Neonatal Bilirubin External Quality Assessment

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Neonatal Bilirubin External Quality Assessment

The RIQAS Neonatal Bilirubin EQA programme has been designed to assess the performance of total and direct bilirubin assays with levels tailored to neonatal bilirubin testing.

  • Lyophilised for enhanced stability
  • Monthly reporting
  • Human based serum
  • Submit results and view reports online via RIQAS.net
  • Rapid turnaround of reports allows for any necessary corrective actions to be taken with minimal disruption to laboratory output

Not accredited to ISO/IEC 17043

Cat NoKit SizeFrequencyCycle StartParameters 
RQ91912 x (6x3ml)MonthlyJuly2

Parameter

  • Direct Bilirubin
  • Total Bilirubin

Please note, product availability may vary country to country.


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 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
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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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/

 

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SARS-CoV-2 (COVID-19) Antigen Testing Pilot Study from Randox Quality Control

News       Coronavirus       QCMD

 

SARS-CoV-2 (COVID-19) Antigen Testing Pilot Study

12 March 2020

SARS-CoV-2 (COVID-19) Antigen Testing Pilot Study

Randox, in partnership with QCMD, is pleased to announce a new QCMD EQA pilot study for SARS-CoV-2 (COVID-19) Antigen Testing. This new pilot is designed to evaluate a laboratory’s ability to detect SARS-CoV-2 (COVID-19) antigen and will provide an opportunity to assess performance against an international peer group.

QCMD is a world leading EQA / Proficiency Testing (PT) provider, 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 fi eld of infectious disease testing.

Features & Benefits

  • null

    Whole PathogenAvailability of whole pathogen samples containing the entire viral genome, ensures commutability with the majority of commercial assays.

  • null

    Smart-Phone App Results SubmissionResults can be returned via a smart-phone app so that participants using lateral flow devices can provide pictures of their device/result with the phone camera.

  • null

    Comprehensive ReportsA real-time rapid report will be provided on submission of results. An individual report is received after each challenge, summarising laboratory performance in comparison to an international peer group.

  • null

    EQA Management SystemIT 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.

  • null

    Not infectiousSamples containing SARS-CoV-2 antigens are inactivated and not infectious ensuring safe handling of material.

  • null

    Suitable for Point of CareSamples are supplied liquid ready-to-use ensuring they are ideal for use at the point care.

     

    For more information visit https://www.randox.com/qcmd-sars-antigen-testing/

    For further enquiries please email marketing@randox.com

    QCMD

    QNOSTICS

    CORONAVIRUS


    QCMD SARS-CoV-2 Antigen Testing Pilot Study

    QCMD

    SARS-CoV-2 (COVID-19) Antigen Testing Pilot Study

    Randox, in partnership with QCMD, is pleased to announce a new QCMD EQA pilot study for SARS-CoV-2 (COVID-19) Antigen Testing. This new pilot is designed to evaluate a laboratory’s ability to detect SARS-CoV-2 (COVID-19) antigen and will provide an opportunity to assess performance against an international peer group.

    QCMD is a world leading EQA / Proficiency Testing (PT) provider, dedicated to improving the quality of molecular diagnostic assays used in the detection of infectious diseases. With an extensive database of over 10,000 participants in over 100 countries, QCMD is one of the largest providers of molecular EQA in the fi eld of infectious disease testing.

    Features & Benefits

    • null
      Smart-Phone App Results Submission

      Results can be returned via a smart-phone app so that participants using lateral flow devices can provide pictures of their device/result with the phone camera.

    • null
      Comprehensive Reports

      A real-time rapid report will be provided on submission of results. An individual report is received after each challenge, summarising laboratory performance in comparison to an international peer group.

    • null
      EQA Management System

      IT 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.

    • null
      Not infectious

      Samples containing SARS-CoV-2 antigens are inactivated and not infectious ensuring safe handling of material.

    • null
      Suitable for Point of Care

      Samples are supplied liquid ready-to-use ensuring they are ideal for use at the point care.

    Specification

    Target Range – Covers the clinical range

    Matrix – Universal p9 virusPHIX sample stabilisation buffer

    Sample Format – Eluted swab samples with a buffer

    Analysis Type – Qualitative

    Shipping Conditions – Ambient

    Format – Liquid ready-to-use

    Ordering Information

    Catalogue Number ChallengesSamples per ChallengeDistribution / Testing Period
    QAS21422433Q2, Q3, Q4

    D-Dimer Control

    Therapeutic Drug Quality Control

    Providing a true third-party solution for D-Dimer testing, this control is manufactured for use on a range of different 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 & 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
    DescriptionSizeAnalytesCat No. 
    D-Dimer Control Level 16x1mLD-DimerDD10463
    D-Dimer Control Level 26x1mLD-DimerDD10464
    D-Dimer Control Level 36x1mLD-DimerDD10465

    Analytes

    • D-Dimer

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    Acusera 24.7 – Interlaboratory Data Management Reporting Software

    Slide

    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

    null

    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.

    null

    Fully Interactive Charts

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

    null

    Highly Flexible

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

    null

    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.

    null

    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.

    null

    24/7 Access

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

    null

    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.

    null

    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.

    null

    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?

    247 Diagram-01

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    Acusera 24.7 Software Update

    The latest update of Acusera 24.7 has officially launched, allowing RX Imola, RX Modena and RX Daytona+ users to import compatible QC data files from a configured analyser to Acusera 

     

    Acusera 24•7 | Update Features

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    Want to know more?

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    Quality Controls


    Whole pathogen multiplex controls to support testing for cold, cough and COVID

    News       Coronavirus        Qnostics

     

    27 October 2020

    Whole pathogen multiplex controls to support testing for cold, cough and COVID

    Just in time for flu season, global diagnostics company Randox Laboratories has unveiled a range of whole pathogen multiplex controls that cover multiple viral and bacterial pathogens which cause respiratory disease.

    Inclusive of SARS-CoV-2, Influenza A & B, and Respiratory Syncytial Virus (RSV), the Qnostics Multiplex Respiratory Pathogen Controls (RTX) facilitate diagnosis of the likes of cold and flu, and importantly, the differentiation of these respiratory diseases from COVID-19.

    Using a control line that covers a range of respiratory pathogens in this way will allow laboratories to streamline their testing, consolidate QC, and ultimately save time, money and resource.

    Lynsey Adams, Randox Quality Control Manager, explained;     

    “When the use of time and resources are critical such as in COVID-19 testing, the use of highly characterised controls enables laboratories to meet their daily QC needs and accreditation requirements.

    “Accurate and reliable laboratory testing is an essential aspect of the management of COVID-19 and other respiratory diseases, so we are pleased to be able to offer these new controls which will crucially support the validation, verification and performance monitoring of molecular respiratory assays.”

    The new RTX controls, which are whole pathogen for compatibility with the majority of commercial and in-house assays, are used to monitor the full testing process, from extraction to amplification and detection.

    The Multiplex Respiratory Controls will support public health testing strategies during the incoming flu season and are suited for the test menus of most syndromic assays.

    Lynsey continued;

    “The Randox Qnostics Multiplex Respiratory Pathogen Controls are clinically relevant for full-process validation. Liquid frozen for user convenience and ease of use, the development of the controls using whole pathogen material ensures clinical relevance from extraction to amplification and detection.”

    Randox Qnostics Multiplex Respiratory Pathogen Controls are manufactured to ISO 13485 standards and are in line with ISO 15189:2012 regulatory requirements.

    Key Features and Benefits of the new RTX Controls:

    • Whole pathogen controls – the controls contain the entire genome meaning they are compatible with the majority of commercial and in-house assays.
    • Full process control – whole pathogen controls are the ideal material for full-process validation, monitoring the testing process from extraction to amplification and detection, to ensure ultimate quality assurance in laboratories.
    • Highly characterised – Qnostics controls are quantified by digital PCR to ensure batch to batch reproducibility and are traceable to an internal reference preparation, to ensure metrological traceability of test results obtained by different diagnostic workflows.
    • True Third Party – An independent, unbiased assessment of assay performance is ensured in line with ISO 15189:2012 regulatory requirements.
    • Superior ManufacturingQnostics controls are manufactured under ISO 13485 guidelines to ensure quality and traceability.
    • Liquid for Ease-of-Use – the controls are conveniently supplied in a liquid frozen format meaning there is no additional preparation or handling required.

    For more information visit https://www.randox.com/molecular-infectious-disease-controls/respiratory-infection-testing/

    For further enquiries please email marketing@randox.com

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    Troponin T Quality Control

    Therapeutic Drug 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
    • 100% human serum
    • Ultra low levels of Troponin T
    • Stable to expiry date at -18-24ºC storage
    • Thawed stability of 7 days at 2°C – 8°C
    DescriptionSize AnalytesCat No 
    Troponin T Control6 x 3 ml1CQ10450

    Analytes

    • Ultra low Troponin T

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