Liquid ready-to-use controls & their benefits
Randox Quality Control is a world leading manufacturer of third party quality controls. With an extensive product portfolio – including the largest range of liquid ready-to-use controls, Randox QC will meet your laboratory requirements and deliver trustworthy results repeatedly.
What control formats are available for your laboratory?
There are three distinct formats available for use in the laboratory with each format having benefits and drawbacks. When choosing a Quality Control material it is important you choose the most convenient solution for your laboratory requirements. The three formats are;
- Lyophilised (freeze dried)
- Liquid frozen
- Liquid stable (ready-to-use)
What format is best?
There are several possible answers to this question, simply because, every laboratory is different. What works for one laboratory may not work for another and for this reason there is no one format that works best for all laboratories.
What we can say however, is that there are varying levels of convenience across the different formats. The most convenient, and arguably, the most favoured of the three formats is liquid ready-to-use. It is not difficult to understand why this format is widely regarded as the preferred choice of control in laboratories – they are simple to use, require no preparation and can be conveniently stored and shipped at 2-8oC.
Why should you consider a liquid ready-to-use control?
There are many benefits to using a liquid ready-to-use control over both liquid frozen and lyophilised controls. One of the main benefits of a liquid stable control material is that it eliminates any potential reconstitution/pipetting errors often associated with lyophilised controls. They also eliminate the additional time taken to thaw liquid frozen controls and can significantly reduce shipping/delivery costs as they do not need to be shipped on dry ice.
Another major benefit of running a liquid ready-to-use control is the fact they are also suitable for use in Point-of-Care-Testing (POCT). With growing popularity amongst laboratory professionals and more people expecting rapid results, POCT is on the rise. Due to their easy to use nature, liquid ready-to-use controls are extremely beneficial to POCT providers.
One further benefit to using a liquid ready-to-use control is the longer open vial stability when compared to both lyophilised and liquid frozen controls. With many lyophilised and liquid frozen controls, the open vial stability can vary and generally is around 7 days when fully thawed or reconstituted in comparison to 28 days with a liquid ready-to-use control.
Randox Quality Control – Liquid Ready-to-Use Control Portfolio
The Randox QC portfolio – better known as Acusera – is convenient, hassle-free and cost effective. Our liquid ready-to-use control range includes; Liquid Cardiac, Blood Gas, Liquid Urine, Urinalysis, Specific Protein, Ammonia Ethanol, Haematology, Liquid HbA1c, Liquid CSF & Liquid Tumour Markers.
For further information on Randox Quality Control or our range of liquid ready-to-use controls please email us at acusera@randox.com.
Product Spotlight: Maternal Screening
Maternal Screening Control
Background
A maternal serum screening test (MSS) is a blood test offered to pregnant women that helps determine the risk of Down’s syndrome and other chromosomal conditions, further testing can be offered if the patient is found to be high risk. It can be performed at 10 weeks (combined first trimester screening test), and 14-20 weeks (second trimester maternal serum screening test).
MSS is generally offered to all pregnant women, but the decision to have the test is a personal decision.
Quality Control is an important part of any diagnostic test but is of particular importance in screening methods, when a disorder must be detected without the presence of symptoms. In such screening methods, errors can present as false negative or false positive results both of which can have devastating consequences. In the case of maternal screening a false positive result could mean additional and often invasive procedures which can carry risk of harm to the unborn child. The accuracy and reliability of the laboratory test results are extremely important in minimising both false positive and false negative results.
Product Overview
The Randox Acusera Maternal Screening quality control is the only commercially available control which covers all six analytes used during first and second trimester screening of Down’s syndrome and Spina Bifida.
Instrument specific target values and ranges are provided for AFP, Inhibin A, PAPP-A, β hCG, Total hCG and Unconjugated Estriol. The inclusion of PAPP-A and Inhibin A eliminates the need to purchase additional controls at extra expense.
Key Benefits & Features
- Lyophilised for enhanced stability
- 100% human serum
- Assayed target values provided for 6 parameters
- Suitable for double, triple and quad screens
- Unconjugated Estriol present at clinically significant levels
- Reconstituted stability of 7 days at 2°C – 8°C
- Stable to expiry date at 2°C – 8°C
Consolidation
As a leading provider of multi-analyte, third party controls, Randox helps busy laboratories significantly reduce the number of controls needed to cover their test menu. Combining multiple analytes into a single control reduces cost, preparation time, and required storage space without sacrificing quality.
Analytes at key decision levels will not only ensure test system performance across the clinical range but will further aid consolidation and maximise laboratory efficiency by eliminating the need to purchase additional and often expensive low or high level controls.
First and second trimester
As the only control on the market to cover all first and second trimester analytes, you can be sure that your lab is covering all bases.
True third party control
The Acusera Maternal Screening Control is a true third party control designed to provide an unbiased assessment of performance with a range of instruments and methods, helping your laboratory meet the ISO 15189 requirements.
“the use of third party control materials should be considered,
either instead of, or in addition to, any control materials
supplied by the reagent or instrument manufacturer”.
Analytes
- AFP
- PAPP-A
- Free Beta hCG
- Total hCG
- Inhibin A
- Unconjugated Oestriol
Related Products:
Download some of our related brochures below and broaden your understanding.
Product Spotlight: Liquid CSF Control
Liquid CSF Control
Cerebral Spinal Fluid (CSF) is produced by the body to protect, provide nutrients, and remove waste from the Central Nervous System (CNS). The CNS consists of the brain, spinal cord, and a complex neuron network. It is responsible for sending information to and receiving information from all parts of the body, co-ordinating organ function and responding to changes in the immediate external environment.
When testing CSF, it is removed from the subarachnoid space via lumbar puncture or spinal tap. The analysis of CSF includes tests such as; clinical chemistry, haematology, immunology and microbiology. These are used to diagnose serious bacterial, fungal, and viral infections, such as meningitis, a cerebral bleed, cancer involving the CNS and inflammatory conditions of the CNS.
Product Overview
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 helping to ensure accurate and reliable patient testing of 14 analytes.
Key Features & Benefits
- Liquid ready-to-use samples requiring no preparation
- Human based material
- Assayed target values available
- True third party control providing unbiased performance assessment
- Shelf life of 2 years from date of manufacture
- Open vial stability of 30 days at 2ºC to 8ºC
Unrivalled Stability
Our Liquid CSF Control boasts a remarkable 30-day open vial stability reducing waste, while remaining easy and convenient to use.
A True Third Party Control
The Acusera CSF Control is a true third party control designed to provide an unbiased assessment of performance with a range of instruments and methods, helping your laboratory meet the ISO 15189 requirements.
“the use of third party control materials should be considered,
either instead of, or in addition to, any control materials
supplied by the reagent or instrument manufacturer”.
Analytes
- Albumin (electrophoresis)
- Alpha – 1- globulin (electrophoresis)
- Alpha – 2- globulin (electrophoresis)
- Beta- globulin (electrophoresis)
- Chloride
- Gamma – globulin (electrophoresis)
- Glucose
- hsIgA
- hsIgG
- hsIgM
- Lactate
- Microalbumin
- Protein (Total)
- Sodium
Download some of our related brochures below and broaden your understanding.
Product Spotlight: PTH Control
PTH Control
PTH is a notoriously unstable analyte and many competitors make reduced stability claims in their Immunoassay controls. Randox’s Liquid PTH Control provides laboratories with a dedicated product with an extended, 30-day, open vial stability to reduce waste and costs.
Parathyroid Hormone, better known as PTH, is produced by the Parathyroid glands to help the body maintain steady
volumes of calcium in the blood stream. PTH is part of a ‘feedback loop’ which also includes; calcium, vitamin
D, phosphate and magnesium. Interruptions to this loop can result in higher or lower levels of calcium or
PTH, leading to Hypercalcaemia or Hypocalcaemia. The Parathyroid Glands are responsible for the secretion of PTH in response to low calcium concentrations in the blood.
Product Overview
Released in 2016, Randox’s Liquid PTH Control provides a true third party solution for the measurement of Intact PTH, delivering an unbiased, independent assessment of analytical performance.
Key Features & Benefits
- Liquid for ease-of-use
- Human based 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
Unrivalled Stability
Our Liquid PTH Control boasts a remarkable 30-day open vial stability! Many competitors fail to make stability claims in their immunoassay controls. Our PTH control includes target values and ranges, eliminating the need for extra validation work.
A True Third Party Control
The Acusera PTH Control is a true third party control designed to provide an unbiased assessment of performance with a range of instruments and methods, helping your laboratory meet the ISO 15189 requirements.
“the use of third party control materials should be considered,
either instead of, or in addition to, any control materials
supplied by the reagent or instrument manufacturer”.
Liquid Frozen
Available in three levels Acusera PTH Control is supplied in liquid frozen format, ensuring ease-of-use with no need to reconstitute. Coupled with it’shuman based matrix, it’s perfect for any laboratories conducting PTH testing.
Analytes
Intact PTH (Parathyroid Hormone)
Download some of our related brochures below and broaden your understanding.
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 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
- A 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
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
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
Description Size Analytes Cat No
Liquid HbA1c Control 2 x 2 x 0.5 ml 1 HA10155
Liquid HbA1c Control Level 1 6 x 1 ml 1 HA10224
Liquid HbA1c Control Level 2 6 x 1 ml 1 HA10225
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.
