Cross Border Collaboration delivers International Award for High Design Quality: Randox Discovery, The Benchtop Lab receives Red Dot Design Award
Cross Border Collaboration delivers International Award for High Design Quality: Randox Discovery, The Benchtop Lab receives Red Dot Design Award
Cross Border Collaboration delivers International Award for High Design Quality: Randox Discovery, The Benchtop Lab receives Red Dot Design Award
The Randox Discovery, an exciting and unique diagnostic analyser which can consolidate molecular and immunoassay testing on one compact benchtop platform, has received the 2021 Red Dot Award for High Design Quality.
Red Dot, which has become established as one of the top profile product design awards has roots dating back as far as 1955 and determines the best products created each year. Recognised as one of the largest global product competitions for innovation excellence, this sought-after seal for quality design attracts submissions from over 50 countries, across 49 different categories including medical devices and technology.
Dr Stuart Jackson, Randox Project Design Engineer, commented;
“Randox are delighted to have achieved the Red Dot design award, the culmination of five years of development and coordination of engineering design teams spanning two continents. The Discovery is a particularly unique innovation capable of automating Randox Biochip molecular diagnostics assays, from sample lysis and end-point PCR to multiplexing detection, with accessibility and ease-of-use at the forefront of the design.”
Dolmen were briefed by the Randox team to develop a creative and dynamic way to showcase the cutting-edge inner workings of the Discovery. Essentially, to turn the magic of the machine into a piece of theatre; not just a tool, but the centre of attention, a focal point for the lab that has excellent usability and accessibility throughout. Dolmen and Randox collaborated closely to deliver a revolutionary instrument that, amongst its many abilities, is a COVID-19 diagnostic analyser that is the first of its kind.
Chris Murphy, CEO and Design Director, Dolmen Design and Innovation, commented;
“We are delighted that our collaboration with Randox has delivered another Red Dot design award for our team. Randox as a team truly value the power of design and how it can deliver better outcomes for end users. It is also wonderful to see our designs delivering positive change at the frontline of the COVID pandemic. This project was hugely collaborative, and we look forward to more collaborations in the future.”
What makes the Discovery special is its ability to conduct the full testing process, inclusive of sample preparation techniques such as extraction, purification, amplification and detection, in one highly intelligent, fully integrated space. The preparation of COVID-19 samples before testing was once lengthy and time-consuming, requiring a separate, sterilized laboratory for each stage, but can now be conducted on-board and by the fully automated Discovery platform, allowing a single operator to run multiple molecular tests simultaneously.
Combining almost 40 years of diagnostics into one platform, bringing multiple labs into one the COVID-19 diagnostic analyser is the first of its kind to combine sample preparation techniques and Biochip Technology.
Professor Dr. Peter Zec, Red Dot CEO, commented;
“The winners of the Red Dot Award: Product Design 2021 were particularly impressive this year. The design of their products is excellent, in terms of both the aesthetic and the functionality. It’s not easy to prevail in such a strong field of competitors and to win over our jury. Consequently, I want to congratulate the laureates very sincerely on their success.”
For further information please email randoxpr@randox.com
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VIRAL RNA EXTRACTION KIT
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.
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SARS-CoV-2 (COVID-19) Antigen Testing Pilot Study from Randox Quality Control
SARS-CoV-2 (COVID-19) Antigen Testing Pilot Study
12 March 2020
SARS-CoV-2 (COVID-19) Antigen Testing Pilot Study
Randox, in partnership with QCMD, is pleased to announce a new QCMD EQA pilot study for SARS-CoV-2 (COVID-19) Antigen Testing. This new pilot is designed to evaluate a laboratory’s ability to detect SARS-CoV-2 (COVID-19) antigen and will provide an opportunity to assess performance against an international peer group.
QCMD is a world leading EQA / Proficiency Testing (PT) provider, dedicated to improving the quality of molecular diagnostic assays used in the detection of infectious diseases. With an extensive database of over 2000 participants in over 100 countries, QCMD is one of the largest providers of molecular EQA in the fi eld of infectious disease testing.
Features & Benefits
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Whole PathogenAvailability of whole pathogen samples containing the entire viral genome, ensures commutability with the majority of commercial assays.
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Smart-Phone App Results SubmissionResults can be returned via a smart-phone app so that participants using lateral flow devices can provide pictures of their device/result with the phone camera.
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Comprehensive ReportsA real-time rapid report will be provided on submission of results. An individual report is received after each challenge, summarising laboratory performance in comparison to an international peer group.
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EQA Management SystemIT EQA Management System (ITEMS) provides an online tool to easily manage all EQA activities from programme registration to submission of results and provision of EQA reports.
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Not infectiousSamples containing SARS-CoV-2 antigens are inactivated and not infectious ensuring safe handling of material.
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Suitable for Point of CareSamples are supplied liquid ready-to-use ensuring they are ideal for use at the point care.
For more information visit https://www.randox.com/qcmd-sars-antigen-testing/
For further enquiries please email marketing@randox.com
QCMD
QNOSTICS
CORONAVIRUS
Emerging SARS-CoV-2 variants: successful detection despite virus mutation
02 February 2021
Test performance not affected by mutation found in new UK, South African and Brazilian variants.
The new SARS-CoV-2 variants that have been identified recently in the UK (known as 501Y.V1, VOC202012/01 or B.1.1.7 lineage), South Africa (known as 501Y.V2 or B.1.351 lineage) and Brazil (B.1.1.248 lineage), contain multiple mutations in the segment of the virus’ genome that codes for the spike protein.
Of particular interest is a double deletion at position 69-70 of the spike protein gene (69-70del), observed in the B1.1.7 variant, which has been found to affect the performance of some diagnostic PCR assays that use an S gene target (S gene dropout).
Detection of SARS-CoV-2 using the multiplex RT-qPCR assay from Randox Laboratories Ltd. is not affected by the identified mutations. This kit is a fast and highly sensitive multiplex diagnostic solution containing the necessary components to provide the detection of two genes (ORf I ab, E gene) to reduce the impact of genetic variation in the SARS-CoV-2 genome. The multiplex primer mix in this assay allows the amplification of specific gene sequences found within the genome of the pathogen, covering all variants. Therefore, the mutations in the B.I.I.7, B.I.351 and B.I.I.248 lineage variants do not affect the detection of SARS-CoV-2 by the PCR test.
Randox Laboratories Ltd. monitors SARS-CoV-2 variants in NCBI and GISAID databases and performs bioinformatics analysis regularly. Based on in silico analysis the performance of the test is not impacted by the mutations.
The Randox multiplex RT-qPCR diagnostic kit supports clinical and public health laboratories to quickly diagnose COVID-19 caused by SARS-CoV-2 infection, assisting the screening and isolation of individuals that require quarantine and immediate intervention.
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Extraction | Viral RNA Extraction Kit
Extraction | Reagent Kit
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Viral RNA Extraction Kit
Designed to enable Automated Purification
- Extracts viral total nucleic acid (RNA) from nasal/throat swabs following brief lysis steps
- 200µl of sample from the nasal/throat swab required for analysis
- Universal kit which can be used for the efficient and automated purification of nucleic acid material
- Kit includes Lysis buffer, Proteinase K and Elution buffer material suitable for the extraction
- Yields highly concentrated nucleic acids that are ready to use in downstream applications such as qualitative or quantitative PCR
- Automated nucleic acid extraction platform available from Randox
The Randox Viral RNA Purification kit is designed for the optimal automated extraction of total nucleic acid (RNA) from nasal/throat samples.
Viral nucleic acid extraction is a critical step in infectious disease testing. Nucleic acid-based detection of viral pathogens requires the extraction of RNA allowing simultaneous detection of any viral infection.
Randox also offer a range of COVID-19 testing solutions including Molecular and Point of Care platforms along with RT-qPCR assays, Quality Controls and EQA schemes.
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Randox unveils SARS-CoV-2 antibody test to determine previous COVID-19 infection in just 1.5 hours
21st December 2020
Randox unveils SARS-CoV-2 antibody test to determine previous COVID-19 infection in just 1.5 hours
Randox Laboratories is proud to announce the launch of its new SARS-CoV-2 IgG test, utilising patented Randox Biochip Technology to simultaneously detect IgG antibodies that are reactive to both of the leading COVID-19 diagnostic antigens – Spike Receptor Binding Domain (RBD) and Nucleocapsid protein (NP).
Maximum test sensitivity is ensured through simultaneous detection of both RBD-only and NP-only responders, making it superior to current commercially available COVID-19 IgG tests that are based on RBD or NP alone, from which false negative results can occur.
The Randox SARS-CoV-2 IgG (RBD & NP) Array provides clinicians with an opportunity to discriminate vaccinated individuals from those naturally infected by COVID-19.
Lynsey Adams, Randox Clinical Marketing Manager commented;
“When there is little or no access to molecular testing, serology tests provide a means to quickly triage suspected cases of COVID-19, enabling appropriate case management, and guiding public health measures, such as quarantine or self-isolation.
“The new Randox SARS-CoV-2 IgG (RBD & NP) Array, provides a unique insight into disease severity, is an established method of indirect disease diagnosis, and facilitates epidemiological surveillance as the COVID-19 pandemic progresses.”
The Randox SARS-CoV-2 IgG (RBD & NP) Array has been developed for the Evidence Investigator, a semi-automated benchtop immunoassay analyser delivering accurate results in just 1.5 hours.
Features of the new Randox SARS-CoV-2 IgG (RBD & NP) Array
- Utilises established diagnostic antigen candidates – RBD and NP
- IgG measurement confirms adaptive immune response to SARS-CoV-2
- Clinical specificity of 99.5%
- Clinical sensitivity of 100% ≥ 14 days post SARS-CoV-2 PCR confirmation
- Dual sample matrix: human serum/plasma.
Contact marketing@randox.com for further information on our latest SARS-CoV-2 array or click to find out more!
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COVID-19 | qPCR Assay
COVID-19 | qPCR Assay
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Detecting SARS-CoV-2 (COVID-19)
Accurate PCR Detection of SARS-CoV-2
- Validated for use on either the Applied Biosystems™ QuantStudio™ 5 (0.2 mL 96 well block) or Applied Biosystems™ 7500
- High throughput: 96 samples including controls from extraction to analysis from automated nucleic acid isolation
- CE marked assay detecting all known SARS-CoV-2 variants of concern
- Multiplex PCR assay accurately detecting both SARS-CoV-2 (ORF1ab) and Sarbecovirus (E-gene)
- Rapid turnaround time & PCR run time of 70 minutes
- High sensitivity and specificity with 98% agreement. Low LOD: 250 copies/mL
Randox Laboratories have recently developed a COVID-19 qPCR assay, which can be used for the detection of nucleic acid from SARS-CovV-2 (ORF1ab) and Severe Acute Respiratory Syndrome ((SARS)/SARS-like) viruses (E-gene). PCR based assays are recommended to include two tests. One to detect a universal SARS-like gene and a secondary confirmatory test for gene sequences exclusive to SARS-CoV-2.
In a multiplex format, the Randox qPCR assay allows for differentiation of SARS-CoV-2 and SARS-like corona infections from other seasonal respiratory illnesses caused by viruses to prevent rapid spread of infection through the isolation of positive cases.
Our assay is compatible with sample matrices including nasal / throat swabs. This test is intended for use in the clinical setting as an aid in the screening and isolation of individuals that require quarantine and immediate intervention.
Internal control provided to monitor assay/sample integrity through the extraction and PCR process.
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Whole pathogen multiplex controls to support testing for cold, cough and COVID
27 October 2020
Whole pathogen multiplex controls to support testing for cold, cough and COVID
Just in time for flu season, global diagnostics company Randox Laboratories has unveiled a range of whole pathogen multiplex controls that cover multiple viral and bacterial pathogens which cause respiratory disease.
Inclusive of SARS-CoV-2, Influenza A & B, and Respiratory Syncytial Virus (RSV), the Qnostics Multiplex Respiratory Pathogen Controls (RTX) facilitate diagnosis of the likes of cold and flu, and importantly, the differentiation of these respiratory diseases from COVID-19.
Using a control line that covers a range of respiratory pathogens in this way will allow laboratories to streamline their testing, consolidate QC, and ultimately save time, money and resource.
Lynsey Adams, Randox Quality Control Manager, explained;
“When the use of time and resources are critical such as in COVID-19 testing, the use of highly characterised controls enables laboratories to meet their daily QC needs and accreditation requirements.
“Accurate and reliable laboratory testing is an essential aspect of the management of COVID-19 and other respiratory diseases, so we are pleased to be able to offer these new controls which will crucially support the validation, verification and performance monitoring of molecular respiratory assays.”
The new RTX controls, which are whole pathogen for compatibility with the majority of commercial and in-house assays, are used to monitor the full testing process, from extraction to amplification and detection.
The Multiplex Respiratory Controls will support public health testing strategies during the incoming flu season and are suited for the test menus of most syndromic assays.
Lynsey continued;
“The Randox Qnostics Multiplex Respiratory Pathogen Controls are clinically relevant for full-process validation. Liquid frozen for user convenience and ease of use, the development of the controls using whole pathogen material ensures clinical relevance from extraction to amplification and detection.”
Randox Qnostics Multiplex Respiratory Pathogen Controls are manufactured to ISO 13485 standards and are in line with ISO 15189:2012 regulatory requirements.
Key Features and Benefits of the new RTX Controls:
- Whole pathogen controls – the controls contain the entire genome meaning they are compatible with the majority of commercial and in-house assays.
- Full process control – whole pathogen controls are the ideal material for full-process validation, monitoring the testing process from extraction to amplification and detection, to ensure ultimate quality assurance in laboratories.
- Highly characterised – Qnostics controls are quantified by digital PCR to ensure batch to batch reproducibility and are traceable to an internal reference preparation, to ensure metrological traceability of test results obtained by different diagnostic workflows.
- True Third Party – An independent, unbiased assessment of assay performance is ensured in line with ISO 15189:2012 regulatory requirements.
- Superior Manufacturing – Qnostics controls are manufactured under ISO 13485 guidelines to ensure quality and traceability.
- Liquid for Ease-of-Use – the controls are conveniently supplied in a liquid frozen format meaning there is no additional preparation or handling required.
For more information visit https://www.randox.com/molecular-infectious-disease-controls/respiratory-infection-testing/
For further enquiries please email marketing@randox.com
QNOSTICS
QCMD
CORONAVIRUS
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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Whole pathogen molecular controls for SARS-CoV-2 (COVID-19) receive CE marking
25 May 2020
Whole pathogen molecular controls for SARS-CoV-2 (COVID-19) receive CE marking
CE marking has been granted to whole pathogen quality controls for SARS-CoV-2 (COVID-19), from global diagnostics company Randox Laboratories.
The molecular controls are currently being used alongside the firm’s pioneering COVID-19 tests, performed on its proprietary Biochip, as part of a nationwide UK testing programme.
Randox is using these third-party quality controls, which include a Positive Control, Negative Control, Analytical Q Panel and Molecular Q Panel, to ensure accurate coronavirus test and system performance, and ultimately, guarantee laboratory quality assurance.
Lynsey Adams, Randox Quality Control Manager, explained;
“Accurate and reliable laboratory testing is an essential aspect of COVID-19 disease management and outbreak control.
“Designed specifically for laboratories currently managing COVID-19 testing, Randox SARS-CoV-2 controls, which have been CE marked, help ensure the accuracy and reliability of molecular assays used in the testing of suspected coronavirus samples, and importantly, give clinicians absolute confidence in any COVID-19 diagnoses they may make.”
Available under the brand name Qnostics, the new SARS-CoV-2 controls are manufactured using whole pathogens. They therefore mimic the patient sample, providing the best sample matrix for laboratories.
Lynsey continued;
“The Randox Qnostics SARS-CoV-2 controls are clinically relevant for full-process validation. Liquid frozen for user convenience and ease of use, the development of the controls using whole pathogen material ensures clinical relevance from extraction to amplification and detection.”
The new coronavirus controls from Randox, which contain the entire SARS-CoV-2 genome, including the conserved regions recommended by CDC and WHO, are compatible for use with both commercial and in-house testing methods, and are quantified by digital PCR to ensure batch to batch reproducibility.
Lynsey added;
“We are proud to be able to support the high demand for coronavirus testing by delivering a full COVID-19 testing package – not only our Coronavirus Biochips but now also the corresponding molecular control material that will ensure the delivery of accurate, and reliable results.
“The World Health Organization (WHO) has been very clear about the importance of testing in the global efforts to contain and delay COVID-19 and we are pleased that our new CE-marked controls comply with guidelines not only from the WHO but also from the Centres for Disease Control and Prevention.”
Randox Qnostics SARS-CoV-2 Controls are heat-inactivated to be non-infectious and are manufactured to ISO 13485 standards.
Key Features and Benefits of Randox SARS-CoV-2 Qnostics Controls:
- Whole pathogen – the controls contain the entire SARS-CoV-2 genome meaning they are compatible with the majority of commercial and in-house assays, and target the CDC and WHO consensus sequences
- Monitor the entire testing process – whole pathogen controls are the ideal clinically relevant material for full-process validation, from extraction to amplification and detection, to ensure ultimate quality assurance in laboratories.
- Non-infectious – the controls are heat-inactivated and gamma-irradiation enabling safe handling of material.
- Highly characterised – the controls are quantified by digital PCR to ensure batch to batch reproducibility.
- Clinically relevant – performance data is available to support the clinical relevance and the compatibility with molecular assays currently in use in clinical laboratories.
- High Quality – the controls are manufactured under ISO 13485 guidelines and are therefore suitable for a broad range of usage.
- Liquid for Ease-of-Use – conveniently supplied in a liquid frozen format meaning there is no additional preparation or handling required.
- Complete QC package – Analytical and Molecular Q Panels available for new assay validation as well as routine performance monitoring.
For more information visit www.randox.com/coronavirus-randox