Laboratory Quality Control – Acusera
Laboratory Quality Control – Acusera
Acusera true third party quality controls offer complete test menu consolidation for laboratory Internal Quality Control.
Providing accurate and reliable sample material and delivering results you can trust.
Key Benefits of Acusera
Commutability
A commutable sample matrix increases confidence that performance mimics that of patient samples.
Flexibility
With an extensive range of assayed/unassayed, liquid/lyophilised and single/multi-analyte controls, the Acusera portfolio has a solution to suit all laboratory preferences.
Traceability
The values assigned to both our calibrators and control materials are traceable to a recognised reference material or reference measurement procedure meeting ISO 17511 and ISO 18153 requirements.
Accurate Target Values
Our process utilises thousands of independent labs globally, ensuring availability of highly accurate, robust target values for a wide range of instruments and methods, ultimately eliminating the need to spend time and money assigning in-house.
True Third Party Controls
Manufactured independently, the Acusera range delivers unbiased performance assessment with any instrument or method, helping to meet ISO 15189:2012 requirements whilst eliminating the need for multiple instrument dedicated controls.
Consolidation
Specialising in consolidation, the Acusera range of multi-analyte controls is designed to reduce the number of individual controls required to cover your test menu, ultimately reducing costs, preparation time and storage space.
Consistency
Our superior manufacturing processes ensure stability claims and analyte levels won’t differ significantly from lot-to-lot. You can therefore be sure of receiving the same standard of product time and time again.
Shelf Life Longevity
With a shelf life of up to four years for lyophilised controls and two years for liquid controls, you can benefit from continuity of lot supply whilst reducing the frequency of new lot validation studies, thus saving time and money.
Clinically Relevant Levels
The presence of analytes at key decision levels not only helps to ensure accurate instrument performance but maximises laboratory efficiency by eliminating the need for additional low/high level controls at extra expense.
Acusera Internal Quality Control Range
With over 390 parameters, choice and flexibility is guaranteed.
Browse the controls below
What Are The Benefits of Third Party Controls?
Customer Testimonials
Sixth People’s Hospital of Zhengzhou City, Henan Province
‘Our laboratory continues to use Randox’s IQC products, including HN1530, HE1532, IA3110, IA3111, CG5021, CG5023, UC5033, UC5034. Compared with the previous use of original quality control, we can now find the quality control deviation caused by the change of reagent batch number in time. Later, we can timely pass the calibration and the calibration to return the laboratory results to the correct level. Randox products have brought us more convenience in our work. We are very satisfied with Acusera series products.’
Patrick Else, Nuffield Health
‘Randox Acusera 24/7 has enabled me to effectively manage 13 separate hub sites effectively through the use of the integrated reports that can be generated. The system allows for routine day to day monitoring of IQC results as well as long term tracking and trending. The Uncertainty of Measurement report has allowed me to free up a large amount of time as this report can be generated whenever for a particular date range meaning no more manual number crunching. The support from Randox has been first class from the initial install through to current working practices and the company are very open to improvements to the system. On the whole I am very happy with the programme. ‘
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Controls Brochure
Importance of Third Party
Acusera 24•7 Online
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Acusera Verify
Laboratory Quality Control – Acusera
Acusera true third party quality controls offer complete test menu consolidation for laboratory Internal Quality Control.
Providing accurate and reliable sample material and delivering results you can trust.
Key Benefits of Acusera
Commutability
A commutable sample matrix increases confidence that performance mimics that of patient samples.
Flexibility
With an extensive range of assayed/unassayed, liquid/lyophilised and single/multi-analyte controls, the Acusera portfolio has a solution to suit all laboratory preferences.
Traceability
The values assigned to both our calibrators and control materials are traceable to a recognised reference material or reference measurement procedure meeting ISO 17511 and ISO 18153 requirements.
Accurate Target Values
Our process utilises thousands of independent labs globally, ensuring availability of highly accurate, robust target values for a wide range of instruments and methods, ultimately eliminating the need to spend time and money assigning in-house.
True Third Party Controls
Manufactured independently, the Acusera range delivers unbiased performance assessment with any instrument or method, helping to meet ISO 15189:2012 requirements whilst eliminating the need for multiple instrument dedicated controls.
Consolidation
Specialising in consolidation, the Acusera range of multi-analyte controls is designed to reduce the number of individual controls required to cover your test menu, ultimately reducing costs, preparation time and storage space.
Consistency
Our superior manufacturing processes ensure stability claims and analyte levels won’t differ significantly from lot-to-lot. You can therefore be sure of receiving the same standard of product time and time again.
Shelf Life Longevity
With a shelf life of up to four years for lyophilised controls and two years for liquid controls, you can benefit from continuity of lot supply whilst reducing the frequency of new lot validation studies, thus saving time and money.
Clinically Relevant Levels
The presence of analytes at key decision levels not only helps to ensure accurate instrument performance but maximises laboratory efficiency by eliminating the need for additional low/high level controls at extra expense.
Acusera Internal Quality Control Range
With over 390 parameters, choice and flexibility is guaranteed.
Browse the controls below
What Are The Benefits of Third Party Controls?
Customer Testimonials
Sixth People’s Hospital of Zhengzhou City, Henan Province
‘Our laboratory continues to use Randox’s IQC products, including HN1530, HE1532, IA3110, IA3111, CG5021, CG5023, UC5033, UC5034. Compared with the previous use of original quality control, we can now find the quality control deviation caused by the change of reagent batch number in time. Later, we can timely pass the calibration and the calibration to return the laboratory results to the correct level. Randox products have brought us more convenience in our work. We are very satisfied with Acusera series products.’
Patrick Else, Nuffield Health
‘Randox Acusera 24/7 has enabled me to effectively manage 13 separate hub sites effectively through the use of the integrated reports that can be generated. The system allows for routine day to day monitoring of IQC results as well as long term tracking and trending. The Uncertainty of Measurement report has allowed me to free up a large amount of time as this report can be generated whenever for a particular date range meaning no more manual number crunching. The support from Randox has been first class from the initial install through to current working practices and the company are very open to improvements to the system. On the whole I am very happy with the programme. ‘
Continue Reading
Controls Brochure
Importance of Third Party
Acusera 24•7 Online
Contact Us
Acusera Verify
Anti-Müllerian Hormone (AMH) Quality Control
The Randox Acusera AMH control is designed for use as a third-party control for the quantitative determination of Anti-Müllerian Hormone (AMH). An AMH test is often used to check a woman’s ability to produce eggs that can be fertilized for pregnancy. Thus, helping women to make informed decisions about their health.
Available in a liquid frozen format, this control should be treated in the same manner as a patient sample.
Features & Benefits
- 30-day stability at +2°C to +8°C
- Liquid Frozen format for convenience and reduced handling errors
- True third-party control providing an unbiased assessment of performance
- Manufactured using human serum, ensuring commutable sample matrix
- Assayed target values provided eliminating the need to assign values in-house
- Control available at recommended cut-off values for AMH
| Description | Pack Size | Cat. Number | Typical Values Beckman DXL / Roche ng/ml | |
|---|---|---|---|---|
| AMH Control 1 | 3 x 2ml | AMH10509 | 0.5 | |
| AMH Control 2 | 3 x 2ml | AMH10514 | 1.0 | |
| AMH Control 3 | 3 x 2ml | AMH10515 | 6.0 | |
| AMH Control 4 | 3 x 2ml | AMH10516 | 16.0 | |
Analyte
- Anti-Müllerian Hormone (AMH)
Serum Indices Quality Control
The Randox Acusera Serum Indices control is designed to be used to monitor an IVD instrument’s response in the detection of haemolyzed, icteric and lipemic (HIL) samples. This control can be utilised in laboratory interference testing to assist in improving error detection of pre-analytical errors affecting clinical chemistry testing.
This control provides a full range of clinically relevant testing levels, including a negative (-) and three positives (+, ++ & +++)
Features & Benefits
- Lyophilised for enhanced stability
- Manufactured using human serum, ensuring commutable sample matrix
- 2-year shelf life from date of manufacture
- True third party control providing unbiased assessment of performance
- Reconstituted stability of 14 days at 2°C – 8°C
- 4 separate levels available including -, +, ++ & +++
| Description | Pack Size | Analytes | Cat. Number |
|---|---|---|---|
| Serum Indices Control | 4 x 5 ml | 3 | SI10448 |
Analytes
- Haemolysis (H)
- Icterus (I)
- Lipemia (L)
Cardiac Quality Control
Intended for use with Roche Abbott and Siemens systems, this control is manufactured using only the highest quality material and offers a 7-day thawed stability at +2ºC to +8ºC.
This control provides a full range of clinically relevant testing levels, including High Sensitivity Troponin I.
Features & Benefits
- Liquid for ease-of-use stability
- Aqueous Material
- 4 Clinically relevant levels (including Ultra-Low)
- Stable to expiry date at -18-24ºC storage
- Thawed stability of 7 days at 2°C – 8°C
| Description | Optimised for | Size | Analytes | Cat No | |
|---|---|---|---|---|---|
| Cardiac Control - Ultra Low | Roche (NT proBNP) & Abbott (Troponin I) | 3 x 3 ml | 2 | CQ10453 | |
| Cardiac Control Ultra Low | Siemens | 3 x 3 ml | 2 | CQ10428 | |
Analytes
- Troponin I
- NT-proBNP
Liquid Bilirubin Control
Providing a true third party solution for the measurement of Bilirubin, the new Acusera Liquid Bilirubin Control is designed to deliver an unbiased, independent assessment of analytical performance helping to ensure accurate and reliable patient testing.
Two levels are available, covering the required clinically relevant decision levels for neonatal testing of Driect and Total Bilirubin. With a 14 day open vial stability and 2 year shelf life the Acusera Liquid Bilirubin Control will reduce waste, whilst remaining easy and convenient to use.
Features & Benefits
- Liquid frozen
- 100% human serum
- 2 year shelf life from date of manufacture
- Clinically relevant decision levels, recommended by ISO15189
- Open vial stability of 14 days at 2°C – 8°C
- Assayed Control
- CE Marked
| Description | Size | Analytes | Cat No. | |
|---|---|---|---|---|
| Liquid Bilirubin Control Level 1 | 3x3mL | Direct Bilirubin Total Bilirubin | BR10442 | |
| Liquid Bilirubin Control Level 2 | 3x3mL | Direct Bilirubin Total Bilirubin | BR10443 | |
Analytes
- Direct Bilirubin
- Total Bilirubin
Related Products
Randox Quality Control launches new Acusera D-Dimer Controls
Randox Quality Control launches new Acusera D-Dimer Controls
16 March 2021: Randox Quality Control launches new Acusera D-Dimer Controls
Randox Quality Control has launched a new range of Acusera Controls for the accurate and reliable testing of D-Dimer.
Providing a true third-party solution for D-Dimer testing, which is most often used to investigate whether a patient has a blood clotting disorder, this control is manufactured for use on a range of different diagnostic systems.
Designed to provide accurate and reliable patient testing, this control comes in a liquid frozen format and is stable for an impressive 28 days when stored at 2ºC to 8ºC.
Three levels are supplied, spanning the full clinical range and FEU.
Features and Benefits
- Liquid frozen
- 100% human serum
- 2 year shelf life from date of manufacture
- Cut-off level of 500 ng/ml (FEU) for most analysers
- Open vial stability of 28 days at 2°C – 8°C
- Assayed Control
For more information visit https://www.randox.com/d-dimer-internal-quality-control/
QUALITY CONTROL
REAGENTS
RX SERIES
Acusera 24.7 – Interlaboratory Data Management Reporting Software
Acusera 24•7 is a live, cloud based interlaboratory data management and peer group reporting software, intended to assist in the management of daily QC activities.
Designed to complement our range of Acusera true third party controls.
Key Benefits of Acusera 24•7
Peer Group Statistics
Updated live in real-time, labs can compare statistics to their peers and identify any unique or widespread issues to help reduce time and money spent on troubleshooting.
Fully Interactive Charts
Ability to compare performance, assess trends and monitor performance with automatically generated Levey-Jennings, Histograms and Performance Summary Charts.
Highly Flexible
Labs can configure their own performance limits, multi-rules, consensus groups and target values for each instrument or lot of QC.
Unique Dashboard Interface
Reduce time spent analysing data as instant identification of any QC failures over the past 7 days and alerts of product expiry are highlighted in the unique dashboard design.
Comprehensive Reports
Comprehensive, easy-to-read and customisable reports have been designed to speed up the review process and include Statistical Metrics, Uncertainty of Measurement, Exception, Audit Trail & more.
24/7 Access
Gain access to this cloud-based software at anytime, anywhere. Removing the need installation, software maintenance and frequent back-ups.
Advanced Statistical Analysis
Automatically calculating advanced statistics including %Bias, Total Error and Sigma Metrics helps enhance performance assessment, improve QC strategy, and meet regulatory requirements.
Automated Data Import
Upload QC data directly to Acusera 24•7 via LIMS and middleware. This automated function eliminates the need for manual data entry and helps save money whilst increasing efficiency.
Technical Support
Expert technical support is available for users. Laboratories can access this service for troubleshooting purposes and therefore eliminates the need for on-site assistance.
What does Acusera 24•7 provide?
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Troponin T 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
- Liquid for ease-of-use stability
- Aqueous based material
- Ultra low levels of Troponin T
- Stable to expiry date at -18-24ºC storage
- Thawed stability of 7 days at 2°C – 8°C
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Troponin T Control | 6 x 3 ml | 1 | CQ10450 | |
Analytes
- Ultra low Troponin T
Bilirubin Linearity Verifier
Our Bilirubin verifier contains both Direct Bilirubin and Total Bilirubin so testing is fully covered. Dedicated for use on Roche
Cobas systems, this verifier spans five levels ensuring the instruments entire reportable range is measured.
Features & Benefits
- Lyophilised for enhanced stability
- 5 levels provided
- Open vial stability of 10 days at 2ºC to 8ºC
- Shelf life of up to 2 years from date of manufacture
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Acusera Enzyme Linearity Verifier | 5 x 3mL | 10 | LV10366 | |
Analytes
- Direct Bilirubin
- Total Bilirubin