Pre-Eclampsia Control
Pre-Eclampsia Control
The Pre-eclampsia Control is intended for use with in vitro diagnostic assays for the quantitative determination of placental growth factor (PlGF) and soluble fms‑like tyrosine kinase‑1 (sFlt-1) in human serum and plasma.
The Pre-eclampsia Control is assayed with target values and is suitable for use on various immunoassay analysers. The Pre-eclampsia Control is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
Features & Benefits
- – Liquid frozen for user convenience
- – Human based serum ensuring a commutable sample matrix
- – 30 days open vial stability when stored at 2ºC to 8ºC keeping waste and costs to a minimum
- – True third party control providing an unbiased assessment of performance
- – Assayed target values provided
Analytes
- – sFlt-1
- – PIGF
*No claims are made regarding values and stability.
Active Vitamin B12 Quality Control
The Randox Acusera Active Vitamin B12 Control is designed to deliver a cost-effective, high quality solution for use in the quantitative determination of Active Vitamin B12 in human serum and plasma.
The human serum based Active B12 Controls are assayed with target values provided and are suitable for use on various analysers.
Features & Benefits
- Liquid frozen for user convenience
- Human based serum ensuring a commutable sample matrix
- True Third Party control providing unbiased assessment of performance
- An impressive open vial stability of 30 days at 2° to 8°C helping to keep waste to a minimum
Analytes
- Active Vitamin B12 (Holotranscobalamin/HoloTC)
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/.
Bone Markers (Serum) Control
The Lyophilised Serum Bone Marker Control is intended for use with in vitro diagnostic assays for the quantitative determination of Procollagen Type 1 N-Terminal Propeptide (P1NP), N-MID Osteocalcin (OC) and Bone Alkaline Phosphatase (B-ALP) in serum samples.
This Lyophilised Serum Bone Marker Control is assayed with target values and is suitable for use on automated analysers.
Features & Benefits
- – Lyophilised for enhanced stability
- – True third party control providing an unbiased assessment of performance
- – Three clinically relevant levels available
- – Human based serum providing a matrix similar to the patient sample
- – 1 year shelf life from date of manufacture allowing for long term QC monitoring and a decrease in new lot validation studies
- – 14- day reconstituted open vial stability applies for PINP and B-ALP helping to keep waste to a minimum, 1-day reconstituted stability for N-MID Osteocalcin
Analytes
- – PINP
- – N-MID Osteocalcin
- – Bone-ALP
*No claims are made regarding values and stability.
Ultra-Low PSA 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 serum 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)
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Ultra-Low PSA Control | 6 x 1ml | 1 | TU10523 | |
Analyte
- Total PSA
Siemens PTH Quality Control
Providing a true third party solution for the measurement of PTH, the Acusera PTH Control has been optimised for use with Siemens instruments to provide an unbiased, independent assessment of laboratory performance.
This notoriously unstable marker, present in a number of immunoassay controls, is available in a liquid frozen format with an impressive 30 day open vial stability, reducing waste while remaining easy-to-use.
| Siemens Advia Centaur XPT (pg/ml) Range | |
| Level One | 21 (13 – 29) |
| Level Two | 153 (104 – 202) |
| Level Three | 435 (296 – 574) |
Features & Benefits
- Liquid frozen
- Human serum based
- Assayed target values are assigned for Siemens analysers
- Stable to expiry date at -20°C to 70°C
- Open vial stability of 30 days at 2°C to 8°C
Analytes
- PTH (Parathyroid Hormone)
Related Products
Xanthochromia Quality Control
The Randox Acusera Xanthochromia Control is designed to deliver a cost-effective, true third party solution for use in monitoring the performance of Bilirubin and Oxyhaemoglobin in Cerebrospinal Fluid (CSF) using a spectrophotometer.
Aqueous based with components of human origin, the Xanthochromia Controls are unassayed and are suitable for use with various UV spectrophotometers.
Supplied in a liquid frozen format, this control should be treated in the same manner as a patient sample.
Features & Benefits
- Liquid frozen format for convenience and reduced handling errors
- Aqueous based with components of human origin
- True Third Party control providing unbiased assessment of performance
- An Open Vial stability of 2 days at 2° to 8°C. Stable for 11 weeks when stored unopened at -18° to -24°C helping to keep waste to a minimum.
Analytes
- Billirubin
- Oxyhaemoglobin
*No claims are made regarding values and stability.
BNP 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.
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
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.
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.
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.
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.
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.
Features of Acusera 24•7
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.
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.
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
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
How To Guide: Logging in
How To Guide: Adding Events
How To Guide: Adding QC Panel
How To Guide: Adding QC Tests
How To Guide: Chart Generation and Overview
How To Guide: Data Entry Options
How To Guide: Exception Report
How To Guide: Home Page
How To Guide: Manual Data Entry
How To Guide: Navigating Side Bars
How To Guide: Peer Group Statistics
How To Guide: Result History
How To Guide: Statistical Analysis Report
How To Guide: Statistical Metrics Report
How To Guide: Uncertainty of Measurement
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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.
Key Benefits of Acusera
Commutability
A commutable sample matrix increases confidence that performance mimics that of patient samples.
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.
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.
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.
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.
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.
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.
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.
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
What Are The Benefits of Third Party Controls?
Customer Testimonials
Sixth People’s Hospital of Zhengzhou City, Henan Province
‘Our laboratory continues to use Randox’s IQC products, including HN1530, HE1532, IA3110, IA3111, CG5021, CG5023, UC5033, UC5034. Compared with the previous use of original quality control, we can now find the quality control deviation caused by the change of reagent batch number in time. Later, we can timely pass the calibration and the calibration to return the laboratory results to the correct level. Randox products have brought us more convenience in our work. We are very satisfied with Acusera series products.’
Patrick Else, Nuffield Health
‘Randox Acusera 24/7 has enabled me to effectively manage 13 separate hub sites effectively through the use of the integrated reports that can be generated. The system allows for routine day to day monitoring of IQC results as well as long term tracking and trending. The Uncertainty of Measurement report has allowed me to free up a large amount of time as this report can be generated whenever for a particular date range meaning no more manual number crunching. The support from Randox has been first class from the initial install through to current working practices and the company are very open to improvements to the system. On the whole I am very happy with the programme. ‘