A Comprehensive Guide to External Quality Assessment Programmes
A Comprehensive Guide to External Quality Assessment Programmes
The importance of External Quality Assessment (EQA) programmes in the realm of medical laboratories is beyond dispute. These programmes serve as external control mechanisms, underpinning the accuracy and reliability of diagnostic tests carried out by laboratories across the globe. By participating in EQA programmes, laboratories gain the ability to monitor their proficiency, identify areas for improvement, enhance their analytical performance, and above all, ensure top-tier patient care.
Today, we find ourselves faced with a multitude of EQA programmes, each touting its own, unique features and benefits. Therefore, the question that naturally follows is – how do you choose the right EQA programme for your laboratory?
Understand Your Laboratory’s Requirements
The first step towards selecting an EQA programme is to clearly understand the requirements of your laboratory. These requirements could encompass the range of tests performed, the desired frequency of assessment, and the specific areas where your lab wishes to improve
Examine the EQA Programmes
The next step is to critically examine each EQA programme. Look at the range of tests they cover, the frequency of their assessments, the type of samples they use, and their approach towards feedback and improvement.
Reporting
One of the most critical aspects of an EQA programme is the results reporting mechanism. This mechanism should provide comprehensive and constructive feedback, highlighting areas of improvement, and offering guidance on how to enhance performance. It is also essential to consider the frequency of reporting. More frequent reporting allows laboratories to identify problems and implement corrective actions swiftly, aiding in the continuous improvement of a laboratory and the confident delivery of accurate patient results.
Accreditation
The accreditation of the EQA programme should also be evaluated. Superior programmes are accredited to ISO17043:2010. Participation in an accredited EQA programme is mandatory under ISO15189:2022 accreditation. Choosing a scheme accredited to ISO17043 ensures that the programme has been rigorously evaluated and meets the necessary criteria of a high-quality EQA programme.
Cost-effectiveness
The cost of the EQA programme should be compared to the benefits your laboratory will reap from participating in the scheme. Although cost should not be the sole determining factor, it’s a crucial element to consider. Factors such as consolidation and number of registrations are key areas where many providers differ.
Customer Support
Finally, it’s vital to consider the customer support provided by the EQA programme. Adequate support will ensure that any issues or queries are addressed in a timely and efficient manner
Our latest educational guide Choosing the Right EQA Programme has been constructed to help you with this decision. Providing more detail on the points discussed above and more, this guide displays how the world-renowned RIQAS EQA programmes can help you maximise the accuracy of your laboratory results and achieve ISO15189:2022 accreditation.
In conclusion, selecting the right EQA programme requires a careful and thorough evaluation of several factors. By taking the time to understand your laboratory’s needs, scrutinising each EQA programme, and considering factors such as reporting, accreditation, cost, and customer support, you can make a well-informed decision that will significantly enhance the proficiency of your laboratory and the quality of patient care.
Remember, the primary objective of an EQA programme is to help your laboratory improve. Therefore, the right EQA programme for your laboratory is the one that best assists you in achieving this objective.
Prostate-specific Antigen & Prostate Cancer
Prostate cancer is the most common form of cancer in men. In the UK, 1 in every 8 men will be diagnosed with the condition within their lifetime, resulting in around 12’000 deaths per year1. Prostate-specific antigen is a major protease found in semen which functions to cleave semeogelins into smaller polypeptides resulting in the liquefication of semen2.
This week, we had the pleasure of welcoming Dr Floris Helmich, who discussed laboratory imprecision relating to Prostate-specific antigen (PSA) and prostate cancer in our latest webinar. Dr Helmich took the time out of his busy schedule to present his experience in PSA quantification and the importance of quality control in yielding accurate and precise results as well as discussing some of the experimental techniques he has found useful in identifying the source of bias laboratory testing. Dr Helmich also discussed the ambiguity relating to reporting ranges and how bias can affect the results of laboratory PSA testing.
What is PSA?
PSA is an enzyme produced by the prostate ductal and acinar epithelium where it is secreted into the lumen before it is used to liquefy semen. Once PSA enters circulation, most are bound to protease inhibitors, however, some remain inactive and circulate in the lumen as free PSA2.
PSA levels in men vary depending on their age. Typically, men between the ages of 50 and 69 should have a PSA level below 3ng/ml. If the PSA concentration exceeds 3ng/ml, it could be a potential indicator of prostate cancer3. However, the challenge with using PSA as the sole monitoring method for prostate cancer is the relatively high false positive rate associated with it. A higher PSA concentration can also be attributed to conditions such as an enlarged prostate, prostatitis, or a urinary tract infection4.
Research indicates that 1 out of 4 men with elevated PSA levels will actually have prostate cancer. Additionally, it has been observed that approximately one in every seven men diagnosed with prostate cancer will maintain normal PSA levels3. These findings highlight the limitations of relying solely on PSA screening for prostate cancer diagnosis. As a result, some countries have started to limit their recommendations regarding PSA-based prostate cancer diagnosis.
In response to these limitations, other countries have chosen to maintain their recommendations for PSA testing but are augmenting the guidelines by incorporating additional criteria to ensure more accurate diagnoses.
Elevated PSA
Elevated levels of PSA should not always be automatically interpreted as a sign of prostate cancer. In older men, one common cause of elevated PSA is benign prostatic hyperplasia (enlarged prostate). Additionally, prostatitis, which refers to inflammation of the prostate, can contribute to an increase in PSA concentration3. It’s important to consider other potential factors that can lead to elevated PSA levels, such as urinary tract infections, recent sexual activity, natural age-related increases, or injury to the groin area5.
Therefore, when assessing PSA levels, it is crucial to recognize that various non-cancerous conditions can also result in elevated PSA. It is recommended to consult healthcare professionals who can evaluate the individual’s medical history, perform further diagnostic tests, and consider other clinical factors to accurately determine the underlying cause of elevated PSA and make informed decisions about the next steps in diagnosis and treatment.
Ultra-low PSA concentrations
The diagnostic accuracy of PSA concentration for prostate cancer is known to be limited. However, there is a clear association between PSA levels and prostate cancer, which confirms it as a valuable tool for risk stratification and diagnosis when used in conjunction with other established factors.
PSA testing also plays a crucial role in monitoring patients who have undergone treatment for prostate cancer. In cases where the patient is deemed cancer-free, their PSA levels should decrease to within the normal range. Following radical prostatectomy (removal of the entire prostate), PSA levels should ideally be undetectable. Post-radiotherapy, it is expected that PSA levels will reach their lowest point (nadir) within 12-18 months. However, it’s important to note that in some cases, a temporary spike in PSA concentration has been observed after radiotherapy. This spike should not be immediately interpreted as recurrent cancer, but these patients should be closely monitored.
If PSA concentrations rise above 2.0ng/ml after radiotherapy, further testing is recommended to assess the possibility of recurrent cancer. Close monitoring and additional evaluations will help healthcare professionals make accurate and timely decisions regarding the patient’s ongoing treatment and care6
Guidelines
Different countries offer varying guidance in relation to Ultra-low PSA testing. The table below details some of these recommended guidelines:
| Guidelines | Description |
| American Urology Association 7 | PSA concentrations of >0.2ng/ml, followed by a subsequent confirmatory >0.2ng/ml result should be considered biochemical recurrence. However, a cut-off of 0.4ng/ml may better predict metastatic relapse. |
| European Association of Urology8 | A detectable PSA indicating relapse should be differentiated from a clinically meaningful relapse. PSA thresholds that predict further metastasises are:
Post-RP = >0.4ng/ml Post-RT = nadir + 2ng/ml |
| Prostate Cancer Foundation1 | Post-RP = PSA 0.2ng/ml is indicative of biochemical recurrence
Post-RT = PSA nadir + 2ng/ml is indicative of biochemical recurrence |
Randox Ultra-low PSA Control
We are excited to introduce Randox’s latest innovation, the Ultra-low PSA Control, designed to assist in the precise quantification and monitoring of ultra-low levels of PSA in post-therapy prostate cancer patients. This control has been specifically optimized for use on Roche systems, ensuring exceptional performance and compatibility. Moreover, it is versatile enough to be utilized on various other platforms, making it the sole control available on the market for measuring ultra-low levels of PSA across a range of instruments.
With the Acusera Ultra-low PSA Control, healthcare professionals can achieve accurate and reliable results, enabling them to monitor the progress and treatment response of prostate cancer patients with heightened sensitivity. With a clinically relevant concentration of approximately 0.055ng/ml, this advancement in control technology contributes to enhanced patient care and supports medical professionals in making informed decisions regarding treatment adjustments or further interventions.
Randox’s commitment to innovation and precision in diagnostic solutions continues with the Ultra-low PSA Control, empowering laboratories to deliver high-quality and dependable PSA measurements, even at the ultra-low levels required for post-therapy monitoring.
Take a look at our webinar, Laboratory Imprecision in Relation to PSA and Prostate Cancer Follow-up, with Dr Floris Helmich to learn about how his clinical laboratory deals with bias at quality control relating to Ultra-low PSA quantification
If you’d like to learn more about PSA testing and prostate cancer, we encourage you to read our new educational guide, Ultra-low PSA and Prostate Cancer
If you would like an additional information on our Ultra-low PSA Control, or anything else relating to Quality Control, don’t hesitate to reach out the marketing@randox.com. Additionally, feel free to visit our QC resource hub where you will find all of our brochures, support tools and a collection of educational material, to aid you in maintaining the highest possible levels of quality.
References
- Prostate Cancer Foundation. About prostate cancer. Prostate Cancer UK. Published 2023. https://prostatecanceruk.org/prostate-information-and-support/risk-and-symptoms/about-prostate-cancer
- Balk SP, Ko YJ, Bubley GJ. Biology of Prostate-Specific Antigen. Journal of Clinical Oncology. 2003;21(2):383-391. doi:https://doi.org/10.1200/jco.2003.02.083
- NHS Choices. Should I have a PSA test? – Prostate cancer. NHS. Published 2019. https://www.nhs.uk/conditions/prostate-cancer/should-i-have-psa-test/
- Isono T, Tanaka T, Kageyama S, Yoshiki T. Structural Diversity of Cancer-related and Non-Cancer-related Prostate-specific Antigen. Clinical Chemistry. 2002;48(12):2187-2194. doi:https://doi.org/10.1093/clinchem/48.12.2187
- Mejak SL, Bayliss J, Hanks SD. Long Distance Bicycle Riding Causes Prostate-Specific Antigen to Increase in Men Aged 50 Years and Over. Steyerberg EW, ed. PLoS ONE. 2013;8(2):e56030. doi:https://doi.org/10.1371/journal.pone.0056030
- Santis D, Gillessen S, Grummet J, et al. EAU-EANM-ESTRO-ESUR-ISUP-SIOG Guidelines on Prostate Cancer.; 2023.
- AUA. Advanced Prostate Cancer: AUA/ASTRO/SUO Guideline (2020) – American Urological Association. www.auanet.org. Published 2023. https://www.auanet.org/guidelines-and-quality/guidelines/advanced-prostate-cancer
- Sindhwani P, Wilson CM. Prostatitis and serum prostate-specific antigen. Current Urology Reports. 2005;6(4):307-312. doi:https://doi.org/10.1007/s11934-005-0029-y
Acusera 24·7 Software Updates v3.3
Randox Quality Control is thrilled to announce the release of our latest software update for Acusera 24·7, which includes a collection of new features to enhance your user experience and create a more effective quality management system for your laboratory. This update shall take place on Tuesday 20th June 2023. Below, you’ll find details of the latest software updates and how these changes can help you improve your daily QC activities.
Events
- Users can now add an event at the assay, instrument or QC levels to allow more accurate monitoring of control events. In addition, this feature adds the capability to record reagent lot changes.
- Users now have the ability to temporarily hide all events from the interactive charts, allowing for a clearer view of QC performance over a selected timeframe.
Uncertainty of Measurement
- User can now add the uncertainty of the calibrator value to the uncertainty of measurement report to provide a more accurate assessment of uncertainty.
- Users now have the ability to hide the intraprecision data from the uncertainty of measurement report if no data has been entered for this field.
Charts
- A selection of new interactive charts have been added to this software. These charts focus on the individual results per analyte that each instrument generates over a specified time period.
Individual results
This graph displays a spread of the individual results for a single machine, per analyte generated over a specified time.
Weekly Count
This Bar Chart shows the weekly count of quality control results for a specific instrument, assay and lot.
Instrument Comparison
Users can now view a line graph, which plots the weekly mean of results from multiple instruments using the same assay and QC lot, allowing a comprehensive overview of your QC data.
If you’d like to learn more about these updates, we encourage you to watch our new Acusera 24·7 video guides: Acusera 24.7 Video Guides
This software update will be live from Tuesday 20th June 2023. To make the upgrade process as smooth as possible, we encourage Acusera 24·7 users to clear their browser cache, visit the Acusera 24·7 site, and you will be ready to avail of these new features!
If you would like an additional information on these updates, or anything else relating to Acusera 24·7, don’t hesitate to reach out the marketing@randox.com. Additionally, feel free to visit our QC resource hub where you will find all of our brochures, support tools and a collection of educational material, to aid you in maintaining the highest possible levels of quality.
Enhancing Laboratory Quality Control with Multi-Rule QC: A Comprehensive Guide
Introduction
We are thrilled to announce the release of our latest educational guide, “Understanding Multi-rule QC,” which delves into the world of laboratory quality control. Designed for laboratory professionals, this comprehensive guide aims to empower you with knowledge and strategies to ensure accurate results and uphold patient safety.
Understanding the Significance of Multi-Rule QC
Laboratory quality control is paramount in maintaining the integrity of test results. The guide begins by exploring the various causes of deviations in laboratory testing processes. From instrument malfunctions to environmental factors, we shed light on potential sources of error that can impact result accuracy.
Next, we dive into the core of the guide: Multi-rule QC. This powerful framework encompasses a series of rules that serve as a robust screening tool for identifying outliers, shifts, and trends in data. Through an in-depth exploration of rules such as 1:2s, 1:3s, 2:2s, R4s, 3:1s, 4:1s, 10x, and 7T, we unveil their underlying principles and their significance in maintaining quality control within laboratory settings.
Applying the Multi-Rule QC Approach
The guide equips laboratory professionals with practical insights on applying the Multi-rule QC approach. By examining consecutive data points, analysing trends, and detecting systematic shifts, you gain the ability to proactively address issues before they compromise result accuracy. We highlight the importance of avoiding overreliance on individual rules for result rejection, emphasizing the need to consider additional factors such as clinical relevance and method performance.
Troubleshooting Out-of-Control Events
No laboratory is immune to out-of-control events. That’s why our guide goes beyond rule implementation and delves into effective troubleshooting strategies. We provide guidance on identifying root causes, implementing corrective actions, and re-establishing control in your laboratory environment. By embracing a culture of continuous improvement, you can minimize the impact of deviations and optimize laboratory performance.
Acusera 24.7
Acusera 24.7 is a cloud-based inter-laboratory data management and peer-group reporting software designed to assist in the management of daily QC activities and aid continuous improvement in the laboratory. It includes multi-rule capabilities that can be utilized 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.
Conclusion
In an era where accuracy and patient safety are paramount, the “Multi-rule QC” guide serves as an invaluable resource for laboratory professionals. By mastering the principles and applications of Multi-rule QC, you can enhance the quality control processes within your laboratory, mitigating risks and delivering reliable test results.
To explore the full potential of Multi-rule QC and embark on a journey of laboratory excellence, we invite you to download the guide today. Stay ahead of the curve and ensure the highest standards of quality and patient care in your laboratory!
You can download the Understanding Multi-rule QC Educational Guide below:
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/.
Differentiating Type 1 and Type 2 Diabetes Mellitus
An estimated 422 million people across the world are living with diabetes1. Diabetes Mellitus (DM) encompasses a collection of chronic diseases characterised by absent or ineffective insulin activity. Insulin is a hormone produced by the pancreas responsible for a host of essential physiological processes related to glucose metabolism and protein synthesis.
There are two main forms of DM, named type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) which result from different mechanisms and more importantly, require different therapeutic approaches. It is estimated that up to 40% of those diagnosed with T1DM after the age of 30 may have been misdiagnosed with T2DM2. This misdiagnosis of T1DM as T2DM will result in poor glycaemic control, frequent healthcare contact for increased treatment, inappropriate insulin regimes and risk of life-threatening ketoacidosis.
In this article, we’ll look at the similarities and differences between these two forms of DM and investigate the mechanisms by which these common diseases arise.
Insulin Pathway
The normal insulin signalling pathway, shown below, is responsible for the processing and transport of glucose in the body. Briefly, insulin binds to the insulin receptor and activates PI3K and, subsequently, serine-threonine kinase (AKT). AKT is responsible for the phosphorylation of glycogen synthase kinase 3-β (GSK-3β), inhibiting its activity and promoting the synthesis of glycogen leading to a reduction in blood glucose concentration. Failing to inhibit GSK-3β will result in hyperglycaemia and eventually T2DM.
Type 1 Diabetes Mellitus
T1DM is most commonly diagnosed at a young age. This form of DM is the result of an autoimmune reaction to proteins produced by the pancreas which results in a lack of insulin secretion. The antibodies responsible for this autoimmunity are detailed in the table below:
A key factor in T1DM pathogenesis is changes in the T cell-mediated immunoregulation, notably in the CD4+ T cell compartment. The activation of the CD4+ T cells is responsible for inflammation of the pancreatic cells which produce insulin, known as insulitis.
Changes in the expression of IL-1 and TNFα cause structural alterations in pancreatic β-cells which result in the suppression of insulin secretion. This insulin deficiency has subsequent effects on glucose metabolism and protein synthesis.
T1DM causes an increase in hepatic glucose levels when gluconeogenesis converts glycogen to glucose. A lack of insulin means the subsequent hepatic uptake of this glucose does not occur.
Insulin is also responsible for regulating the synthesis of many proteins. This regulation can be positive or negative but ultimately results in an increase in protein synthesis and a decrease in protein degradation. Therefore, when hypoinsulinemia occurs, decreasing insulin concentration in the blood, protein catabolism is increased leading to increased plasma amino acid concentration.
Type 2 Diabetes Mellitus
The pathogenesis of T2DM, detailed in the diagram below, is multi-factorial. It arises from a combination of genetic and environmental factors which affect insulin activity.
In T2DM, the regulatory mechanisms related to glucose metabolism fail resulting in impaired insulin activity or insulin resistance.
Mutations in genes involved in insulin production can cause the secretion of abnormal insulin molecules, known as insulinopathies. Insulinopathies are unable to effectively metabolise glucose which results in the accumulation of this sugar. Additionally, obesity is considered to be a causal factor in the development of T2DM.
Unlike those with T1DM, patients with T2DM can maintain circulating insulin levels. T2DM is characterised by glucose intolerance, impaired glucose tolerance, diabetes with minimal fasting hyperglycaemia, and DM in association with overt fasting hyperglycaemia.
Individuals with impaired glucose tolerance have hyperglycaemia despite preserving high levels of plasma insulin. These levels of insulin decline from impaired glucose tolerance to DM. It is insulin resistance is considered the primary cause of T2DM.
Misdiagnosis
The misdiagnosis of these types of DM is common, due to similar symptoms. The simplest differentiating factor is when these symptoms manifest. T1DM is an autoimmune disorder and therefore, symptoms generally occur much earlier in one’s life. T2DM is typically diagnosed in later life. The common symptoms of DM are:
- Frequent urination, particularly throughout the night.
- Polydipsia (excessive thirst)
- Polyphagia (excessive hunger)
- Lethargy
- Sudden weight loss
- Genital itching or thrush
- Blurred vision
The misdiagnosis of T2DM as T1DM results in unnecessary initial insulin therapy, higher drug and monitoring costs and often, an increase in the number and severity of symptoms. Conversely, the incorrect classification of T1DM as T2DM causes poor glycaemic control, frequent visits to healthcare services for treatment, inappropriate insulin regimes and risk of Diabetic Ketoacidosis.
Diabetic Ketoacidosis (DKA)
DKA is a potentially life-threatening condition caused by an accumulation of ketones in the body due to insulin deficiency, which is common in patients with T1DM, however, an increasing number of cases have been reported in patients with T2DM. Diagnosis of DKA consists of a high anion gap metabolic acidosis, ketone bodies present in serum and/or urine, and high blood glucose concentration. The symptoms of DKA include:
- Polyuria (excessive urination) and polydipsia (thirst)
- Weight loss
- Fatigue
- Dyspnoea (shortness of breath)
- Vomiting
- Fever
- Abdominal pain
- Polyphagia (excess hunger)
- Fruity-smelling breath caused by acetone accumulation.
Randox Type 1 Diabetes Mellitus Genetic Risk Array
T1DM is largely genetic and is associated with over 50 distinct genetic signatures, many of which are single nucleotide polymorphisms (SNPs). This is of great advantage in testing as unlike traditional biomarkers, genetic markers don’t change throughout one’s life, providing a robust method for diagnosis and risk stratification. Genetic data gathered can then be used to develop a genetic risk score, allowing an individual’s probability of developing the disease to be quantified.
Using this principle, together with our patented Biochip array technology, Randox have developed a T1DM GRS array. Using a combination of 10 SNPs from the HLA region and the non-HLA region commonly detected in T1DM patients, and a selection of other risk factors and biomarkers, this molecular array can accurately discriminate between T1DM and T2DM.
Conclusions
Misdiagnosis of DM can have life-threatening consequences. Both types of DM are very common and distinguishing between T1DM and T2DM is crucial.
T1DM is an autoimmune disorder with a lack of insulin secretion, while T2DM is primarily due to insulin resistance. Understanding their mechanisms is vital for accurate diagnosis and treatment. Genetic testing, like the Randox Type 1 Diabetes Mellitus Genetic Risk Array, can differentiate between T1DM and T2DM by analysing genetic markers and providing personalized treatment insights.
Accurate diabetes diagnosis is crucial for proper management, prevention of complications, and improving the lives of millions. Together, we can make a difference in the lives of those affected by diabetes!
If you’d like to learn more about the different types of DM, including the pathogenesis, pathophysiology, associated risk factors, and more, please take a look at our educational guide Diabetes Solutions.
Alternatively, feel free to reach out to our marketing team at marketing@randox.com who will be happy to help you with any queries you may have.
References
- World Health Organization. Diabetes. World Health Organisation. Published April 5, 2023. Accessed April 25, 2023. https://www.who.int/news-room/fact-sheets/detail/diabetes
- The Misdiagnosis of type 1 and type 2 diabetes in adults. The Lancet Regional Health. 2023;29:100661-100661. doi:https://doi.org/10.1016/j.lanepe.2023.100661
Introducing Comprehensive Educational Guides on Updated CLIA Proficiency Testing Regulations
We are thrilled to present two educational guides that delve into the newly updated minimum performance specifications for Proficiency Testing by CLIA (Clinical Laboratory Improvement Amendments). These regulations, set to be implemented by 2024, aim to enhance the accuracy and reliability of test results in clinical laboratories. Here, we introduce these invaluable resources designed to assist laboratories in navigating the evolving landscape of proficiency testing.
1. Proficiency Testing Regulations Related to Analytes and Acceptable Performance – A Final Rule (Microbiology):
Our first guide focuses on the specific regulations and requirements pertaining to microbiology proficiency testing. With a comprehensive exploration of these guidelines, this guide is a useful resource for microbiology labs striving to ensure precision and integrity in their testing procedures. From the required categories of testing to maintaining optimal testing conditions, the guide details the updates that promote adherence to the highest standards of quality and safety.
2. Proficiency Testing Regulations Related to Analytes and Acceptable Performance – A Final Rule (Non-Microbiology):
For non-microbiology laboratories, our second guide delves into the updated proficiency testing regulations concerning various analytes. From chemistry to haematology, molecular diagnostics to immunology, this guide offers a comprehensive overview of the new requirements and minimum performance specifications. By embracing these regulations, medical laboratories can uphold the utmost accuracy and reliability in their test results, ensuring optimal patient care and clinical decision-making.
Elevating Laboratory Practices:
These educational guides are indispensable tools that empower laboratories to navigate the changing landscape of proficiency testing regulations. By staying informed and adopting the updated minimum performance specifications, laboratories can maintain compliance, demonstrate excellence, and ultimately deliver the highest quality of care to their patients.
Accessing the Guides:
We invite you to access these comprehensive educational guides by following the link provided below. They offer a wealth of knowledge and practical insights, serving as essential references for laboratory professionals, quality managers, and anyone involved in clinical diagnostics.
With the implementation of updated CLIA proficiency testing regulations on the horizon, these educational guides come at a crucial time. By embracing the knowledge and guidance they provide, laboratories can navigate the changing landscape with confidence and ensure their adherence to the highest standards of proficiency testing. Together, let’s strive for excellence, precision, and patient-centric care in clinical laboratory practices.
#CLIARegulations #ProficiencyTesting #ClinicalLaboratories #QualityAssurance #PatientCare
Microbiology
Non-Microbiology
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/.
D-3-Hydroxybutyrate & Diabetic Ketoacidosis
Diabetic Ketoacidosis is characterised by an accumulation of ketone bodies in response to insulin deficiency, most commonly occurring in T1DM patients, but is becoming increasingly prevalent among sufferers of T2DM.
Diabetic ketoacidosis is associated with symptoms such as polyuria, polydipsia, fever, vomiting, abdominal pain and fatigue with the most severe cases resulting in disastrous consequences such as cerebral oedema and death.
D-3-Hydroxybutyrate is considered to be the predominant ketone bodies associated with diabetic ketoacidosis and novel methods of detection utilise this biomarker to provide robust and accurate quantification of ketone bodies and aid in confident diagnosis of diabetic ketoacidosis.
This guide discusses the physiological and pathological processes associated with diabetic ketoacidosis and the relevant biomarkers, the complications associated with this condition and classic and novel detection methods.
To download this guide, simply click the image at the top of this post!
For more information on this assay visit https://www.randox.com/d-3-hydroxybutyrate-ranbut/
To read about some of our other superior performance reagents visit https://www.randox.com/superior-performance-and-unique-
Or, to view our wide range of diagnostic solutions visit https://www.randox.com/
Determining bilirubin concentration in paediatric facilities – Vanadate Oxidation Method
The quantification of bilirubin has a wide range of diagnostic utility. In paediatric settings, bilirubin concentrations are commonly used to identify cases of bilirubin encephalopathy or kernicterus.
Historically, bilirubin quantification has been achieved through various techniques derived from the diazo method, first described by Van der Bergh and Muller in 1918. New technologies and novel methods, like the Vanadate Oxidation method, have emerged and have been shown to display superior diagnostic power, driven by its lower sensitivity to interference caused by haemolysis and lipemia when compared with other methods.
This week, we present our educational guide, ‘Determining bilirubin concentrations in paediatric facilities’ which details the key points relating to bilirubin quantification, along with descriptions and comparisons of the methods mentioned above.
To download this guide, simply click the image at the top of this post!
For more information on our Vanadate Oxidation Bilirubin assay visit: www.randox.com/bilirubin
To view our wide range of diagnostic solutions visit: www.randox.com/
Or, if you’d like to discuss this assay, or any of our other products, please contact us at: marketing@randox.com
The Importance of Maintaining Regular Dietary Patterns to reduce CVD risk
Cardiovascular disease (CVD) is the leading cause of mortality worldwide. An estimated 17.9 million people died from some form of CVD in 2019, accounting for 32% of all-cause mortality that year1. Associations between diet and risk of cardiovascular complications have long been established, largely relating to alterations in lipid profiles.
For as long as anyone can remember, breakfast has been considered the most important meal of the day. Previous studies2 have shown an association between skipping breakfast and increased CVD risk prompting recommendations that up to 30% of one’s daily energy intake should be consumed during the first meal of the day. It has been reported that over 25% of adults skip breakfast. These individuals are often socioeconomically disadvantaged, shift workers, individuals who work particularly long hours, those who suffer from depression or those with poor health literacy2. Another study3 showed that skipping breakfast, when compared with consuming a high-energy breakfast, was associated with a 1.6x and 2.6x higher probability of non-coronary and general atherosclerosis respectively, when all other CVD risk factor had been controlled. This suggests a close relationship between eating breakfast and reducing CVD risk, however, the mechanisms and magnitude of this relationship are poorly understood.
Small, dense low-density lipoprotein cholesterol (sdLDL-C) is a smaller form of LDL-C which boasts greater propensity for uptake by arterial tissue, increased proteoglycan binding, and increased susceptibility for oxidation4. sdLDL-C concentration is strongly associated with CVD risk, yet once again, the mechanisms of this association remain enigmatic. It is thought that all of the metabolic changes associated with alterations in sdLDL-C concentration collectively contribute to the increased risk of CVD, with the main drivers being its propensity for uptake by arterial tissues and its long circulatory stability4
Skipping breakfast and sdLDL-C
A recent study investigated the relationship between skipping breakfast and the effects on lipid parameters5. In a cohort of around 28’000 people from the Japanese population, this study looked at the several markers, including sdLDL-C, to develop an understanding of the importance of regular dietary patterns for reducing the risk of CVD.
The study participants were divided into two main categories: breakfast eaters and breakfast skippers. These categories were further subdivided to differentiate men and women, over and under 55 years old, and those who eat staple products (rice, pasta, bread, etc.) and those who did not. The participants contributed blood samples which were tested for several cardiovascular biomarkers: Creatinine, Liver ALT, Total Cholesterol, Triglycerides, direct LDL-C, HDL-C and sdLDL-C.
They found that around 26% of men and 16.9% of women skipped breakfast regularly. Of these, most were considered young and had significant increases in concentration of triglycerides, LDL-C and sdLDL-C compared with those who ate breakfast almost every day.
Table 1. Median concentration of triglycerides, LDL-C, and sdLDL-C for breakfast skippers and eaters5
| Analyte | Breakfast Skippers (mg/dL) | Breakfast Eaters (mg/dL) |
| Triglycerides | 103 | 93 |
| LDL-C | 124 | 122 |
| sdLDL-C | 34.7 | 32 |
This investigation also revealed that in this cohort, 20% of men and 27.3% of women did not regularly consume staple foods as part of their diet and had higher median sdLDL-C concentration.
Table 2. Median concentration of sdLDL-C in men and women who eat or skip staple food products in their diet5
| Gender | Staple Skippers (mg/dL) | Staple Eaters (mg/dL) |
| Men | 34.1 | 31.6 |
| Women | 25.8 | 24.7 |
The data from this study supports the finding that individuals who skipped breakfast had higher sdLDL-C concentrations than those who ate breakfast consistently. Skipping breakfast can therefore be associated with troublesome lipid parameters in both genders and all age groups in the Japanese population. This study suggests that eating breakfast every day is crucial to maintain beneficial lipid parameters and reduce the risk of developing CVD.
The data also show that individuals who skipped staple foods in their meals presented with higher concentrations of sdLDL-C and a higher sdLDL-C/LDL-C ratio, in men and postmenopausal women, when compared with those who included staple foods in their meals. It is becoming increasingly common to remove staple foods from one’s diet due to their high carbohydrate content and the prevalence of low-carbohydrate diets. This data exhibits the importance of maintaining a nutritionally balanced diet to help reduce the risk of developing CVD.
As the first large scale study of its kind, this analysis provides clear insight into the increased risk of CVD associated with not only skipping breakfast, but failing to maintain a nutritionally balanced diet. The major limitation of this analysis is that it only includes individuals from the Japanese population and the same affects may not be seen in populations from other ethnicities. Therefore, further in-depth analysis is required to confirm these findings in other ethnicities
Randox sdLDL-C Assay
The Randox sdLDL-C assay employs the clearance method which displays good correlation with the gold standard in sdLDL-C quantification, giving laboratories increased confidence in their results first time, every time. Supplied as liquid ready-to-use reagents, this this test can be applied to a wide range of clinical chemistry analysers, producing results in as little as 10 minutes. Relevant controls and calibrators are also available from Randox as part of the Acusera range.
Randox sdLDL-C Assay Key Features
- Direct, automated test for convenience and efficiency.
- Rapid analysis results can be produced in as little as ten minutes, facilitating faster patient diagnosis and treatment plan implementation.
- Liquid ready-to-use reagents for convenience and ease of use.
- Applications available detailing instrument specific settings for a wide range of clinical chemistry analysers.
- sdLDL-C controls and calibrator available.
References
- World Health Organization. Cardiovascular Diseases. World Health Organization. Published June 11, 2021. https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds)
- Ofori-Asenso R, Owen AJ, Liew D. Skipping Breakfast and the Risk of Cardiovascular Disease and Death: A Systematic Review of Prospective Cohort Studies in Primary Prevention Settings. Journal of Cardiovascular Development and Disease. 2019;6(3):30. doi:https://doi.org/10.3390/jcdd6030030
- Uzhova I, Fuster V, Fernández-Ortiz A, et al. The Importance of Breakfast in Atherosclerosis Disease. Journal of the American College of Cardiology. 2017;70(15):1833-1842. doi:https://doi.org/10.1016/j.jacc.2017.08.027
- Rizvi AA, Stoian AP, Janez A, Rizzo M. Lipoproteins and cardiovascular disease: An update on the clinical significance of atherogenic small, dense LDL and new therapeutical options. Biomedicines. 2021;9:1579. doi:https://doi.org/10.3390/biomedicines9111579
- Arimoto M, Yamamoto Y, Imaoka W, et al. Small dense low-density lipoprotein cholesterol levels in breakfast skippers and staple food skippers. Journal of Atherosclerosis and Thrombosis. 2023;30. doi:https://doi.org/10.5551/jat.64024
For more information on our sdLDL-C assay or any of our other products, please contact us at: marketing@randox.com
