Assay

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Article • QC at AACC 2023

New risk-based quality control assessment for clinical labs

Juggling the cost of quality control (QC) resources versus the risk of testing error is a balancing act no clinical laboratory manager enjoys. It is an inexact process, itself prone to error, which…

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News • Point-of-care diagnostic platform

Inhalable sensors for early lung cancer detection

Using a new technology developed at MIT, diagnosing lung cancer could become as easy as inhaling nanoparticle sensors and then taking a urine test that reveals whether a tumor is present.

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Sponsored • AutoLumo A1860/A1800

Immunoassay user experience: simple and smart

AutoLumo A1860/A1800 is the new generation of Autobio AutoLumo Series with compact structure and innovative design, providing simpler, smarter and better user experience for small and medium size…

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News • Drug discovery

New FDSS-GX: Hamamatsu presents high-performance kinetic plate imager

Hamamatsu Photonics announces the release of a new high-speed kinetic plate imager, the FDSS-GX, designed for kinetic cell-based assay development.

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Sponsored • Disease management

Multiplex Testing: A Solution to Manage Surge in Respiratory Illnesses as Concerns over “Multi-demic” Rise

Eunsin Bae, M.D. specializes in laboratory medicine and leads the Institute of Clinical Research at Seegene Inc. Her research focuses on microbiology, molecular biology, and hematology. Dr. Bae is…

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News • Vortex fluidic device

Next step in rapid diagnostics for infectious diseases

The speedy, high-tech method of inexpensive, accurate and high-throughput protein biomarker assay testing is being touted as a much-needed development in point-of-care (PoC) testing.

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News • 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 scientists’ discovery, published in Science Translational Medicine, opens promising new avenues for tracking immunity acquired by infection or vaccination.

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News • 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 those who plan to undergo controlled ovarian stimulation as part of an in vitro fertilisation (IVF) protocol.

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News • 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 patient’s level of antibodies in response to a previous SARS-CoV-2 infection. The ability to establish a quantitative baseline to evaluate an individual’s immune response to the SARS-CoV-2 virus allows…

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Article • 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 hsTnI assay has been redeveloped and updated, including the antibodies and the paramagnetic particles used. As specialists in developing and manufacturing products that simplify and automate complex…

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News • 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 became available globally this summer. It demonstrates the ability to detect neutralizing antibodies and reports quantitative results measuring the amount of neutralizing antibodies present in a patient's…

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News • 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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News • 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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News • 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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Sponsored • 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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