Does Customer Information Fulfill MEDDEV Criteria in Cases of Product Problems of In Vitro Diagnostics for Infection Testing?

2014 ◽  
pp. 23-30 ◽  
Author(s):  
Jürgen Hannig ◽  
Rüdiger Siekmeier
Keyword(s):  
In Vitro Diagnostics ◽  
Customer Information

scholarly journals Nanoimprinted multifunctional nanoprobes for a homogeneous immunoassay in a top-down fabrication approach

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Hubert Brueckl ◽  
Astrit Shoshi ◽  
Stefan Schrittwieser ◽  
Barbara Schmid ◽  
Pia Schneeweiss ◽  
...  
Keyword(s):  
Thin Film ◽  
Nanoimprint Lithography ◽  
Thin Film Deposition ◽  
Film Deposition ◽  
In Vitro Diagnostics ◽  
Top Down ◽  
Highly Sensitive ◽  
Optical And Magnetic Properties ◽  
Lift Off

AbstractMultifunctional nanoparticles are discussed as versatile probes for homogeneous immunoassays for in-vitro diagnostics. Top-down fabrication allows to combine and tailor magnetic and plasmonic anisotropic properties. The combination of nanoimprint lithography, thin film deposition, and lift-off processing provides a top-down fabrication platform, which is both flexible and reliable. Here, we discuss the material compositions and geometrical designs of monodisperse multicomponent nanoparticles and their consequences on optical and magnetic properties. The rotational hydrodynamics of nanoparticles is measured and considered under the influence of magnetic shape anisotropy in the framework of the Stoner-Wohlfarth theory. The plasmon-optical properties are explained by discrete-dipole finite-element simulations. Rotational dynamical measurements of imprinted nanoprobes for two test proteins demonstrate the applicability as highly sensitive biomolecular nanoprobes.

scholarly journals Nanotomography of Cell Surfaces with Evanescent Fields

2008 ◽  
Vol 2008 ◽  
pp. 1-7 ◽  
Author(s):  
Michael Wagner ◽  
Petra Weber ◽  
Wolfgang S. L. Strauss ◽  
Henri-Pierre Lassalle ◽  
Herbert Schneckenburger
Keyword(s):  
Total Internal Reflection ◽  
3D Imaging ◽  
Cell Swelling ◽  
Cholesterol Depletion ◽  
In Vitro Diagnostics ◽  
Axial Resolution ◽  
Cell Surfaces ◽  
Cell Substrate ◽  
Cell Topology

The technique of variable-angle total internal reflection fluorescence microscopy (TIRFM) and its application to nanotomography of cell surfaces are described. Present applications include (1) 3D imaging of chromosomes in their metaphase to demonstrate axial resolution in the nanometre range, (2) measurements of cell-substrate topology, which upon cholesterol depletion shows some loosening of cell-substrate contacts, and (3) measurements of cell topology upon photodynamic therapy (PDT), which demonstrate cell swelling and maintenance of focal contacts. The potential of the method for in vitro diagnostics, but also some requirements and limitations are discussed.

Design and Construction of Three-Dimensional Physiologically-Based Vascular Branching Networks for Respiratory Assist Devices

Lab on a Chip ◽  
2021 ◽  
Author(s):  
Jose Santos ◽  
Alla A Gimbel ◽  
Athanasios Peppas ◽  
James G Truslow ◽  
Daniel Lang ◽  
...  
Keyword(s):  
Drug Development ◽  
Three Dimensional ◽  
Lab On A Chip ◽  
In Vitro Diagnostics ◽  
Assist Devices ◽  
Branching Networks ◽  
Physiologically Based ◽  
Vascular Branching ◽  
Design And Construction

Microfluidic lab-on-a-chip devices are changing the way that in vitro diagnostics and drug development are conducted, based on the increased precision, miniaturization and efficiency of these systems relative to prior...

Platinum-Decorated Gold Nanoparticles with Dual Functionalities for Ultrasensitive Colorimetric in Vitro Diagnostics

Nano Letters ◽  
2017 ◽  
Vol 17 (9) ◽  
pp. 5572-5579 ◽  
Author(s):  
Zhuangqiang Gao ◽  
Haihang Ye ◽  
Dianyong Tang ◽  
Jing Tao ◽  
Sanaz Habibi ◽  
...  
Keyword(s):  
Gold Nanoparticles ◽  
In Vitro Diagnostics

scholarly journals Combining in Vitro Diagnostics with in Vivo Imaging for Earlier Detection of Pancreatic Ductal Adenocarcinoma: Challenges and Solutions

Radiology ◽  
2015 ◽  
Vol 277 (3) ◽  
pp. 644-661 ◽  
Author(s):  
Paul F. Laeseke ◽  
Ru Chen ◽  
R. Brooke Jeffrey ◽  
Teresa A. Brentnall ◽  
Jürgen K. Willmann
Keyword(s):  
Pancreatic Ductal Adenocarcinoma ◽  
In Vivo Imaging ◽  
Ductal Adenocarcinoma ◽  
In Vitro Diagnostics

Industry Watch

2008 ◽  
Vol 12 (05) ◽  
pp. 36-63
Keyword(s):  
Rural Areas ◽  
Joint Venture ◽  
Production Plant ◽  
In Vitro Diagnostics ◽  
Oncology Research ◽  
Synthetic Rubber ◽  
Roche Diagnostics ◽  
Life Sciences Industry ◽  
And Training

Invitrogen Enters into a Licensing Agreement with IMBcom. Stem Cell Sciences Enters into an Agreement with Myelin Repair Foundation. European Company NovaSecta Joins First Chinese CRO Service Alliance for Drug Discovery Solutions. DuPont (DD) Opens Fluoropolymer Production Plant in China. Satyam Opens Center to Cater to Life Sciences Industry. Eisai and Accenture Launch Clinical Data Management in India. Sanofi Pasteur and Statens Serum Institute Team Up against Tuberculosis. Roche Diagnostics and Mankind Pharma Collaborate on Accu-Chek Go. Nicholas Unit Signs Drug Development Pact with Eli Lilly & Co. Pierre Fabre and Nicholas Piramal Sign Oncology Research Agreement. Fortis HealthWorld Works with Godrej Aadhaar to Reach Out to Rural Areas in India. Karo Bio and Zydus Cadila Sign Research Agreement. ICGEB Joins with Emory Vaccine Center. DiscoveRx Corporation Signs Agreement with Cosmo Bio. Sysmex and bioMérieux Form Commercial Joint Venture for the Japanese In Vitro Diagnostics Market. Progeniq Launches Next-generation BioBoost v4.0 Accelerator. Celltrion and CSL Announce Collaboration to Develop and Manufacture Monoclonal Antibody. Antitope Ltd Announces Research Agreement with China Synthetic Rubber Corporation. Merck and DCB Announce Cooperation to Create New Biotech Services and Training Center. Taiwan's PharmaEssentia Signs Deal with Malaysia's Black Gold Global.

scholarly journals The Model List of Essential In Vitro Diagnostics: nuisance or opportunity?

Diagnosis ◽  
2019 ◽  
Vol 6 (3) ◽  
pp. 187-188
Author(s):  
Giuseppe Lippi ◽  
Mario Plebani ◽  
Emmanuel J. Favaloro
Keyword(s):  
In Vitro Diagnostics

Practical implementation of the German Genetic Diagnostics Act (GenDG) in Laboratory Medicine, the Human Genetics Laboratory and Genetic Counselling1)

2012 ◽  
Vol 35 (5) ◽  
pp. ---
Author(s):  
Matthias Orth ◽  
Imma Rost ◽  
Georg F. Hoffmann ◽  
Hanns-Georg Klein
Keyword(s):  
Human Genetics ◽  
State Of The Art ◽  
Personalised Medicine ◽  
Direct Analysis ◽  
Genetic Diagnostics ◽  
Practical Implementation ◽  
Gene Products ◽  
In Vitro Diagnostics ◽  
Current Version

Abstract The German Genetic Diagnostics Act (GenDG) in its current version, effective since February 2010, has far-reaching consequences for all physicians and also for many patients. After more than 1 year of experience working with the GenDG, much of the previous criticism has proved to be inadequate. From the beginning, experts complained that besides the direct analysis of germline DNA, gene products should not be included in the scope of the act – potentially having a very broad impact on the entire in vitro diagnostics field. Problems with applying the act range from the impossibility of distinguishing between genetic and non-genetic examinations to enormous bureaucratic hurdles, which in some areas interfere with an efficient, state-of-the-art patient care (i.e., newborn screening, treatment with blood products). The rapid progress in technology, which is currently revolutionizing genetic diagnostics worldwide, has been set with narrow boundaries by the German GenDG, while at the same time “personalised medicine”, applying exactly the same technologies, is being funded by government research grants. From the viewpoints of the concerned physicians and patients, there is an urgent need to amend the act itself, and efficient action should be taken by the committee on genetic diagnostics (GEKO), which was appointed to define guidelines for the practical use of the GenDG.

Application of SERS-Based Microfluidics for In Vitro Diagnostics

2019 ◽  
pp. 53-70 ◽  
Author(s):  
Jinhyeok Jeon ◽  
Namhyun Choi ◽  
Joung-Il Moon ◽  
Hao Chen ◽  
Jaebum Choo
Keyword(s):  
In Vitro Diagnostics

scholarly journals Emerging Standards and Analytical Science for Nanoenabled Medical Products

2020 ◽  
Vol 13 (1) ◽  
pp. 431-452 ◽  
Author(s):  
Bryant C. Nelson ◽  
Caterina Minelli ◽  
Shareen H. Doak ◽  
Matthias Roesslein
Keyword(s):  
Reference Materials ◽  
Test Methods ◽  
Diverse Group ◽  
In Vitro Diagnostics ◽  
Global Marketplace ◽  
Analytical Science ◽  
Medical Products ◽  
Standards Development ◽  
Regulatory Evaluation

Development and application of nanotechnology-enabled medical products, including drugs, devices, and in vitro diagnostics, are rapidly expanding in the global marketplace. In this review, the focus is on providing the reader with an introduction to the landscape of commercially available nanotechnology-enabled medical products as well as an overview of the international documentary standards and reference materials that support and facilitate efficient regulatory evaluation and reliable manufacturing of this diverse group of medical products. We describe the materials, test methods, and standards development needs for emerging medical products. Scientific and measurement challenges involved in the development and application of innovative nanoenabled medical products motivate discussion throughout this review.

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