Differentiating Viral from Bacterial Infections
Differentiating Viral from Bacterial Infections
Estimates claim that over 1.2 million people died in 2019 as a direct result of an antibiotic-resistant bacterial infection. Statistics show that up to 4.95 million deaths in the same year were associated with antimicrobial resistance (AMR)1. The overuse and misuse of antibiotics is considered to be the largest contributing factor to the rise of AMR. Antibiotics are effective at treating a wide range of bacterial infections, however, when used to treat viral infections, they have little to no effect. Even still, many physicians continue to prescribe so-called empirical antibiotics as an all-encompassing treatment strategy. In their defence, differentiating viral from bacterial infections can be troublesome. Traditional testing takes the form of paired serology, which requires patients to visit a healthcare facility twice during a 2–4-week period. Many of these infections have distressing symptoms, making this an unreasonable time-to-diagnosis period. Novel molecular techniques can reduce the time to result in the determination of many infections. However, some of these methods are associated with high false positive rates and low specificity resulting in further misuse of antibiotics.
Mxyovirus resistance protein A (MxA) is a biomarker associated with viral infections. It displays antiviral activity against positive, double-stranded RNA viruses and some DNA viruses2. In a study from earlier this year, MxA was used to differentiate viral from bacterial infections in a cohort of 61 adults with an AUROC of 0.9 and a sensitivity and specificity of 92.3% and 84.6% respectively3. An additional study, known as the TREND study, found that a cut-off of 430μg/L could effectively differentiate bacterial and viral infections with an AUROC of 0.9, a sensitivity of 92% and a specificity of 100%4.
C-reactive protein (CRP) is a non-specific acute phase protein which is associated with bacterial infection. However, CRP levels have also been shown to be elevated in response to various viral infections such as Influenza virus, malaria5 and SARS-COV-26, limiting its utility in differentiating the aetiology of an infection.
Using both biomarkers in combination can help physicians determine the true aetiology of infection with high specificity, supporting antimicrobial stewardship and reducing the harmful use of these drugs. Available on the VeraSTAT, Randox provides tests for MxA and CRP, which together provide a fast and accurate method of detection and differentiation of bacterial and viral infections from a small sample.
We have provided an educational guide which describes these biomarkers and their usefulness in the arena of viral and bacterial detection. If you’re interested in learning more, you can find our educational guide here.
Differentiating Viral from Bacterial Infections
Alternatively, don’t hesitate to browse our range on our website or get in touch with one of our team at marketing@randox.com who will be happy to help with any query you have!
References
- Murray CJL, Ikuta KS, Sharara F, et al. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. The Lancet. 2022;399(10325):629-655. doi:10.1016/S0140-6736(21)02724-0
- Liao S, Gao S. MxA: a broadly acting effector of interferon-induced human innate immunity. Visualized Cancer Medicine. 2022;3:2. doi:10.1051/vcm/2022002
- Metz M, Gualdoni GA, Winkler HM, et al. MxA for differentiating viral and bacterial infections in adults: a prospective, exploratory study. Infection. Published online February 3, 2023. doi:10.1007/s15010-023-01986-0
- Rhedin S, Eklundh A, Ryd-Rinder M, et al. Myxovirus resistance protein A for discriminating between viral and bacterial lower respiratory tract infections in children – The TREND study. Clinical Microbiology and Infection. 2022;28(9):1251-1257. doi:10.1016/j.cmi.2022.05.008
- Joseph P, Godofsky E. Outpatient Antibiotic Stewardship: A Growing Frontier—Combining Myxovirus Resistance Protein A With Other Biomarkers to Improve Antibiotic Use. Open Forum Infect Dis. 2018;5(2). doi:10.1093/ofid/ofy024
- Paranga TG, Pavel-Tanasa M, Constantinescu D, et al. Comparison of C-reactive protein with distinct hyperinflammatory biomarkers in association with COVID-19 severity, mortality and SARS-CoV-2 variants. Front Immunol. 2023;14. doi:10.3389/fimmu.2023.1213246
RX Imola: Inflammatory Biomarkers in COVID-19
Over the course of human history, few events have had such a dramatic impact as the COVID-19 pandemic. According to the World Health Organization (WHO), as of 12th July 2023, the SARS-CoV-2 virus has claimed almost 7 million lives and figures continue to rise1. While many who become infected are only subject to mild symptoms, those who develop a more severe form of the infection are encumbered with a debilitating flu-like condition, often requiring days, if not weeks of bed rest. In a paper from June 20232, the Rx Imola was used to study C reactive protein concentrations, along with other biomarkers, in mild and severe COVID-19 patients in order to develop novel risk stratification methods for this potentially life-threatening viral infection.
The impact on healthcare services around the world cannot be understated. In developed countries, access to services for both COVID-related and other conditions took a catastrophic hit. In low-to-middle-income countries, the impact has been even more distressing, all but eliminating basic medical care in favour of combating COVID-19, partly due to inferior resources and facilities3.
In times of medical emergency, it is crucial to have an efficient and effective means of stratifying the risk to patients and a process for suitably categorising those into the least and most at risk of severe complications or death. Due to the rate at which COVID-19 spread, unfortunately, the world lacked these mechanisms for SARS-CoV-2, resulting in mass hospital overpopulation, cancelled appointments for other life-threatening conditions and ultimately the staggering mortality statistics we’ve been bombarded with since January 2022. This prompted an unprecedented surge in medical research and major advances in testing capabilities, giving us new methods of detecting SARS-CoV-2 and determining the risk posed to individuals.
One such investigation, by Paranga et al., (2023) studied a total of 13 biomarkers to determine which could accurately differentiate mild, moderate, and severe cases and identify biomarkers which were good predictors of fatality2. C reactive protein (CRP) was the best-described biomarker relating to COVID-19 throughout the pandemic. This paper compares it to 12 other biomarkers including suPAR, sTREM-1, ferritin, MCP-1 and Lactate dehydrogenase. Of these, it was discovered that CRP was clearly the most effective biomarker for differentiating mild from severe cases, with concentrations in those with severe infection being, on average, 45% higher than in those with mild symptoms2. Additionally, the authors discovered that CRP levels were not significantly affected by age, a factor known to affect the inflammation and immune responses, providing a powerful and inclusive risk stratification tool. Some of the additional conclusions drawn from this paper can be seen below2:
- Lactate dehydrogenase, sTREM-1 and HGF were good predictors of mortality in COVID-19.
- suPAR was identified as a crucial molecule in characterising Delta variant infection and mortality.
- The initial values of inflammatory biomarkers were good to excellent predictors of disease severity in COVID-19 patients.
- Disease severity and mortality are associated with a higher rate of comorbidities including thrombocytopenia and other blood diseases, circulatory and respiratory system diseases and liver diseases such as cirrhosis.
So, what is CRP and how does it become elevated in response to a SARS-CoV-2 infection? CRP is a non-specific, acute-phase protein, meaning its concentration is altered in response to inflammation4. The acute respiratory distress syndrome induced by SARS-CoV-2 is, in part, a result of the hyperinflammation caused by the virus2. CRP is a well-characterised inflammatory biomarker and is therefore well-suited for identification and risk stratification in an emerging disease.
This investigation2 utilised the RX Imola, a rapid, comprehensive clinical chemistry platform, to quantify CRP. With the RX Imola, laboratories can gain access to the world’s largest clinical chemistry test menu covering routine chemistries as well as specific proteins, lipids, and more providing a cost-effective and user-friendly platform. With 60 cooled reagent positions and a sample carousel with 20 cooled positions for controls and calibrators, the RX Imola is an ideal solution for small to medium-throughput laboratories seeking an innovative and reliable clinical chemistry system. Randox also supplies suitable, high-quality reagents, and through Acusera, state-of-the-art controls and calibrators, completing the clinical chemistry portfolio.
References
1. World Health Organisation. WHO Coronavirus (COVID-19) Dashboard. https://covid19.who.int/.
2. Paranga TG, Pavel-Tanasa M, Constantinescu D, et al. Comparison of C-reactive protein with distinct hyperinflammatory biomarkers in association with COVID-19 severity, mortality and SARS-CoV-2 variants. Front Immunol. 2023;14. doi:10.3389/fimmu.2023.1213246
3. Jain P. Impact of COVID-19 Pandemic on Global Healthcare Systems and the role of a new era of global collaborations. Sushruta Journal of Health Policy & Opinion. 2021;14(3):1-5. doi:10.38192/14.3.2
4. Nehring S. C Reactive Protein . https://www.statpearls.com/articlelibrary/viewarticle/18744/.
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
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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
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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