Beckman Coulter’s Access SARS-CoV-2 IgG assay is now available in markets accepting the CE Mark, the company said in statement 15 June. It has already shipped tests to more than 400 hospitals, clinics and diagnostics laboratories in the United States and has begun shipping to customers globally. Beckman Coulter has more than 16,000 immunoassay analysers worldwide and has increased manufacturing to deliver more than 30 million tests a month.
Many of Beckman Coulter’s analysers can deliver up to 400 routine tests an hour. The Access SARS-CoV-2 IgG test can also be run on Beckman Coulter’s Access 2 analyser, a compact table-top analyser enabling high-quality serology testing to be carried out in small hospitals and clinics.
The Access SARS-CoV-2 IgG Assay is a qualitative immunoassay that detects IgG antibodies directed to the receptor-binding domain of the spike protein of the novel coronavirus that is driving the ongoing global pandemic. It is believed that these antibodies have the potential to be neutralizing antibodies and may play a role in lasting immunity. The test has a confirmed 99.8% specificity and 100% sensitivity at 18 days post PCR confirmed positive test. The assay uses immobilized virus antigens on magnetic particles to capture IgG antibodies from patient serum or plasma samples and reveals them using labelled anti-IgG antibodies.
Commenting on the assay, Shamiram R. Feinglass, M.D., MPH, Chief Medical Officer, Beckman Coulter, said: “An IgG antibody assay such as the test Beckman Coulter has developed can provide valuable information regarding community levels of immunity that will inform public health decision making and rollout of a vaccine when one does become available. The very high sensitivity and specificity of this assay provides a high positive predictive value, even when the overall incidence of disease is low. Additionally, since our assay can be run on multiple different types of analysers, it can be adapted to a variety of healthcare settings to best meet the needs of each community.”
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TRIMERO Diagnostics offers IVD CE urinary assays of low molecular weight proteins, by nephelometry or turbidimetry, for the assessment of renal tubular function:

• Retinol-Binding Protein (RBP)
• Alpha-1 Microglobulin (α1μ)
• Cystatin C (CysC)
• Beta-2 Microglobulin (β2μ)
• KLoneus® Kappa and Lambda Free Light Chains (FLC)
• Kappa and Lambda (B&F) Light Chains

These assays, specifically designed for their use on urine samples, are available for the nephelometers and the most popular clinical chemistry analyzers present in the market.
Other TRIMERO’s available nephelometric and turbidimetric assays include:
Serum Amyloid A (SAA), IgD Immunoglobulins, Soluble Transferrin Receptor (sTfR), Hemopexin, Complement C1q, Complement C5, Factor B (C3 Proactivator), C1 (Esterase) Inhibitor.
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Postnova Analytics reports how its latest generation of Asymmetrical Flow Field Flow Fractionation (AF4) systems are providing labs worldwide with a uniquely powerful technique to characterize and quantitate virus and virus-like particles.
Virus and virus-like particles are widely used in the healthcare industry for vaccination via immune response stimulation. Because these particles are to be injected into patients there is a critical requirement for a technique that allows detection and separation of the monomeric, oligomeric and aggregated species in a typical formulation.
While Size Exclusion Chromatography (SEC) has been a traditional analytical technique used for this application it has significant limitations relating to the size exclusion limit of the separation column that restricts the upper molar mass and particle size range that can be measured.
By comparison, Asymmetrical Flow Field Flow Fractionation (AF4) is an advanced separation technique that can address the problems associated with SEC. In AF4, an open, unpacked separation channel is used in place of a packed column. The absence of a stationary phase in AF4 systems results in the ability to use a wider range of solvents, elimination of SEC shear force and matrix interaction effects as well as the ability to separate particles over a very wide size range, from 1 nm up to above 1 µm. These capabilities enable AF4 to provide a complete picture of virus and virus-like particles including monomer content, insoluble and soluble aggregates, as well as the subvisible particle fraction.

• For a copy of a new application study describing the separation and characterisation of adeno associated virus serotypes by AF4, visit https://bit.ly/2SXdyPj
• To discuss how AF4 systems can separate and characterise your virus, virus-like particles and vaccine components please email Postnova Analytics: info@postnova.com

Founded in 1997, Postnova Analytics is the inventor and leading international supplier of Field-Flow Fractionation (FFF) systems for markets including biopharmaceuticals, polymers, materials, nanotechnology and environmental sciences.
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Testa Analytical Solutions has published a new applications report that demonstrates how Dynamic Light Scattering (DLS) can be used as an effective analytical technique for analysing virus particles in solution.
The report examines four fish viruses incubated under laboratory culture conditions that have the potential to wreak significant economic damage to both recreational and commercially important fish populations.
Traditional visual methods of observing virus particles in solution give a snapshot of only a very small and potentially unrepresentative sampling volume. By comparison, the technique of particle analysis using dynamic light scattering yields an ensemble average of particles present in these solutions. Data presented in the report is from DLS measurements made on a NanoBrook ZetaPALS instrument equipped with a BI-MAS accessory to provide particle sizing capability.
The authors discuss how analysing virus particles incubated in the laboratory present a challenge, as they must be grown within cells in a media containing albumin and other small proteins, such as those present in Fetal Bovine Serum (FBS) solution. When virus particles are released from the cells, the cell fragments are large and can be separated by centrifugation, but the smaller proteins of the media cannot be removed. Careful selection of the distribution parameters from a dynamic light scattering experiment allows the size distributions of virus particles to be clearly observed in the presence of much smaller proteins that constitute the media.
The results presented in the applications report clearly show the presence of virus particles with the expected average dimensions when observed by an intensity weighted distribution. However the absence of these particles in the number distribution shows the virus particles are present in relatively small numbers compared to the proteins and other small molecules in cell growth media.
The Nanobrook ZetaPALS from Testa Analytical provides a platform for zeta potential determination of nanoparticles and colloids in water with salt concentrations less than 75 millimolar ionic strength. The instrument is designed to eliminate the shortcomings inherent in other zeta potential instruments.

• For a copy of the application report, visit https://testa-analytical.com/papers/paper24.html
• For further information on the NanoBrook ZetaPALS instrument, visit https://www.testa-analytical.com/zeta-potential-equipment.html

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Cytel Inc., an advanced analytics leader providing sophisticated quantitative insights to decision-makers in clinical investigation, has launched East Alloy. This new platform is a web-native extension of Cytel’s world-renowned East software for adaptive clinical trial design and analysis.
By leveraging the speed of cloud computing and the pace of SaaS delivery, East Alloy enables easy implementation of computationally intensive Bayesian methods that may be otherwise impractical. The launch of East Alloy builds on Cytel’s time-tested record of delivering cutting-edge Bayesian tools and engines to the pharmaceutical industry for optimized clinical trials.
Bayesian methods are of growing interest to the drug development industry, as they allow clinical investigators to leverage historical trial data as well as learnings from new data as it accrues throughout a trial. The result is better-informed decision making, greater program flexibility, and the ability to run smaller, more resource-efficient trials.
“Our longstanding dedication to adaptive Bayesian approaches means we’re perfectly placed to meet and exceed the growing innovation needs of the pharmaceutical sector,” said Pantelis Vlachos, Director and Strategic Consultant at Cytel. “But it’s key to ensure our customers can practically implement this kind of innovation. East Alloy, reinforced by industry-leading verification, training, and support from Cytel experts, means users can sustainably adopt Bayesian designs to expedite clinical development and overcome uncertainty without compromising scientific rigor.”
The release of East Alloy follows the launch of East Hosted in 2019, which brought Cytel’s East software into the cloud for the first time to simplify the deployment of software updates, reduce on-premise IT burden, and ultimately broaden access to Cytel’s trial design and analysis engines.

• For more information about Cytel, visit: https://www.cytel.com

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