PRODUCT CLI EXOSOMICS

Exosomics implements PRODUCT NanoFCM’s NanoAnalyzer to provide advanced extracellular vesicles-focused research services

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PRODUCT CLI RANDOX

Randox unveils new coronavirus test at Medlab Middle East 2020

A ground-breaking test for the potentially fatal 2019-nCoV strain of coronavirus, is in the final stages of development at global health diagnostics company Randox Laboratories. The soon-to-be-launched test, developed on Randox’s patented Biochip Technology, will be available for immediate SARS-COV-2 testing, but an additional enhanced multiplex array will also include tests for other respiratory viruses which can display the same symptoms. The new enhanced Biochip will therefore allow clinicians to quickly and efficiently differentiate between potentially lethal and non-lethal infections.
Dr Peter FitzGerald, Managing Director of Randox Laboratories, commented; “Current technologies for the diagnosis of coronavirus are designed simply to detect the presence or lack of 2019-nCoV, and therefore neglect to differentiate between this strain and other respiratory infections. Whilst we’re very quickly developing an efficient novel test for this new strain of coronavirus, we are therefore also working on an extended Viral Respiratory Infection Array that will test simultaneously for 2019-nCoV and a range of other viruses. This will eliminate the need for multiple back-and-forth tests before the root cause of symptoms is found, and empower clinicians to make fast and informed decisions.” The test will be available for the Point of Care analyser, the Vivalytic, within 3 hours, and within 5 hours on the Randox Evidence Investigator. Benefits of the new Randox SARS-COV-2 test

  • Quick Turnaround Times (3 hours on Vivalytic and 5 hours on Evidence Investigator)
  • Multiplex array differentiates between mild and serious infection
  • Automated and Semi-Automated options available

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PRODUCT CLI EUROIMMUN

Compact random access analyser

The RA Analyzer 10 is a compact random access device which provides fully automated processing of chemiluminescence immunoassays (ChLIA) for autoimmune and infection diagnostics as well as antigen detection. It is ideal for use in small- to medium-sized laboratories, or to complement high-throughput-devices in large laboratories.
The device allows continuous loading, also as part of a laboratory track system, ensuring that every sample is processed with minimal effort as a single determination. Up to 85 results can be obtained per hour. EUROIMMUN ChLIA technology offers short reaction times, with first results in just 25 minutes. Test- and lot-specific information, including stored standard curves, is imported by means of RFID codes, enabling error-free and convenient loading, along with efficient and secure test evaluation. Automatic identification of samples and reagents by means of barcodes ensures complete traceability. The system offers preferential processing of emergency samples (STAT), giving laboratories unparalleled flexibility in their laboratory routine.
New CE-marked EUROIMMUN ChLIA for use on the RA Analyzer 10 are available for detection of antibodies against Borrelia (IgG, IgM) Epstein-Barr virus (EBV-CA IgG, IgM; EBNA IgG), proteinase 3 (PR3, IgG) and phospholipase A2 receptor (PLA2R, IgG). Further ChLIA for detection of antibodies against tissue transglutaminase (tTG, IgA), CCP (IgG), myeloperoxidase (MPO, IgG), parvovirus B19 (IgG, IgM), HSV-1 (IgG) and HSV-2 (IgG), as well as calprotectin and biomarkers in Alzheimer’s disease will be available soon. Assays for many other parameters are under development.
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PRODUCT CLI BOSCH

Multiplex assay for 10 STI’s receives CE mark

CE marking has been granted to one of the most comprehensive cartridge-based STI tests. The test, developed by the UK’s largest health diagnostics company, Randox Laboratories, tests simultaneously for 10 of the most common sexually transmitted infections, on the firm’s patented Biochip Technology. Quickly and efficiently testing for multiple STIs, which often have mild symptoms if any at all, ensures early diagnosis at a stage when treatment is most successful, supports the targeted use of antibiotics, and ultimately reduces their mishandling. Dr Peter FitzGerald, Managing Director of Randox Laboratories, commented; “Antibiotic stewardship is a critical issue which we all have a responsibility to embrace and drive forward. The CE marking of the STI assay, which incorporates Randox Biochip Technology, will be a game-changer for clinicians and patients across Europe, by facilitating early, accurate and comprehensive diagnoses of STIs that allows for the best possible patient outcome. Never before has there been this level of accessibility and speed with regards to STI testing.”
The Randox STI assay is performed on the Vivalytic system, an intuitive point-of-care platform, developed in partnership with German technology company Bosch that provides the broadest range of test options ever seen for an analyser of its size. Harnessing the application of multiplex assays to provide greater information from a single patient sample, the Vivalytic simplifies the testing process for otherwise complex laboratory testing procedures.
Marc Meier, Managing Director of Bosch Healthcare Solutions, a subsidiary of Bosch Group, said: “We are enthusiastic about partnering with Randox to offer their assay technology on the Vivalytic platform. The core competencies of Bosch in automation, miniaturization, sensor technology and connectivity are complemented by Randox’s expertise in developing excellent biocontent for a wide range of assays and commercializing innovative diagnostic solutions.”
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PRODUCT CLI DIASYS

DiaSys assay for cardiovascular disease, stroke Lp-PLA2 biomarker

Lp-PLA2 (Lipoprotein-associated phospholipase A2) is an inflammatory enzyme expressed in atherosclerotic plaques. It is determined as an additional and vascular specific biomarker to predict risk for cardiovascular disease and stroke.
Guidelines from four major international societies (European Society of Cardiology, American College of Cardiology, American Heart Association and American Society of Endocrinology) recommend measurement of Lp-PLA2 for risk stratification in asymptomatic adults.
The liquid-stable, enzymatic DiaSys test Lp PLA2 FS, which determines the activity of the enzyme Lp-PLA2 in serum and plasma, has been available for many years. The assay covers a wide measuring range up to 2000 U/L, offers outstanding onboard and calibration stability and shows excellent precision at clinical cut-off levels. No significant interferences are observed by endogenous compounds; frequently used drugs for dyslipidemia and atherosclerosis do not affect the test.
As no reference method or material for Lp-PLA2 has been available, DiaSys applied the scientifically proven traceability to the reagent specific molar extinction coefficient of 4 nitrophenol to their parameter Lp-PLA2 FS. By this proceeding, DiaSys Lp-PLA2 FS is directly traceable to the Lp-PLA2 reaction product 4-nitrophenol.
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PRODUCT CLI HARVARD

Diagnostics in your hand

Handheld electrochemical sensors are part of the daily routine for millions of people with diabetes around the globe who monitor their blood sugar levels with electric glucometers. While such sensors have revolutionized at-home medical testing for diabetics, they have not yet been successfully applied to diagnosing other conditions.
Sensors like glucometers detect glucose in blood based on the activity of an enzyme, and there are only a limited number of enzymes that can be used to sense biomarkers of human disease. An alternative detection strategy based on binding events between antibodies and their molecular targets have been investigated to expand the use of electrochemical sensors for medicine, but these sensors fall victim to the rapid accumulation of “fouling” substances from biological fluids on their conductive surfaces, which deactivate them. Existing antifouling coatings are difficult to mass-manufacture, suffer from quality and consistency issues, and are not very effective. Now, a new diagnostic platform technology developed by researchers at the Wyss Institute for Biologically Inspired Engineering at Harvard University known as “eRapid” enables the creation of low-cost, handheld electrochemical devices that can simultaneously detect a broad range of biomarkers with high sensitivity and selectivity in complex biological fluids, using as little as a single drop of blood. The technology is described in Nature Nanotechnology.
“As long as an antibody exists for a given target molecule, eRapid can detect it,” said co-author Pawan Jolly, Ph.D., a Senior Research Scientist at the Wyss Institute. “By solving the biofouling problem with a simple yet robust design, we are now able to easily mass-produce biochemical sensors for a wide variety of applications at low-cost.” The team demonstrated the commercial utility of this approach by creating a multiplexed sensor with three separate electrodes, each coated with the BSA/gold nanowire matrix and a layer of antibodies against a specific clinically relevant target molecule: interleukin 6 (IL6), insulin, or glucagon. When they incubated the sensor with the respective target molecules in undiluted human plasma, they observed excellent electrical signals with picogramper- mL sensitivity. Conversely, electrodes coated with a published “PEG-SAM” anti-fouling coating failed to produce distinct signals, indicating that they had been irreversibly fouled by off-target molecules in human plasma samples. In addition, the BSA/gold-nanowire-coated sensors can be washed and reused multiple times with minimal signal loss, allowing serial monitoring of biomarkers easily and at low cost.
Since then, the Wyss team has been able to detect more than a dozen different biomarkers ranging from 100 Da to 150,000 Da in size with eRapid, and they are continuing to experiment with conductive nanomaterials to optimize the electrode coating and the system’s performance, as well as reduce the cost even further.
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PRODUCT CLI MICROLUTE

Porvair Sciences sets a new standard for labs with Microlute Protein Precipitation Plate

Incorporating a novel dual hydrophobically treated matrix filter, Microlute Protein Precipitation Plate from Porvair Sciences sets a new standard for labs looking to remove interfering proteins from serum, plasma or whole blood samples prior to analysis by Liquid Chromatography / Mass Spectrometry (LC/MS). Biological samples commonly contain proteins that interfere with downstream applications such as LC/MS analysis. Microlute Protein Precipitation Plates (PPP) use the CRASH method, in which protein is denatured with acetonitrile and the flocculant filtered out, allowing 96 samples to be processed in parallel. Based on the industry standard MicroLute format, but without the chromatographic sorbent, protein ‘crashes’ out of solution and precipitates directly in each well when acetonitrile is added, thus solving all common problems associated with the CRASH technique of protein cleanup. The novel dual frit, hydrophobically treated matrix used by the Microlute PPP means that there is no ‘wetting out’ and leakage of sample before the application of vacuum. Due to its ease of use, high performance and reliability the Microlute PPP is commonly used as the protein precipitation plate of choice in many major pharmaceutical companies worldwide. Established in 1992, Porvair Sciences is one of the largest global manufacturers of ultra-clean microplates and top-quality microplate equipment for life science, synthetic chemistry and many other applications.
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iMLayer

Revolutionary sample preparation for MS imaging

Shimadzu’s iMLayer boosts spatial resolution for MS imaging experiments. It enables reproducible matrix coating with small crystals and minimizes delocalization effects. Get a crystal clear view of microstructures in your sample.
Features

  • Creation of fine matrix crystals by unique matrix vapor deposition technology (sublimation) enabling high resolution MS imaging experiments
  • Minimized delocalization effects compared to conventional spraying method due to sublimation technique
  • Good reproducibility through automated matrix layer thickness control
  • Simple touch pad operation making the easy-to-use standalone instrument a sample preparation tool for any MS imaging experiment

For information please click here.
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Amino Acid Analysis

New Assay Amino Acid Analysis (AAA) by LC-MS/MS

The new assay MassChrom® Amino Acid Analysis (AAA) from Chromsystems is designed for the quantitative determination of 48 amino acids in plasma/serum. It is CE0123-IVD certified and can be used for a range of applications including follow-up testing in newborn screening, therapy monitoring as well as for other amino acid testing purposes, such as aminoacidopathy diagnosis or nutritional research. 48 of the clinically most important amino acids are analysed with a run time of 20 min. Alternatively, the same assay allows the determination of 7 parameters for the common metabolic diseases PKU and MSUD in 8-9 min – ideal for laboratories with a higher sample throughput. Both modes can be used without changes to the chromatographic setup or sample preparation.
For more information, click here
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CLI 200408 doc image B2m 800

Beta-2 Microglobulin (β2m), for serum and urine, on IMMAGE® series nephelometers

TRIMERO Diagnostics offers IVD CE marked Beta-2 Microglobulin (β2m) serum and urine assays for IMMAGE® series nephelometers.
The assays, for serum and urine samples, have been developed specifically for the Beckman Coulter’s IMMAGE® and IMMAGE® 800 Immunochemical Systems, using UDR particle-enhanced reagents.
In order to ensure lot to lot traceability, assays have been standardized to the to the 1st International Standard for Beta2 Microglobulin (code: B2M) of the WHO (World Health Organisation).
B2-microglobulin turbidimetric assays are also available for the most popular clinical chemistry analysers, for both urine and serum samples.
Other available assays for IMMAGE® nephelometers and turbidimetry include: KLoneus® Free Light Chains (FLC), Serum Amyloid A (SAA), IgD Immunoglobulins, Retinol Binding Protein (RBP) for serum and urine, Soluble Transferrin Receptor (sTfR), Hemopexin, Cystatin-C for serum and urine, A1-Microglobulin, Kappa and Lambda Light Chains for serum and urine, Complement C1q, Complement C5, Factor B (C3 Proactivator), C1 (Esterase) Inhibitor.
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