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.
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.
PCR rapid tests for Candida auris for Vivalytic by Bosch now available
World’s first fully automated PCR test for detection of the multidrug-resistant fungus at the point of care.Ā
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Vivalytic test detects Candida auris in under an hour at the point of care, making it the world’s first test suitable for screenings.
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Candida aurisĀ infection rates are on the rise in Germany and can cause severe infections, for example in the bloodstream (sepsis).
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Hospitals can use the new screening test to detect colonization, allowing them to implement measures to contain outbreaks.
Bosch Healthcare solutions has developed a PCR test for detecting Candida auris (C. auris)Ā and on the Vivalytic platform. The test is a global innovation now available for order from distribution partners including Randox Laboratories Ltd. and R-Biopharm. This test enables the fully automated detection of the frequently multi-resistant fungus in less than an hour at the point of care. The rapid testing capability also makes it suitable for carrying out screenings when necessary. In contrast, traditional culture tests in centralized laboratories require one to three days, delaying diagnosis and the initiation of targeted treatment. āConsidering the heightened risk of severe progression in individuals with pre-existing conditions, we have developed a new test that enables clinics to respond more swiftly,ā states Marc Meier, managing director of Bosch Healthcare Solutions. Patients with compromised immune systems, such as those in intensive care, individuals with serious underlying conditions such as diabetes, or those who are immunosuppressed due to cancer or HIV, as well as patients about to undergo invasive surgery, face a heightened risk of active infection with C. auris. The mortality rate for C. auris infections ranges from 30 to 72 percent.
āCandida aurisĀ can be transmitted from person to person through contact and contaminated surfaces. When this fungus presents, rapid detection is therefore rapid detection is therefore paramount to enable implementation of effective control and prevention strategies,” says Dr. med. Alexander Maximillian Aldejohann,Ā deputy head of the WĆ¼rzburg Laboratory at the National Reference Center for Invasive Fungal Infections (NRZMyk.) Since July 2023, Germany has implemented a limited statutory reporting requirement under the Infection Protection Act. Aldejohann is in favor of extending this reporting obligation: āThe fungus has the capacity to rapidly develop resistance to many common antifungal agents coupled with the ability to survive for a relatively long time on surfaces. This high so-called tenacity also increases the risk of outbreaks that are difficult to contain.ā
Increasing spread of Candida auris
C. auris is spreading globally. In some states in the U.S, the annual incidence rate has been shown to increase by a factor of 2 to 3. The Robert Koch Institute (RKI) also drew attention to a rise in cases within Germany during the past year in the Epidemiological Bulletin at the at the beginning of May. The RKI points out that in specific areas screening could be beneficial. In the U.S, the annual case count has in the meantime reached the thousands. The Centres for Disease Control and Prevention (CDC) already consider the screening of patients, visitors, and staff for C. auris as a crucial strategy to curb its spread in healthcare settings. While the fungus is harmless for healthy individuals, it can it can lead to severe nosocomial infections, i.e. infections acquired in hospitals or other healthcare environments, in patients at high risk and, if the fungus enters the bloodstream, can trigger sepsis.
Easy handling, rapid detection The Vivalytic Analyser enables effortless testing directly at the point of care: The sample is placed into the test cartridge, which already contains all necessary reagents. The cartridge is then inserted into the Vivalytic Analyser for automated processing. Healthcare professionals require only minimal training to use the system, and the fully automated process significantly lowers the risk of infection. The Vivalytic Analyser thus facilitates rapid and precise diagnostics in PCR quality, bypassing the frequently lengthy process through a central laboratory. Bosch Healthcare Solutions is expecting CE certification for the Vivalytic C. auris test soon.
For More Information Please Contact:
Martin Conway, Phone: +44 (0) 28 9442 2413
E-mail: martin.conway@randox.co
Vivalytic | Strep A
Vivalytic | Strep A
–
Detection of Streptococcus pyogenes
*Currently under development. Not available for sale.
Qualitative RT-PCR detection of Streptococcus pyogenes
- Quick turnaround time of less than 30 minutes, beneficial for both the patient and for the containment of Strep A reducing aerogenic transmission.
- Convenient 4 step process from sample entry to results. Suitable for use in laboratory and non-laboratory settings.
- Real-time PCR enables rapid and targeted detection up to 4 weeks after the onset of symptoms Streptococcus pyogenes.
Clinical Significance
Group A Streptococcus (GAS) is the primary culprit behind bacterial pharyngitis in school-aged children. Typically resulting in a mild illness characterised by symptoms such as a sore throat, headache,
and fever, GAS infections may also manifest as scarlet fever, presenting with a fine, red rash. Although often manageable, severe cases warrant antibiotic treatment for effective resolution.
An automated, qualitative in vitro diagnostic test employing real-time polymerase chain reaction (PCR) is utilised to detect nucleic acids from Streptococcus pyogenes in human oropharyngeal swabs. This advanced test serves as a valuable aid in diagnosing streptococcal pharyngitis in symptomatic individuals.
Features
Sample Type: Oropharyngeal swabs
Sample Volume: 300 μl
Detection Method: Real-Time PCR
Time to result: Less than 30 minutes
| Detectable Pathogen |
|---|
| Streptococcus pyogenes |
Vivalytic Group B Streptococcus (GBS) (In Development)
Real-time PCR for the detection of Streptococcus agalactiae – More information to follow
| Detectable Pathogen |
|---|
| Streptococcus agalactiae (B-Streptococci) |
“AWARD-WINNING DESIGN DELIVERS
AN UNCOMPLICATED USER EXPERIENCE”
Vivalytic Workflow
Intuitive engineering of Vivalytic ensures the analyser is user friendly. The process of patient sample to result comprises a very simple 4 step workflow.
To begin the test, the user scans or enters sample information. The cartridge code is then scanned into the embedded Vivalytic software. The user then adds sample into the dedicated cartridge slot, closes the lid and inserts the cartridge into the Vivalytic.
The touchscreen display will countdown the time remaining to test completion. Results will be displayed on the screen. Multiple Vivalytics can be wirelessly connected allowing the user to control multiple tests at one time all reporting to a master Vivalytic platform.
Want to know more?
Contact us or visit our COVID-19 Monitoring & Management page
Related Products
Viral Respiratory Infection Array
SARS-CoV-2 Pooling Test
Vivalytic
Vivalytic Test Menu
Vivalytic | Candida auris
Vivalytic | Candida auris
–
Detection of Candida auris
Qualitative RT-PCR detection of Candida auris
- Quick turnaround time of less than 1 hour, beneficial for both the patient and for the containment of Candia auris and reducing transmission.
- Convenient 4 step process from sample entry to results. Suitable for use in laboratory and non-laboratory settings.
- Real-time PCR enables rapid and targeted detection up to 4 weeks after the onset of symptoms of the multidrug-resistant fungal Candia auris.
Clinical Significance
Candida auris is an emerging and often multidrug-resistant fungal species that poses a significant threat to public health. This yeast-like fungus can cause severe infections, primarily affecting individuals with compromised immune systems, those in healthcare facilities, or those with underlying medical conditions. Candida auris is particularly concerning due to its ability to persist on surfaces, leading to healthcare-associated outbreaks. Diagnosis can be challenging as it is often misidentified with other Candida species. Effective management involves prompt identification, strict infection control measures followed by treatment. The Vivalytic Candida auris test is an automated, qualitative in vitro diagnostic employing real-time PCR to detect Candida auris DNA from swabs taken from the human axilla, groin, nasal, and rectal areas.
This test serves to screen individuals at risk for colonisation, playing a crucial role in the prevention and control of Candida auris outbreaks and infections within healthcare settings.
Features
Sample Type: Swab
Sample Volume: 300 μl
Detection Method: Real-Time PCR
Time to result: Less than 1 hour
| Detectable Pathogens |
|---|
| Candida auris |
“AWARD-WINNING DESIGN DELIVERS
AN UNCOMPLICATED USER EXPERIENCE”
Vivalytic Workflow
Intuitive engineering of Vivalytic ensures the analyser is user friendly. The process of patient sample to result comprises a very simple 4 step workflow.
To begin the test, the user scans or enters sample information. The cartridge code is then scanned into the embedded Vivalytic software. The user then adds sample into the dedicated cartridge slot, closes the lid and inserts the cartridge into the Vivalytic.
The touchscreen display will countdown the time remaining to test completion. Results will be displayed on the screen. Multiple Vivalytics can be wirelessly connected allowing the user to control multiple tests at one time all reporting to a master Vivalytic platform.
Want to know more?
Contact us or visit our COVID-19 Monitoring & Management page
Related Products
Viral Respiratory Infection Array
SARS-CoV-2 Pooling Test
Vivalytic
Vivalytic Test Menu
Vivalytic | CT/NG
Vivalytic | riTA CT/NG
–
Detection of Chlamydia trachomatis and Neisseria gonorrhoeae
*Currently under development. Not available for sale.
Qualitative RT-PCR detection of STI causative Species
- Quick turnaround time of less than 30 minutes, beneficial for both the patient and for the containment of STIs and reducing transmission.
- Convenient 4 step process from sample entry to results. Suitable for use in laboratory and non-laboratory settings.
- Isothermal amplification enables rapid and targeted detection up to 4 weeks after the onset of symptoms and differentiate the STI pathogenic species.
Clinical Significance
Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are bacterial sexually transmitted infections (STIs). Chlamydia, primarily transmitted through sexual contact, is often asymptomatic, necessitating testing for diagnosis. Symptoms may include painful urination, and if untreated, it can lead to complications like pelvic inflammatory disease. Gonorrhoeae, also transmitted sexually, presents symptoms such as painful urination and genital discharge. Early detection is crucial for both infections to prevent complications and further transmission.
Utilising isothermal nucleic amplification technology, our system qualitatively detects nucleic acids from Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG).
Features
Sample Type: Swab or Urine
Sample Volume: 300 μl
Detection Method: Isothermal amplification
Time to result: Less than 30 minutes
| Detectable Pathogens | |
|---|---|
| Chlamydia trachomatis | Neisseria gonorrhoeae |
“AWARD-WINNING DESIGN DELIVERS
AN UNCOMPLICATED USER EXPERIENCE”
Vivalytic Workflow
Intuitive engineering of Vivalytic ensures the analyser is user friendly. The process of patient sample to result comprises a very simple 4 step workflow.
To begin the test, the user scans or enters sample information. The cartridge code is then scanned into the embedded Vivalytic software. The user then adds sample into the dedicated cartridge slot, closes the lid and inserts the cartridge into the Vivalytic.
The touchscreen display will countdown the time remaining to test completion. Results will be displayed on the screen. Multiple Vivalytics can be wirelessly connected allowing the user to control multiple tests at one time all reporting to a master Vivalytic platform.
Want to know more?
Contact us or visit our COVID-19 Monitoring & Management page
Related Products
Viral Respiratory Infection Array
SARS-CoV-2 Pooling Test
Vivalytic
Vivalytic Test Menu
Growth through medical technology: Randox and Bosch invest heavily in the Vivalytic analysis platform
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New partnership for Vivalytic analysis platform: Bosch and Randox
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Laboratories Ltd. to invest 150 million euros in research, development, and
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distribution
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Strategic growth field: point-of-care molecular diagnostics expected to
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become a future market worth billions
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Growth with fully automated laboratory diagnostics: the two companies aim to
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achieve sales in the nine-figure range by 2030.
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Smartphone-sized laboratory: sepsis IVD grade test based on cutting-edge
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BioMEMS technology is a joint development objective.
With many diseases, every minute counts, and determining whether a patient is presenting the symptoms of a simple cold, the flu, or something as severe as life-threatening meningitis is usually only possible after time-consuming and expensive
laboratory diagnostics. With its Vivalytic analysis platform, Bosch has set itself the goal of making fast and highly precise diagnostics accessible at the point of care ā and aims to use molecular diagnostics to become a leading provider in the
market by 2030. To achieve this, Bosch has now agreed on a strategic partnership with Randox Laboratories Ltd., a leading diagnostic and medical technology company. The two companies will invest around 150 million euros in joint research, development, and sales activities for new tests for the Vivalytic analysis platform provided by Bosch Healthcare. One goal is the development ofĀ a sepsis IVD1 grade test that will be the first to feature highly innovative and novel BioMEMS technology.
Bosch has defined medical technology as a strategic growth field. Point-of-care molecular diagnostics is expected to become a future market worth billions. And with its Vivalytic analysis platform, Bosch aims to achieve a leading position in this market. āWith cutting-edge technology from our own labs and our own production lines, we want to grow long-term together with partners in the field of precision diagnostics,ā says Stefan Hartung, chairman of the Bosch board of management. āHere, our medical technology can draw considerable benefit from our diversification, from our expertise, from the groundwork we have done in automation, miniaturization, molecular diagnostics, and from our experience in microchip development and manufacturing,ā Hartung adds. āWe are investing long-term in an exciting high-tech growth field and continuously developing it together with partners. With technology āInvented for lifeā, we can relieve the burden on medical professionals and help make the diagnose and treatment of disease fasterā.
Shared growth: decentralized diagnostics at the point of care
Bosch Healthcare Solutions and Randox are now joining forces in an attempt to accelerate the development and market launch of new tests and to make distribution channels more efficient. The partnership is set to run for more than ten years. With Vivalytic, the two companies aim to achieve sales in the medium nine-figure range by 2030. āGlobally, healthcare is moving toward decentralized and personalized diagnostics, that enable rapid interventions and individual treatment plans,ā says Marc Meier, managing director of Bosch Healthcare
Solutions GmbH. āWith our partner Randox, we want to further expand the test portfolio of our Vivalytic analysis device. Our fully automated molecular diagnostics PCR tests provide clarity directly at the site of sample collection,
shorten waiting times, and take the strain off the healthcare system,ā Meier adds. The two partners are a good fit: Bosch can contribute its technology and manufacturing expertise across the fields of molecular diagnostics, microchip
development and manufacturing, and miniaturization. The universal Vivalytic platform for molecular diagnostics was developed in over ten years by Bosch researchers and brought to market maturity by Bosch Healthcare Solutions. Randox has 40 years of experience in the design and development of highly sensitive IVD tests performed on a variety of technologies, including microfluidic platforms. In combination with the companyās extensive market knowledge and global sales and distribution network, this adds up to considerable opportunities for growth. āRandox has always been committed to improving health worldwide and sees the need to invest in research and development initiatives that will support clinical decision making across a variety of disease areas. Diagnostics has always been an indispensable component of healthcare, and the alignment of both science and technology makes for the perfect fit in an area for high potential impact, especially in pressure-driven environments,ā says Dr. Peter Fitzgerald, Managing Director of Randox Laboratories Ltd. Bosch Healthcare Solutions and Randox already collaborated during the Covid-19 pandemic. In spring 2020, Bosch launched one of the worldās first fully automated PCR tests for the SARS-CoV-2 coronavirus. Together with Randox, the rapid test for use in doctorās offices, nursing homes, testing stations, and hospitals was made ready for the Vivalytic analysis device within the space of just a few weeks.
Development goal: sepsis test based on BioMEMS technology
One focus of the development partnership with Randox is the implementation of a highly sensitive multiplex2test for sepsis on the Vivalytic analysis platform.Sepsis, also known as āblood poisoning,ā is a potentially life-threatening complication3 that can occur in conjunction with various infectious diseases. A medical emergency that can lead to multiple organ failure, it requires immediate medical treatment. The planned IVD grade sepsis test is to be based for the first time on the highly innovative and novel BioMEMS technology developed by teams from Bosch corporate research in Renningen and Bosch Healthcare Solutions in Waiblingen. āWe have set ourselves the ambitious goal
of adding the functions of a high-performance silicon chip based on microsystems technology to our test cartridges for the Vivalytic platform. In doing so, we will combine Boschās unique expertise in the areas of MEMS chips, molecular diagnostics, and microfluidics,ā Marc Meier says. āClinical outcomes in sepsis depend on timely diagnosis and appropriate early therapeutic intervention. Current methods of sepsis diagnosis are insufficient and time-consuming. With over 10 years of experience in the field of infectious diseases diagnostics, we aim to develop a state-of-the-art sepsis test using the highly multiplexing BioMEMS technology. Such a test could revolutionize sepsis diagnosis, ultimately leading to improved treatment outcomes and lower mortality rates from this life-threatening condition,ā says Dr. Peter Fitzgerald.
Smaller and faster: from microfluidics to nanofluidics ā thanks to BioMEMS
The powerful BioMEMS chip adds a further innovative analysis method to the Vivalytic test cartridge, enabling it to test simultaneously and significantly faster for a large number of different pathogens. It is called BioMEMS because it combines microelectromechanical systems (MEMS) with microfluidics for applications in the field of medical technology. In microfluidics, very small amounts of fluid in the microliter range are moved in a very small space. Miniaturization allows qualitative biochemical polymerase chain reactions (PCR) to run in parallel in real-time on a single BioMEMS chip. āCompared to previous PCR reactions, the volumes of liquids are reduced by a factor of 1,000 to the nanoliter range. The analysis of liquids is left to a small microchip,ā Marc Meier explains. With the new BioMEMS technology, fully automatic testing up to 250 genetic characteristics4 (e.g. pathogens) in one cartridge is possible in less
than 15 minutes. The test cartridge is a highly complex laboratory the size of a smartphone, so to speak. Another future advantage of BioMEMS will be simpler and faster adaptation of new tests or existing tests on the chip itself. For example, existing tests can easily be expanded to include additional features. āThe BioMEMS technology paves the way for us to move into nanofluidics, where each pathogen will be examined in a reaction vessel the thickness of a hair,ā Meier says. To achieve this, Bosch wants to create more capacity on a MEMS chip and expand it what are known as ānanocavitiesā. Thanks to t
hese very small cavities, even more biochemical processes will be able to run in parallel on a
chip. With increasing miniaturization, the technology has potential to be used in oncology as well over the long term. The BioMEMS chips are to be manufactured at the Bosch semiconductor plant in Reutlingen, with bio-integration and cartridge
assembly to be carried out at Bosch Healthcare Solutions in Waiblingen.
Vivalytic platform: easy application at the point of sample collection
The advantages of carrying out PCR tests on the Bosch Vivalytic platform lie not only in speedy a
nalysis, but also in the ease of use: Once the sample has been taken, it is placed in the test cartridge. The cartridge, which contains all the necessary reagents for the respective test, is then inserted into the Vivalytic analyser for automated evaluation. Medical staff require only brief training on how to operate it. This enables fast and targeted diagnostics directly at the point of sample collection ā either at the doctorās office or in the hospital ā without the often long and time-consuming detour via a central laboratory. Bosch Healthcare Solutions already distributes various tests for diseases of the upper and lower respiratory tract, such as SARS-CoV-2 ā also a pooling variant and as a saliva test ā or a test to differentiate between SARS-CoV-2, RSV virus and influenza. There are also tests for pathogens that cause sexually transmitted infections (STI) and MRSA / SA (āhospital germā). Starting in summer, it is planned to expand the portfolio with tests for whooping cough (Bordetella holmesii, Bordetella parapertus
sis, and Bordetella bronchiseptica), urinary tract infections (UTI), bacterial meningitis, the two most common sexually transmitted diseases (Chlamydia trachomatis; CT and Neisseria gonorrhoeae; (NG), fungal infections (Candida auris), and three tests for diarrheal diseases
(norovirus, Clostridioides difficile, HSP)
Contact persons for press inquiries:
Robert Bosch GmbH
Dƶrthe Warnk, Phone: +49 711 811-55508
E-mail: doerthe.warnk@bosch.com
Randox Laboratories Ltd.
Martin Conway, Phone: +44 (0) 28 9442 2413
E-mail: martin.conway@randox.com
Vivalytic | Bacterial Meningitis
Vivalytic | Bacterial Meningitis
–
Rapid Detection of bacterial pathogens associated with Meningitis
*Research Use Only
Qualitative RT-PCR detection of bacterial pathogens associated with Meningitis
- Compared to the time-consuming traditional procedures, Vivalytic’s quick turnaround time of 30 minutes allows for the prompt and specific antibiotic treatment to be initiated immediately
- Convenient 4 step process from sample entry to results. Suitable for use in laboratory and non-laboratory settings
- Detection from a small CSF sample of only 200μl
Clinical Significance
Bacterial meningitis is an infectious disease characterised by infection and inflammation of the meninges, which leads to significant morbidity and mortality worldwide. Even with early diagnosis and proper treatment, 8-15% of patients succumb to the disease within 24 to 48 hours of symptom onset. While meningitis can affect individuals of all ages, young children face the greatest risk. Newborns are particularly vulnerable to Group B streptococcus, while meningococcus, pneumococcus, and Haemophilus influenzae pose higher risks for young children. Young adults and adolescents are prone to meningococcal disease, whereas the elderly are at a higher risk of pneumococcal disease.
The Vivalytic Bacterial Meningitis panel provides the capability to identify six bacterial pathogens implicated in meningitis from a single test, improving screening processes and lowering costs. With minimal steps from sample collection to result, screening for meningitis on the Vivalytic is the most effective wait to contain and prevent spread, requiring no additional further lab equipment.
Features
Sample Type: Cerebral Spinal Fluid (CSF)
Sample Volume: 200 μl
Detection Method: Real-Time PCR
Time to result: 30 minutes
| Detectable Pathogens | |
|---|---|
| Escherichia coli K1 | Neisseria meningitidis |
| Haemophilus influenzae | Streptococcus agalactiae |
| Listeria monocytogenes | Streptococcus pneumoniae |
Viral Meningitis (In Development)
Real-time PCR test for the detection of pathogens related to Viral Meningitis – More information to follow
| Detectable Pathogens | |
|---|---|
| HSV1/HSV2 | VZV |
| Enterovirus | |
“AWARD-WINNING DESIGN DELIVERS
AN UNCOMPLICATED USER EXPERIENCE”
Vivalytic Workflow
Intuitive engineering of Vivalytic ensures the analyser is user friendly. The process of patient sample to result comprises a very simple 4 step workflow.
To begin the test, the user scans or enters sample information. The cartridge code is then scanned into the embedded Vivalytic software. The user then adds sample into the dedicated cartridge slot, closes the lid and inserts the cartridge into the Vivalytic.
The touchscreen display will countdown the time remaining to test completion. Results will be displayed on the screen. Multiple Vivalytics can be wirelessly connected allowing the user to control multiple tests at one time all reporting to a master Vivalytic platform.
Want to know more?
Contact us or visit our COVID-19 Monitoring & Management page
Related Products
Viral Respiratory Infection Array
SARS-CoV-2 Pooling Test
Vivalytic
Vivalytic Test Menu
Vivalytic | Urinary Tract Infection
Vivalytic | UTI Rapid Test
–
Rapid multiplex detection of common urinary tract infections
*Research Use Only
UTI testing made simple
- Quick turnaround time of 150 minutes compared to 72 hours minimum for standard urine culture, beneficial for both the patient and for the containment of the most common UTIs
- Convenient 4 step process from sample entry to results. Suitable for use in laboratory and non-laboratory settings
- Detect 16 different uropathogens and identify the presence of 7 antimicrobial resistance genes all from one single urine sample
Clinical Significance
Urinary tract infections (UTIs) are highly prevalent infections acquired both in the community and hospital settings. The widespread use of antibiotics has led to an alarming rise in UTIs caused by organisms that are resistant to multiple drugs, affecting approximately 150 million people worldwide each year.
UTIs can be categorised as either uncomplicated or complicated, depending on various factors such as anatomical or functional abnormalities within the urinary tract, comorbidities, recurrent UTIs, catheter-associated UTIs, and urosepsis.
A single native urine sample, along with the Vivalytic PCR-based assay, for simultaneous qualitative detection of causative UTI bacterial and fungal pathogens can detect 16 different uropathogens and identify the presence of 7 antimicrobial resistance genes, allowing for a swift and effective treatment plan to begin. With a rapid time-to-result of 2.5 hours and capable of identifying a multitude of bacterial targets, the UTI panel on Vivalytic leads to improved patient outcomes and effective management of urinary tract infections.
R&D project manager Dr Heather McMillan discusses the importance of diagnostics in the treatment of UTI’s.
Features
Sample Type: Native Urine
Sample Volume: 300 μl
Detection Method: Randox Biochip Technology (end-point PCR)
Time to result: 2.5 Hours
| Detectable Pathogens | ||
|---|---|---|
| GRAM-NEGATIVE BACTERIAL SPECIES | GRAM-POSITIVE BACTERIAL SPECIES | ANTIMICROBIAL RESISTANCE GENES |
| Acinetobacter baumannii | Enterococcus faecalis | TRIMETHOPRIM RESISTANCE |
| Enterobacter cloacae | Enterococcus faecium | dfrA1 |
| Escherichia coli | Staphylococcus aureus | dfrA5 |
| Klebsiella aerogenes | Staphylococcus epidermidis | dfrA12 |
| Klebsiella oxytoca | Staphylococcus saprophyticus | dfrA17 |
| Klebsiella pneumoniae | Streptococcus agalactiae | METHICILLIN RESISTANCEVANCOMYCIN RESISTANCE |
| Morganella morganii | mecA | |
| Proteus spp. | Vancomycin Resistance | |
| Providencia stuartii | vanA | |
| Pseudomonas aeruginosa | vanB | |
“AWARD-WINNING DESIGN DELIVERS
AN UNCOMPLICATED USER EXPERIENCE”
Vivalytic Workflow
Intuitive engineering of Vivalytic ensures the analyser is user friendly. The process of patient sample to result comprises a very simple 4 step workflow.
To begin the test, the user scans or enters sample information. The cartridge code is then scanned into the embedded Vivalytic software. The user then adds sample into the dedicated cartridge slot, closes the lid and inserts the cartridge into the Vivalytic.
The touchscreen display will countdown the time remaining to test completion. Results will be displayed on the screen. Multiple Vivalytics can be wirelessly connected allowing the user to control multiple tests at one time all reporting to a master Vivalytic platform.
Want to know more?
Contact us or visit our COVID-19 Monitoring & Management page
Related Products
Viral Respiratory Infection Array
SARS-CoV-2 Pooling Test
Vivalytic
Vivalytic Test Menu
Vivalytic | Rota-, Norovirus & C. diff
Vivalytic | Rota-, Norovirus & C. diff
–
Rapid Detection of Rota-, Norovirus & C. diff Infections
Qualitative RT-PCR detection of Rota-, Norovirus & C. diff
- Quick turnaround time of less than 60 minutes, beneficial for both the patient and for the containment of Rota-, Norovirus & C. diff
- Convenient 4 step process from sample entry to results. Suitable for use in laboratory and non-laboratory settings
- Detection from liquid or soft human stool specimens to distinguish between C. difficile, norovirus and rotavirus and delivers fast and precise results.
Clinical Significance
Gastroenteritis refers to the inflammation of the stomach, small intestine, and large intestine. The majority of acute gastrointestinal illnesses (AGIs) are caused by viruses like Norovirus or Rotavirus, as well as bacterial pathogens such as Clostridioides difficile (C. difficile).
The Vivalytic Rota-, Norovirus and C. difficile Panel is capable of detecting these three common gastrointestinal pathogens. With a rapid and accurate time-to-result, this state-of-the-art test enables swift identification of multiple targets, leading to improved patient outcomes and efficient management of gastrointestinal illnesses.
Features
Sample Type: Swab samples from liquid or soft human stool specimens
Sample Volume: 300 μl
Detection Method: Real-time PCR
Time to result: Less than 60 minutes
| Detectable Pathogens | ||
|---|---|---|
| Rotavirus type A | Norovirus (genogroup I/II) | C. difficile genes (tcdA/tcdB) |
“AWARD-WINNING DESIGN DELIVERS
AN UNCOMPLICATED USER EXPERIENCE”
Vivalytic Workflow
Intuitive engineering of Vivalytic ensures the analyser is user friendly. The process of patient sample to result comprises a very simple 4 step workflow.
To begin the test, the user scans or enters sample information. The cartridge code is then scanned into the embedded Vivalytic software. The user then adds sample into the dedicated cartridge slot, closes the lid and inserts the cartridge into the Vivalytic.
The touchscreen display will countdown the time remaining to test completion. Results will be displayed on the screen. Multiple Vivalytics can be wirelessly connected allowing the user to control multiple tests at one time all reporting to a master Vivalytic platform.
Want to know more?
Contact us or visit our COVID-19 Monitoring & Management page
Related Products