Assay

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…

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…

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…

News • Total antibody test

Siemens Healthineers to expand SARS-CoV-2 testing

Siemens Healthineers announced it is expanding its infectious disease testing capabilities to aid in the COVID-19 pandemic.

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…

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…

News • 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…

Article • 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…

News • 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…

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,…

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,…

News • 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…

News • Acute Coronary Syndrome

Access hsTnI assay rules out ACS in 2 hours

The clinical performance of Beckman Coulter's high-sensitivity troponin I (hsTnI) assay Access hsTnI has been validated in a study. Within 2 hours, the assay delivers an accurate assessment of patients with suspected acute coronary syndrome (ACS).

News • 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…

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.

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…

News • FDA-cleared Procalcitonin (PCT)

Beckman Coulter Diagnostics expands chemistry menu

Beckman Coulter Diagnostics along with partner Diazyme Laboratories announces FDA clearance of a new procalcitonin (PCT) assay, an important tool for the management of bacterial infections and sepsis.

Article • LC-MS/MS

Wanted: automated clinical analyser with broad, expandable testing menu

Combining the physical separation power of liquid chromatography with the mass analysis capability of mass spectrometry – i.e. liquid chromatography tandem mass spectrometry (LC-MS/MS) – enables accurate, sensitive and selective separation, detection and identification of molecules in complex mixtures such as blood, serum and urine.

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…

News • 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…

Article • Immunoassay

CLIA: Advancement and market dynamic

With the combination of the basic principle of radioimmunoassay, high sensitive chemiluminescence and high specific immunoassay, the year 1977 saw the emergence of a new technology-Chemiluminescence Immunoassay (CLIA) which provided one of the best solutions for the quantification of specimens from a complex mixture with the non-radioactive nature, making it an advantage to replace RIA in…

Article • Innovation

A swift new lab automation system

‘Every single hour, more than 200,000 people worldwide are being diagnosed or treated with our devices,’ Michael Reitermann, COO of Siemens Healthineers, proudly reports. No reason, however, for Siemens to rest on its laurels. Quite the contrary: the company continues to drive innovation.

News • Lateral flow immunoassay

Up to 10-fold increase in assay sensitivity

BBI Solutions has launched Morffi, a novel conjugate blocking technology that enhances signal intensity and improves the sensitivity of lateral flow immunoassaysThe technology, developed in-house by BBI Solutions scientists, improves the limit of detection of an assay, providing an increase in sensitivity of up to ten times and a faster time to result.

Diabetic biomarker test successfully verified

EKF Diagnostics announces that its newly introduced Glycated Serum Protein (GSP) LiquiColor® diabetic biomarker test has been verified for use on the Siemens Vista chemistry analyzer. In a scientific poster published by scientists at the Memorial Healthcare System, Hollywood, USA [1], it was demonstrated that EKF’s GSP assay enhances the versatility of the Vista system for the specialized…

News • Infection

Siemens Zika test receives FDA emergency use authorization

The U.S. Food and Drug Administration (FDA) has granted Siemens Healthcare Diagnostics Inc. (Siemens) an Emergency Use Authorization (EUA) for its real-time PCR Zika Virus assay, the VERSANT® Zika RNA 1.0 Assay (kPCR) Kit. With respect to Zika in vitro diagnostic tests, FDA has been authorized to issue EUAs to allow for use of unapproved medical products or unapproved uses of approved medical…

8 show more articles