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…
Siemens Healthineers announced it is expanding its infectious disease testing capabilities to aid in the COVID-19 pandemic.
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…
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…
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…
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…
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…
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,…
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,…
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…
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).
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…
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.
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…
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.
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.
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…
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…
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…
‘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.
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.
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…
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…
Since several years, LC-MS/MS technology is making an important breakthrough in the field of clinical research. The progress of tandem MS or MS/MS in that field is mainly due to its ability for high sensitivity detection, high selectivity, as well as possibilities of multiplexing compounds in one analysis without the risk of cross reactions inherent to immuno-assay tests.
During the past 15 years, liquid chromatography tandem mass spectrometry (LC-MS/MS) has evolved into a vital technology used to perform routine tests in many clinical laboratories. Historically, LC-MS/MS had been used primarily by research, pharmaceutical, or commercial laboratories; however, advances in the technology, decreasing costs for basic systems, intelligible software, an increased…