Troponin T Quality Control

Home - lyophilised

Troponin T Quality Control

Therapeutic Drug Quality Control

Intended for use with the Roche system, this control is manufactured using only the highest quality material and offers an unrivalled 7-day thawed stability at +2ºC to +8ºC.

Features & Benefits

  • Lyophilised for enhanced stability
  • 100% human serum
  • Ultra low levels of Troponin T
  • Stable to expiry date at -(18-24)ºC storage
  • Reconstituted stability of 7 days at 2°C – 8°C
DescriptionSizeAnalytesCat No 
Troponin T Control6 x 3 ml1CQ10450

Analytes

  • Heart Type Fatty Acid Binding Protein

Ethanol Calibrator/Control Set

Therapeutic Drug Quality Control

Dedicated calibrator and control set designed for the calibration and quality control of the Randox Ethanol assay.

Features & Benefits

  • Liquid ready-to-use
  • Human urine
  • Stable to expiry date when capped and stored at 2oC – 8oC
  • Open vial stability of 28 days at 2oC – 8oC
DescriptionSizeAnalytesCat No 
Ethanol Calibrator/Control Set4 x 10ml1DA2703

Analytes

Ethanol


Metabolic Syndrome Array II Quality Control

Therapeutic Drug Quality Control

A multi-analyte quality control with target values and ranges provided for 3 parameters associated with metabolic syndrome.

Features & Benefits

  • Lyophilised for enhanced stability
  • 100% human material
  • Stable to expiry date at 2oC – 8oC
  • Reconstituted stability of 72 hours at 2oC – 8oC and 7 days at -20°C
  • Assayed values available for Randox Biochip systems
DescriptionSizeAnalytesCat No 
Metabolic Syndrome Array II Control3 x 3 x 1ml3EV3761
Metabolic Syndrome Array II Calibrator9 x 1 ml3EV3760

Analytes

  • Adiponectin
  • CRP
  • Cystatin C

Reconstituting Lyophilised Controls

What is Lyophilisation?

Lyophilisation or ‘freeze drying’ is the process by which water is removed from a product after it is frozen and placed under a vacuum, allowing the ice to change directly from solid to vapor without passing through a liquid phase. The process consists of three separate processes:

  1. Freezing
  2. Primary Drying (Sublimation)
  3. Secondary Drying (Desorption)

There are many benefits to using a lyophilised control including; improved product shelf-life and enhanced stability of volatile analytes. For example, many lyophilised controls have a shelf life of up to four years from the date of manufacture resulting in a reduction of costly new lot validation studies. Furthermore, lyophilised controls can be aliquoted and refrozen to extend the working stability of the product.

Reconstituting Lyophilised QC Material

The process of reconstitution involves adding a specified volume of distilled water to lyophilised QC material. The water should completely dissolve the lyophilised contents, giving a liquid solution, which is ready for analysis.

Reconstitution is a straightforward process, but requires a high level of precision. Small errors can have serious implications to the reconstituted material:

  • If too much water is pipetted during reconstitution, the material will be heavily diluted and results will be lower than expected
  • If too little water is pipetted during reconstitution, the material will not be sufficiently diluted, and results will be higher than expected
  • If the correct volume of water is pipetted, but a small amount of water gets stuck in the pipette tip due to poor pipetting technique, results will be higher than expected

If a lyophilised control has been reconstituted incorrectly the contents of the vial will be wasted. It is therefore vitally important that controls are reconstituted with care.

Materials and Methods Required

The list of requirements for an accurate and consistent reconstitution technique is not extensive, but each requirement is vital. Labs should have:

  • Calibrated volumetric pipettes
  • Sterile, appropriately sized pipette tips
  • Distilled water, or other reconstitution fluid as specified
  • Technician with good pipetting technique
  • Lyophilised QC stored according to manufacturer’s specifications

How to Reconstitute Lyophilised QC Material

Each different lyophilised control may require slightly different preparation, always refer to the instructions for use before reconstituting control material. The below guide provides a general overview of the reconstitution process, using the Randox Human Assayed Chemistry Premium Plus control (HN1530) as an example

  1. Place the vial of lyophilised QC on a flat surface, carefully remove the lid and the rubber stopper making sure not to spill any material
  2. Using a calibrated pipette and sterilised pipette tip, add exactly 5ml of distilled water directly into the QC vial, ensuring no water is left in the pipette tip, or on the rim/side of the vial
  3. Place the rubber stopper and lid firmly back onto the QC vial, and leave to stand for 30 minutes
  4. After 30 minutes, gently invert the QC vial 10-15 times to ensure the contents is completely dissolved, making sure to avoid the formation of foam. It is important that you DO NOT SHAKE the vial. Alternatively place the vial on a roller for 30 minutes to ensure the contents is thoroughly mixed
  5. Once satisfied all material has been completely dissolved, proceed to use the QC product in accordance with the ‘Control’ section of the individual analyser application
  6. Once finished, refrigerate any unused material. It is good practice to label the vial with the date of reconstitution to prevent the use of material outside of the recommended stability period
  7. Prior to reusing lyophilised material, mix the contents thoroughly by gentle inversion, as highlighted in Step 4

Additional Considerations

It is important to remember that there may be slightly different reconstitution requirements for different QC material. For this reason, it is vital that the instructions provided on the QC Kit Inserts are closely followed.

Reconstituting lyophilised QC can be time-consuming. Therefore, Randox Acusera offer convenient 5ml distilled water serum diluent to assist laboratories with reconstitution of lyophilised controls. These user-friendly pour over vials streamline the reconstitution process and eliminate the risk of pipetting errors.

If you have any further questions regarding lyophilised controls or would like to contact us, please do so by emailing us at acusera@randox.com or use the contact us button provided.


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 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.


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 Control4 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

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