From Fear to Freedom: A QC Data Management Revolution
From Fear to Freedom: A QC Data Management Revolution
What if we told you we had a solution to the multitude of monotonous hours spent analysing reams of IQC data and could provide you with an intuitive tool packed with comprehensive and customisable reports, interactive charts, and automated statistical analysis to help improve your QC data management?
Perhaps it sounds too good to be true?
This time, it isn’t.
Uncertainty of Measurement. 6Sigma. QC Multi-rules. These words can strike fear into the hearts of even the most experienced laboratory staff.
With Acusera 24.7, we’ve reached under the bed and forced the monster that is advanced statistical analysis out into the cold.
Acusera 24.7 is a live, cloud-based, interlaboratory QC data management and peer group comparison software.
A mouthful. I know.
But let’s break it down.
A live, cloud-based software means you can access your QC data from anywhere, anytime.
Bid farewell to the labyrinth of folders you hunt through when troubleshooting or looking for a specific dataset.
Interlaboratory management describes the momentous task many QC managers face – monitoring the QC performance of multiple laboratories in different locations, ensuring they all maintain the high standards required for accreditation and accurate patient results.
Unlike some big-name subscription services, we encourage you to use our software at different locations to help you monitor all your laboratories and instruments to see how their results stack up against one another.
Acusera 24.7 provides multiple levels of access which are completely customisable. This allows you to grant or restrict access to different parts of the software depending on what is required by your staff. This also allows QC managers to view data from all their sites in one location without needing multiple email chains from each laboratory.
Peer group comparison? Isn’t that what EQA is for?
Well, you would be right.
Yes, EQA does provide a comparison with your peer group, but it doesn’t have exclusive rights.
There are many benefits to comparing your IQC data with your peer group. The real-time comparison data aids with troubleshooting, or you can show off how great you are to your friends and colleagues.
You can select your peer group for an instrument, method and more, providing you with a comprehensive picture of how your laboratory performance compares to your peers using the same lot of control.
There are no submission deadlines. One less thing for you to worry about.
Still think it sounds too good to be true?
Then let’s look at some of the software features and how they can be used to make your daily QC data management easier.
Charts
For many laboratories, review of their QC data is a momentous task involving an abundance of printouts with different data tables and graphs and hastily scribbled notes going back maybe months, if not years.
With Acusera 24.7’s interactive Levey-Jennings charts, you can see the QC data from a specified date range. This helps visualise trends and biases over any period to simplify the troubleshooting and lot validation processes, or, can be used as evidence during accreditation assessments. These charts can be generated for a single analyte or for multiple analytes and QC levels.
You can also add events to the graph to record factors that might impact the performance of your analyser such as preventive maintenance, calibrations or switching QC lots. So, when you come to review the QC data and see a shift in the results, you can see at a glance if there was an explanation for the change in QC results.
What’s more, the points plotted on the chart will appear in orange or red if they trigger your alert or reject protocols respectively. Those that appear as a triangle indicate a comment is attached. Comments can be added to any data point directly on the Levey-Jennings chart, allowing you to record any information relevant to the data, saving you time, not to mention the cost of all those sticky notes.
This complements the Panel feature of the software. Within Acusera 24.7 you can create a panel of tests, for example, a Liver Function Test panel, grouping all the tests together. You can then view all the QC data for this panel at the click of a few buttons. Shown below is the collective data for a clinical chemistry panel.
When you do need the paper copy, all the charts and reports found in Acusera 24.7 can be exported to Excel or PDF for independent analysis or printing, making it easy to bring your data to meetings or for hardcopy filing and audits.
For peer group comparison, you can get a performance summary chart. This chart basically does the analysis for you! You define the date and time range, and the software looks at all the data points within it for you and your peer group, comparing individual data, means, CVs and SDs. Like our other charts, you can combine any number of these for multi-analyte analysis.
Advanced Statistics
Some people love statistics. Others can think of nothing worse.
Either way, there’s a lot of work involved in advanced statistical analysis.
Even if you’re in the love camp, you might find yourself sickened before you’ve finished this metaphorical jar of marmite.
The role of a pathology laboratory is not to run QC and show off their statistical skills, but to provide accurate and appropriate patient results.
As the old saying goes, time is money.
But in your case, time is the difference between a fast or delayed diagnosis for a patient.
This may impact their condition or treatment.
By making use of the suite of statistical options included in Acusera 24.7, including QC Multi-rules, 6Sigma and Uncertainty of Measurement, you can focus on providing the most accurate and efficient testing for patients.
Data Entry
To save even more time, Acusera 24.7 can be integrated with many LIMS or Middleware packages for fully automated data transfer. At a predefined time, your internal software will send your QC data to a shared folder on your network and from there to a Randox Cloud IP address, meaning we don’t go into your IT system and take anything; we won’t cause any information security problems. This data is then taken from the cloud and populated onto 24.7.
All this in less time than it takes you to say, ‘fully automated data transfer.’
You can also import your data through a semi-automated upload procedure. For this, the data is exported from your LIMS or middleware and imported manually to your Acusera 24.7 account using an EDI import file. Simply put, all you have to do is send the file, and the software will populate it onto the system. Alternatively, you can upload the data manually on the simple and intuitive data entry page.
Acusera 24.7, while comprehensive and initially daunting due to its vast array of features, is incredibly easy to use. The Acusera 24.7 and QC operations teams are always eager to help new and existing Acusera 24.7 users with any issues they experience. We provide complete onboarding assistance and full training on the software for new customers while delivering prompt and effective customer support for existing users.
We’ve only begun to cover the range of features available on Acusera 24.7 for QC data management! For more information or to arrange a demo, get in touch with our team at marketing@randox.com. Or, you can take a look at our website here.
Differentiating Viral from Bacterial Infections
Estimates claim that over 1.2 million people died in 2019 as a direct result of an antibiotic-resistant bacterial infection. Statistics show that up to 4.95 million deaths in the same year were associated with antimicrobial resistance (AMR)1. The overuse and misuse of antibiotics is considered to be the largest contributing factor to the rise of AMR. Antibiotics are effective at treating a wide range of bacterial infections, however, when used to treat viral infections, they have little to no effect. Even still, many physicians continue to prescribe so-called empirical antibiotics as an all-encompassing treatment strategy. In their defence, differentiating viral from bacterial infections can be troublesome. Traditional testing takes the form of paired serology, which requires patients to visit a healthcare facility twice during a 2–4-week period. Many of these infections have distressing symptoms, making this an unreasonable time-to-diagnosis period. Novel molecular techniques can reduce the time to result in the determination of many infections. However, some of these methods are associated with high false positive rates and low specificity resulting in further misuse of antibiotics.
Mxyovirus resistance protein A (MxA) is a biomarker associated with viral infections. It displays antiviral activity against positive, double-stranded RNA viruses and some DNA viruses2. In a study from earlier this year, MxA was used to differentiate viral from bacterial infections in a cohort of 61 adults with an AUROC of 0.9 and a sensitivity and specificity of 92.3% and 84.6% respectively3. An additional study, known as the TREND study, found that a cut-off of 430μg/L could effectively differentiate bacterial and viral infections with an AUROC of 0.9, a sensitivity of 92% and a specificity of 100%4.
C-reactive protein (CRP) is a non-specific acute phase protein which is associated with bacterial infection. However, CRP levels have also been shown to be elevated in response to various viral infections such as Influenza virus, malaria5 and SARS-COV-26, limiting its utility in differentiating the aetiology of an infection.
Using both biomarkers in combination can help physicians determine the true aetiology of infection with high specificity, supporting antimicrobial stewardship and reducing the harmful use of these drugs. Available on the VeraSTAT, Randox provides tests for MxA and CRP, which together provide a fast and accurate method of detection and differentiation of bacterial and viral infections from a small sample.
We have provided an educational guide which describes these biomarkers and their usefulness in the arena of viral and bacterial detection. If you’re interested in learning more, you can find our educational guide here.
Differentiating Viral from Bacterial Infections
Alternatively, don’t hesitate to browse our range on our website or get in touch with one of our team at marketing@randox.com who will be happy to help with any query you have!
References
- Murray CJL, Ikuta KS, Sharara F, et al. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. The Lancet. 2022;399(10325):629-655. doi:10.1016/S0140-6736(21)02724-0
- Liao S, Gao S. MxA: a broadly acting effector of interferon-induced human innate immunity. Visualized Cancer Medicine. 2022;3:2. doi:10.1051/vcm/2022002
- Metz M, Gualdoni GA, Winkler HM, et al. MxA for differentiating viral and bacterial infections in adults: a prospective, exploratory study. Infection. Published online February 3, 2023. doi:10.1007/s15010-023-01986-0
- Rhedin S, Eklundh A, Ryd-Rinder M, et al. Myxovirus resistance protein A for discriminating between viral and bacterial lower respiratory tract infections in children – The TREND study. Clinical Microbiology and Infection. 2022;28(9):1251-1257. doi:10.1016/j.cmi.2022.05.008
- Joseph P, Godofsky E. Outpatient Antibiotic Stewardship: A Growing Frontier—Combining Myxovirus Resistance Protein A With Other Biomarkers to Improve Antibiotic Use. Open Forum Infect Dis. 2018;5(2). doi:10.1093/ofid/ofy024
- Paranga TG, Pavel-Tanasa M, Constantinescu D, et al. Comparison of C-reactive protein with distinct hyperinflammatory biomarkers in association with COVID-19 severity, mortality and SARS-CoV-2 variants. Front Immunol. 2023;14. doi:10.3389/fimmu.2023.1213246
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.
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
- 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
RX Imola: Inflammatory Biomarkers in COVID-19
Over the course of human history, few events have had such a dramatic impact as the COVID-19 pandemic. According to the World Health Organization (WHO), as of 12th July 2023, the SARS-CoV-2 virus has claimed almost 7 million lives and figures continue to rise1. While many who become infected are only subject to mild symptoms, those who develop a more severe form of the infection are encumbered with a debilitating flu-like condition, often requiring days, if not weeks of bed rest. In a paper from June 20232, the Rx Imola was used to study C reactive protein concentrations, along with other biomarkers, in mild and severe COVID-19 patients in order to develop novel risk stratification methods for this potentially life-threatening viral infection.
The impact on healthcare services around the world cannot be understated. In developed countries, access to services for both COVID-related and other conditions took a catastrophic hit. In low-to-middle-income countries, the impact has been even more distressing, all but eliminating basic medical care in favour of combating COVID-19, partly due to inferior resources and facilities3.
In times of medical emergency, it is crucial to have an efficient and effective means of stratifying the risk to patients and a process for suitably categorising those into the least and most at risk of severe complications or death. Due to the rate at which COVID-19 spread, unfortunately, the world lacked these mechanisms for SARS-CoV-2, resulting in mass hospital overpopulation, cancelled appointments for other life-threatening conditions and ultimately the staggering mortality statistics we’ve been bombarded with since January 2022. This prompted an unprecedented surge in medical research and major advances in testing capabilities, giving us new methods of detecting SARS-CoV-2 and determining the risk posed to individuals.
One such investigation, by Paranga et al., (2023) studied a total of 13 biomarkers to determine which could accurately differentiate mild, moderate, and severe cases and identify biomarkers which were good predictors of fatality2. C reactive protein (CRP) was the best-described biomarker relating to COVID-19 throughout the pandemic. This paper compares it to 12 other biomarkers including suPAR, sTREM-1, ferritin, MCP-1 and Lactate dehydrogenase. Of these, it was discovered that CRP was clearly the most effective biomarker for differentiating mild from severe cases, with concentrations in those with severe infection being, on average, 45% higher than in those with mild symptoms2. Additionally, the authors discovered that CRP levels were not significantly affected by age, a factor known to affect the inflammation and immune responses, providing a powerful and inclusive risk stratification tool. Some of the additional conclusions drawn from this paper can be seen below2:
- Lactate dehydrogenase, sTREM-1 and HGF were good predictors of mortality in COVID-19.
- suPAR was identified as a crucial molecule in characterising Delta variant infection and mortality.
- The initial values of inflammatory biomarkers were good to excellent predictors of disease severity in COVID-19 patients.
- Disease severity and mortality are associated with a higher rate of comorbidities including thrombocytopenia and other blood diseases, circulatory and respiratory system diseases and liver diseases such as cirrhosis.
So, what is CRP and how does it become elevated in response to a SARS-CoV-2 infection? CRP is a non-specific, acute-phase protein, meaning its concentration is altered in response to inflammation4. The acute respiratory distress syndrome induced by SARS-CoV-2 is, in part, a result of the hyperinflammation caused by the virus2. CRP is a well-characterised inflammatory biomarker and is therefore well-suited for identification and risk stratification in an emerging disease.
This investigation2 utilised the RX Imola, a rapid, comprehensive clinical chemistry platform, to quantify CRP. With the RX Imola, laboratories can gain access to the world’s largest clinical chemistry test menu covering routine chemistries as well as specific proteins, lipids, and more providing a cost-effective and user-friendly platform. With 60 cooled reagent positions and a sample carousel with 20 cooled positions for controls and calibrators, the RX Imola is an ideal solution for small to medium-throughput laboratories seeking an innovative and reliable clinical chemistry system. Randox also supplies suitable, high-quality reagents, and through Acusera, state-of-the-art controls and calibrators, completing the clinical chemistry portfolio.
References
1. World Health Organisation. WHO Coronavirus (COVID-19) Dashboard. https://covid19.who.int/.
2. Paranga TG, Pavel-Tanasa M, Constantinescu D, et al. Comparison of C-reactive protein with distinct hyperinflammatory biomarkers in association with COVID-19 severity, mortality and SARS-CoV-2 variants. Front Immunol. 2023;14. doi:10.3389/fimmu.2023.1213246
3. Jain P. Impact of COVID-19 Pandemic on Global Healthcare Systems and the role of a new era of global collaborations. Sushruta Journal of Health Policy & Opinion. 2021;14(3):1-5. doi:10.38192/14.3.2
4. Nehring S. C Reactive Protein . https://www.statpearls.com/articlelibrary/viewarticle/18744/.