Molecular diagnostics is known to have superior advantages for routine detection of infectious diseases and now has a very prominent place in clinical laboratories. Based on the principle of DNA/RNA amplification, molecular diagnostic techniques help in early diagnosis of infectious diseases, providing the added edge of excellent sensitivity and specificity. However, this technique has, thus far, been limited to centralized laboratories due to dependency on complex and expensive infrastructure, highly skilled manpower, special storage conditions and a need for batch testing. This results in high turn-around time and poses major logistics challenges, such as sample degradation, contamination, report delays, etc.
Molbio Diagnostics Pvt Ltd has developed and commercialized Truelab™, a commercial point-of-care (POC) molecular diagnostics platform that uses PCR technology with Truenat test chips. Truenat™ disease-specific test chips are available for the diagnosis of 22 infectious diseases (such as TB, H1N1, dengue, HIV, hepatitis, etc) and an additional 43 diseases (such as coronavirus, MERS, etc) are in the pipeline.
The Truelab™ platform, a global first, is a compact, battery-operated system, with single testing capability and provides sample-toresult times within 1 hour. Hence, it enables same-day reporting and initiation of evidencebased treatment for the patient. Doctors benefit from this technology by having a definitive diagnosis, early in the infection cycle, without patients/samples having to travel extensively to centralized facilities.
The Truenat™ assay is rapid and affordable with minimal infrastructure requirements. Thus, placing the Truelab™ multi-disease detection system in the most remote settings will enable mass access to advanced molecular testing for people of all socio-economic backgrounds, across the globe. The device has real-time data transfer capability (through SMS/email) for immediate reporting of results in emergency cases. Additionally, a cloud-based centralized data monitoring and surveillance network can be created and linked to all devices in a region. Complete data from tests performed can be accessed, analysed and recorded in real time. Such same-day reporting of results will strengthen the healthcare systems across countries by improving effectiveness of providing treatment and quarantining of patients, thus controlling spread of communicable diseases. The device is ideal for places that do not get regular electricity, and will work well even in primary healthcare centres, unlike other devices that require uninterrupted power supply, elaborate infrastructure and air-conditioning.
Molbio’s technology has been approved by the Indian Council of Medical Research in 2018, after 3 years of validation study across various sites in India. Internationally, the World Health Organization (WHO), after conducting a multicountry study, has released a rapid communication in January 2020 endorsing Truenat™ as an initial diagnostic test of Mycobacterium tuberculosis (MTB) and MTB-RIF (MTB rifampicin resistance) in view of its high diagnostic accuracy. The WHO has further endorsed Truenat™ for diagnosis of TB as a replacement of the less sensitive sputum smear microscopy. The performance of Truenat™ shows comparable accuracy with other WHO approved tests such as Genexpert, TB-LAMP® and line probe assay. Truenat™ will help in decentralizing and democratizing access to high quality diagnostics to millions of patients suffering from TB and other infectious diseases even at peripheral and remote settings.
At present, Truelab™ devices are installed in over 500 private laboratories, 350 government primary health centres in India and in 27 countries around the globe, extending across the continents of Asia, Africa, Europe and South America. WHO endorsement will further enable the product to be commercialized across more than 150 countries.
Truelab™ is patented across over 100 countries which enables the transition from presumptive to efficient, real-time and precise diagnosis of multiple diseases at reasonable price even in primary healthcare centres and smaller diagnostics labs, which can now deliver high-end molecular diagnostic tests.
Molbio Diagnostics is driven by the urgent need to provide world-class medical devices to enable better medicine through precise, faster, cost effective diagnosis and envisions to be a leading global player in the POC diagnostics segment by continuing to innovate and bring new technologies for social betterment.
In addition, given the current coronavirus pandemic, Molbio is pleased to announce that the Truenat™ Beta-CoV POC RT-PCR test is currently being validated through a regulatory process and is expected to be commercially available in the next couple of weeks. This rapid, portable, POC solution will enable molecular testing for COVID-19 to be performed even at the community level and will provide results within 1 hour from sampling.
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Point-of-care blood gas system
, /in Product News /by 3wmediaSiemens Healthineers recently announced the new RAPIDPoint 500e blood gas system, their latest
solution in critical point-of-care testing. The new system generates blood gas, electrolyte and metabolyte results used to diagnose and monitor critically ill patients typically in the intensive care unit, operating room or emergency room. The RAPIDPoint 500e blood gas system is available now in all countries requiring the CE mark. Developed with extensive customer feedback, the system is designed to elevate confidence in patient results with Integri-sense technology, streamline workflow with improved simplicity and raise the bar in data security. Cybersecurity is becoming a key operational factor. Health-care providers must protect confidential operator and patient information.
The RAPIDPoint 500e blood gas system incorporates Integri-sense technology, a comprehensive series of automated functional checks designed to deliver accurate test results at the point-of-care. Integri-sense technology combines three levels of automatic quality control (AutomaticQC), multiple calibration routines and advanced software algorithms to generate reliable and clinically actionable test results. It also integrates seamlessly into hospital networks with the Siemens Healthineers Point of Care Ecosystem which offers convenient, remote management of operators and devices located across multiple sites.
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Centrifuge with full colour touchscreen
, /in Product News /by 3wmediaFeaturing an ergonomically enhanced, novel industrial design complemented by a wide range of rotors, the Thermo Scientific general purpose Pro Centrifuge Series has been developed to deliver a safe and regulatory-compliant benchtop separation solution to meet an array of application needs, from clinical protocols and cell culture procedures to microplate processing. The series has been equipped with an advanced touchscreen interface that gives users easy access to prestored protocols, temperature control and system health checks to improve productivity and reduce time spent performing manual maintenance. The general purpose Pro Centrifuge Series provides scientists with: a unique glass touchscreen that facilitates a simpler user interface for immediate, effortless workflow and operation monitoring, and easy cleaning; an ergonomically enhanced industrial design that enables the quick and safe change of any of its 19 rotor types in just three seconds through its Auto-Lock rotor exchange function; superior sample capacity, performance and bio-containment through its Fiberlite carbon fibre rotors and ClickSeal biocontainment lids; a compact separation solution fea-turing connectivity-ready technology, while optimizing benchtop space. The ge-neral purpose Pro Centrifuge Series meets global compliance standards and includes the Thermo Scientific Sorvall, Thermo Scientific Multifuge and Thermo Scientific Megafuge configurations, which can be easily configured with a selection of rotors to address a range of application needs.
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Total solution for lipid and cardiac risk testing
, /in Product News /by 3wmediaCardiovascular disease caused by atherosclerosis is the leading cause of morbidity in Western Countries [1]. It involves the hardening and narrowing of vessels in the systemic system. The process originates from the build-up of fatty deposits through a process known as atherogenesis. If the build-up increases, plaque rupturing may occur leading to myocardial infarction [2].
The mission of The National Lipid Association (NLA) is “to enhance the practice of lipid management in clinical medicine.” NLA advocates advancing the current lipid testing profile as the traditional panel consists of testing LDL cholesterol (LDL-C), HDL cholesterol (HDL-C) and triglycerides, which only detects approximately 20 % of all atherosclerotic cardiovascular disease patients. Advanced lipid testing is recommended to optimize patient treatment [3].
Offering a total solution for lipid and cardiac risk testing, Randox has developed novel and superior performance markers to identify the true weight of lipid profiling. Its range of niche and superior performance assays comprises 13 assays including: small dense LDL-C (sdLDL-C), Lipoprotein (a) (Lp(a)) and HDL3-C.
sdLDL-C will more readily permeate the inner arterial wall having a lower affinity to the hepatic LDL-C receptor which circulates in the blood longer and more susceptible to oxidation.
As sdLDL-C is particularly atherogenic, a person with elevated sdLDL-C levels has a 3-fold increased risk of myocardial infarction [4].
Elevated Lp(a) levels are associated robustly and specifically with increased cardiovascular disease (CVD) risk. The unique Randox Lp(a) assay is one of the only methodologies on the market that detect the non-variable part of the Lp(a) molecule which suffers minimal size related bias.
HDL3-C is the scavenger of cholesterol within arterial walls and if HDL3-C levels are significantly depleted, the ability to remove this cholesterol is reduced. Therefore, it is widely accepted that there is an inverse correlation between HDL3-C and CVD risk.
It is necessary to review the traditional lipid testing panel, enabling clinicians to gain a more comprehensive view of a patient’s CVD risk and therefore take the appropriate
measures to prevent CVD related deaths.
References
1. Burnett JR. Lipids, lipoproteins, atherosclerosis and cardiovascular disease. Clin Biochem Rev 2004; 25(1): 2 [cited: 3 December 2018]. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1853363/.
2. Zimmermaann KA. Circulatory system: facts, function & diseases. Live Science [Online] 16 March 2018 [cited: 3 December 2018]. https://www.livescience.com/22486-circulatory-system.html.
3. National Lipid Association. National Lipid Association releases updated recommendations on the use of PCSK9 inhibitors at the 15th Annual Scientific Session. [Online] no date [cited: 3 December 2018]. https://www.lipid.org/nla/national-lipid-association-releases-updated-recommendations-use-pcsk9-inhibitors-15th-annual.
4. Austin MA, Breslow JL, Hennekens CH, Buring JE, Willett WC, Krauss RM. LDL subclass patterns and risk of MI. JAMA 1988; 260(13): 1917–1921.
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AMSBIO has expanded its range of cfPure Cell Free DNA Purification Kits
, /in Product News /by 3wmediaAMSBIO has expanded its range of cfPure™ Cell Free DNA Purification Kits for rapid and efficient isolation of circulating cell free DNA (cfDNA). A new cfPureMax kit is now available for use on samples of 5 ml volume or greater.
AMSBIO cfPure kits use silica-coated paramagnetic particles to purify cell free DNA from less than 1 ml to greater than 10 ml of serum or plasma. The buffers were developed to ensure efficient recovery of 100-500 bp DNA fragments in order to maximize recovery of cell free DNA. The recovered DNA is suitable for a wide range of down-stream applications, such as bisulfite sequencing, NGS, and qPCR.
The cfPure protocol is rapid and easy, allowing users to process several samples in an hour or less and making it ideal for biomarker screening. Using proprietary silica-coated magnetic bead technology, cfPure kits are able to efficiently recover low molecular weight cell free DNA during isolation – a key success factor for successful analysis of cfDNA. Designed for scalability, cfPure kits enable you to use just the number of beads and amount of reagent that you need for your cfDNA extraction. This also means that the number of extractions per kit is dependent on the amount of sample you wish to purify DNA from.
In addition to being easy to perform, scalable and easy to automate, cfPure kits allow you to use less magnetic bead solution if you are purifying small amounts of plasma – saving you money.
Since cfDNA is typically found at very low concentrations and in a fragmented state, very efficient DNA capture, as provided by AMSBIO’s cfPure Cell Free DNA Purification Kits, is vital to provide sensitive and reliable results.
For more information, visit www.amsbio.com/circulating-cell-free-DNA.aspx
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Euroimmun releases flexible laboratory management software
, /in Product News /by 3wmediaThe EUROLabOffice 4.0 system provides a flexible central interface in the diagnostic laboratory, ensuring efficient workflow for many different applications and requirements. The software encompasses indirect immunofluorescence, ELISA, chemiluminescence, immunoblot and microarray analyses in autoimmune, infection, allergy and molecular genetic diagnostics. Continuous data exchange with the LIS and instruments ensures that all processes run smoothly, making the system suitable for random access applications. The software is simple and intuitive to operate, with no unnecessary manual steps, thus saving time and reducing workload for laboratory staff. The clear user interface makes it ideal for all workplaces, including the laboratory, microscopy room and office. Predefinable workflows and automatically created protocols ensure efficient organisation of the daily workload and thus faster generation of results. The software incorporates fully automated evaluation of indirect immunofluorescence results, including pattern recognition for antinuclear antibodies (ANA, based on the ICAP consensus) and anti-neutrophil cytoplasmic antibodies (ANCA). For Crithidiae luciliae (CLIFT), cell-based assays (e.g. anti-neuronal antibodies) and antigen dots (EUROPLUS), the system offers clear positive/negative classification. Furthermore, the program provides titer estimations with confidence values. The software consolidates all results into one report per patient, which includes the patient’s complete history and all images. Different user levels provide a hierarchical review of results, thus increasing security. After the verification procedure, result reports can be signed electronically and forwarded at the click of the mouse or exported into an existing LIS. Patient data, customer details and article information are all administered and archived by the system, ensuring a streamlined laboratory routine.
For more information, visit: www.euroimmun.com
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Porvair Sciences expands range of black microplates
, /in Product News /by 3wmediaPorvair Sciences has expanded its range of high quality, black microplates that minimise sample degradation by exposure to light, even over long storage periods.
Available in a choice of 48-, 96- and 384-well formats – the black plates are precisely manufactured to applicable ANSI / SLAS dimensions ensuring complete compatibility with almost all readers and automated equipment. Manufactured from polypropylene, the range of black microplates offer excellent heat and solvent resistant qualities. Using only ultra-pure grade polymer means that each black plate has near zero leachates ensuring long-term sample integrity. The black plates are supplied RNase / DNase free meaning they can be used to store the most sensitive biological samples. To prevent evaporation, hydration of DMSO solutions and to completely eliminate light from samples – Porvair Sciences additionally offers a selection of Absorb Max light blocking sealing films that may be applied to the top of the black plates. A split backing and edge cut-outs make positioning and applying the sealing film quick and simple. The light-blocking and absorbing properties of Porvair Sciences black microplates, used in conjunction with Absorb Max sealing films, provides a perfect combination for protecting light-sensitive assays or samples during storage.
For more information, visit: www.microplates.com/solid-bottom
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GE Healthcare Life Sciences releases software for cell therapy workflow
, /in Product News /by 3wmediaGE Healthcare Life Sciences continues to build out its flexible solutions across the cell therapy workflow with the commercial availability of SpinOculation C-Pro Protocol Software. Part of the Sepax™ C-Pro Cell Processing System, the software closes and automates the cell transduction step. When used in combination with the Sepax C-Pro instrument and CT-60.1 single-use kit, the software enables users to choose the volume and cell concentration from initial cell preparation through transduction to final resuspension, without compromising cell viability and virus stability.
Catarina Flyborg, General Manager, Cell and Gene Therapy, GE Healthcare Life Sciences, said: “Cell therapy manufacturing is complex and requires advanced technologies.
The SpinOculation C-Pro software application automates and simplifies a critical step in the cell therapy workflow and helps accelerate the development of next generation therapeutics.” Additionally, the SpinOculation C-Pro Protocol helps users:
The SpinOculation C-Pro application software is available worldwide.
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Colourful, stretchable silicon lids securely cover open beakers and bottles
, /in Product News /by 3wmediaUsing aluminium foil or plastic wrap to cap beakers and flasks has always been a quick fix with questionable effectiveness. In an effort to provide lids that are safe and easy to use, DWK Life Sciences, a leading manufacturer of precision labware, has developed KIMBLE® Silicon Lids that stretch and conform to beaker tops for a tight and secure seal.
Available in three sizes and three colours, KIMBLE Silicon Lids easily conform to fit on beakers, flasks, bottles and cylinders. The stretchy silicone material creates a seal on spouts, beaded tops or threaded necks on glass or plastic vessels. The lids are resistant to heat and chemicals and designed with tabs, so they are easy to put on or take off, even when wearing gloves. Dishwasher-safe and reusable, the lids are a sustainable solution for environmentally conscious labs. The lids come in bright colours for easy colour coding.
“We’ve been surprised with the popularity of these unique covers – we knew they were safe, secure and provided a better seal for different laboratory containers, but we were just as happy to see how scientists liked their appearance – they’re using the lids to improve the appearance of the labs by replacing makeshift foil caps and stoppers with bright colours,” said Rick Schwartz, Senior Vice President of Marketing and Sales at DWK Life Sciences. “There is currently no other lab grade product available that remotely resembles our lids.”
KIMBLE Silicon Lids have stretchable diameters; small 43 to 61 mm diameter, medium 64 to 76 mm diameter, and large lids are 84 to 116 mm diameter. Colour choices include pink, green and blue. Lids easily accommodate most 50 ml beakers up to 800 ml beakers. The silicon is resistant to most chemicals and withstands heat with a usable temperature range of 40°C to 180°C. KIMBLE Silicon Lids are sold individually or in packages of 3 containing a small, medium and large sized lid in each package.
For more information, visit: https://dwk.com/colorsplash
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Ziath’s 2D-barcoded cryogenic tubes set a new standard
, /in Product News /by 3wmediaThe Ziath range of CryzoTraq™ 2D-barcoded cryogenic tubes set a new standard for cryogenic storage of biological specimens at temperatures as low as -196°C.
Worldwide biobanks and biorepositories support many types of life science research including Genomics and Personalized Medicine. To ensure the integrity and viability of specimens stored in these sample storage facilities over long periods of time, the specimens are placed in a sterile storage tubes and immersed in vapor phase Liquid Nitrogen. Leak-free cryogenic tubes are therefore of utmost importance to ensure sample integrity. Produced using an innovative 2-stage injection moulding process the caps on CryzoTraq tubes deliver outstanding leak resistance. This high integrity closure on CryzoTraq tubes ensures that the sample cannot leak out and conversely that no contaminants can enter the tube. This is vitally important because if the specimen is contaminated, it is rendered useless for further research.
To ensure full sample traceability, all CryzoTraq tubes have a 2D datamatrix barcode inserted in the base of the tube. The insert is secured in place by the use of ultrasound to weld it into place. During this manufacturing process, a linear barcode is printed onto the side of the tube first, and the 2D code is automatically generated from the linear barcode therefore ensuring the two barcodes will always be the same with no errors.
Available in 2 ml and 5 ml volumes, CryzoTraq tubes are certified free from DNA, DNase, RNase, pyrogens and ATP. Each lot is sterilized with electron beam radiation. CryzoTraq tubes are manufactured from medical grade polypropylene and the caps from medical grade polyethylene.
To enable fast and precise decoding of the 2D-barcodes on CryzoTraq tubes, Ziath offers its high performance DataPaq™ Multirack and Cube scanners.
For more information, visit: www.ziath.com/index.php/products/tubes/ cryzotraq-tubes-and-racks
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Molecular diagnostics platform for fast and point-of-care disease diagnosis
, /in Corona News, Product News /by 3wmediaMolecular diagnostics is known to have superior advantages for routine detection of infectious diseases and now has a very prominent place in clinical laboratories. Based on the principle of DNA/RNA amplification, molecular diagnostic techniques help in early diagnosis of infectious diseases, providing the added edge of excellent sensitivity and specificity. However, this technique has, thus far, been limited to centralized laboratories due to dependency on complex and expensive infrastructure, highly skilled manpower, special storage conditions and a need for batch testing. This results in high turn-around time and poses major logistics challenges, such as sample degradation, contamination, report delays, etc.
Molbio Diagnostics Pvt Ltd has developed and commercialized Truelab™, a commercial point-of-care (POC) molecular diagnostics platform that uses PCR technology with Truenat test chips. Truenat™ disease-specific test chips are available for the diagnosis of 22 infectious diseases (such as TB, H1N1, dengue, HIV, hepatitis, etc) and an additional 43 diseases (such as coronavirus, MERS, etc) are in the pipeline.
The Truelab™ platform, a global first, is a compact, battery-operated system, with single testing capability and provides sample-toresult times within 1 hour. Hence, it enables same-day reporting and initiation of evidencebased treatment for the patient. Doctors benefit from this technology by having a definitive diagnosis, early in the infection cycle, without patients/samples having to travel extensively to centralized facilities.
The Truenat™ assay is rapid and affordable with minimal infrastructure requirements. Thus, placing the Truelab™ multi-disease detection system in the most remote settings will enable mass access to advanced molecular testing for people of all socio-economic backgrounds, across the globe. The device has real-time data transfer capability (through SMS/email) for immediate reporting of results in emergency cases. Additionally, a cloud-based centralized data monitoring and surveillance network can be created and linked to all devices in a region. Complete data from tests performed can be accessed, analysed and recorded in real time. Such same-day reporting of results will strengthen the healthcare systems across countries by improving effectiveness of providing treatment and quarantining of patients, thus controlling spread of communicable diseases. The device is ideal for places that do not get regular electricity, and will work well even in primary healthcare centres, unlike other devices that require uninterrupted power supply, elaborate infrastructure and air-conditioning.
Molbio’s technology has been approved by the Indian Council of Medical Research in 2018, after 3 years of validation study across various sites in India. Internationally, the World Health Organization (WHO), after conducting a multicountry study, has released a rapid communication in January 2020 endorsing Truenat™ as an initial diagnostic test of Mycobacterium tuberculosis (MTB) and MTB-RIF (MTB rifampicin resistance) in view of its high diagnostic accuracy. The WHO has further endorsed Truenat™ for diagnosis of TB as a replacement of the less sensitive sputum smear microscopy. The performance of Truenat™ shows comparable accuracy with other WHO approved tests such as Genexpert, TB-LAMP® and line probe assay. Truenat™ will help in decentralizing and democratizing access to high quality diagnostics to millions of patients suffering from TB and other infectious diseases even at peripheral and remote settings.
At present, Truelab™ devices are installed in over 500 private laboratories, 350 government primary health centres in India and in 27 countries around the globe, extending across the continents of Asia, Africa, Europe and South America. WHO endorsement will further enable the product to be commercialized across more than 150 countries.
Truelab™ is patented across over 100 countries which enables the transition from presumptive to efficient, real-time and precise diagnosis of multiple diseases at reasonable price even in primary healthcare centres and smaller diagnostics labs, which can now deliver high-end molecular diagnostic tests.
Molbio Diagnostics is driven by the urgent need to provide world-class medical devices to enable better medicine through precise, faster, cost effective diagnosis and envisions to be a leading global player in the POC diagnostics segment by continuing to innovate and bring new technologies for social betterment.
In addition, given the current coronavirus pandemic, Molbio is pleased to announce that the Truenat™ Beta-CoV POC RT-PCR test is currently being validated through a regulatory process and is expected to be commercially available in the next couple of weeks. This rapid, portable, POC solution will enable molecular testing for COVID-19 to be performed even at the community level and will provide results within 1 hour from sampling.
Read more