementing it in the lab.

As part of the validation process laboratories are required to assay both the old and new lots side by side. The current lot is then used to help verify if the new lot will be acceptable to run within the lab. Such validation studies can be very costly for a lab as well as being extremely time consuming – with some studies taking up to a month to complete! By choosing a control with a longer shelf life laboratories can aim to use the same lot of control for a longer time period. Ultimately this means fewer lot changes and minimal inconvenience for the lab. With a shelf life of 2 years for liquid controls and up to 4 years for lyophilised, coupled with unrivalled stability claims, employing Randox Quality Control in your laboratory will ensure that expensive lot changes will be a thing of the past. Our comprehensive control offering is guaranteed to increase efficiency and reduce costs in any laboratory without compromising on quality.

Contact us today to find out more information on our Acusera range of Quality Controls.


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)


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.


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 for ease-of-use
  • 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


Sweat Testing External Quality Assessment

The RIQAS Sweat Testing EQA programme has been designed to cover the analysis of Sweat Testing in clinical laboratories measuring the concentration of Chloride and Conductivity in sweat, used in the testing of Cystic Fibrosis (CF).

  • Liquid ready-to-use samples
  • Monthly reporting
  • Testing covers the full range of clinically relevant decision levels
  • Submit results and view reports online via RIQAS.net
  • 12 month subscription

Not accredited to ISO/IEC 17043

Cat NoKit SizeFrequencyCycle StartParameters 
RQ917312 x 2mlMonthlyMarch2

Parameter

  • Chloride
  • Conductivity

Please note, product availability may vary country to country.


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