Celebrating World Hepatitis Day 2022!
Celebrating World Hepatitis Day 2022!
Hepatitis is a condition that affects the liver and can be caused by an infection with a virus. With five different types of Hepatitis from A to E, the most common types of viral Hepatitis are A, B and C. These three viruses affect millions of people worldwide, causing both short-term illnesses and long-term liver disease.
World Hepatitis Day highlights the need to accelerate the fight against viral hepatitis and the importance of testing and treatment for those in need. The “I can’t wait” campaign brought to us by World Hepatitis Alliance, amplifies the voices of those affected demanding immediate action and the end of the stigma and discrimination attached.
Currently there are 325 million people who live with hepatitis globally with more than 1.1 million lives lost to hepatitis B and hepatitis C.
It is important to note that the use of appropriate quality control measures is vital in ensuring the appropriate daily performance of the assay used in the laboratory independent of the technology.
Features & Benefits of Randox Molecular Blood Borne Virus (BBV) Controls
- Traceable to International Standard (where available) or to Internal Reference Material
- Liquid frozen for user convenience and ease of use
- The panels are suitable for use with the majority of commercial and in-house molecular methods
- Manufactured to ISO: 13485 quality standards
Download brochure here
In addition to this, we have our third party Infectious Disease (Serology) Controls which are designed to deliver a cost-effective, high-quality solution for the analysis of infectious disease. Our controls are compatible for use on wide range of immunoassay platforms.
Features and Benefits
- Liquid ready to use – All samples are provided in a user-friendly, liquid ready-to-use format significantly reducing preparation time and the risk of pipetting errors.
- Commutability- Manufactured from human plasma each control is designed to react to the test system in the same manner as the patient sample, helping to meet ISO 15189:2012 requirements.
- True third-party controls – Designed to deliver an independent, unbiased assessment of performance with any instrument or method the Acusera range will help to meet ISO 15189:2012 requirements and eliminate the need for multiple instrument specific controls.
- Reduced waste – With a working stability of 60 days art 2oc to 8oC waste and costs are kept to a minimum.
- Consolidation – The availability of multi-marker controls will reduce the number of individual controls required ultimately reducing costs, time, and storage space.
- Clinically relevant – Designed to challenge clinically relevant ranges our low reactive samples will ensure accurate and reliable instrument performance.
- Acusera 24.7 – Our Acusera Infectious Disease (Serology) Controls are compatible for use with our interlaboratory data management software Acusera 24.7.
For more information about Third party Infectious Disease (Serology) Controls:
Visit our website: Serology Quality Controls
Or email: qualitycontrol@randox.com
Serology Control
Serology Brochure
Molecular IQC
Resource Hub
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 Level 1 | Roche (NT proBNP) & Abbott (Troponin I) | 3 x 3 ml | 2 | CQ10454 | |
| Cardiac Control Level 2 | Roche (NT proBNP) & Abbott (Troponin I) | 3 x 3 ml | 2 | CQ10455 | |
| Cardiac Control Level 3 | Roche (NT proBNP) & Abbott (Troponin I) | 3 x 3 ml | 2 | CQ10456 | |
| Cardiac Control Ultra Low | Siemens | 3 x 3 ml | 2 | CQ10428 | |
| Cardiac Control Level 1 | Siemens | 3 x 3 ml | 2 | CQ10429 | |
| Cardiac Control Level 2 | Siemens | 3 x 3 ml | 2 | CQ10430 | |
| Cardiac Control Level 3 | Siemens | 3 x 3 ml | 2 | CQ10431 | |
Analytes
- Troponin I
- NT-proBNP
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 No | Kit Size | Frequency | Cycle Start | Parameters | |
|---|---|---|---|---|---|
| RQ9191 | 2 x (6x3ml) | Monthly | July | 2 | |
Parameter
- Direct Bilirubin
- Total Bilirubin
Please note, product availability may vary country to country.
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
SARS-CoV-2 (COVID-19) Antigen Testing Pilot Study from Randox Quality Control
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
-
Whole PathogenAvailability of whole pathogen samples containing the entire viral genome, ensures commutability with the majority of commercial assays.
-
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.
-
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.
-
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.
-
Not infectiousSamples containing SARS-CoV-2 antigens are inactivated and not infectious ensuring safe handling of material.
-
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
- 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.
- 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.
- 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.
- Not infectious
Samples containing SARS-CoV-2 antigens are inactivated and not infectious ensuring safe handling of material.
- 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 | Challenges | Samples per Challenge | Distribution / Testing Period |
|---|---|---|---|
| QAS214224 | 3 | 3 | Q2, Q3, Q4 |
Related Products
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?
