Ultra-Low PSA Quality Control

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Ultra-Low PSA Quality Control

Therapeutic Drug Quality Control

The Acusera ultra-low PSA control delivers a true third party solution for use in monitoring the performance of in vitro diagnostic assays used in the quantitative determination of low levels of PSA.

The control has been optimised for use with Roche systems but is suitable for use across a variety of other platforms.

Name Unit Target Analyser
Ultra-Low PSA ng/ml 0.055 * Roche Cobas e801

* Example of values for Roche Cobas e801. Other systems may vary dependent on laboratory assignment. Typical values displayed, please see control IFU for lot specific values.

Features & Benefits

  • Impressive 30-day stability at +2°C to +8°C minimising waste
  • Liquid ready-to-use control ensuring minimal sample preparation
  • True third-party control providing an unbiased assessment of performance
  • Manufactured using human based material providing a matrix similar to the patient sample
  • 1 year shelf life from date of manufacture ensuring continuity of lot supply
  • Target values for specific instruments are available

This control is for Research Use Only (RUO)

DescriptionSizeAnalytesCat No
Ultra-Low PSA Control6 x 1ml1TU10523

Analyte

  • Total PSA

BNP Quality Control

Therapeutic Drug Quality Control

The new Acusera BNP Control is designed for use with in vitro diagnostics assays for the quantitative determination of BNP in human serum and plasma. The BNP control delivers an unbiased independent assessment of analytical performance, helping to ensure accurate and reliable patient testing for BNP.

With a 30 day open-vial stability, the BNP control will reduce waste, whilst remaining easy and convenient to use.

This tri-level control is optimised for use on Beckman, Abbott and Siemens analysers however, it can be used across other platforms.  Our control will provide accurate and reliable results that your laboratory can trust.

Features & Benefits

  • 30-day stability at +2°C to +8°C minimising waste.
  • Liquid ready-to-use control ensuring no preparation of material is required and therefore eliminates manual error.
  • True third-party control providing an unbiased assessment of performance.
  • Manufactured using human serum providing a matrix similar to the patient sample.
  • Optimised for use with Abbott, Beckman and Siemens. Also suitable for use with other platforms.
DescriptionPack SizeAnalytesCat. NumberContact Us
BNP Controls (Beckman)3 x 1 x 1 ml1CQ10520
BNP Controls (Abbott)3 x 1 x 1 ml1CQ10521
BNP Controls (Siemens)3 x 1 x 1 ml1CQ10522

Analyte

  • Brain Natriuretic Peptide (BNP)

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

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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.

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Fully Interactive Charts

Ability to compare performance, assess trends and monitor performance with automatically generated Levey-Jennings, Histograms and Performance Summary Charts.

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Highly Flexible

Labs can configure their own performance limits, multi-rules, consensus groups and target values for each instrument or lot of QC.

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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 & more.

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24/7 Access

Gain access to this cloud-based software at anytime, anywhere. Removing the need installation, software maintenance and frequent back-ups.

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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.

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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.

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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.

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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.

Features of Acusera 24•7

  • Home Screen
  • Comprehensive Reports
  • Interactive Charts
  • Daily Data Review
  • Preview Mode
  • Results Entry
Computer screen with Acusera 24.7 the interlaboratory data management system

The fast, intelligent user interface on 24•7 enables rapid review of QC data and QC failures, reducing the time spent analysing and identifying errors.

The new and improved home screen allows users to carry out tasks such as: Creation of new tests/panels | Filtering results by analyte/ instrument/ lot number | Entering single or several QC test(s) without having to navigate away to multiple areas within the application.

Computer screen with a statistical analysis report from Acusera 24.7 the interlaboratory data management system

Specifically designed to speed up the review process, our comprehensive range of easy-to read reports include: Data Review | Exception Report | Statistical Analysis Report | Statistical Metrics Report

Customise reports to show data for a specific date range aswell as a particular test or instrument.

Computer screen with a Levey Jennings Chart from Acusera 24.7 the interlaboratory data management system

Instant access to interactive Levey-Jennings, Histogram and Performance Summary Charts as well as the ability to add events and multiple data sets to a single chart allows for swift performance monitoring and superior identification of trends across multiple instruments.

One location for all of your statistical analysis needs.

 

The enhanced data review screen on 24•7 allows users to review all QC results within a 7-day date range.

Reviewing all QC results and not just violations on a daily basis provides greater control of any potential issues occurring before they become widespread.

Preview mode on 24•7 allows users to recall the assay and instrument configurations used to create each QC test directly from the home screen.

Direct access into: Results Entry | Charts | Data Entry | QC Test Configuration | Assay Configuration for a single test, from any area in the application

Computer screen with a data review from Acusera 24.7 the interlaboratory data management system

New toggle feature allows users to set whether they are entering single or summarised results.

Reducing the number of fields for single result entry and therefore keystroke tabbing, allowing for greater ease-of-use.

Resources

We Are Here To help

To learn more about how 24•7 works as an interlaboratory data management system/ peer group reporting software. Or, to see the software in action, click below or visit our video demonstrations now.

 

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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 15189:2022 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 for Internal 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 for Internal Quality Control
QC - Vial (Orange)

Customer Testimonials

Continue Reading

Controls Brochure

Importance of Third Party

Acusera 24•7 Online

Contact Us

Acusera Verify


Anti-Müllerian Hormone (AMH) Quality Control

Therapeutic Drug 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

 

DescriptionPack SizeCat. NumberTypical Values
Beckman DXL / Roche ng/ml
AMH Control 13 x 2mlAMH105090.5
AMH Control 23 x 2mlAMH105141.0
AMH Control 33 x 2mlAMH105156.0
AMH Control 43 x 2mlAMH1051616.0

Analyte

  • Anti-Müllerian Hormone (AMH)

Serum Indices Quality Control

Therapeutic Drug 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 -, +, ++ & +++
DescriptionSizeAnalytesCat No
Serum Indices Control4 x 5 ml3SI10448

Analytes

  • Haemolysis (H)
  • Icterus (I)
  • Lipemia (L)

Randox International Quality Assessment Scheme (RIQAS)

RIQAS is the world’s largest External Quality Assessment scheme with more than 75,000 laboratory participants spanning over 138 countries.

Key Benefits of RIQAS

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Cost Effective

Consolidate EQA analysis, reduce workload and costs with our comprehensive, multi-parameter programmes.

Flexible

Flexible Programme Options

Flexible programme options are available to suit all laboratory budgets. The option to register up to five instruments per programme (volume permitting) at no extra cost for comparative performance assessment

Highly Accredited

Accredited

RIQAS is accredited to ISO/IEC 17043:2010 “Conformity Assessment – General Requirements for Proficiency Testing” which is accepted by national and international accreditation bodies. Please see accreditation schedule for additional information.

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Expansive Peer Group Database

The availability of large peer groups ensures robust data is available for a wide range of instruments and methods.

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Rapid, User-Friendly Reports

Our rapid, user-friendly reports allow at-a-glance performance assessment. Complimentary multi-instrument, inter-laboratory and end-of-cycle reports are also available.

Commutable

Commutable Samples

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

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Early Identification of Test System Errors

Frequent reporting allows early identification of test system errors, while our 72 hour report turnaround enables corrective action to be taken with minimum disruption to the lab.

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Convenient Data Upload System

RIQAS.net is a convenient, web-based data entry system which allows participants to return results and view reports online.

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High Quality Samples

EQA samples are manufactured to the highest quality standard and span clinically relevant levels.

RIQAS EQA Programmes

Choice & flexibility are guaranteed with our 36 programme portfolio.

Browse the programmes below

 

RIQAS EQA Reports

User-friendly, one-page per parameter reports allow for at-a-glance performance assessment.

Browse the reports below.

What Does RIQAS Provide?

The benefits of Randox Riqas as an external quality assessment

RIQAS Calendar 2024

Continue Reading

RIQAS Brochure

RIQAS Parameters

RIQAS.net

RIQAS Calendar

Contact Us


Bilirubin Linearity Verifier

Therapeutic Drug Quality Control

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
DescriptionSizeAnalytesCat No
Acusera Enzyme Linearity Verifier5 x 3mL10LV10366

Analytes

  • Direct Bilirubin
  • Total Bilirubin

Enzyme Linearity Verifier

Therapeutic Drug Quality Control

Our Enzyme Linearity Verifier contains 10 commonly tested enzymes in one unique multi-marker verifier allowing you to
consolidate testing. Spanning 5 clinical levels, this verifier ensures the systems entire reportable range is measured. Designed
specifically for use with Roche Cobas systems, our Verifier is available in a convenient liquid frozen format.

Features & Benefits

  • Convenient, liquid frozen format
  • 5 levels provided
  • 14 day stability when stored at 2ºC to 8ºC
  • Shelf life of up to 2 years from date of manufacture
DescriptionSizeAnalytesCat No
Acusera Enzyme Linearity Verifier5 x 3mL10LV10366

Analytes

  • ALT
  • ALP
  • a-Amylase
  • Pancreatic Anylase
  • AST
  • CK
  • CKMB
  • yGT
  • LDH
  • Lipase

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