Internal Quality Control and ISO 15189
Internal Quality Control and ISO 15189
As a major contributor to the IVD industry, like many of you, the trials and tribulations of quality control are an everyday consideration. It is for this reason we strive to make the process of IQC as straightforward as possible. We recognise how busy life in the laboratory can get and believe it is our duty to simplify your QC process as much as possible.
The Acusera range has been designed with this in mind. Our true third-party control range boasts unrivalled levels of consolidation, supplied at clinically relevant concentrations in a suitable, commutable matrix. When used in combination with Acusera 24.7, our interlaboratory management software, the Acusera range will help to reduce analytical errors and maximise precision in your laboratory.
With the recent updates to ISO 15189:2022, we understand that there will be added pressure on many laboratories who are trying to maintain their accreditation. To assist you with your gap analysis and transition to these updated standards, we have produced this accreditation guide, detailing all of the key points relating to this new version of the highly sought after accreditation.
If you’d like to find out more about what we can do to help your laboratory or view our range of Internal Quality Controls, don’t hesitate to contact us at marketing@randox.com or feel free to browse the range on our website https://www.randox.com/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. ‘
Continue Reading
Controls Brochure
Importance of Third Party
Acusera 24•7 Online
Contact Us
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
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 Direct and Total Bilirubin. With a 7 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 7 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
Protected: QCMD – Molecular External Quality Control (NEW)
RX series (Concept 3)
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.
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.
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.
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 2000 participants in over 100 countries, QCMD is one of the largest providers of molecular EQA in the field of molecular diagnostics.
Frequency
A variety of programme options are available. Choose the number of challenges that best suit your laboratory’s requirements.
Online EQA Management System
ITEMS provides an online tool to easily manage all EQA activities from programme registration to submission of results and provision of EQA reports. Different levels of user access are available so data can be accessed by whoever needs it.
High level of participation
Over 2000 participants in more than 100 countries ensuring peer group numbers are maximised.
Comprehensive reports
Receive individual reports for each challenge and a final supplementary report at the end of the cycle visual assessment of performance.
International accreditation
Programmes are accredited to ISO 17043.
- Blood Borne Viruses
- Central Nervous System Diseases
- Drug Resistance
- Exotic / Emerging Diseases
- Gastrointestinal Diseases
- Immunocompromised Associated Diseases
- Multiple Pathogen / Syndromic Infections
- Respiratory Diseases
- Serology
- Sexually Transmitted Infections
- Transplant Associated diseases
- Typing
- New Pilot Studies
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.
Contact Us
QCMD Website
RIQAS EQA
*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.
Protected: RX series (Concept)
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.
