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The serology test has a specificity greater than 99.8% and sensitivity of 100% (14 Days post-PCR confirmation)
The high specificity of the test is crucial to determine reliably if a person has been exposed to the virus and if the patient has developed antibodies
Roche will provide high double-digit millions of tests already in May for countries accepting the CE mark and in the U.S. under Emergency Use Authorization, further ramping up capacities
The test is available on Roche’s cobas e analysers which are widely available around the world
“Thanks to the enormous efforts of our dedicated colleagues we are now able to deliver a high-quality antibody test in high quantities, so we can support healthcare systems around the world with an important tool to better manage the COVID-19 health crisis,” said Severin Schwan, CEO Roche Group. ”I am in particular pleased about the high specificity and sensitivity of our test, which is crucial to support health care systems around the world with a reliable tool to better manage the COVID-19 health crisis.”
Elecsys® Anti-SARS-CoV-2 is an immunoassay for the in-vitro qualitative detection of antibodies (including IgG) to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in human serum and plasma. Through a blood sample, the test, which is based on an in-solution double-antigen sandwich format, can detect antibodies to the new coronavirus causing COVID-19, which could signal whether a person has already been infected and potentially developed immunity to the virus. Based on the measurement of a total of 5272 samples, the Elecsys® Anti-SARS-CoV-2 assay has 99.81% specificity and shows no cross-reactivity to the four human coronaviruses causing common cold. This means it can lower the chance of false positives due to the detection of similar antibodies that may be present in an individual, but are specific for coronaviruses other than SARS-CoV-2. Elecsys® Anti-SARS-CoV-2 detected antibodies with 100% sensitivity in samples taken 14 days after a PCR-confirmed infection. The importance of specificity and sensitivity of a particular test will be dependent on its purpose and disease prevalence within a given population. Hospitals and reference laboratories can run the test on Roche’s cobas e analysers, which are widely available around the world. These fully automated systems can provide SARS-CoV-2 test results in approximately 18 minutes for one single test, with a test throughput of up to 300 tests/hour, depending on the analyser.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
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The Mainz-based biotech company and the US pharmaceutical giant have started the clinical trial of their COVID-19 vaccine candidate BNT162. Twelve study participants in Germany have been vaccinated with BNT162 since the start of the study on April 23, 2020, as the two companies announced. This concludes the first dose cohort.
In order to find the optimal dose for the further studies, about 200 healthy volunteers between the ages of 18 and 55 should be vaccinated, the dose range is 1 to 100 micrograms. The safety and immunogenicity of the vaccine will also be investigated. Subjects at higher risk for a severe course of COVID-19 infection are included in the second part of the study.
The study is the first clinical trial of a vaccine candidate against the lung disease COVID-19 caused by the novel coronavirus in Germany. The two companies expect approval of studies for BNT162 in the United States shortly.
BioNTech and Pfizer are working together to develop BNT162. BioNTech will ensure clinical delivery of the vaccine through its manufacturing facilities in Europe. The company is also working with Fosun Pharma to develop BNT162 in China, where the companies plan to conduct clinical trials.
Electromobility and medical technology are among the most important revenue generators for the German laser industry in the co...
Two industries provide a tailwind for manufacturers of beam sources and laser-based systems.
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Photo: trumpf The copper elements installed in the Stators of electric motors can first be de-coated by laser and then welded precisely. |
Schmitz spoke at the annual press conference of the working group of an expected "exponential growth" in e-mobility. This is particularly beneficial for laser technology, since meaningful mass production is only possible with it. In concrete terms, this is primarily concerned with the components that are new to the electric car, such as the battery, electric drive and high-performance electronics.
"A focus in the field of electromobility is technologies for welding highly conductive materials such as copper, copper alloys and aluminium," says Schmitz. For example, Trumpf relies on the specially developed green laser, which has been optimised for use in industrial environments, especially for the welding of copper materials. Especially in battery technology, the manufacturing process is increasingly being followed by consistent process monitoring for consistent quality management. Within the narrow process windows, more and more artificial intelligence is also being used.
Christoph Ullmann, Managing Director of Laserline GmbH and Vice-Chairman of the Working Group, also sees "new potential" for blue diode lasers. Among other things, they enable the melting of copper material in heat conduction mode, which results in splash-free, smooth seams even with very thin materials. Due to the high seam quality, the process is also very suitable for applications in electrical engineering, especially in the production of components in power electronics, where the joining points must be particularly temperature-resistant, says Ullmann. In the competition of technologies, it is now a matter of finding the optimal application.
The working group also sees growth opportunities in the biophotonics and medical technology market. According to Thomas Merk, Executive Vice President Industrial Lasers and Systems ILS at Coherent Munich and Vice Chairman of the VDMA Working Group, developments in biophotonics are becoming increasingly important. One of its most important tasks is, for example, to maintain the health of a globally ageing society or to combat chronic diseases. With the use of optical technologies, it is now crucial to find new cost-effective and effective solutions for diagnostics and treatment and to meet trends such as personalised medicine, explained the machine builder.
One example is laser-assisted flow cytometry. It allows the analysis of cells using fluorescent dyes. Depending on the structure, shape, and coloring of the cell, different effects are created from which the properties of the cell are derived. The quantified and highly analytical recording of cells and their interactions is a prerequisite for their functional understanding. This understanding, in turn, makes it possible to break new ground in transplantation and oncology.
DNA cytometry enables significantly faster analysis by detecting individual tumor cells and provides the prerequisite for personalized medicine in cancer therapy.
Gerhard Hein, Managing Director of the Working Group (AG) Laser in the VDMA, presented the latest figures on the laser industry in Germany. As a result, the manufacturers represented in the AG have increased the production value of laser production plants at the German site to € 1.06 billion. This applies to plants with CO2, solid-state and diode direct lasers and corresponds to an increase of around 13%. Order intake in 2018 was €1.31 billion, roughly the same as the previous year's level. A whopping 82% of orders came from abroad.
The realized export of laser systems rose to € 950 million (+23 %), with growth mainly due to the export of equipment with solid-state lasers.
Hein continued to be optimistic when looking to the future. There is a sustained "technology push", especially for short-pulse applications and highly flexible systems. In addition, there is an increasing transfer from research to industrial application. From the point of view of the working group, the diversity of the beam sources remains and is even increasing. In addition, additive manufacturing, which is often laser-based, is further developing towards series production.
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Data glasses are supposed to provide a higher supply
quality. Doctors and participants in the Aachen test are convinced of
this.
Photo: Czaplik / Uniklinik RWTH Aachen |
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| Dieter Zetsche: The Daimler CEO (here at the 2015 Annual General Meeting) explains that emissions-free driving is the center of the strategy. (Photo: Daimler) |
"No infringement detected"
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| Tesla Model 3: With the fresh money from China a smooth start of the serial production of the "Model 3" is to be secured. (Photo: Tesla) |
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| Autonomous over-car. (Photo: Volvo) |
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Daimler wants to take part in the largest Mercedes dealer in the
world. (Photo: Daimler) |







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