Assay

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Functional diagnostics

New assay could advance personalized cancer treatment

A new study from the University of Helsinki shows that cells that are freshly isolated from lung cancers can be used to create robust drug response data. This approach can identify actionable or…

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Covid-19 detection

New blood test measures immunity against SARS-CoV-2 and its variants

The Lausanne University Hospital (CHUV) and EPFL teamed up to develop a new test that’s sensitive enough to measure the amount of SARS-CoV-2 neutralizing antibodies present in the bloodstream. The…

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Infertility

Beckman Coulter launches Access AMH Advanced

Beckman Coulter announced the launch of an AMH test that uses a validated cut-off to aid in the assessment of poor ovarian response. This new assay helps clinicians predict poor ovarian response in…

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Coronavirus infection response

SARS-CoV-2 IgG II antibody test launched in CE Mark countries

Clinical diagnostics company Beckman Coulter launched its Access SARS-CoV-2 IgG II assay in countries accepting the CE Mark. The new Access SARS-CoV-2 IgG II assay quantitatively measures a…

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High-sensitivity troponin I assay

Speeding up diagnosis of myocardial infarction

The new generation troponin I assay unveiled by Beckman Coulter is helping improve heart attack diagnosis. Delivering high sensitivity, and rapid result turnaround times, every element of the Access…

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Coronavirus assay receives CE Mark

Quantitative Covid-19 test to measure neutralizing antibodies

Siemens Healthineers announced its SARS-CoV-2 IgG Antibody Test (sCOVG) has proven to measure neutralizing antibodies and has achieved CE Mark. The test is an enhanced version of the assay which…

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In countries accepting CE Mark

Beckman Coulter launches SARS-CoV-2 IgM antibody test

Beckman Coulter announced the launch of its Access SARS-CoV-2 Immunoglobulin M (IgM) assay in countries accepting the CE Mark. The new IgM antibody test demonstrated 99.9% specificity with 1,400 negative samples and 100% sensitivity at >18 days post symptom onset and post positive PCR. Beckman Coulter’s IgM assay is part of a full suite of testing solutions the company is developing to…

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COVID-19 diagnostics

SARS-CoV-2 IgG antibody test receives FDA Emergency Use Authorization

Beckman Coulter announced that its Access SARS-CoV-2 IgG assay has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA). Beckman Coulter has already shipped tests to more than 400 hospitals, clinics and diagnostics laboratories in the U.S., and has begun distribution of the new antibody test globally to countries that accept the FDA EUA and CE Mark. The…

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Pandemic prevention

German lab developed coronavirus detection method

Investigators at Hannover Medical School (MHH) in Germany have developed a molecular assay for detecting the novel coronavirus SARS-CoV-2 (previously 2019-nCoV) on the automated Panther Fusion system by Hologic. The preclinical assay is described online in the Journal of Clinical Virology. “Rapid diagnosis is critical to combatting the spread of pandemics, and the Panther Fusion system is well…

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Immunoassay

The quantitative measurement of cardiac troponin I concentration

Pathfast hs-cTnI is a chemi-luminescent enzyme immunoassay (CLEIA) for the quantitative measurement of cardiac troponin I (cTnI) concentration in whole blood or plasma at the point-of-care (POC). Reagents are single use in all-in-one cartridges and up to six tests in parallel can be analysed,’ the manufacturer Mitsubishi reports. ‘Low concentrations of cTnI can be analysed by using high…

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IT Solutions

Siemens Healthineers shows the power of data in the lab at AACC 2019

At the 71st AACC Annual Scientific Meeting & Clinical Lab Expo, Siemens Healthineers features in Booth #1039 its innovative IT solutions to combat the laboratory’s staffing challenges, limited budgets, and the increasing complexity in sample management and testing. “We will be demonstrating the power of our broad IT offerings and how the data they deliver, and artificial intelligence, can…

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Improvement of cardiac care

Rapid myocardial infarction verification

The use of troponin assays to rule in or rule out myocardial infarction (MI) rapidly is critical on several levels. The quick result can reassure the patient that they have not had a heart attack and can return home safely; or, in the event of MI, the relevant treatment can start very soon. It also ensures that clinicians can make the right decision with confidence. Troponin levels have been the…

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Bordetella

Launch of Hologic's whooping cough detection assay in Europe

Hologic, Inc. announced that its Panther Fusion Bordetella assay has received CE mark in Europe. This assay, the latest in a growing menu of Panther Fusion and Aptima assays, brings full automation, efficiency and excellent assay performance to Bordetella (whooping cough) detection. The Panther Fusion system retains all the key benefits of the Panther platform, including full sample-to-result…

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Testing technology

Vitamin D testing: LC-MS outperforms immunoassays

In recent years, clinicians have increasingly focused on vitamin D deficiency. Studies show that previous reference values – particularly for Vitamin D3 – were most probably set too high. Liquid chromatography with mass spectrometry (LC-MS) can help achieve more precise measurements of vitamin D levels than previously established immunoassay procedures, explains Dr Torsten Binscheck-Domass,…

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Lab equipment

It takes a team

Clinical laboratories need to meet greater testing demands, improve efficiency, and deliver reliable, high-quality results, while at the same time, facing an increasing shortage of skilled employees and growing budget constraints. Both patient and physician satisfaction are frequently tied to the time it takes to receive lab test results. In a recent survey commissioned by Siemens Healthineers,…

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Lab equipment

Atellica Solution gets 'thumbs up' from early adopters

Clinical laboratories are challenged to meet greater testing demands, improve efficiency, and deliver reliable, high-quality results, while facing an increasing shortage of skilled employees and growing budget constraints. Recognizing that technology can play a critical role in addressing each of these challenges, Siemens Healthineers brought to market the Atellica Solution immunoassay and…

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Immunoassay and clinical chemistry analyzers

This is why laboratories worldwide adopt the Atellica Solution

LBM Bioesterel in France, Arcispedale S. Maria Nuova in Italy and Friarage Hospital in the United Kingdom are among the first laboratories to install the Atellica Solution immunoassay and clinical chemistry analyzers. The trending motivators for installing the latest innovation from Siemens Healthineers include the unprecedented flexibility to automate redundant and complex procedures to simplify…

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Augmenting antibody services and assay development

Acquisition: BBI gains MBS

BBI Solutions (BBI), immunoassay developer and reagent supplier, acquired Maine Biotechnology Services Inc. (MBS) in July 2017, adding antibody development to the firm’s end to end assay development services. This also strengthens BBI’s reagents antibodies portfolio, providing a wide range of high quality biomarkers for infectious disease.

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Fast triage of chest pain patients

ADVIA Centaur High-Sensitivity Troponin I Assay

The ADVIA Centaur® High-Sensitivity Troponin I (TNIH) assay* is the latest addition to Siemens Healthineers’ comprehensive cardiac menu to assist clinicians with the diagnosis and treatment of chest pain patients. Designed to aid in diagnosing acute myocardial infarctions (AMI) through the quantitative measurement of cardiac troponin I in serum or plasma, high-sensitivity troponin plays a…

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Clinical testing

Total laboratory automation with Tosoh and DiaSys

Tosoh and DiaSys announce a collaboration for clinical laboratory testing with the combination of Tosoh’s new generation analyzers (AIA-CL1200 for immunoassay and G11 for HbA1c) and DiaSys’ BioMajesty JCA-BM6010 / C. Instruments are linked through Evoline and Evoline Manager, Tosoh’s open laboratory automation and middleware solution. The collaboration addresses current requirements…

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Mass spectrometry

SCIEX announces first FDA-cleared Vitamin D assay kit

SCIEX Diagnostics, the in vitro diagnostics division of SCIEX, a global leader in mass spectrometry in the life sciences industry, announced the first and only FDA-cleared (via the de novo pathway) LC-MS based Vitamin D assay kit, the Vitamin D 200M Assay, exclusively for the SCIEX Topaz System. The Topaz System is a fully integrated LC-MS platform driven by ClearCore MD, the new and intuitive…

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