Vivalytic | Extensive SARS-CoV-2 Pooling
Vivalytic | Extensive SARS-CoV-2 Pooling
Vivalytic | Extensive SARS-CoV-2 Pooling Test
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15 Samples, 1 Cartridge
Simultaneous SARS-CoV-2 detection from up to 15 pooled samples
- Detection from real-time PCR using saliva lollipop swab collection.
- Up to 15 patient samples may be pooled and added to a single cartridge targeting the E gene sequence
- The SARS-CoV-2 pooling test has recently received CE marking.
- Simple and easy to use POC analyser with a small footprint making it suitable for use in laboratory and non-laboratory settings
- Rapid turnaround time of less than 45 minutes for results.
- Convenient 4 step process from sample entry to results. No laboratory training required
Extensive SARS-CoV-2 Pooling is a rapid real-time PCR test cartridge, providing clear and concise results in a timely manner, direct at the point of care on the Vivalytic. The SARS-CoV-2 polling test with lollipop swab allows for the screening of up to 15 patient samples. One of the first rapid pooling PCR tests on the market, the Vivalytic produces results in less than 45 minutes delivering high accuracy for extensive and faster testing ideal for rapid and confirmatory SARS-CoV-2 screening in any environment.
Ideal for mass testing, the pooling could be done at the level of a ward, medical speciality, social bubble, or group of colleagues. It has potential for use in other settings, such as pre-operative screening, schools and universities, prisons, nursing homes, primary care, and large workplaces. Sample pooling allows more people to be tested quickly using fewer testing resources.
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.
“AWARD-WINNING DESIGN DELIVERS
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Want to know more?
Contact us or visit our COVID-19 Monitoring & Management page
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Vivalytic’s rapid coronavirus test delivers results for positive samples in less than 30 minutes
18th December 2020
Cloud-based software update means a faster PCR test for SARS-CoV-2
We are happy to announce that due to improved software for the Vivalytic analysis device, the CE marked Vivalytic SARS-CoV-2 rapid coronavirus test, which uses polymerase chain reactions (PCR), now delivers its results even faster. By applying optimized evaluation strategies, the Vivalytic analysis device can detect a positive SARS-CoV-2 sample through its high viral load in less than 30 minutes, right where the sample is collected.
This modified product is part of a research and development project relating specifically to COVID-19, funded by the German Federal Ministry of Education and Research (BMBF) to the tune of 4.97 million euros. The project’s aim is to expand the options for detecting acute infections of the coronavirus, looking particularly at on-the-spot testing in which the sample is analyzed in a fully automatic PCR process, as this offers rapid yet reliable results.
- Improved software for Vivalytic: turnaround time for positive SARS-CoV-2 samples reduced to under 30 minutes.
- Update from the cloud: Vivalytic analysis devices are updated over the internet.
Dr. Volkmar Denner, chairman of the board of management of Robert Bosch GmbH said;
“In the fight to contain the coronavirus pandemic, speed is of the essence. With Vivalytic, we are delivering cutting-edge medical technology. Our IT and software expertise have helped to make the Bosch Corona test for positive samples even faster – all within a short period of time.”
The new update is available for the SARS-CoV-2 singleplex test and the SARS-CoV-2 pooled test. Updating the Vivalytic testing devices is simple and straightforward – all that is required is an internet connection to access the Bosch cloud platform Vivasuite. Developed in-house at Bosch, the Vivasuite cloud platform allows users to digitally manage and update all their Bosch Healthcare Solutions devices. This is also an advantage when Vivalytic devices are in use in the field. The platform meets the strictest security standards and data privacy is guaranteed at all times: for example, there is no remote access to Vivalytic devices, and no possibility of accessing patient data.
The turnaround time for samples negative for SARS-CoV-2 is still 39 minutes. PCR tests are considered the gold standard, and Bosch’s rapid coronavirus tests have a sensitivity of 98 percent and a specificity of 100 percent.
Contact marketing@randox.com for further information on the latest vivalytic software update for SARS-CoV-2 testing.
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Randox & Bosch Healthcare – Collaboratively Combating COVID-19
29th October 2020
Randox & Bosch Healthcare – Collaboratively Combating COVID-19
A game-changing partnership between Randox Laboratories and Bosch Healthcare Solutions continues to change the testing landscape and capabilities of both laboratory and non-laboratory settings in rapidly detecting COVID-19.
Providing clear and concise results, direct at the point of care, the Randox and Bosch Healthcare Solutions collaborative approach not only allows patients to take the recommended safety precautions without delay, but also provides a solution to both analyse and differentiate COVID-19 from other viral respiratory diseases. Multiple testing approaches with the same aim – to overcome COVID-19!
Combining science & technology, timing is of the essence in the fight against coronavirus. Together, we have combined efforts in successfully launching the Vivalytic – the all in one solution for molecular diagnostics consolidating nucleic acid extraction, polymerase chain reaction (PCR) and detection onto one small platform.
These efforts reflect a global partnership of both cooperation’s working together to deliver world-class diagnostic solutions, harnessing the power of innovation to improve health worldwide, providing an all in one approach minimising the spread of COVID-19 globally.
Launched after just six weeks at the beginning of the COVID-19 pandemic back in March 2020, the Viral Respiratory Infection array (VRI) set the benchmark for rapidly detecting SARS-CoV-2 (COVID-19) whilst simultaneously differentiating between nine other respiratory diseases, in under two and a half hours.
Proactively working together to combat the spread of COVID-19, Randox, Bosch Healthcare Solutions and R-Biopharm are proud to offer variable analysis strategies to detect SARS-CoV-2 (COVID-19). Capable of providing reliable results in just 39 minutes, with a sensitivity of 98% and specificity of 100%, the Vivalytic SARS-CoV-2 rapid test is currently among one of the fastest PCR tests worldwide.
Since the outbreak of COVID-19, we have significantly combined our efforts to provide a diverse range of testing solutions and approaches to meet the need of the rise in global cases. Our approaches have been utilised at all possible levels and together we open up a range of different testing strategies, with developments still underway with the upcoming release of the SARS-CoV-2 Pooling test.
The SARS-CoV-2 Pooling test is a rapid solution for the detection of SARS-CoV-2 (COVID-19) offering an accelerated decentral testing approach to effectively and efficiently monitor and detect viral infection from the offset. Capable of detecting SARS-CoV-2 (COVID-19) from up to five pooled samples simultaneously with a capacity to process more than 160 patient samples a day. The pooling could be done at the level of a ward, medical specialty, social bubble, or group of colleagues. It has potential for use in other settings, such as pre-operative screening, schools & universities, prisons, nursing homes, primary care, and large workplaces. Sample pooling allows more people to be tested quickly using fewer testing resources.
Partnering together, we continue to increase our testing capacity, enabling fully automated processing of patient samples to rapidly combat COVID-19.
Please contact marketing@randox.com for further information.
Randox in the media
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New 39-minute COVID test available on Randox-Bosch Vivalytic
02 October 2020
New 39-minute COVID test available on Randox-Bosch Vivalytic
- The world’s fastest PCR based SARS-CoV-2 test for the point of care delivers reliable results in 39 minutes.
- Has a sensitivity of 98 percent and a specificity of 100 percent.
- Simultaneous testing of five people with one cartridge by pooling will be available from early October.
- Work is in progress to further reduce time to result.
A rapid new coronavirus test, which provides results for Covid-19 in just 39 minutes, is now available on the Vivalytic, a point of care platform brought to market by Randox Laboratories and Bosch.
The test for detection of the SARS-CoV-2 pathogen, is currently the fastest PCR test (the gold standard of test methods) worldwide, and is predestined for decentralized use in mobile test centres at service stations or in airports, so that people who take the test can obtain a reliable result while at the testing site.
Available now in Europe, the CE-approved test, which has a sensitivity of 98 percent and a specificity of 100 percent, helps avoid time in quarantine, relieve laboratories, and make travel and work safer again.
“Rapid and accurate testing plays a crucial role in identifying cases of Covid-19 – to contain any outbreaks and limit the spread of the virus,” says Dr. Heather McMillan, Molecular R&D Manager at Randox Biosciences.
“This new rapid test will be a game-changer in the coronavirus testing landscape by allowing patients to receive their results at the point of care faster than ever before.”
Randox and Bosch launched the first rapid test for the Vivalytic analyser at the end of March, after just six weeks’ development.
As a multiplex test, it simultaneously checks samples for the SARS-CoV-2 virus as well as nine other respiratory diseases in two and a half hours, whereas the new accelerated test is exclusively for SARS-CoV-2.
“With our different coronavirus tests and variable analysis strategies, we open up a range of testing scenarios with a Vivalytic device – from screening all the way to supporting differential diagnosis for similar symptoms,” says Marc Meier, president of Bosch Healthcare Solutions GmbH.
And development work for Covid tests on the Vivalytic is ongoing: as of early October 2020, by pooling samples together it will be possible to simultaneously evaluate five samples in one test cartridge and at a comparable speed – a world first.
This will increase available testing capacity, by enabling fully automated processing of more than 160 samples a day using a Vivalytic device.
Key Benefits of SARS-CoV-2 test on Vivalytic point of care platform
The advantages of the rapid SARS-CoV-2 test on Vivalytic lie not only in speedy analysis, but also in ease of use. A sample is taken from the nose or throat using a swab, and placed in the test cartridge. Then the cartridge, which contains all the reagents required for the test, is inserted into the Vivalytic device for automated analysis.
- Turnaround time of 39 mins from sample entry to result.
- The SARS-CoV-2 rapid test has recently received CE marking.
- The SARS-CoV-2 pooling test can run up to 5 samples on-board one single cartridge.
- Easy 4-step user-friendly process from sample entry to result. Minimal training required.
- Detection from real-time PCR from Nasopharyngeal and/or Oropharyngeal swab.
- Suitable for use in any laboratory and non-laboratory settings.
The development of the new Vivalytic PCR singleplex test is part of a research and development project funded by the German Federal Ministry of Education and Research (BMBF).
For more information please contact marketing@randox.com
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Point of care coronavirus test from Randox and Bosch will launch in April 2020
26 March 2020
Vivalytic Viral Respiratory Tract Infection Array Detecting SARS-CoV-2 (COVID-19)
A game-changing point of care coronavirus test from global diagnostics company Randox Laboratories and leading technology manufacturer Bosch Healthcare Solutions will launch in April 2020.
The Vivalytic Viral Respiratory Tract Infection (VRI) Array can identify SARS-CoV-2 (COVID-19) and differentiate it from nine other respiratory infections with similar symptoms, including influenza and all known coronaviruses.
This provides a more comprehensive respiratory screening which enables precise and informed treatment decisions to be made.
Dr. Heather McMillan, Molecular R&D Manager at Randox Biosciences, commented;
“This array focuses not only on the identification of the novel coronavirus strain that causes COVID-19, but also nine other respiratory infection targets simultaneously, including Influenza A and B, Sarbecovirus and MERS. The aim is to diagnose patients fast and accurately from a single genetic sample, maximising containment of the virus whilst minimising the spread. With the development of this array onto a fully automated platform, patients can be diagnosed rapidly at point of care locations globally such as pharmacies and doctor surgeries.”
The Viral Respiratory Tract Infection Array is one of the world’s first multiplex molecular diagnostic tests meeting the COVID-19 testing recommendations of the World Health Organisation (WHO) and the Centres for Disease Control (CDC).
The target genes for COVID-19 being used on the VRI array represent conserved regions of the genome which have been chosen for their high sensitivity and specificity.
Marc Meier, Managing Director of Bosch Healthcare Solutions, a subsidiary of Bosch Group, said:
“We are enthusiastic about partnering with Randox to offer their assay technology on the Vivalytic platform. The core competencies of Bosch in automation, miniaturization, sensor technology and connectivity are complemented by Randox’s expertise in developing excellent biocontent for a wide range of assays and commercializing innovative diagnostic solutions.”
The new VRI test will be conducted on Vivalytic a point of care platform brought to the market by Randox Laboratories and Bosch. The Vivalytic system is a fully-automated, cartridge-based platform capable of both Hi-Plex and Lo-Plex testing. The cartridges are fully-sealed which minimises the risk of contamination, require room temperature storage (space-saving), contain all the reagents on-board the cartridge and utilises end point PCR. The test only requires a single nasal swab from the patient and an easy four step process to be carried out by the user to run the patient sample.
Key Benefits of Vivalytic | Point of Care Platform
- Fully-automated
- User friendly
- No laboratory training required
- 4 step work flow
- Minimal contamination risk – fully contained system
- No peripherals required – hygienic
- Touchscreen
- Connects to LIMS (Laboratory Information Management System)
- Sample Type: Nasopharyngeal Swab
- Sample Volume: 300µl clinical sample
For more information or to arrange interviews, please contact info@randoxbiosciences.com
RESEARCH
BIOPHARMA
CLINICAL LAB
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Multiplex STI assay for 10 sexually transmitted infections receives CE marking
02 March 2020
Multiplex assay for 10 sexually transmitted infections receives CE marking
CE marking has been granted to one of the most comprehensive cartridge-based STI tests.
The test, developed by the UK’s largest health diagnostics company, Randox Laboratories, tests simultaneously for 10 of the most common sexually transmitted infections, on the firm’s patented Biochip Technology.
Quickly and efficiently testing for multiple STIs, which often have mild symptoms if any at all, ensures early diagnosis at a stage when treatment is most successful, supports the targeted use of antibiotics, and ultimately reduces their mishandling.
Dr Peter FitzGerald, Managing Director of Randox Laboratories, commented;
“Antibiotic stewardship is a critical issue which we all have a responsibility to embrace and drive forward. The CE marking of the STI assay, which incorporates Randox Biochip Technology, will be a game-changer for clinicians and patients across Europe, by facilitating early, accurate and comprehensive diagnoses of STIs that allows for the best possible patient outcome. Never before has there been this level of accessibility and speed with regards to STI testing.”
The Randox STI assay is performed on the Vivalytic system, an intuitive point-of-care platform, developed in partnership with German technology company Bosch that provides the broadest range of test options ever seen for an analyser of its size.
Harnessing the application of multiplex assays to provide greater information from a single patient sample, the Vivalytic simplifies the testing process for otherwise complex laboratory testing procedures.
Marc Meier, Managing Director of Bosch Healthcare Solutions, a subsidiary of Bosch Group, said:
“We are enthusiastic about partnering with Randox to offer their assay technology on the Vivalytic platform. The core competencies of Bosch in automation, miniaturization, sensor technology and connectivity are complemented by Randox’s expertise in developing excellent biocontent for a wide range of assays and commercializing innovative diagnostic solutions.”
Benefits of the Randox STI assay technology on the Vivalytic system
- Fully automated, cartridge-based molecular diagnostics.
- Multiplex technology detects multiple STIs, including co-infections, from a single patient sample.
- Full molecular workflow of extraction, PCR amplification and detection.
- A hygiene and space-saving all-in-one solution that does not require additional peripherals such as laptop, keyboard, barcode scanner or filling stations.
- Ultimate protection of data and valuable sample material thanks to integration of software with instrument that ensures a safe and reliable run.
- Test results can be presented either in summary or in detailed raw data form.
- Instantly available results due to easy integration with popular standard IT systems.
The assay tests simultaneously, from one patient sample, for the STIs below;
- Chlamydia trachomatis (CT)
- Neisseria Gonorrhoeae (NG)
- Trichomonas vaginalis (TV)
- Mycoplasma genitalium (MG)
- Treponema pallidum (syphilis) (TP)
- Herpes simplex virus 1 (HSV-1)
- Herpes simplex virus 2 (HSV-2)
- Haemophilus ducreyl (HD)
- Mycoplasma hominis (MH)
- Ureaplasma urealyticum (UU)
For further information please contact the Randox PR team on 028 9442 2413 or email randoxpr@randox.com
RESEARCH
BIOPHARMA
CLINICAL LAB
BIOREAGENTS
Cystic Fibrosis Awareness Month at Randox Biosciences
May is National Cystic Fibrosis (CF) Awareness Month. The purpose of having the awareness month is to educate and raise additional awareness to the public about the horrible disease and how it affects those who suffer. According to the Cystic Fibrosis Foundation, more than 30,000 people are living with cystic fibrosis. More than 75% of these people are diagnosed in their early childhood 1.
What is CF?
Cystic Fibrosis is a genetic, life-threatening disease which affects the respiratory and digestive system. A person with CF is born with the condition and therefore it is not possible to catch it from someone else. The gene affected by CF controls the movement of salt and water in and out of cells, which results in a build-up of thick sticky mucus in the lungs, digestive system and other organs. This causes a wide range of challenging symptoms affecting the entire body.2
Symptoms of CF:
There are many symptoms to Cystic Fibrosis which can make life for someone who suffers with CF challenging. The build-up of sticky mucus in the lungs can make breathing difficult and clog up the pancreas which as a result can increase the risk of developing a lung infection or worse, death. This can make it difficult for those who have CF to absorb nutrients from food properly and therefore they must eat more calories to avoid malnutrition. Other symptoms include the following:3
- recurring chest infections
- wheezing, coughing, shortness of breath and damage to the airways (bronchiectasis)
- difficulty putting on weight and growing
- jaundice
- diarrhoea, constipation, or large, smelly poo
- a bowel obstruction in new-born babies (meconium ileus) – surgery may be needed
Complications of CF:
3People with CF also have a higher risk of developing other conditions. These include:
- weak and brittle bones (osteoporosis)– medicines called bisphosphonates can sometimes help
- diabetes– insulin and a special diet may be needed to control blood sugar levels
- nasal polyps and sinus infections – steroids, antihistamines, antibiotics or sinus flushes can help
- liver problems
- fertility problems – it’s possible for women with CF to have children, but men won’t be able to father a child without help from fertility specialists (see a doctor or fertility specialist for more advice)
4There is no cure for CF, but with improved treatment and management people with Cystic Fibrosis are living longer. It’s thought that children born with CF nowadays are likely to live to an average age of over 50 years old.
How we can help:
Randox Biosciences offer the Vivalytic with the Chronic Lung Disease cartridge, in combination with our intelligent Biochip Array Technology which detects 132 pathogens. The 132 species are simultaneously detected across this 320 Array including bacterial, viral, fungal targets and an antibiotic resistance marker from a single sputum sample!
For more information at info@randoxbiosciences.com or visit us at: wwww.randoxbiosciences.com
- https://www.cff.org/What-is-CF/About-Cystic-Fibrosis/
- https://www.blf.org.uk/support-for-you/cystic-fibrosis/what-is-it
- https://www.nhs.uk/conditions/cystic-fibrosis/
- https://www.nhsinform.scot/illnesses-and-conditions/lungs-and-airways/cystic-fibrosis
Randox / Bosch partnership delivers game-changing device in fight against antibiotic resistance
A partnership between Randox Laboratories, the UK’s largest manufacturer of in-vitro diagnostics, and the German technology giant Bosch is changing the way doctors will treat patients with antibiotics, with the launch of a revolutionary product – the Vivalytic.
It’s estimated that 20% of antibiotics currently prescribed are unnecessary, and fuel the growing threat of global antibiotic resistance. This threatens the ability to treat common infectious diseases, and a growing number are becoming harder, and in some cases impossible, to treat. The World Health Organisation warns that without action, we are heading towards a post-antibiotic era.
This problem is being addressed by the Vivalytic. The result of a decade of R&D, it is an intuitive point-of-care analyser that, depending on the complexity of the test, will deliver results from 30 minutes: enabling doctors to select the right course of therapy faster than before. In some cases, this will be life-saving.
The first tests available on the Vivalytic are Randox’s panels for respiratory and sexually-transmitted infections*.
Using Randox’s patented Biochip Array Technology, the Respiratory Multiplex Array simultaneously reports on 22 viral and bacterial pathogens including Bordetella pertussis and parapertussis which causes whooping cough – without the need for secondary or confirmatory testing to inform clinical treatment decisions. The STI array enables the detection of 10 STIs from a single sample. Every day more than 1 million STIs are acquired, and many have mild if any symptoms at all. Identifying these infections correctly first time reduces the misuse of antibiotics and supports their targeted use.
The Managing Director of Randox Dr Peter FitzGerald commented:
“Antibiotic stewardship is a critical issue which we all have a responsibility to embrace and drive forward. This partnership is ideal, combining our expertise in molecular laboratory diagnostics with Bosch’s cutting-edge engineering. The Vivalytic is a game-changer for clinicians and patients: never before has there been this level of accessibility to this range of molecular diagnostics.”
Marc Meier, General Manager of Bosch Healthcare Solutions, a wholly owned subsidiary of Bosch Group, said:
“We are enthusiastic about having gained Randox as the first partner on our platform with two initial panels available from the start. It´s the beginning of jointly expanding the Vivalytic test portfolio for our clients. In this partnership the core competencies of Bosch in automation, miniaturization, and networking are complemented by Randox’s expertise in developing and commercializing innovative diagnostic solutions.”
Vivalytic and the panels will be presented to industry professionals for the first time at the ECCMID 2018 Congress in Madrid, Spain, in hall 10, booth 55A between 21st – 24th April.
*CE pending and FDA planned.
For further information about the Vivalytic, please contact randoxpr@randox.com
Vivalytic: The all-in-one solution for Molecular Diagnostics
A game-changing partnership between Randox Laboratories and Bosch is changing the accessibility to molecular diagnostics with the launch of a revolutionary product – the innovative platform Vivalytic.
Using Randox-patented Biochip Array Technology, it is the easiest-to-use and most-comprehensive multiplex PCR platform on the market. It provides the broadest range of test options ever seen for an analyser of its size, and also supports single-plex and low-plex testing, simplifying the processes for otherwise-complex laboratory test procedures. Depending on the test application, results will be delivered from 30 minutes.
Biochip Array Technology, developed by Randox Laboratories, is the innovative multiplexing technology which is utilised within the cartridge aspect of the platform. The Biochip allows for the simultaneous detection of multiple analytes from a single sample.
The new platform will be initially released with two molecular arrays available including Respiratory Tract Infection and Sexually Transmitted Infection with other tests to follow.
The Vivalytic is the perfect fit for any laboratory with numerous benefits to enhance your laboratories testing capabilities.
Hygienic and space saving
No other peripherals such as laptop, keyboard, barcode scanner or filling stations are required. This makes Vivalytic a hygienic and space-saving all-in-one solution.
Direct and clear results
The test result is presented clearly in a summary, but also details on the raw data of each individual measurement can be displayed.
Protected system
The Vivalytic integrates the software with the instrument to ensure a safe and reliable run. This is the ultimate protection of the data and the valuable sample material.
Networked and combinable
Easy integration with popular standard IT systems makes test results instantly available. An analyser device can be networked and combined with several other devices so that multiple series of tests can be performed simultaneously. All devices are based on the same hardware and software, so that the product family can be expanded quickly and without major development effort.
28th European Congress of Clinical Microbiology and Infectious Diseases
Randox Laboratories will be attending the 28th European Congress of Clinical Microbiology and Infections from the 21st – 24th April 2018.
Our innovative diagnostic solutions have been developed with consolidation and economy in mind, providing cost savings whilst using pioneering technology.
Diagnostics is our passion. We are dedicated to developing solutions that not only meet your needs, but are of the highest quality, the most reliable and the most cost-effective. We look forward to meeting you in Madrid at IFEMA – Feria de Madrid to launch the Vivalytic at our stand 55A.
For further information, visit https://goo.gl/S2Yj2c or email info@randoxbiosciences.com
