Combatting AMR with Rapid UTI Diagnostics
Combatting AMR with Rapid UTI Diagnostics
Antimicrobial Resistance Awareness Week: Combatting AMR with Rapid UTI Diagnostics
Antimicrobial Resistance (AMR) poses one of the most critical health challenges of our time. Indeed, the World Health Organisation (WHO) has identified AMR as one of the top 10 global health threats (1). Furthermore, in the UK, AMR is recognised on the National Risk Register (2), reflecting the severity of the issue at both national and international levels. With AMR-related deaths reaching 4.95 million globally in 2019 (1), including 1.27 million directly attributed to resistant infections (1), urgent and coordinated action is required to preserve the efficacy of existing antimicrobials.
As part of Antimicrobial Resistance Awareness Week (18–24 November), we are focusing on the critical role of rapid diagnostics in combating AMR. Specifically, we are introducing the Randox Vivalytic UTI Rapid Test as a valuable tool in this global effort. By enabling faster and more accurate detection of infections, this innovative diagnostic technology supports the targeted use of antibiotics, thereby helping to reduce unnecessary prescriptions and mitigate the spread of resistance.
Understanding AMR: The Need for Effective Screening and Targeted Treatment
AMR develops when microorganisms such as bacteria, viruses, fungi, and parasites evolve to resist the effects of antimicrobial medicines. While this resistance occurs naturally, it is significantly accelerated by factors such as the overuse and misuse of antibiotics, poor infection control, and the slow pace of new antimicrobial drug development. Consequently, the implications of AMR extend far beyond infection treatment: surgeries, cancer therapies, and routine medical procedures also rely heavily on effective antimicrobials to prevent infections. Therefore, this underscores the pressing need to manage resistance effectively and proactively.
For instance, routine treatments for UTIs heavily depend on antibiotics. UTIs are among the most common bacterial infections, particularly affecting women, with over 50% experiencing a UTI at least once in their lives (3). However, with resistance levels increasing, it becomes crucial to avoid unnecessary antibiotic prescriptions. Additionally, when antibiotics are prescribed, they must be carefully targeted to maximise efficacy and minimise resistance development. In this context, rapid diagnostics play a pivotal role by enabling precise and timely identification of infections, which ensures that treatments are both effective and appropriate.
Introducing the Vivalytic UTI Rapid Test
The Randox Vivalytic UTI Rapid Test offers a cutting-edge solution for the efficient screening and diagnosis of UTIs. Unlike traditional culture methods—which, according to a recent study, take an average of 2.75 days to yield results (4)—the Vivalytic UTI Rapid Test is a cartridge-based PCR test specifically designed for in-clinic use, delivering results in just 2.5 hours. This rapid turnaround is transformative in the management of UTIs, where timely diagnosis is crucial to preventing the progression of infections. Moreover, it helps to minimise unnecessary antibiotic use by ensuring treatment is both prompt and precisely targeted, ultimately supporting the fight against antimicrobial resistance.
Key Features of the Vivalytic UTI Rapid Test:
- Comprehensive Detection: The Vivalytic UTI Rapid Test identifies 16 uropathogens, encompassing both gram-negative and gram-positive bacterial species, in just 150 minutes—significantly faster than traditional culture methods.
- AMR Gene Identification: This advanced test also detects 7 antimicrobial resistance genes, including those conferring resistance to methicillin (mecA) and vancomycin (vanA and vanB), as well as genes associated with trimethoprim resistance (dfrA1, dfrA5, dfrA12, dfrA17). This capability supports targeted treatment decisions and helps in combating antimicrobial resistance.
- Wide Application: Designed for versatility, the test is suitable for various healthcare settings, from GP practices to hospitals. It facilitates UTI diagnosis across diverse use cases, including catheter-associated UTIs and pre-surgical screenings for patients with conditions such as benign prostatic hyperplasia (BPH) or renal stones.
Additionally, a recent study demonstrated that the Vivalytic UTI Rapid Test achieved diagnostic accuracy exceeding 90% for 16 bacterial species, providing a reliable and efficient solution for rapid pathogen identification in UTI cases (4).
The Role of Rapid Diagnostics in Combating AMR
Rapid diagnostic tests, such as the Vivalytic UTI Rapid Test, play a critical role in addressing antimicrobial resistance (AMR) and improving patient care through the following:
- Reducing Misuse of Antibiotics: By rapidly identifying the specific bacteria responsible for the infection and detecting resistance genes, clinicians can prescribe antibiotics only when necessary. This targeted approach ensures that the most effective treatment is selected, helping to combat antibiotic misuse.
- Supporting Antimicrobial Stewardship: Point-of-care testing directly supports the goals outlined in the UK’s AMR 5-Year National Action Plan, which aims to reduce antibiotic consumption by 5% and ensure that 70% of antibiotics are sourced from safer, first-line options (5). Rapid tests enable optimised antibiotic usage, contributing to these national targets and the broader fight against AMR.
- Enhancing Patient Outcomes: Faster and more accurate diagnostics at the point of care enable timely and targeted treatment, reducing the risk of complications such as severe UTI-related kidney infections. Furthermore, a study on the Vivalytic UTI Rapid Test demonstrated that pathogen detection rates were slightly higher when tests were conducted immediately on-site, underscoring the importance of rapid diagnostics in delivering better patient outcomes (4).
AMR and the Future of Healthcare
The rise in AMR jeopardises the future of modern medicine. An estimated 10 million lives could be lost per year by 2050 (6), according to a review commissioned by the UK Prime Minister. Without effective diagnostics and treatments, procedures such as hip replacements, caesarean sections, and cancer therapies could become significantly more dangerous. This is due to the heightened risk of untreatable infections (1). Addressing this escalating threat requires innovation, education, and unwavering commitment.
AMR also imposes immense economic consequences. The World Bank projects that by 2050, AMR could add an extra US$1 trillion to global healthcare costs. It may also cause annual GDP losses ranging from US$1 trillion to US$3.4 trillion as early as 2030 (7). These economic burdens highlight the urgent need for global action.
Addressing AMR is crucial to achieving the Sustainable Development Goals (SDGs) outlined by the United Nations (UN). Progress in areas such as access to clean water, sustainable food production, and responsible antimicrobial use is vital in mitigating AMR. However, rising levels of AMR exacerbate challenges related to health, poverty reduction, food security, and economic growth (8). Coordinated efforts across multiple sectors are essential to tackle this complex issue effectively.
Randox is proud to lead the charge in the fight against antimicrobial resistance (AMR), equipping healthcare professionals with innovative tools such as the Vivalytic UTI Rapid Test. By enabling timely and accurate diagnoses, we contribute to preserving the efficacy of antimicrobials and safeguarding their availability for future generations.
This Antimicrobial Resistance Awareness Week, join us in highlighting the critical importance of AMR management and the transformative role of rapid diagnostics in creating a safer, healthier future for all.
Learn more about the urgency of AMR on the WHO website: Antimicrobial resistance.
For further details about the Vivalytic UTI Rapid Test, visit Vivalytic | UTI Rapid Test | Randox Laboratories or reach out to us at marketing@randox.com.
References
- World Health Organization (2023). Antimicrobial resistance. [online] World Health Organization. Available at: https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance.
- HM Government (2023). National Risk Register 2023 Edition. [online] Available at: https://assets.publishing.service.gov.uk/media/64ca1dfe19f5622669f3c1b1/2023_NATIONAL_RISK_REGISTER_NRR.pdf.
- Bono MJ, Reygaert WC. Urinary Tract Infection. Nih.gov. Published 2018. https://www.ncbi.nlm.nih.gov/books/NBK470195/
- Hartmann, J., Fritzenwanker, M., Imirzalioglu, C., Hain, T., Arneth, B.M., and Wagenlehner, F.M.E., 2024. Point-of-care Testing in Complicated Urinary Tract Infection: Evaluation of the Vivalytic One Urinary Tract Infection Analyser for Detecting Uropathogenic Bacteria and Antimicrobial Resistance in Urine Samples of Urological Patients in a Point-of-care Setting. European Urology Focus. Available at: https://doi.org/10.1016/j.euf.2024.09.018
- Department of Health and Social Care (2024). UK 5-year action plan for antimicrobial resistance 2024 to 2029. [online] GOV.UK. Available at: https://www.gov.uk/government/publications/uk-5-year-action-plan-for-antimicrobial-resistance-2024-to-2029.
- O’Neill, J. (2016). Tackling Drug-resistant Infections Globally: Final Report and Recommendations. Archives of Pharmacy Practice, 7(3), p.110. doi:https://doi.org/10.4103/2045-080x.186181.
- World Bank (2017). Drug-Resistant Infections: A Threat to Our Economic Future. [online] World Bank. Available at: https://www.worldbank.org/en/topic/health/publication/drug-resistant-infections-a-threat-to-our-economic-future.
- World Health Organization (WHO) (2021). Antimicrobial resistance and the United Nations sustainable development cooperation framework: guidance for United Nations country teams. [online] www.who.int. Available at: https://www.who.int/publications/i/item/9789240036024.
Acusera 24Ā·7 and Data Innovations – Automated QC Data Upload
Automated QC Data Upload to Acusera 24·7
Now Available via Instrument Manager™ from Data Innovations
Randox Laboratories in conjunction with Data Innovations are pleased to announce the launch of a new driver that enables seamless, automated QC data upload via API from any instrument connected to Instrument Manager (IM) directly into Acusera 24.7. This new feature eliminates the need for manual data entry, reduces transcription errors and improves laboratory efficiency.
What you need to know
Uni-Directional License – Anyone wishing to avail of automated QC data upload to Acusera 24.7 will need a uni-directional license for Instrument Manager. A new license can be requested directly from a Data Innovations representative, or an existing license previously used for an analyser may be re-purposed.
Driver Download – Once a license has been secured, you will be required to download the Acusera 24.7 Driver from the MY DI Community website – https://datainnovations.my.site.com/s/drivers. To locate the driver simply select Randox from the Manufacturer drop down menu and then select Acusera 24.7 from the list of available drivers.
Configuration – Once the driver has been downloaded, you will receive help files that document the process to be followed. The same steps are to be followed as with connecting any instrument or analyser to Instrument Manager.
Once the driver has been successfully set up, Instrument Manager will automatically send QC data to Acusera 24.7, removing the need for manual data entry.
Key Considerations
- You must have have an Acusera 24.7 license and configured your Acusera 24.7 account before connecting to Instrument manager.
This new capability allows laboratories to optimise workflows, reduce errors, and streamline QC data management.
About Data Innovations
Data Innovations is a global software company that is passionate about excellence in patient care. Through innovative solutions and world-class service, they enable enterprise management of hospitals and independent laboratories. Founded in 1989 with headquarters in Vermont, Data Innovations serves more than 6,000 hospitals and laboratories in 80+ countries.
What is Instrument Manager?
Laboratory Information Management Systems (LIMS) by Data Innovations LLC
Instrument Manager™ (IM) is a truly vendor-neutral middleware platform that allows for the connection of any clinical lab instrument to any Lab Information System (LIS), with a library of over 1,000 instrument drivers. IM offers a suite of lab enablement solutions spanning productivity, quality, analytics, performance and reliability.
Labs using IM auto verification with time-saving workflows are able to achieve quicker turnaround times and increased productivity. IM quality assurance programs ensure that all connected instruments deliver the most accurate possible test results.
Candida auris: An Urgent Fungal Threat
An Urgent Fungal Threat: Tackling Candida auris in Healthcare Environments
Candida auris (C. auris), is an emerging fungal threat that has garnered global attention due to its multidrug-resistant nature and ability to cause severe, life-threatening infections. First identified in 2009, C. auris has quickly spread worldwide, particularly in healthcare settings, posing a significant challenge to both clinicians and public health professionals.
Understanding Candida auris
Candida auris is a yeast-like fungus that can lead to severe infections, especially in patients with compromised immune systems or underlying health conditions. It is frequently found in healthcare environments such as hospitals and long-term care facilities. The most concerning aspect of C. auris is its ability to persist on surfaces, increasing the risk of outbreaks in these environments. Once introduced into a healthcare setting, it can rapidly spread from one patient to another, making infection control a significant challenge.
In Illinois alone, 921 C. auris cases were confirmed between 2016 and 2022 (1). Additionally, in 2022, 2377 cases of C. auris were reported to the CDC (2), further highlighting the increase in cases each year. In Europe, survey responses were received from all 30 invited EU/EEA countries. From 2013 to 2021, a total of 1,812 Candida auris cases were reported by 15 of these countries. The number of cases nearly doubled from 335 in 2020 to 655 in 2021, indicating a significant increase compared to previous years (3).
C. auris primarily causes bloodstream infections, but it can also infect wounds, the respiratory tract, and the ear. Patients in critical care, especially those using invasive medical devices such as ventilators, catheters, or feeding tubes, are particularly susceptible. In fact, data indicates that more than one in three people with an invasive C. auris infection affecting the blood, heart, or brain, do not survive (1).
The Growing Threat of Multidrug Resistance
One of the major concerns surrounding C. auris is its resistance to multiple classes of antifungal medications, which are typically used to treat Candida infections. This multidrug resistance often leads to treatment failure and poor outcomes in affected patients. In addition to its drug resistance, Candida auris is often misidentified as other Candida species using standard laboratory methods, further delaying appropriate treatment.
The Importance of Rapid and Accurate Detection
Given the risks posed by Candida auris, rapid detection is crucial for preventing the spread of this dangerous fungus. Early identification allows healthcare professionals to implement strict infection control measures such as isolating patients, cleaning and disinfecting affected areas, and preventing further transmission within healthcare facilities. However, traditional detection methods may be slow and prone to misidentification, making timely response difficult.
Enter Vivalytic
The early identification and containment of Candida auris are essential to prevent large-scale outbreaks. This is especially important in healthcare environments where patients may be vulnerable. The Vivalytic’s rapid detection of C. auris colonisation and infection allows for earlier implementation of infection control measures. This reduces the burden on public health systems and helps save lives.
At Randox Laboratories, the focus is on advancing the detection of infectious diseases like Candida auris. The Vivalytic, developed with Bosch, offers a reliable and accurate testing solution. This supports healthcare providers in protecting patients and controlling the spread of the fungus. Real-time PCR technology is used by the Vivalytic Candida auris test to detect DNA from swabs. These swabs may be taken from the axilla, groin, nasal, or rectal regions.
Key Benefits of Vivalytic Testing for Candida auris:
- Quick Results: The Vivalytic provides results in under 1 hour, enabling healthcare providers to make swift, informed decisions about patient care and infection control. This quick turnaround is essential for both treating the patient and containing the spread of Candida auris within a healthcare facility.
- Simple, 4-Step Process: The test uses a convenient 4-step process, from scanning the sample to receiving the results, making it easy to use in both laboratory and non-laboratory settings. The system’s fully automated, cartridge-based platform minimises the risk of contamination and simplifies workflow.
- Accurate Detection: The real-time PCR method used by Vivalytic ensures precise detection of Candida auris, even in cases where traditional methods might misidentify the fungus. This accuracy is vital in initiating appropriate antifungal treatment and curbing the infection.
- Convenient for Various Settings: The Vivalytic platform is designed to be used in a wide range of settings, from large laboratories to point-of-care environments, making it versatile and adaptable to the needs of different healthcare providers.
| Detectable Pathogens |
|---|
| Candida auris |
References
- dph.illinois.gov. (n.d.). Candida auris (C. auris). [online] Available at: https://dph.illinois.gov/topics-services/diseases-and-conditions/infectious-diseases/candida-auris.html.
- CDC (2024). Tracking C. auris. [online] Candida auris (C. auris). Available at: https://www.cdc.gov/candida-auris/tracking-c-auris/index.html.
- Kohlenberg, A., Monnet, D.L. and Plachouras, D. (2022). Increasing number of cases and outbreaks caused by Candida auris in the EU/EEA, 2020 to 2021. Eurosurveillance, 27(46). doi:https://doi.org/10.2807/1560-7917.es.2022.27.46.2200846.
Randox Testing Services – Drug and Alcohol Testing
At Randox Testing Services, we provide reliable and cost-effective drug and alcohol testing solutions for a wide range of industries. Sectors we work with include aviation, maritime, manufacturing, and more. Additionally, our Collection Officer Network operates 24 hours a day, 365 days of the year with a target call-out time of 2 hours. With over 40 years of experience in the diagnostics industry, our services not only ensure safety but also compliance in workplaces across the UK and Ireland.
We understand that every industry has unique needs, which is why we craft customised testing packages to meet specific workplace requirements. Whether it’s random testing to deter substance abuse or post-incident testing following an accident, we offer flexible solutions that cater to your business’s safety priorities. Furthermore, our expertise is trusted by industries ranging from safety-critical sectors to the medico-legal field such as family law, ensuring that our clients receive accurate, reliable, and legally defensible results.
- Pre-Employment Testing: Essential for ensuring candidate suitability and maintaining a safe environment for your current workforce.
- Random Testing: A highly effective deterrent for substance abuse, as employees are aware they could be tested at any time, ensuring integrity across all levels of the organisation.
- With-Cause Testing: Conducted when there is suspicion or allegations of drug or alcohol abuse in the workplace, or when drugs and alcohol have been found.
- Post-Incident Testing: Occurs after an accident or incident to determine if drugs or alcohol played a role.
- Abstinence Testing: Used to monitor employees who previously tested positive to ensure they remain abstinent from substance misuse.
We utilise discreet and non-invasive methods for sample collection, offering options such as urine, hair, oral fluid, breath or a combination of these. This enables both short-term and long-term drug profiling. Moreover, our testing methods are designed to suit your organisation’s needs and ensure accuracy and reliability in detecting drug and alcohol use. Each sample is handled following strict chain of custody procedures to guarantee sample integrity from collection to reporting.
We follow a thorough and professional process to deliver tailored drug and alcohol testing solutions:
-
- Consultation: We start with a free consultation to discuss your requirements and create a customised testing package.
- Policy Creation: We help develop a clear and concise workplace drug and alcohol policy that outlines employer rights while protecting employees.
- Policy Implementation: Our training and educational services help you effectively communicate the policy to your team.
- Sample Collection: Our trained officers collect samples at a time and location that suits you, maintaining sample integrity throughout the process.
- Sample Analysis: Using our advanced Biochip Array Technology, we screen samples for a wide range of substances, ensuring reliable and accurate results.
- Results Reporting: Results are delivered confidentially via our secure web portal, with options for alternative methods if preferred.
We test for a wide range of drugs across different panels using both instant testing kits and lab-based confirmatory analysis. This flexibility allows us to meet the diverse needs of our clients, ensuring all substances of concern are covered. Substances include:
| Substances Tested | |||
|---|---|---|---|
| Amphetamine | Phencyclidine | Alcohol | LSD |
| Buprenorphine | Cannabinoids | Barbiturates | Opioids |
| Benzodiazepine | Oxycodone | Benzodiazepine 1 | Mephedrone |
| Cocaine Metabolite | Tramadol | Benzodiazepine 2 | Pregabalin |
| Methadone | EDDP | Methaqualone | Gabapentin |
| Methamphetamine | Ketamine | Fentanyl | Zolpidem |
| Opiates | MDMA/Ecstasy | Propoxyphene | Zopiclone |
- Expertise across various industries, including workplace and medico-legal
- Accurate and reliable testing methods
- Global network of trained sample collection officers
- Customised training and education seminars
- Free policy review and consultation
Randox Testing Services is committed to helping businesses enhance workplace safety, reduce absenteeism, and ensure compliance with drug and alcohol regulations. Contact us today at testingservices@randox.com or call +44 (0) 28 9445 1011 to speak with one of our experts.
Understanding Xanthochromia
Understanding Xanthochromia
When faced with a potential subarachnoid haemorrhage (SAH), the tools we use to diagnose can quite literally be life-saving. Cerebrospinal fluid (CSF) analysis plays a pivotal role, especially when common diagnostic tools like Computed Tomography (CT) scans might not catch early signs.
Traditionally, xanthochromia detection relied on visual assessment – a method that suffers from inconsistency due to subjective interpretation and lacks uniformity across the industry. Today, spectrophotometry has emerged as the preferred method for its precision and reliability in detecting xanthochromia. To ensure the highest accuracy, this technique requires stringent quality control measures. Here, we discuss xanthochromia and SAH, before introducing our dedicated Xanthochromia true third-party control.
What is Xanthochromia?
Xanthochromia, derived from the Greek word, ‘xanthos,’ meaning yellow, refers to the yellow, or sometimes pink, discolouration of CSF, primarily due to bilirubin, a by-product of haemoglobin breakdown. Why does this matter? Because it’s a tell-tale sign of bleeding within the brain, often indicating SAH when CT scans don’t. Understanding this can help us catch and treat critical conditions before they worsen. Xanthochromia may also be an indicator of intracerebral haemorrhage, brain tumours, infection, or severe systemic jaundice1.
Subarachnoid Haemorrhage
SAH is a spontaneous intracranial bleed characterised by significant mortality and morbidity rates. Approximately 12% of patients die before receiving medical attention, 33% within 48 hours, and 50% within 30 days of an SAH. Among the survivors, half suffer from permanent disabilities, with an estimated lifetime cost more than double that of an ischemic stroke2. Patients which have displayed symptoms often complain of severe headache, nausea, vomiting, photophobia and/or phonophobia3.
CT scans, particularly non-contrasted CTs of the brain or CT angiograms (CTAs), are often the first line of diagnostic tools for suspected SAH. However, up to 5% of SAH cases may not show any signs of haemorrhage on these scans within the first 24 hours, with this figure rising to 50% by the end of the first week and remaining around 30% by the second week4.
In contrast, xanthochromia in the CSF can be detected as early as two hours after a bleed and is observed in over 90% of patients within 12 hours of an SAH event. This detection can persist for up to three to four weeks, offering a critical diagnostic window that imaging alone might miss. The conversion from haem to bilirubin in CSF takes roughly 6 to 12 hours, suggesting that xanthochromia is most reliably identified between 6- and 12-hours post-bleed. More than 75% of patients may still present with xanthochromia at 21 days following an SAH1.
Pathophysiology explained
A ruptured cerebral aneurysm will begin to leak blood into the CSF. This blood is gradually degraded by macrophages to yield various by-products including oxyhaemoglobin, which is subsequently converted to bilirubin in a process lasting between 6 and 12 hours1. Crucially, this conversion to bilirubin can only occur in vivo, providing a unique marker for diagnosing subarachnoid haemorrhage when observed in the CSF1.
The Importance of Accurate Detection
In many parts of the world, including the US, visual detection remains a common initial test for xanthochromia in CSF.
- Procedure: Spinning a CSF sample in a centrifuge and comparing the supernatant against a vial of water, held against a white backdrop to detect a yellow or pink tint.
- Indication: A change in colour indicates that blood has been present in the spinal fluid for at least two hours, with all patients showing signs by 12 hours post-bleed1.
However, this method is prone to false positives due to:
- Dietary influences: High intake of carotenoids (like carrots and spinach).
- Medication: Use of Rifampin.
- Medical conditions: Clinical jaundice or high protein levels in CSF, which can be seen in conditions like carcinomatosis and meningitis1.
Spectrophotometry
Spectrophotometry offers a more precise alternative by measuring light absorption in materials at specific wavelengths:
- It can detect the presence of bilirubin, which absorbs light at 440 to 460 nm, a definitive indicator of xanthochromia.
- Advantages over visual detection: This method eliminates the interference from other pigments or proteins and can distinguish bilirubin from oxyhaemoglobin, crucial for accurate diagnosis.
Quality control is crucial in spectrophotometry to ensure the accuracy and reliability of xanthochromia tests:
- Regular Maintenance: Routine checks and maintenance of the spectrophotometer are fundamental to its operation. This helps in maintaining the instrument’s precision in measuring light absorption at specific wavelengths crucial for detecting bilirubin in CSF.
- Calibration: Calibrating the spectrophotometer with known standards is essential. This process adjusts the instrument to measure the absorption accurately, particularly vital given bilirubin’s narrow detection window between 440 and 460 nm.
Implementing these stringent QC measures enhances the diagnostic precision of spectrophotometry, boosting confidence in the results. Such practices ensure that patients are diagnosed accurately and receive timely, appropriate treatment, solidifying the value of advanced diagnostic techniques in medical settings.
Introducing Randox Xanthochromia Controls
Diagnosing SAH swiftly and precisely is critical due to its significant immediate and long-term impacts. To aid precise detection, our Liquid Frozen Xanthochromia Positive & Negative Controls are essential tools for laboratories conducting CSF analysis. Here’s what makes them stand out:
- Dedicated Xanthochromia true third-party control with only 2 analytes for limited cross-reactivity – Bilirubin & Oxyhaemoglobin
- 2-day open vial stability at 2° to 8°C and a 11-week shelf life from date of manufacture when stored at -18ºC to -24ºC.
- Liquid frozen control provides suitable matrix in an easy-to-use format.
- Consistent, clinically significant values.
- Suitable for use with UV spectrophotometers, these controls help monitor bilirubin and oxyhaemoglobin levels effectively.
The Randox Xanthochromia Controls are ideally suited for laboratories, both public and private, as well as researchers who perform CSF analysis. Their use is crucial in ensuring the precision of SAH testing, which contributes to more accurate diagnostics and ultimately leads to better patient outcomes.
Considering the crucial role of accurate xanthochromia detection in diagnosing SAH, isn’t it time to review your lab’s capabilities? Explore how Randox Xanthochromia Controls can enhance your diagnostic processes. For more details on how to get these tools in your lab, contact us at marketing@randox.com.
In the fight against conditions like SAH, every second and every test counts. Equip your lab with Randox Xanthochromia Controls to ensure that your diagnostics are as precise and reliable as possible, helping save lives and improve healthcare outcomes.
References
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- Dugas C, Jamal Z, Bollu PC. Xanthochromia. StatPearls Publishing; 2024. Accessed August 5, 2024. https://www.ncbi.nlm.nih.gov/books/NBK526048/
- Sehba FA, Hou J, Pluta RM, Zhang JH. The importance of early brain injury after subarachnoid hemorrhage. Prog Neurobiol. 2012;97(1):14-37. doi:10.1016/j.pneurobio.2012.02.003
- NHS. Subarachnoid haemorrhage. https://www.nhs.uk/conditions/subarachnoid-haemorrhage/.
- Chakraborty T, Daneshmand A, Lanzino G, Hocker S. CT-Negative Subarachnoid Hemorrhage in the First Six Hours. Journal of Stroke and Cerebrovascular Diseases. 2020;29(12):105300. doi:10.1016/j.jstrokecerebrovasdis.2020.105300
Alzheimer’s Disease, ApoE & Risk Detection
Alzheimer’s Disease, ApoE4 & Risk Detection
Alzheimer’s disease touches all of us, whether directly through an affected loved one or through its frequent presence in the news. Alzheimer’s disease is a progressive neurodegenerative disorder characterised by cognitive decline, memory loss, and functional impairments. It is the most common cause of dementia, affecting millions of individuals worldwide 1 and posing significant challenges to healthcare systems. As the global population ages, the prevalence of Alzheimer’s disease is expected to rise, highlighting the urgent need for effective diagnostic and therapeutic strategies.
The current methods used to diagnose Alzheimer’s disease consist of clinical assessment and supporting neuroimaging techniques which can be expensive and, in some cases, fail to provide a definitive diagnosis at the early stages required to facilitate timely intervention and slow disease progression.
With novel therapeutics which aim to slow the progression of Alzheimer’s Disease achieving approval in the United States and being considered for approval in other countries, diagnostics which can identify those at risk of developing this disease are more important than ever. Biomarkers have emerged as vital tools in the early detection and risk assessment of Alzheimer’s disease. Among these, the apolipoprotein E gene (ApoE) has garnered significant attention. The apolipoprotein E protein (ApoE) exists in three common isoforms: ApoE2, ApoE3, and ApoE4. These isoforms combine to form six common genotypes in the general population. Notably, the presence of the ApoE4 allele is associated with a significantly increased risk of developing Alzheimer’s disease.
The Randox ApoE4 Array marks a significant advancement in Alzheimer’s disease biomarkers. This quick and sensitive blood test allows direct ApoE4 genotyping, eliminating the need for traditional molecular techniques. With its fast and accurate results, healthcare providers can efficiently assess an individual’s genetic risk for Alzheimer’s disease.
In this article, we present a summary of our latest whitepaper: Alzheimer’s Disease, ApoE4 & Risk Detection in which we explore the critical role of ApoE genotyping in Alzheimer’s Disease, the innovative technology behind the Randox ApoE4 Array, and its implications for clinical practice. You can download this whitepaper through the link below.
Apolipoprotein E and Alzheimer’s Risk
The ApoE gene transcribes a 229 amino acid protein which primarily functions to mediate lipid transport in the brain and periphery. ApoE is also involved in immune modulation, synapse regeneration, and the clearance/degradation of amyloid-β, a peptide crucial to the development of Alzheimer’s disease2.
There are 3 common isoforms of the human ApoE, differentiated through single nucleotide polymorphisms (SNPs) at amino acid positions 112 and 1582:
These three isoforms combine to produce six common genotypes: E2/E2, E2/E3, E2/E4, E3/E3, E3/E4, and E4/E4. Each genotype is associated with a different level of risk for developing Alzheimer’s disease, with the ApoE4 and ApoE2 isoforms presenting the highest3 and lowest risk 4 respectively.
The structural differences among ApoE isoforms affect their ability to bind lipids, receptors, and amyloid-β, influencing cognitive decline. ApoE2 and ApoE3 bind effectively to HDL (High density lipoprotein), while ApoE4 binds to VLDL (Very low-density lipoprotein), resulting in poor lipidation and toxic aggregates1,2. Cholesterol is crucial for brain function, supporting membrane integrity, signal transduction, and amyloid-β regulation. The interaction of ApoE with amyloid-β regulates amyloid plaque formation, influencing Alzheimer’s disease onset. Cholesterol must be converted to 24S-hydroxycholesterol to cross the blood-brain barrier. Poor cholesterol and phospholipid transport by ApoE4 increases the risk of late-onset Alzheimer’s disease in E4 carriers2.
Randox ApoE Array
The Randox ApoE4 Array is a rapid and highly sensitive blood test that facilitates direct ApoE4 genotyping without the need for traditional molecular techniques. It measures both total ApoE and ApoE4 protein levels directly from a plasma sample, using the ApoE4/total ApoE ratio to classify the ApoE4 status as negative or positive. Additionally, the array can distinguish between heterozygous and homozygous individuals among ApoE4 positive samples, aiding in the assessment of Alzheimer’s disease risk.
Using Randox proprietary chemiluminescent biochip-sandwich immunoassays, the array provides accurate results within three hours from a minimally invasive plasma sample. This method has shown 100% concordance with genotypes achieved through restriction fragment length polymorphism (RFLP) in two separate centres5. Compared to other methods like isoelectric focusing, mass spectrometry, bead-based immunoassay, Sandwich ELISA, and PCR, the Randox ApoE Array offers advantages in speed, simplicity, and automation.
Clinical Implications
The Randox ApoE Array offers significant benefits for managing Alzheimer’s disease through early detection and personalised treatment plans. This minimally invasive blood test identifies individuals at higher genetic risk for Alzheimer’s Disease enabling:
- Timely Interventions: Early identification allows for preventive measures and lifestyle modifications, such as cognitive training and increased physical activity, to delay symptom onset.
- Regular Monitoring: High-risk individuals can be monitored for cognitive changes, enabling early intervention for mild cognitive impairment.
Personalised Treatment Plans
Accurate ApoE genotyping supports personalised treatment:
- Targeted Therapies: ApoE phenotype informs the selection of therapies, especially for ApoE4 carriers.
- Risk Stratification: Patients can be stratified by genetic risk for targeted preventive measures.
- Optimised Medication: Genotype information guides medication choices, enhancing efficacy.
- Family Counselling: Genotyping aids family counselling, advising on preventive measures and monitoring.
Conclusions
The Randox ApoE Array represents a groundbreaking advancement in the early detection and management of Alzheimer’s disease. By providing a rapid, highly sensitive, and minimally invasive method for ApoE genotyping, it empowers healthcare providers to implement timely interventions and personalised treatment plans. This innovative approach not only enhances the accuracy of Alzheimer’s risk assessment but also supports the development of targeted therapies and optimised medication regimens, ultimately improving patient outcomes.
Early detection of Alzheimer’s disease allows for proactive measures that can delay the onset of symptoms, while personalised treatment strategies tailored to an individual’s genetic profile offer a more effective management approach. Furthermore, the array’s capability to provide real-time insights into a patient’s disease stage makes it an invaluable tool in the fight against Alzheimer’s disease.
For a deeper understanding of the critical role of ApoE genotyping in Alzheimer’s disease and the innovative technology behind the Randox ApoE Array, we invite you to download our comprehensive whitepaper be clicking on the image below. You can also visit our website to access this and other valuable resources and to learn more about the Randox ApoE4 Array.
References
- Raulin AC, Doss S V., Trottier ZA, Ikezu TC, Bu G, Liu CC. ApoE in Alzheimer’s disease: pathophysiology and therapeutic strategies. Mol Neurodegener. 2022;17(1):72. doi:10.1186/s13024-022-00574-4
- Husain MA, Laurent B, Plourde M. APOE and Alzheimer’s Disease: From Lipid Transport to Physiopathology and Therapeutics. Front Neurosci. 2021;15. doi:10.3389/fnins.2021.630502
- Qian J, Wolters FJ, Beiser A, et al. APOE-related risk of mild cognitive impairment and dementia for prevention trials: An analysis of four cohorts. PLoS Med. 2017;14(3):e1002254. doi:10.1371/journal.pmed.1002254
- Reiman EM, Arboleda-Velasquez JF, Quiroz YT, et al. Exceptionally low likelihood of Alzheimer’s dementia in APOE2 homozygotes from a 5,000-person neuropathological study. Nat Commun. 2020;11(1):667. doi:10.1038/s41467-019-14279-8
- Badrnya S, Doherty T, Richardson C, et al. Development of a new biochip array for APOE4 classification from plasma samples using immunoassay-based methods. Clinical Chemistry and Laboratory Medicine (CCLM). 2018;56(5):796-802. doi:10.1515/cclm-2017-0618
Active vs Total Vitamin B12
Total vs Active B12
Vitamin B12, or cobalamin, is a vital water-soluble vitamin that plays an essential role in myelination initiation and development, cellular energy and fatty acid metabolism. It is a cofactor for enzymes methionine synthase and L-methyl-malonyl-coenzyme A mutase and, in addition to folate, is essential for DNA and protein synthesis. In the UK, up to 6% of adults under 60 have been diagnosed with Vitamin B12 deficiency and figures are much higher in elderly populations1. Additionally, these data do not consider the high rates of missed diagnosis associated with B12 deficiency, which some reports claim to be as high as 26%2. New guidance from the National Institute of Health and Care Excellence (NICE) advise that Active vitamin B12 testing is recommended for some groups of patients. In this article, we’ll look at this essential vitamin, B12 deficiency and the associated complications, compare the biomarkers used to diagnose B12 deficiency, and finally, present the new Acusera Active B12 Control.
Aetiology
Vitamin B12 deficiency can arise due to dietary insufficiency, malabsorption resulting from damage to the small intestine, often caused by conditions like Coeliac disease or Crohn’s disease, or via pernicious anaemia – an autoimmune condition which results in an inability to absorb vitamin B12.
It is a common problem in the elderly population – bodily stores of vitamin B12 can take up to 20 years to become depleted, meaning complications have often already begun before diagnosis occurs. The most common source of vitamin B12 comes from dietary intake of animal products therefore vegetarian dietary requirements are considered a considerable risk factor for vitamin B12 deficiency.
Pathophysiology and Complications
Vitamin B12 deficiency significantly impacts health, affecting various bodily functions, potentially leading to a range of complications. Megaloblastic anaemia is a common complication associated with vitamin B12 deficiency and is characterised by the presence of large red blood cell precursors (megaloblasts) in the bone marrow3. The lack of vitamin B12 results in impaired DNA synthesis and an inhibition of nuclear division. However, cytoplasmic maturation is less effected. This results in asynchronous maturation of the nucleus and cytoplasm in erythrocytes and causes the synthesis of abnormally large megaloblasts. This causes the cessation of DNA synthesis and DNA replication errors, culminating in apoptotic cell death. Common symptoms of megaloblastic anaemia include weakness, shortness of breath, palpitations, tachycardia, Hunter glossitis or splenomegaly3.
Pernicious anaemia is a condition commonly associated by vitamin B12 deficiency. Pernicious anaemia is an autoimmune disorder which affects the gastric mucosa resulting in impaired absorption of vitamin B12. Common symptoms of pernicious anaemia include glossitis, hair loss, dry skin, memory loss, poor concentration, poor sleep, confusion and dizziness, shortness of breath, Diarrhoea, indigestion, loss of appetite, mood swings and suicidal thoughts.
Neurological issues may also arise, including numbness, mobility loss, and memory issues, and in some cases, depression4. Additionally, B12 deficiency is linked to increased risks of cardiovascular events5, infertility6, and autoimmune diseases like multiple sclerosis7 and lupus8. In children, vitamin B12 deficiency can manifest as failure of brain and overall growth and development, developmental regression, hypotonia, lethargy, hyperirritability, or coma9.
Active B12 as a marker of Deficiency
There are several markers of vitamin B12 deficiency. The most used in clinical practice are total vitamin B12, homocysteine, methylmalonic acid (MMA), and Holotranscobalamin (HoloTC) – also known as Active B12. HoloTC accounts for between 10-30% of total B12 and is the metabolically active form of vitamin B12.
When compared with total B12 quantification, HoloTC measurement has been shown to be a more sensitive and specific biomarker of B12 deficiency, particularly at borderline clinical levels10, in various cohorts11,12 including those on vegan diets13 – a known risk factor for B12 deficiency. Furthermore, HoloTC was shown to provide the higher diagnostic accuracy in clinical and subclinical B12 deficiency versus Total B12, MMA and homocysteine with significantly higher accuracy in women over 5011 – a population at high risk of B12 deficiency.
In response to the mounting evidence of the superior utility of HoloTC quantification, the National Institute for Health and Care Excellence (NICE) have produced new guidelines recommending either total B12 or HoloTC for the initial testing of suspected vitamin B12 deficiency. These guidelines specify the use of active B12 during pregnancy and suggest that active B12 might provide a more specific assessment in certain clinical contexts.
Acusera Active B12 Control
For the reasons stated above, Randox are proud to present the Acusera Active Vitamin B12 Control. This control is designed for use with in vitro diagnostic assays for the quantitative determination of HoloTC in human serum and plasma and is suitable for use on a variety of analysers. This true third-party control is provided in a liquid ready-to-use format reducing preparation time and has an impressive 30-day open vial stability, helping to minimise waste. Like all Acusera controls, the Active B12 Control is supplied at consistent, clinically relevant levels to ensure the test system is challenged at the critical decision limits used to aid diagnosis. Furthermore, this control is provided with assayed target values for a range of analysers which are available through our new SmartDocs portal.
Summary of Benefits:
- Dedicated, HoloTC control.
- 30-day Open Stability.
- 2-year shelf life.
- Liquid Ready-to-use.
- Human Serum Based.
- Consistent, clinically significant values.
- True third-party controls.
- Assayed target values.
Ensure the accuracy of your vitamin B12 testing with Randox’s Acusera Active Vitamin B12 Control. Join the other laboratories around the world who trust Acusera to help deliver reliable, clinically relevant test results. Contact us today at marketing@randox.com to learn more and order your supply of the Acusera Active B12 Control.
References
- Hunt A, Harrington D, Robinson S. Vitamin B12 deficiency. BMJ. 2014;349(sep04 1):g5226-g5226. doi:10.1136/bmj.g5226
- Oh RC, Brown DL. Vitamin B 12 Deficiency Clinical Manifestations of Vitamin B 12 Deficiency. Vol 67.; 2003. www.aafp.org/afp
- Hariz A, Bhattacharya PT. Megaloblastic Anemia. StatPerals Publishing; 2024.
- Patel S V., Makwana AB, Gandhi AU, Tarani G, Patel J, Bhavsar V. Factors associated with vitamin B12 deficiency in adults attending tertiary care Hospital in Vadodara: a case control study. Egypt J Intern Med. 2022;34(1):11. doi:10.1186/s43162-022-00104-0
- Pawlak R, Parrott SJ, Raj S, Cullum-Dugan D, Lucus D. How prevalent is vitamin B12 deficiency among vegetarians? Nutr Rev. 2013;71(2):110-117. doi:10.1111/nure.12001
- Green R, Graff JP. Megaloblastic Anemia. In: Atlas of Diagnostic Hematology. Elsevier; 2021:47-51. doi:10.1016/B978-0-323-56738-1.00004-X
- Najafi MR, Shaygannajad V, Mirpourian M, Gholamrezaei A. Vitamin B(12) Deficiency and Multiple Sclerosis; Is there Any Association? Int J Prev Med. 2012;3(4):286-289.
- Segal R, Baumoehl Y, Elkayam O, et al. Anemia, serum vitamin B12, and folic acid in patients with rheumatoid arthritis, psoriatic arthritis, and systemic lupus erythematosus. Rheumatol Int. 2004;24(1):14-19. doi:10.1007/s00296-003-0323-2
- Stabler SP. Vitamin B12 Deficiency. New England Journal of Medicine. 2013;368(2):149-160. doi:10.1056/NEJMcp1113996
- Bondu JD, Nellickal AJ, Jeyaseelan L, Geethanjali FS. Assessing Diagnostic Accuracy of Serum Holotranscobalamin (Active-B12) in Comparison with Other Markers of Vitamin B12 Deficiency. Indian Journal of Clinical Biochemistry. 2020;35(3):367-372. doi:10.1007/s12291-019-00835-y
- Jarquin Campos A, Risch L, Nydegger U, et al. Diagnostic Accuracy of Holotranscobalamin, Vitamin B12, Methylmalonic Acid, and Homocysteine in Detecting B12 Deficiency in a Large, Mixed Patient Population. Dis Markers. 2020;2020:1-11. doi:10.1155/2020/7468506
- Verma A, Aggarwal S, Garg S, Kaushik S, Chowdhury D. Comparison of Serum Holotranscobalamin with Serum Vitamin B12 in Population Prone to Megaloblastic Anemia and their Correlation with Nerve Conduction Study. Indian Journal of Clinical Biochemistry. 2023;38(1):42-50. doi:10.1007/s12291-022-01027-x
- Lederer AK, Hannibal L, Hettich M, et al. Vitamin B12 Status Upon Short-Term Intervention with a Vegan Diet—A Randomized Controlled Trial in Healthy Participants. Nutrients. 2019;11(11):2815. doi:10.3390/nu11112815
Combating Gastroenteritis – Advanced Diagnostic Techniques for Effective Management
Gastroenteritis, often referred to as stomach flu or a stomach bug, affects millions globally each year with symptoms such as diarrhoea, vomiting, abdominal pain, and fever. It is primarily caused by viral and bacterial infections, with rotavirus, norovirus, and Clostridium difficile being the main culprits.
At Randox, we’re dedicated to improving healthcare worldwide. That’s why we’ve produced an educational guide on gastroenteritis and the latest advancements in diagnostic techniques, including a range of novel gastroenteritis test for the Vivalytic POCT system. In this blog, we’ll look at a few of the key points raised in our latest educational guide. You can download this educational guide by clicking the below.
Why Gastroenteritis Matters
Gastroenteritis can lead to severe dehydration, especially in vulnerable groups like children and the elderly. It spreads mainly through the faecal-oral route, which includes consuming contaminated food and water. Prompt and accurate diagnosis is crucial for effective management.
Key Pathogens
Rotavirus
Rotavirus is a major cause of severe gastroenteritis in children. Highly contagious, it leads to rapid dehydration, making rehydration and supportive care essential. Vaccines like Rotarix and RotaTeq are effective in preventing infections.
Norovirus
Norovirus is responsible for most viral gastroenteritis outbreaks. Extremely contagious, it spreads quickly through direct contact and contaminated food. Symptoms include sudden vomiting and diarrhoea, often leading to dehydration. While there’s no specific treatment, staying hydrated is key.
Clostridium difficile
Clostridium difficile, or C. diff, is a leading cause of antibiotic-associated diarrhoea, particularly in healthcare settings. It produces toxins that cause inflammation and damage to the colon, requiring targeted antibiotic treatment for severe cases.
Advanced Diagnostics: The Vivalytic System
Accurate and timely detection of gastroenteritis pathogens is crucial for effective patient management. The Vivalytic Point of Care Testing (POCT) system, developed by Bosch Healthcare Solutions and Randox Laboratories, offers rapid and reliable diagnostics. This system helps healthcare professionals make quicker decisions, improving patient outcomes.
The Vivalytic Gastroenteritis Panels
The Vivalytic panels detailed in our guide include tests for rotavirus, norovirus, and Clostridium difficile. These panels utilise advanced molecular techniques to provide quick and accurate results, helping to streamline the diagnosis process and enhance patient care. By using these panels, healthcare providers can efficiently identify the specific pathogens responsible for gastroenteritis, allowing for targeted treatment and improved patient outcomes.
Features of the Vivalytic System
The Vivalytic system is user-friendly and efficient. It supports both High-Plex and Low-Plex testing, allowing for the simultaneous detection of multiple pathogens from a single sample. This versatility makes it an invaluable tool for healthcare professionals.
Conclusion
Gastroenteritis, caused by pathogens like rotavirus, norovirus, and Clostridium difficile, presents significant health challenges. Advanced diagnostic technologies, such as the Vivalytic system, are crucial in managing and controlling this condition. For a comprehensive understanding of gastroenteritis and innovative diagnostic techniques, download our detailed educational guide.
For more information on the Vivalytic, the panels mentioned, or any of our products, don’t hesitate to reach out to us at marketing@randox.com
Serum Indices – Product Spotlight
Errors can occur at any point in the pre-analytical, analytical, or post-analytical stages of a diagnostic test. It is general practice for errors in the analytical stage to be identified through quality control procedures. However, pre-analytical errors are often treated with less importance than those in later stages of testing. Interference caused by haemolysis, icterus and lipemia (HIL) are common forms of pre-analytical error which affect assay methods, yielding erroneous results. The Randox Acusera Serum Indices (SI) control is designed to monitor an IVD instrument’s response in the detection of HIL interferences.
HIL interference is not novel and has been historically identified through a series of visual assessments. While haemolytic, icteric and lipemic interference causes a visual change in the sample, these methods are not quantitative and are subject to interpretation by laboratory professionals. Modern analysers have built-in capabilities for the automated detection of HIL interference which can quantitatively or semi-quantitatively measure haemolysis, icterus and lipemia, and provide and an index for each. This data can then be used to determine if a sample should be accepted for testing or rejected due to intrinsic interference.
The pre-analytical phase of laboratory testing includes collection, handling, transportation, storage, and preparation of samples. Even when the highest level of care is taken to ensure that all aspects of the pre-analytical phase are suitable and correct, errors can occur, exhibiting the need for clear and efficient quality control processes.
As part of our Acusera quality control range, Randox has developed the Serum Indices quality control to aid in the detection of the common pre-analytical error’s haemolysis, icterus and lipemia, collectively known as HIL. HIL interference can have disastrous effects on the quantification of many analytes, and it is therefore vital to determine levels of interference to improve laboratory efficiency and reduce the frequency of erroneous results.
The graph below shows the wavelengths at which each of these interferents may affect assays and the table below describes these forms of interference:
Classical determination of HIL interference took the form of a visual assessment. A sample was examined for tell-tale signs of one or more of these types of interference. However, these methods are subject to operator interpretation and lack harmonisation and uniformity across the industry. These signs are detailed in the table and illustrated in the graphic below:
Modern clinical chemistry analysers have onboard HIL detection capabilities which offer objective, semi-qualitative or qualitative analysis of these forms of interference in a more precise and consistent manner. Automation of HIL detection improves laboratory throughput along with test turnaround times and enhances the reportability of the results.
Errors at any stage of the analytical process will result in retesting of the sample. Errors in the pre-analytical phase can have repercussions such as increased cost of repeated sample collection and testing, poor test turnaround times, and more seriously, delayed or incorrect diagnosis causing an exacerbation in the condition of the patient. To add to the adverse outcomes on patients, repeated testing places additional stress on laboratory resources and staff which ultimately affects every aspect of a laboratory’s daily activities.
To correctly analyse HIL interference, absorbance readings at different strategically selected wavelengths supplement the calculation of the interference indices. C56-A recommends laboratories consider several parameters when selecting an HIL interference analysis method:
Before implementing results obtained from any method detecting HIL in patient samples, it is imperative to evaluate the specificity and sensitivity of the method at a minimum of two clinically relevant concentrations. This assessment should encompass the sensitivity of the icterus index to haemoglobin and lipids, the haemolysis index to bilirubin and lipids, and the lipemic index to haemoglobin and bilirubin.
In instances of HIL interference, laboratories bear the responsibility of managing the associated results and samples. It is crucial never to utilise an HIL index for the correction of patient results. Typically, if a sample is determined to be affected by one or more of these interferences, the laboratory should reject the result and appropriately dispose of the sample. Nonetheless, in certain scenarios, threshold values can be established. For instance, haemolysis may exert a lesser impact on samples with elevated analyte concentrations. In such cases, laboratories may opt for a distinct procedure in handling these results compared to those exhibiting haemolytic interference at lower analyte concentrations.
Acusera Serum Indices Control
The Randox Acusera Serum Indices (SI) control is designed to be used to monitor an IVD instrument’s response in the detection of haemolyzed, icteric and lipemic (HIL) samples. This control can be utilised in laboratory interference testing to assist in improving error detection of pre-analytical errors affecting clinical chemistry testing. This control provides a full range of clinically relevant testing levels, including a negative (-) and three positives (+, ++ & +++).
The Randox Control offers a comprehensive solution with 3 levels for each form of interference and a negative control, providing a wider coverage compared to alternatives in the market. Our product is conveniently supplied in a lyophilized format, ensuring an extended shelf-life and ease of storage. Customers appreciate the stability of our control, as it consistently meets the 14-day open stability claims, minimizing waste and optimizing laboratory efficiency.
Typical Values
RIQAS Serum Indices External Quality Assessment
The RIQAS Serum Indices EQA programme is designed for the pre-analytical assessment of Haemolytic, Icteric and Lipemic (HIL) interferences. Available in a bi-monthly format with the option to report either quantitative or semi-quantitative results for the HIL parameters, this programme also provides an assessment on how these interferences impact on up to 25 routine chemistry parameters. This provides invaluable information on whether a correct judgement is being made to report results.
• Lyophilised for enhanced stability
• Human based serum ensuring commutable sample matrix
• Bi-monthly reporting
• HIL parameters include the option of quantitative or semi-quantitative reporting
• Interpretation of chemistry parameter results
• Submit results and view reports online via RIQAS.net
How can Randox help?
It is crucial laboratories test for haemolysis, icterus and lipemia to ensure the accuracy of their test processes are maintained. ISO 15189:2022 promotes the identification and control of non-conformities in the pre-analytical process, therefore, using Randox Serum Indices control and RIQAS Serum Indices EQA will help laboratories fulfil the requirements of the new edition of this standard.
Randox Serum Indices control displays improved consolidation, stability, and commutability to ensure laboratories are equipped to accurately determine pre-analytical interferences. Our Serum Indices control can be used with most major chemistry analysers including Roche, Abbot, Beckman, Ortho, and Siemens. When used in conjunction with Acusera 24.7, this control offers laboratories the ability to compare their HIL results with their peer group and identify potential failures in their pre-analytical process.
Simply send us an email by clicking the link below and we will get in touch!
Medical Laboratory Professionals Week 2024
Medical Laboratory Professionals Week (MLPW) is recognised every year in the last full week of April. It’s an opportunity to increase the public understanding of, and appreciation for, the hard work of clinical laboratory staff around the world. It’s also an opportunity to inject a little fun into the laboratory. So, this year, we’ve created a Lab Professionals QC Bingo card. Have a go and see how many your laboratory can get!
How many boxes does your lab tick?
If you’re calling Bingo! you must be an Acusera 24.7 customer. If not, keep reading to find out how you can make daily life in your laboratory more straightforward.
What are Medical Laboratory Professionals?
Medicine wouldn’t be where it is today without the work of these laboratory professionals. They’re on the frontline. Around 70% of medical decisions are based on results provided by medical laboratory staff. That’s a lot of pressure on the labs to make sure their results are accurate. Clinical laboratory staff not only perform the tests used to guide diagnosis and disease prevention, but they also check all the tests they use through rigorous quality control (QC) procedures.
This involves testing samples of known values to prove that the test system and its components perform as they should and provide accurate results. To do this, laboratories require QC material. It’s important that what’s in a QC is as similar to what you’d find in a patient sample as possible. This is known as commutability. Good commutability helps limit cross-reactivity in the test and inaccurate results.
It’s also important to make sure the QC material has concentrations of analytes at similar values to those used to make diagnostic decisions. If you wanted to validate the length of the ruler on your desk, it wouldn’t be helpful to set it down on a 100m running track. Similarly, when laboratory professionals want to ensure a test is producing accurate results, they want to test the system at the critical values used to make medical decisions so that they can be confident the results at these values are accurate.
Once lab staff have confirmed the accuracy of their tests, they can begin testing patient samples. For most people, what happens to a sample after it’s taken is a bit of a mystery. MLPW is the perfect opportunity to unravel this a little:
After your sample is collected, it gets sent over to the lab. Even just moving it there needs careful handling to make sure it’s still good for testing when it arrives. Once it’s in the lab, the team checks the equipment to make sure it’s working right and giving accurate results. The QC procedure varies depending on what they’re testing for, but they always make sure their tests are legitimate. Once they’ve checked everything and carried out the tests, a pathologist looks at the results to figure out what’s going on. They use this information to help decide on the best treatment plan for you.
Even this watered-down explanation makes it sound like a lot of work, right? At Randox, we recognise the vital role and dedicated efforts of medical laboratory professionals, and the invaluable contributions they make to society, and we hope that now, you do too.
Acusera 24.7
Bingo! That’s exactly how our customers feel when they realise how much time Acusera 24.7 can save them. Our innovative and intuitive QC data software is cloud-based, allowing you to log in from anywhere in the world to review your QC data.
Along with a wide range of interactive charts, including Levey-Jennings charts, Acusera 24.7 determines measurement uncertainty and sigma metrics for you, saving you the time and stress of manually calculating these tricky statistical analyses. And that’s just the beginning. Acusera 24.7 can link to LIMS for automated data entry, meaning lab staff don’t have to manual type long datasets, unless they want to of course; we also provide both semi-automated data upload and manual data entry options.
Access to a range of reports has never been easier. Acusera 24.7 is particularly useful when gaining or renewing your accreditation, and live peer group QC data, to give additional confidence in the accuracy of your results.
But this article is supposed to be about laboratory professionals, so we won’t bang on about it anymore. We just want everyone to know about Acusera 24.7 so they can get that daily bingo! feeling for themselves. If you want to learn more about our reports, charts, advanced statistical analysis, Acusera 24.7 more generally, or how Acusera 24.7 can help you achieve your accreditation, you can follow the links to the relevant blog post.
Last year, we interviewed two of our laboratory staff, Dean and Meadhbh, to find out what a normal day looked like for them. To find out what a day in the life of a laboratory professional is like, take a look at the interviews here
If you’d like to get in touch with us to discuss the advantages of Acusera 24.7, or you’ve made up your mind and want to get in on the action, reach out to us at marketing@randox.com. We’re always happy to brag about how great Acusera 24.7 is, and how we make life simpler for more and more laboratories every day.