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In May 2022 a shortage of several lab tests may come as many manufacturers struggle to comply with EU regulation requirements covering in vitro diagnostic medical devices (IVDR, Regulation (EU) 2017/746). Even modified tests and laboratory-developed tests will present a problem for hospitals and labs as explained by Dr Thomas Streichert.
Ransomware attacks are a highly profitable and flourishing business in the 21st century. They can have a drastic impact on hospitals, clinical laboratories, and patients. The Sophos Group, a British security hard/software company, has reported survey responses from 328 healthcare IT managers in 30 countries.
A new rapid molecular diagnostic test from Cepheid has received the CE mark for distribution in the European market. The test, called Xpert Xpress CoV-2/Flu/RSV plus, is designed for qualitative detection of the viruses causing Covid-19, Flu A, Flu B, and respiratory syncytial virus (RSV) infections from a single patient sample. The new plus version of the test provides a third gene target for…
Autoimmune hepatitis (AIH) is a chronic liver inflammation that is triggered by an immunological malfunction. In this case, the immune system falsely recognises the patient's own liver cells as "foreign to the body". The symptoms of this rare liver disease are unspecific, and the exact cause is not yet known. If left untreated, AIH can lead to abnormal scarring (fibrosis) of the liver,…
Researchers at the DZNE and the University Medical Center Göttingen (UMG) have identified molecules in the blood that can indicate impending dementia. Their findings, which are presented in the scientific journal “EMBO Molecular Medicine”, are based on human studies and laboratory experiments. Various university hospitals across Germany were also involved in the investigations.
Fast, flexible laboratory information management systems (LIMS) that cope with data and workflow complexities of molecular and genetic testing now work in laboratories internationally. Here, in the first in a new Lab Pinnacle Series, experts from the CliniSys Group, Sunquest Information Systems and Data Innovations (all owned by Roper Technologies), discuss the value of a LIMS in molecular and…
In the fight against diseases like amyotrophic lateral sclerosis (ALS), biomedical engineering researchers at the University of Southern California have created a powerful lab model to better see how our muscles and neurons connect.
Infectious disease diagnostics are notoriously slow. The gold standard for laboratory diagnosis of bacterial and fungal infection involves growing the pathogen from a clinical specimen – an overnight event, or even longer. The healthcare focus is on improving the use of antibiotics for better patient outcomes and reducing the environmental pressures that drive antibiotic resistance. To impact…
MedTech Europe, the European trade association for the medical technology industry including diagnostics, medical devices and digital health, ran an industry survey, which shows an urgent, high risk to the availability of IVD medical tests once the new IVD Regulation fully applies.
A new technology that can study which therapies will work on patients with solid cancerous tumours has been developed by scientists at University College London (UCL). Researchers say the tool, which can rapidly test tumorous tissue against different treatments, such as chemotherapy, immunotherapy or radiotherapy, could be used by clinicians to pinpoint the best therapy for a particular patient.
Researchers in Thailand have developed a device to get the most out of vaccine supplies: The automated vaccine filling machine from the Faculty of Engineering at Chulalongkorn University can fill AstraZeneca vaccine into syringes with precision, speed, and safety, helping to increase the number of vaccinated people by 20 percent. The prototype is now operating at Chula Vaccination Center and more…
To avoid adverse reactions, personalised laboratory medicine can help to predict a patient’s drug response. Investigations based on DNA and other omics technologies – e.g. genomics, transcriptomics, proteomics, metabolomics – along with microarray technologies, is making a particularly valuable contribution to cancer care, in which personalised approaches are becoming possible through…
The risk of colorectal cancer can be predicted more accurately by determining seven blood-based micro-RNAs (miRNAs) than by using traditional methods - and can be done so many years before a diagnosis is made. In a current study, researchers from the German Cancer Research Center and the National Center for Tumor Diseases (NCT) Heidelberg show that miRNA profiles provide greater predictive…
A novel study published in AACC’s The Journal of Applied Laboratory Medicine shows that delaying the second Covid-19 vaccine dose for more than the recommended 3-4 weeks results in higher antibody levels. This finding could play a vital role in shaping vaccine distribution strategies that increase access to the vaccine around the globe.
Home test kits to check for Covid-19 spike proteins and anti-Covid-19 antibodies are fast and simple to use but lack the sensitivity and accuracy of laboratory tests. Researchers from Eindhoven University of Technology with Utrecht University have developed a new type of sensor that combines the sensitivity and accuracy of current laboratory-based measurements with the speed and low-cost of…
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.
Life science research and clinical diagnostics company Bio-Rad Laboratories announced the launch of its PREvalence ddPCR SARS-CoV-2 Wastewater Quantification Kit, a tool to detect the virus that causes Covid-19 in a community’s wastewater. "With wastewater testing becoming more widely adopted, this assay provides the ability for a community to determine if the virus is present days to…
In a collaboration with the Faculty of Statistics at TU Dortmund and the University Medical Center in Mainz, a research team at the Leibniz Research Centre for Working Environment and Human Factors in Dortmund (IfADo) has developed a test that can be used to predict the success of therapy for breast cancer. Breast cancer is one of the most common tumour diseases worldwide. One in eight women will…
SpeeDx Pty, Ltd. and MolGen announced the signing of an agreement to collaborate on supply and distribution of clinical diagnostics products and instrumentation across Europe and Asia Pacific. The partnership links specimen handling, nucleic acid extraction, assay set-up, amplification, and results reporting in a seamless integration of the companies technologies. “This partnership capitalises…
When patients are admitted to a hospital emergency room (ER) it is immediately vital to determine whether s/he has Covid-19. However, with a regular PCR test a result can take up to a few hours. Thus, initially, the patient must be isolated. During the height of the corona pandemic last year, researcher Ruben Deneer from Eindhoven University of Technology (TU/e) and clinical chemist Arjen-Kars…
Integrating laboratory functions on a microchip circuit is helping improve the cost-effectiveness of drug development. So-called ‘lab-on-a-chip’ or ‘human-on-a-chip’ technology can highlight which treatments may, or may not, work before advancing along the clinical trial process. It can also have benefits for chronic and rare diseases, as well as helping shape personalised medicine.…
Blood cultures are important laboratory tests to diagnose serious infections. Contamination is a constant concern – a patient could be misdiagnosed due to a false-positive test. Initial specimen diversion (ISD) could radically change this.
The idea of visiting the doctor’s office with symptoms of an illness and leaving with a scientifically confirmed diagnosis is much closer to reality because of new technology developed by researchers at McMaster University. Engineering, biochemistry and medical researchers from across campus have combined their skills to create a hand-held rapid test for bacterial infections that can produce…
In-vitro-diagnostics company bioMérieux has launched Episeq SARS-CoV-2, a genomic software solution to support microbiology labs in identification and reporting from raw sequencing data related to SARS-CoV-2 variants. Viral mutation is a naturally occurring phenomenon leading to the emergence of variants that can have different characteristics. Today, a number of SARS-CoV-2 variants are…