Internal Quality Control and ISO 15189

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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.

 

QC - Vial (Orange)

Key Benefits of Acusera

Laboratory Quality Control Acusera Commutability

Commutability

A commutable sample matrix increases confidence that performance mimics that of patient samples.

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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.

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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.

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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.

third party controls

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.

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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.

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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.

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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.

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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

 

QC - Vial (Orange)

What Are The Benefits of Third Party Controls?

Benefits of Acusera Laboratory Quality Control
QC - Vial (Orange)

Customer Testimonials

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.

 

QC - Vial (Orange)

Key Benefits of Acusera

Laboratory Quality Control Acusera Commutability

Commutability

A commutable sample matrix increases confidence that performance mimics that of patient samples.

null

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.

null

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.

null

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.

third party controls

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.

null

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.

null

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.

null

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.

null

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

 

QC - Vial (Orange)

What Are The Benefits of Third Party Controls?

Benefits of Acusera Laboratory Quality Control
QC - Vial (Orange)

Customer Testimonials

Continue Reading

Controls Brochure

Importance of Third Party

Acusera 24•7 Online

Contact Us

Acusera Verify


Liquid Bilirubin Control

Therapeutic Drug Quality 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
DescriptionSizeAnalytesCat No.
Liquid Bilirubin Control Level 13x3mLDirect Bilirubin
Total Bilirubin
BR10442
Liquid Bilirubin Control Level 23x3mLDirect Bilirubin
Total Bilirubin
BR10443

 

Analytes

  • Direct Bilirubin
  • Total Bilirubin

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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.

Select An Analyser
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.

View Our Test Menus

Fully Automated
Test Menu

Semi-Automated
Test Menu

Niche
Test Menu


QCMD – Molecular External Quality Control

QCMD - Molecular EQA for Infectious Disease Testing

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.

Features & Benefits

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.

EQA Programmes
  • 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
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.

Explore Further

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.

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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.


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