Protected: QCMD – Molecular External Quality Control (NEW)

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RX series (Concept 3)

clinical chemistry analyser

The RX series range of clinical chemistry analysers includes both semi-automated and fully automated testing for a range of clinical settings. With a world leading test menu comprising of routine chemistries, specific proteins, lipids, therapeutic drugs, drugs of abuse, antioxidants and diabetes testing, the RX series offers laboratories the complete clinical chemistry package and results you can trust. The RX series was built with three core values in mind – Reliability, Accuracy and Precision.

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Why Choose the RX series?

Consolidation of Routine & Specialised Testing on One Single Platform 

With an extensive product portfolio covering over 100 disease markers within routine and nice testing, the RX series removes the need for a separate nephelometry system for specific proteins and allows laboratories to bring all testing in-house; thus ensuring minimal downtime and providing real cost savings through consolidation.

Low Reagents & Sample Volumes

Built with excellence in mind, the RX series range of analsyers require a low sample volume to deliver consistent high quality results which is beneficial when working with paediatric patients and animals. Combined with our high quality reagents, the RX series reduce the possibility of misdiagnoses, offering  accurate, reliable and precise results each time, every time.

Robust Hardware & Intuitive Software 

The RX series boasts many features including user-friendly Windows based software, an in-built inventory management system and multiple levels of password protection ensuring optimum performance, flexibility and excellent functionality.

Unrivalled Customer Support

Our team of trained engineers are on hand to work with you in preserving the continuity of your operations while maximising the potential of your RX series instrument. We know time is critical in any laboratory and our global network means we are uniquely positioned to meet your needs with local service and support whenever you need it.

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Fully Automated
Test Menu

Semi-Automated
Test Menu

Niche
Test Menu


QCMD – Molecular External Quality Control

QCMD is a world leading External Quality Assessment (EQA) / Proficiency Testing (PT) scheme, dedicated to improving the quality of molecular diagnostic assays used in the detection of infectious diseases.

With an extensive database of over 15,000 participants in over 100 countries, QCMD is one of the largest providers of molecular EQA in the field of molecular diagnostics.

Features & Benefits
Reports & Feedback

After the close of the results return phase, EQA participants will receive an individual report outlining their performance relative to their method and technology groups. A supplementary report may be commissioned – this includes any additional relevant information regarding the annual EQA distribution, as well as scientific expert commentary and feedback on the overall results within that distribution.

*Randox are authorised by QCMD to provide the QCMD EQA schemes under a strategic global partnership. The EQA design, composition, data analysis & reporting remain the responsibility of QCMD. Please refer to specific geographical regions for further details on availability.

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QCMD Website

RIQAS EQA


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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


Aliquoting for longer QC stability

Al-i-quot: An amount that is an exact divisor of the whole quantity of a substance (Collins Dictionary of Medicine, R. Young, 2005).

Why aliquot QC material?

Aliquoting QC material can extend the open vial stability of a lyophilised control, according to manufacturer recommendations. By splitting your QC material into a number of tubes and freezing these you can extend the working stability of the control, ultimately reducing wastage and the amount of money spent on unnecessary additional controls.

Example

A laboratory purchases a lyophilised QC with a volume of 3ml once reconstituted the control is stable for 7 days at 2-8oC. However, the laboratory only uses 1ml of this control per week, meaning that 2ml could potentially be wasted. The manufacturer states that the control can be frozen after reconstitution, extending the working stability from 7 days at 2-8oC to 30 days at -20 oC to -80oC. The following outlines the process for aliquoting reconstituted material and extending the control’s working stability.

Aliquoting reconstituted material
  1. Reconstitute the QC material according to the manufacturer’s instructions.
  2. Using a micropipette aliquot the required volume (generally a minimum of 0.5ml should be used) of reconstituted material into a tube.
  3. Repeat step 2 until all the reconstituted material has been aliquoted.
  4. Label each tube with the date the material was reconstituted to avoid the use of expired material.
  5. Store each aliquot at -20oC in a frost free freezer. Be sure to check the kit insert for frozen stability claims.
  6. Remove and thaw each aliquot as and when required making sure to use all material within the frozen stability period.
  7. Once thawed do not refreeze, dispose of any leftover QC material.
Conclusion

Aliquoting reconstituted material is an ideal way of extending the control’s open vial stability. This will ensure that your laboratory minimises the amount of QC material wasted and saves money by eliminating the need to purchase additional controls. Please note that not all lyophilised controls can be frozen like this. To ensure the controls you are selecting are suitable for aliquoting check the product’s kit insert or contact your supplier.

What can Randox Quality Control offer?

We have a number of lyophilised controls which can be prepared and stored in this way across our extensive product portfolio. To find out more visit www.randoxqc.com or contact us via acusera@randox.com to arrange a visit from one of our QC Consultants.


Lipid Quality Controls

acusera-qc-logo

Our Acusera Lipid Quality Controls have been manufactured from 100% human serum to ensure they are commutable, mirroring the behaviour of a real patient sample, with minimal lot to lot value shifts. As all of our lipid quality controls are lyophilised, they contain no stabilisers or preservatives which are known to affect the overall performance of the controls. The multi-analyte controls enable test menu consolidation which, along with the four year shelf life from the date of manufacture, ensures minimal waste helping your lab reduce costs.

Lyophilised Lipid Quality Controls

Lipid Control

7 Analytes

Apoplipoprotein Control

4 Analytes

Lipoprotein (a) Control

1 Analyte

sdLDL Control

1 Analyte

 


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