Autoantibodies in myositis: An upgrade for comprehensive serological testing

by Dr Jacqueline Gosink
The autoimmunogenic myositides (idiopathic inflammatory myopathies, IIM) constitute a group of systemic autoimmune rheumatic diseases that are characterized by chronic inflammation of muscles. Unfortunately, the general misdiagnosis rate is high resulting in a delay to diagnosis of several years. Moreover, a significant proportion of patients with IIM suffer from a generalized feeling of severe illness due to the damage caused by both the disease and its treatment. Autoantibodies are useful biomarkers to differentiate clinically indistinguishable subforms of IIM. Despite the low prevalences and isolated occurrence of many autoantibodies in IIM, they constitute the basis for serological diagnostics. The diagnostic information is maximized by employing comprehensive multiparametric assays covering both myositis-specific and myositis-associated autoantibodies.

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1 PRODUCT CHROMSYSTEMS

Chromsystems expands therapeutic drug monitoring by LC-MS/MS to 200 drugs

MassTox TDM Series A, Chromsystems’ unique modular system for therapeutic drug monitoring (TDM), has been extended to cover 200 drugs. The most recent extensions are additional neuroleptics and antimycotis, including bromperidol, caspofungin, isavuconazole, flupentixol and many others.
All 200 drugs can be determined with the same chromatographic setup and identical sample preparation. This eliminates the need for column switching or changes at the setup of the mass spectrometer, thereby helping to minimise workload in the laboratory for efficient drug monitoring by LC-MS/MS.
The system consists of the analytical column, the Basic Kit for sample preparation and chromatography as well as 13 individual parameter sets, which contain all relevant multilevel calibrators, quality plasma controls and internal standards.
For more information, visit: https://chromsystems.com
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Insight into mass spectrometry in clinical science and diagnostics

by Pauline Griffeuille and Dr Sylvain Dulaurent
Mass spectrometry (MS) can be combined with a number of chromatographic separation and ionization methods, which results in powerful technologies for both qualitative and quantitative molecular analysis. CLI caught up with Dr Bhattacharyya (Thermo Fisher’s Senior Manager for Clinical Research and Toxicology) to find out more about the past, present and potential future uses of MS in clinical science and diagnostics.

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5B PRODUCT UNIQSIS

Uniqsis introduces multi-experiment flow system for reaction optimization

The FlowSyn Multi-X from Uniqsis takes the drudgery out of reaction optimization – effortlessly converting batch chemistry methods to more efficient, higher yielding flow chemistry protocols.
Flow chemistry in microreactors offers many advantages over batch processing notably better reproducibility and scalability, improved yields and fewer problems with unstable intermediates or exothermic reactions.
The FlowSyn Multi-X uses an enhanced FlowSyn control interface to control either a single or a 4-rack fraction collector thereby enabling a sequence of experiments to be performed without the need for a separate PC. Capable of running unattended, it will perform up to 10 sequential experiments and collect the results as fractions or steady state samples allowing the user to vary the key flow-through parameters (stoichiometry, temperature and residence time) in each case.
The entry-level FlowSyn Multi-X system is compact with an integrated controller enabling the user to quickly explore or optimize reaction conditions. Setting up a series of experiments on the FlowSyn Multi-X system is easy – just follow three simple steps. First, set up a single ‘prototype’ reaction, then set up the fraction collector before selecting ‘Table View’ to edit individual experiments and then press ‘Start’ and walk-away.
The option of a Data Logging Software Package enables the FlowSyn Multi-X to both visualize data in real time and save pressure and temperature traces. Alternatively, the powerful FlowControl II system control software can be selected, which links via Wi-Fi and automatically saves complete experimental procedures with all data, including automation events. FlowControl II allows previous experiments to be reloaded and either viewed or repeated with or without modification.
To expand the capabilities of the FlowSyn Multi-X, additional pumps and reactor modules can be added and sequences of up to 100 individual experiments can be performed.
Designed by a team of experienced flow chemists and engineers, FlowSyn Multi-X is based upon the internationally popular FlowSyn, a fully integrated, easy to use continuous flow reactor for seamless reaction optimization and scale up from milligrams to hundreds of grams.
For more information, visit: www.uniqsis.com
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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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