Product Focus: Randox Cardiac
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
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
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Evidence Immunoassay Control | 4 x 3 x 5ml | 14 | EV3570 | |
Analytes
- CEA
- Estradiol
- FSH
- Free T4
- Free T3
- Leutinising Hormone
- Prolactin
- Progesterone
- PSA (Total)
- PSA (Free)
- Testosterone
- Total T4
- Total T3
- TSH
Cardiac Array Quality Control
Multi-analyte cardiac control designed for use in the routine monitoring of accuracy and precision on clinical chemistry and immunoassay systems. This is the only control of its type to include the novel marker heart type fatty acid binding protein (H-FAP). Three levels of control are supplied spanning the complete clinical range.
Features & Benefits
- Lyophilised for enhanced stability
- Assayed values available for Randox Biochip systems
- 100% human serum
- Stable to expiry at 2oC – 8oC
- Reconstituted stability of 16 hours at 2oC – 8oC or 7 weeks at -80oC
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Cardiac Array Control | 3 x 3 x 1ml | 4 | EV3691 | |
Analytes
- Heart-type acid binding protein (H-FABP)
- Myoglobin (MYO)
- Troponin I (cTnI)
- Creatine-Kinase Muscle Brain (CK-MB)
Not for sale in the USA
CYFRA 21-1 External Quality Assessment
The RIQAS CYFRA 21-1 EQA programme is designed to cover the analysis of CYFRA 21-1 in clinical laboratories when monitoring the response to treatment of cancers such as non-small cell lung carcinoma, cervical, breast and bladder cancer.
- Lyophilised 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 No | Kit Size | Frequency | Cycle Start | Parameters | |
|---|---|---|---|---|---|
| RQ9175 | 12 x 1ml | Monthly | March | 1 | |
Parameter
- CYFRA 21-1 (Cytokeratin 19)
Please note, product availability may vary country to country.
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Anti-TSH Receptor External Quality Assessment
The RIQAS Anti-TSH Receptor EQA programme is designed to cover the analysis of Anti-TSH Receptor in clinical laboratories when thyroid dysfunction is suspected.
- Lyophilised 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 No | Kit Size | Frequency | Cycle Start | Parameters | |
|---|---|---|---|---|---|
| RQ9174 | 12 x 1ml | Monthly | March | 1 | |
Parameter
- Anti-TSH Receptor (TRAb)
Please note, product availability may vary country to country.
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Immunosuppressant External Quality Assessment
The RIQAS Immunosuppressant EQA programme has been designed to cover the analysis of Immunosuppressants in clinical laboratories. Immunosuppressants are primarily used after transplant operations to prevent the host body from rejecting donor organs.
- Lyophilised 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
- LC/MS reference values provided enabling participants to compare results to an accurately assigned value
Not accredited to ISO/IEC 17043
| Cat No | Kit Size | Frequency | Cycle Start | Parameters | |
|---|---|---|---|---|---|
| RQ9159 | 12 x 2ml | Monthly | March | 4 | |
Parameters
- Cyclosporin
- Everolimus
- Sirolimus
- Tacrolimus
Please note, product availability may vary country to country.
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Lipid Control Calibrators
Apolipoprotein Calibrator
Multi-analyte, apolipoprotein calibrator with values provided for Apolipoprotein A-1 and Apolipoprotein B.
Features & Benefits
- Lyophilised for enhanced stability
- 100% human serum
- Stable to expiry date at 2°C – 8°C
- Reconstituted stability of up to 7 days at 2°C – 8°C
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Apolipoprotein Calibrator | 3 x 1ml | 2 | LP3023 | |
Analytes
- Apo A-1
- Apo B
Apolipoprotein Calibrator 2
Multi-analyte calibrator covering four specialised apolipoprotein assays. A reconstituted stability of up to 28 days helps to keep waste and costs to a minimum.
Features & Benefits
- Lyophilised for enhanced stability
- 100% human serum
- Stable to expiry date at 2°C – 8°C
- Reconstituted stability of up to 8 hours at 2°C – 8°C and one month at -20°C when frozen once
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Apolipoprotein Calibrator 2 | 3 x 1ml | 4 | LP5047 | |
Analytes
- Apolipoprotein A-II
- Apolipoprotein C-III
- Apolipoprotein C-II
- Apolipoprotein E
Lipoprotein (a) Calibrator
Dedicated Lipoprotein (a) calibrator specifically designed for use with the Randox Lipoprotein (a) assay.
Features & Benefits
- Lyophilised for enhanced stability
- 100% human serum
- Stable to expiry date at 2°C – 8°C
- Reconstituted stability of up to 14 days at 2°C – 8°C
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Lipoprotein (a) Calibrator | 5 x 1ml | 1 | LP3404 | |
Analytes
- Lipoprotein (a)
Direct HDL/LDL Cholesterol Calibrator
Dedicated HDL and LDL cholesterol calibrator specifically designed for use with direct methods of measurement.
Features & Benefits
- Lyophilised for enhanced stability
- 100% human serum
- Stable to expiry date at 2°C – 8°C
- Reconstituted stability of up to 5 days at 2°C – 8°C and 1 month at -20°C
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| HDL/LDL Cholesterol Calibrator | 3 x 1ml | 2 | CH2673 | |
Analytes
- HDL Cholesterol
- LDL Cholesterol
sdLDL Cholesterol Calibrator
Dedicated sdLDL Cholesterol calibrator designed for use with the Randox sdLDL Cholesterol assay.
Features & Benefits
- Lyophilised for enhanced stability
- 100% human serum
- Stable to expiry date at 2°C – 8°C
- Reconstituted stability of up to 5 days at 2°C – 8°C
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| sdLDL Cholesterol Calibrator | 3 x 1ml | 1 | CH5050 | |
Analytes
- sdLDL Cholesterol
Therapeutic Drugs Control Calibrator
Therapeutic Drug Calibrator
Multi-analyte calibrator set covering 5 different therapeutic drugs. Six levels are available with a reconstituted stability of 4 weeks helping to keep waste to a minimum.
Features & Benefits
- Lyophilised for enhanced stability
- 100% human serum
- Stable to expiry date at 2°C – 8°C
- Reconstituted stability of 4 weeks at 2°C – 8°C or 8 weeks at -20°C
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Therapeutic Drug Calibrator Series | 6 x 3ml | 5 | TD3417 | |
Analytes
- Carbamazepine
- Digoxin
- Phenobarbital
- Phenytoin
- Valproic Acid