Serum Indices Quality Control
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.
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
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Serum Indices Control | 4 x 5 ml | 3 | SI10448 |
Analytes
- Haemolysis (H)
- Icterus (I)
- Lipemia (L)
Cardiac Quality Control
Intended for use with Roche and Abbott 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 | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Cardiac Control - Ultra Low | 3 x 3 ml | 2 | CQ10453 | |
| Cardiac Control Level 1 | 3 x 3 ml | 2 | CQ10454 | |
| Cardiac Control Level 2 | 3 x 3 ml | 2 | CQ10455 | |
| Cardiac Control Level 3 | 3 x 3 ml | 2 | CQ10456 |
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.
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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.
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Not infectiousSamples containing SARS-CoV-2 antigens are inactivated and not infectious ensuring safe handling of material.
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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.
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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
Our brand new Acusera 24.7 video is here! Take a look now
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Quality Controls
Whole pathogen multiplex controls to support testing for cold, cough and COVID
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 Manufacturing – Qnostics 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