Advanced Statistics with Acusera 24.7

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Advanced Statistics with Acusera 24.7

The only thing that sounds more terrifying than statistics, is advanced statistics. For many of us, the dread associated with having to carry out complex calculations can be too much to bear.  For others, statistics are not just a set of numbers; they’re a captivating puzzle waiting to be solved. The allure of dissecting intricate patterns, unravelling hidden relationships, and drawing meaningful conclusions makes these statistical enthusiasts embrace the challenges of advanced statistics with excitement rather than apprehension.

No matter which camp you’re in, we bet you’re going to love the advanced statistics features included in Acusera 24.7. From Uncertainty of Measurement to Sigma Metrics, we’ve got you covered. Let’s explore these features and how we can make your statistical analysis easier than ever before.

Measurement Uncertainty

If you’re involved in laboratory quality control, you’ll have heard all about measurement uncertainty (MU). To some it’s intuitive. To some it’s a labyrinth. MU is defined as a parameter associated with the result of a measurement that characterises the dispersion of values that could reasonably be attributed to the measured quantity. For example, if we say the pencil below measures 16cm ± 1cm, at the 95% confidence level we are really saying that we are 95% sure that the pencil measures between 15cm and 17cm.

In other words, the calculation of MU gives medical laboratories an estimate of the overall variability in the values they report. This is important for 3 reasons:

  1. It helps ensure the measured results are useful and not wildly inaccurate.
  2. It permits meaningful comparison of medical decision limits and previous results of the same kind in the same individual.
  3. It’s a regulatory requirement – ISO 15189:2022

All measurements involve some degree of inherent variability due to factors such as instrument limitations, environmental conditions, and biological variation. MU aims to quantify the doubt or range of possible values around the measurement result, helping to provide an understanding of the reliability and limitations of measurements. To complete this task comprehensively, the entire measurement process must be examined and should consider components such as systematic errors, random errors and uncertainties related to calibration, equipment, and the environment.

ISO 15189:2022 states:

So, if you are seeking ISO15189 accreditation, there’s no avoiding MU and advanced statistics. Lucky for you, Acusera 24.7 can calculate MU and provide you with a report which you can export to Excel or PDF for auditing or archiving.

By liberating you from the need to manually calculate MU for all your assays and control levels, Acusera 24.7 streamlines the statistical analysis process, freeing you up to complete your other essential duties. It also helps reduce the chance of errors in the calculation; after all, no matter how talented you are at mathematics, we all make mistakes. The real-time nature of this kind of monitoring means you don’t have to recalculate every time you get more data – simply press the refresh button and you’ll automatically get a new MU report.

By incorporating automated tools to calculate MU, you gain the ability to proactively pinpoint and rectify potential error sources, mitigating the risk of inaccurate measurements and the repercussions that may follow.

For more information on MU and how it’s calculated, see our education guide – How to Measure Uncertainty.

Sigma Metrics

The Sigma model was originally developed for the manufacturing industry as a method of process improvement focusing on minimising errors in process outputs. It has since been adopted by the medical laboratory to improve result reporting.

This model calculates the number of standard deviations or ‘Sigmas’ that fit within the quality specifications of the process – as the sources of error or variation are removed, the standard deviation becomes smaller, and the sigma score increases – 6 being the target. A 6 Sigma process can be expected to produce 3.4 defects, or false results, per million.

sigma6

Using your predetermined performance limits, including biological variation (standard), RiliBÄK and CLIA, as the total allowable error (TEa), Acusera 24.7 can calculate a Sigma Score for a particular assay, method, or instrument, saving you the hassle of calculating this manually – freeing you up to investigate the sources of error and make improvements to your process.

This is displayed in our Statistical Metrics report along with Count, Bias%, and CV for your chosen range, your cumulative results and those from other Acusera 24.7 users from around the world to provide straightforward and comprehensive statistical analysis and peer group comparison.

Once you’ve found out your Sigma Score for an assay, you can use this to determine your QC frequency and the multi-rules you should apply to your QC. The higher your Sigma Score, the less multi-rules you need to apply to your analysis and the less often you need to run QC for that assay. The table below shows the multi-rules and QC frequencies associated with each Sigma Score.

Acusera 24.7 includes multi-rule capabilities that can be utilised to monitor your QC data and index it as accepted, rejected, or trigger an alert, depending on the pre-defined multi-rules against which you want to check your data. These features enable the identification of nonconformities and reduce the need for laborious manual statistical analysis while enhancing the accuracy and precision of the laboratory. To read more about the multi-rule features of Acusera 24.7, take a look at our educational guide – Understanding QC Multi-rules.

Now that we’ve found which of our assays are underperforming, we can begin to take corrective action. The Sigma Score is affected by bias and imprecision of laboratory results, therefore improving these values will increase the Sigma Score. Some of the steps a laboratory can take are:

  • Improved staff training
  • Instrument maintenance
  • Frequent calibration
  • Strict adherence to SOPs when preparing controls and calibrators.

If you are still in the dark ages, carrying out your statistical calculations and analysis manually, reach out to us today to learn more about the time and expense we can help you save. Every day, more people are discovering the power of Acusera 24.7 and the benefits it has in their laboratory.

The updates to ISO151589:2022 are based around increasing patient safety and reducing erroneous results, making advanced statistics essential. Assessors get excited when they see Acusera 24.7 in the lab because they know quitting time is that bit closer. Allow us to help you achieve your accreditation and provide the best possible patient care. With complete onboarding assistance and first-class customer support, you’ll always be ready to get to the bottom of any problems you might face. Get in touch today at marketing@randox.com


Pursuing Perfection: Insights into Global IQC Practices

In a time when medical laboratory personnel are pushed to their limits, internal quality control and quality management are easy to consider a nuisance. However, these processes are vital to ensure accuracy and precision in the potentially life-saving tests performed in these laboratories. Most High-to-middle-income countries have strict regulations governing quality procedures in medical laboratories, but global standardisation in these areas is lacking. Over 70% of clinical decisions are based on laboratory testing but many clinicians are unaware of the accuracy and precision limitations associated with many of these tests. This places the responsibility on laboratory staff to ensure that all results provided to clinical decision-makers are as true as possible. For this, they rely on IQC and a robust quality management system.

To determine the state of the industry, a report by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on Global Laboratory Quality (TF-GLQ) surveyed over 100 IFCC full and affiliate members, receiving responses from 46 countries1. This survey consisted of a series of multiple-choice questions in relation to quality practices in their respective countries.

Findings by IFCC Task Force on Global Laboratory Quality

90% of respondents indicated that quality standards are in use in their country, despite being mandatory in only 46.7% of those countries.

These responses are encouraging showing that at least some level of predefined QC practice is implemented even in countries that do not legislatively mandate the inclusion of quality standards. This also hints that in those countries where it is not mandatory, it may soon become a requirement to adhere to a specified QC system. Nevertheless, in countries where regulatory measures are currently absent, the rigour of the implemented quality control procedures may not be adequate to ensure the accurate reporting of results.

42.5% of respondents indicated that IQC was not run in all laboratories in their country.

These respondents indicated that IQC is run in 50-99% of laboratories in their country. This less encouraging result shows that minimum IQC practices are not implemented globally. However, due to the multiple-choice nature of this survey, it is difficult to determine how drastic this issue is. Although it does raise the question of how these laboratories verify the precision of their results.

66.7% of respondents indicated that they use assay manufacturer quality control material.

This refers to first party quality control materials which are optimised by the manufacturer for use with a specific assay, instrument or method. These controls are often manufactured from the same material as the calibrator, making them less sensitive to subtle changes in performance, allowing them to mask weaknesses in the assay in question and therefore should be considered less effective options than third-party controls. Additionally, ISO15189:2022 encourage the use of third-party controls and require laboratories seeking accreditation that do not use third party controls to provide a sufficient explanation as to why this is the case.

“The use of third-party IQC material should be considered, either as an alternative to, or in addition to, control material supplied by the reagent or instrument manufacturer.”

ISO15189:2022 section 7.3.7.2

60% of respondents indicated that not all laboratories in their country had written IQC policies and procedures.

This highlights an important aspect of a quality management system. Without written IQC policies and procedures it is almost impossible to standardise the IQC process and corrective action across laboratory staff, never mind on a national scale. Drafting this documentation can be cumbersome, however, many organisations can be contracted to assist with the drafting and implementation of these procedures for laboratories seeking to gain accreditation.

28.6% of respondents reported that manual interpretation of the IQC data was normal practice.

Manual data interpretation also poses challenges to the standardisation of IQC processes. Written IQC policies and procedures are crucial in implementing standard acceptance criteria for IQC results. Manual data interpretation also implements restrictions on the ability to carry out more advanced statistical analysis of the QC data.

Discussion

The implementation of robust IQC practices is crucial for ensuring the trueness and precision of the results produced by a laboratory.  Used correctly, IQC can monitor variability caused by instrumentation and lot changes as well as various other sources of analytical error. ISO15189:2022 provides a thorough framework for designing rigorous IQC policies and procedures, highlighting key areas such as the use of third party QC material, levels of QC material, the frequency at which IQC should be completed, matrix composition, acceptance/rejection criteria and non-conformance procedures. For more information on ISO15189:2022 accreditation, take a look at our educational guide ISO15189:2022 Updates.

The results from this survey conducted by IFCC show a clear disparity between IQC processes around the globe, displaying differences in requirements, recommendations, and legislation. Standardisation of IQC is not without its challenges. However, by striving to achieve the highest possible levels of quality, and following the guidance laid out in ISO15189:2022, laboratories can be confident in the results they provide to clinicians.

Acusera Quality Control

The Acusera range offers unbiased, independent third party quality controls for medical and research laboratories of all shapes and sizes. Our assayed controls are provided with target values for most commercially available analysers, ensuring that your test menu will be covered. With enhanced stability, commutability and consolidation, all our controls are manufactured to provide a clinically relevant challenge to your test method, aiding in ISO15189 accreditation. For more specialist laboratories, our teams are happy to discuss your requirements and help to provide bespoke quality control material, providing an extremely flexible QC range.

Acusera 24.7

Designed for use with the Acusera range of third party controls, the Acusera 24•7 software will help you monitor and interpret your QC data. Access to an impressive range of features, including interactive charts, the automatic calculation of Measurement Uncertainty & Sigma Metrics and live peer group data generated from our extensive database of laboratory participants, ensures Acusera 24•7 is the most comprehensive package available. For laboratories performing manual review of their IQC data, Acusera 24•7 provides a comprehensive yet easy-to-use platform for advanced statistical analysis and monitoring of these data.

For more information on our Acusera range of IQC material, or Acusera 24•7, feel free to reach out to us at marketing@randox.com or alternatively, browse our range of literature at the QC Resource Hub

References

  1. Wheeler SE, Blasutig IM, Dabla PK, et al. Quality standards and internal quality control practices in medical laboratories: an IFCC global survey of member societies. Clinical Chemistry and Laboratory Medicine (CCLM). 2023;0(0). doi:10.1515/cclm-2023-0492

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
DescriptionSizeAnalytesCat NoContact Us
Pre-eclampsia Control Level 1 3 x 2 x 2 ml2PE10527
Pre-eclampsia Control Level 23 x 2 x 2 ml2PE10528
Pre-eclampsia Control Level 33 x 2 x 2 ml2PE10529

 

Therapeutic Drug Quality Control

Analytes

  • – sFlt-1
  • – PIGF

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 material 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
DescriptionSizeAnalytesCat No
Active Vitamin B12 Control Level 13 x 2 ml1VB10524
Active Vitamin B12 Control Level 23 x 2 ml1VB10525
Therapeutic Drug Quality Control

Analytes

  • Active Vitamin B12 (Holotranscobalamin/HoloTC)

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
DescriptionSizeAnalytesCat NoContact Us
Bone Makers (Serum) Control Level 1 6 x 2ml3SBM10574
Bone Makers (Serum) Control Level 26 x 2ml3SBM10587
Bone Makers (Serum) Control Level 36 x 2ml3SBM10588

 

Therapeutic Drug Quality Control

Analytes

  • – PINP
  • – N-MID Osteocalcin
  • – Bone-ALP

*No claims are made regarding values and stability.


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

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
  • Human Based Material
  • 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.
DescriptionSizeAnalytesCat NoContact Us
Xanthochromia Positive Control6 x 4 ml2XN10505
Xanthochromia Negative Control6 x 4 ml2XN10502
Therapeutic Drug Quality Control

Analytes

  • Billirubin
  • Oxyhaemoglobin

*No claims are made regarding values and stability.


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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