Diagnosis and treatment of urinary tract infections

Expert opinions from Dr Ewan Chirnside
The diagnosis and treatment of urinary tract infections (UTIs) is currently a balance between starting empirical treatment immediately or waiting a minimum of 48|hours to begin treatment based on the results of pathogen identification and antibiotic susceptibility testing, which provides better antibiotic stewardship but prolongs patient suffering. As part of this issue’s focus on Urine Analysis, Dr Ewan Chirnside (Director of Research Collaborations and co-founder of ODx Innovations, Inverness, UK) shares his knowledge of UTI diagnostics.

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6C PRODUCT ATIK

Atik Cameras develops new cameras for qPCR instruments

In response to global demand for dependable technologies designed to optimize COVID-19 testing, Atik Cameras, specialist designer and manufacturer of advanced scientific imaging solutions, has developed the new VS255 and VS825 cameras for use specifically with quantitative Polymerase Chain Reaction (qPCR) instruments – the most commonly used systems for detection of the SARS-CoV-2 virus. These commercially-competitive, custom cameras, which mark the latest additions to Atik Cameras’ VS Series of scientific charge-coupleddevice (CCD) cameras, offer superior sensitivity and image quality.
“The camera of a qPCR instrument plays a key role at the amplification stage of the testing process, recording the fluorescent signals of the viral genetic material, with the greyscale version of the image being analyzed to generate either a positive or negative result,” explained Stephen Chambers, CEO at Atik Cameras. “With the paramount importance of the COVID-19 challenge, it was vital that Atik Cameras provided products that were well suited to the task. Drawing on our scientific imaging expertise, as well as our extensive research and development capabilities, we’ve developed the VS255 and VS825 cameras to offer Original Equipment Manufacturers (OEMs) and clinical diagnostic laboratories high-performing tools to facilitate the accurate diagnosis of active COVID-19 infections.”
The VS255 camera has been equipped with a wealth of features designed to maximize the diagnostic potential of qPCR instruments. Owing to its advanced cooling capabilities, the camera offers optimal sensitivity and image quality through the reduction of dark current. Image quality is further enhanced due to the camera’s binning capabilities combined with its pixel size. The VS825 camera is a bespoke, modified version of Atik Cameras’ Infinity camera, featuring integrated cooling capabilities alongside custom firmware and software.
For more information, visit: www.atik-cameras.com/product/atik-vs-range/
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Urine biomarkers for lupus nephritis: the road ahead

by Dr Samar Soliman and Prof. Chandra Mohan
Lupus nephritis is diagnosed with a renal biopsy. Unfortunately, a biopsy is invasive and cannot be serially repeated. Researchers are finding that proteins in the urine may have the potential to predict the ongoing pathology within the kidneys. Studies show that such urine biomarkers may have the potential to predict current and future disease outcome in this disease. Given that there may be many hundreds to thousands of proteins in the urine, how does one identify the most predictive of these candidates? Here we discuss three very different technologies that have contributed to this effort over the past year.

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Qnostics develops SARS-CoV-2 test controls

Qnostics, a world leading manufacturer of QC solutions for molecular infectious disease testing, has developed a range of products designed to support the validation, verification and performance monitoring of molecular assays used in the testing of SARS-CoV-2.
Conveniently combining SARS-CoV-2, Flu A, Flu B and RSV, the new RTX plus control is ideal for use with multiplex assays. A dedicated SARS-CoV-2 control is also available.
Comprising the full SARS CoV-2 genome, the control range is compatible for use with the majority of commercial and in-house assays. Whole pathogen controls are ideal for full-process validation, monitoring the testing process from extraction to amplification and detection, ensuring the ultimate quality assurance in laboratories.
Additionally, the third-party nature of these controls ensures an independent, unbiased assessment of assay performance in-line with ISO 15189 regulatory requirements. Supplied in a liquid easy to use format, minimal preparation is required. A complementary negative control is also available delivering a complete testing package.
For more information, visit: https://www.randox.com/sars-cov-2-molecular-control/
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Kynurenine pathway and Parkinson’s disease

by Dr Jia-he Bai, Prof. Yong-peng Yu and Dr Ya-li Zheng
The diagnosis of early-stage Parkinson’s disease (PD) is still a worldwide clinical problem: it is necessary to identify a biomarker to aid the diagnosis of early-stage PD. This article discusses the current worldwide research progress of kynurenine and PD, in order to provide new directions and ideas for clinical and scientific research.

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3 PRODUCT EFK

EKF launches PrimeStore MTM pathogenic sample collection and transportation kit

EKF Diagnostics, the global in vitro diagnostics company, has launched a PrimeStore MTM (molecular transport media) sample collection kit. This new kit enables convenient and safe collection, transportation and handling of pathogenic samples, including COVID-19 and influenza. Two kit configurations are now available: a postal sample kit ideal for home use and a multi-pack of sample kits suitable for on-site mass sampling. To meet growing demand for this sample collection device, EKF has increased its manufacturing capacity in the UK and mainland Europe.
Pathogenic samples stored in the FDA-cleared, CE-IVD marked PrimeStore MTM novel viral transport media, including SARS-CoV-2, are inactivated within minutes of collection. This allows such samples to be transported safely through the postal system or via courier and complies with UN3373 packaging regulations.
Furthermore, as samples are stable in PrimeStore MTM for seven days at ambient temperatures, this removes the need for all cold chain logistics during sample collection, transportation and storage. Thereby, preventing mishandled samples and making postal collection a realistic option.
The new sample collection kit pairs PrimeStore molecular transport media in a cryovial with a sterile flocked swab (for nasal and oral sampling) in a CE marked kit, which also includes a UN3373 95kPa compliant specimen collection bag, absorbent pad and instructions for use. In addition, the postal sample collection kit includes a UN3373 compliant postal box with security seal for sample return and postal pouch for collection kit delivery.
For more information, visit: www.ekfdiagnostics.com
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PESI-MS/MS method for testing oral fluid samples for suspected driving under the influence of drugs

by Pauline Griffeuille and Dr Sylvain Dulaurent
People driving under the influence of drugs do not only risk their own health but also endanger other road users. The results of the roadside tests performed by the police have to be double-checked in a laboratory, which is currently time consuming and costly. Here, a new testing method is described which provides results in a time- and cost-saving way using oral fluid samples.

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4 PRODUCT OXGENE

OXGENE introduces TESSA technology for robust, reproducible AAV manufacture at scale

OXGENE, a biotechnology company designing and developing scalable gene therapy technologies, has launched its scalable, plasmid-free manufacturing system for AAV. OXGENE’s new TESSA technology addresses industrywide challenges associated with robust and reproducible AAV manufacture at scale. These include high cost of goods and low packaging efficiency. TESSA aims to deliver a paradigm shift in scalable AAV manufacture.
Adeno-associated virus, or AAV, is a popular choice of viral vector to deliver gene therapies to patients, owing to its low immunogenicity, favourable safety profile and the ease with which it transduces numerous cell and tissue types. However, manufacturing systems have not kept pace with biological advances, leaving these therapies costly, difficult to produce at scale, and subject to inherent batch-to-batch variability. This represents a serious challenge to regulators and health authorities when it comes to approving these treatments for clinical use.
OXGENE’s TESSA technology overcomes manufacturing obstacles by taking advantage of AAV’s natural relationship with another virus – the adenovirus. In nature, AAV co-exists with adenovirus, which provides the ‘help’ AAV needs to replicate. However, as well as replicating the AAV, the adenovirus also replicates itself, leading to high levels of adenoviral contamination if this process is translated to an industrial context.
OXGENE has addressed these challenges by manipulating the adenoviral life cycle so that it can still provide high quality help for AAV replication, but is unable to manufacture itself, reducing adenoviral contamination by 99.9999% in a manufacturing run. Integration of the AAV rep and cap genes into the adenoviral vector means that everything required for AAV production, except the AAV genome, can be provided in a single viral vector. Meanwhile, the AAV genome can either be encoded within a second TESSA vector, in a plasmid, or within an AAV particle itself. Using two TESSA vectors improves yields of AAV2 by 40-fold, accompanied by a 2000-fold increase in particle infectivity compared to a standard three-plasmid manufacturing approach.
Once this first AAV seed stock has been produced, co-infecting cells with this AAV alongside another TESSA vector can further amplify the AAV in a simple, reproducible and scalable manner, removing the reliance on expensive and limiting plasmids for AAV manufacture.
OXGENE has so far developed and validated TESSA vectors for AAV2, 5, 6 and 9 and is now taking requests for service projects and product pre-orders to further develop and evaluate this technology.
For more information, visit: www.oxgene.com/TESSA
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7 PRODUCT SAKURA

Sakura Finetek Europe launches Tissue-Tek SmartConnect to enhance lab automation

Sakura Finetek Europe has launched Tissue-Tek SmartConnect – an automated transfer system that creates a continuous flow between the SMART solutions Tissue-Tek Xpress x120 Rapid Tissue Processor and Tissue-Tek AutoTEC a120 Automated Embedding System.
This SMART solution enables a laboratory to optimize their workflow and work more efficiently, eliminating repetitive and unnecessary manual work.
“Our team has done an outstanding job by creating this complex robotic solution in just two years with the high-quality Sakura Finetek is known for. We created a fully automated process, starting with grossed tissues as input to embedded blocks as output,” explained Andries Dragt, vice president, Strategy & Business Development. “This solution is a unique step towards future-proof pathology and enables lab technicians to spend more of their valuable time on what really matters.”
For more information, visit: www.sakura.eu/smartconnect
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8 PRODUCT MOGRIFY

Mogrify introduces EpiMOGRIFY platform to systematically identify epigenetic switches driving cell identity and cell maintenance

Mogrify, a UK company aiming to transform the development of ex vivo cell therapies and pioneer the field of in vivo reprogramming therapies, has launched EpiMOGRIFY. The platform models the epigenetic state of the cell to predict the switches important for cell identity, cell maintenance, directed differentiation and cell conversion.
EpiMOGRIFY is an extension of the Company’s proprietary direct cellular conversion technology, MOGRIFY, and enables the identification of the optimal culture conditions required to maintain cells in chemically defined media. This can be applied in cGMP manufacture and enhances directed differentiation or cell conversion to support the development of scalable off-the-shelf therapies for diseases with a high unmet clinical need.
EpiMOGRIFY combines gene-regulatory information with a model of a cell’s epigenetic landscape and leverages changes in the level of DNA-histone methylation (H3K4me3 modifications). The platform utilizes data from more than 100 human cell/tissue types (available via the ENCODE and Epigenome Roadmap consortia) to accurately define culture conditions that can maintain the cell identity or induce cell conversion.
The predictive power of EpiMOGRIFY has been validated in two ways: cell maintenance and differentiation. EpiMOGRIFY-predicted factors are able to maintain astrocytes and cardiomyocytes in vitro in chemically defined media and promote the generation of astrocytes and cardiomyocytes from neural progenitors and embryonic stem cells, respectively. In both cell maintenance and differentiation, EpiMOGRIFY defined conditions performed as well as or better in all cases when compared to existing undefined conditions, significantly increasing cell growth and survival, as well as resulting in a higher differentiation efficiency.
For more information, visit: https://mogrify.co.uk/science/#epimogrify
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