Clinical, Medical & Diagnostic Products
Molecular Syndromic Test for Respiratory Infections Achieves CE Mark
GenMark Diagnostics, Inc has announced that it has achieved CE Mark under the European In-Vitro Diagnostic Devices Directive (98/79/EC) for its ePlex® Respiratory Pathogen Panel 2 (RP2). The molecular test provides results in less than two hours for more than 20 viruses and bacteria that cause common and often serious respiratory infections, including COVID-19, influenza A and B, respiratory syncytial virus (RSV) and rhinovirus. This panel was previously made commercially available in the US and is awaiting Emergency Use Authorization by the FDA.
A syndromic diagnostic test, RP2 provides rapid results for infections with similar symptoms such as fever, cough and body aches, which will be critical in preparing for fall and winter as the flu season coincides with the ongoing risk of COVID-19. RP2 includes a new, simplified workflow making it even easier for labs to run the test. Incorporating COVID-19 into the existing ePlex Respiratory Pathogen (RP) Panel streamlines the diagnostic process for hospitals by allowing them to check for multiple pathogens with a single test, saving time and resources and improving bed management. A study at two acute large tertiary care hospitals demonstrated that using the ePlex RP panel in the Emergency Department led to earlier patient results, which resulted in an 8.4% reduction in hospital admission.
The ePlex RP2 Panel is designed for use with the company’s ePlex system, along with the ePlex RP Panel and Blood Culture Identification (BCID) Panels (Gram-positive, Gram-negative and Fungal pathogens), all of which have achieved CE Mark.
The ePlex RP2 Panel has been funded in part with federal funds from the United States Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50120C00022.
More information online:
ilmt.co/PL/WV4a 53274pr@reply-direct.com
Rapid COVID-19 Diagnostic Infection Testing
Porvair Sciences reports on the Vyon® porous plastic filters it is supplying to University of Cambridge spinout company, Diagnostics for the Real World, for their game-changing SAMBA II machine that provides diagnosis of COVID-19 infection in under 90 minutes.
SAMBA II provides a simple and accurate system for the diagnosis of infection with SARS-CoV-2, the virus that causes the disease COVID-19. The machine looks for traces of genetic material belonging to the virus, amplifies it billions of times chemically and therefore can provide extremely sensitive detection of active infections. SAMBA II is a fully automated machine, performing sample preparation, extraction, amplification and detection.
Alan Hughes, Porous Plastics Accounts Manager for Porvair Sciences commented: “We are delighted to be able to play a small part in the development of a machine that can be routinely used by healthcare workers at point-of-care in order to rapidly diagnose patients with COVID- 19.” He added: “Porvair Sciences was chosen as the filter supplier for the SAMBA II sample preparation cartridge because Vyon® porous plastics are made from clean, regulatory controlled materials and manufactured using no release agent, therefore are completely free from contaminants. In addition, the tortuous path of our proprietary Vyon® porous plastic materials ensures unmatched sample clean-up eliminating the chance of breakthrough of even tiny particles that could interfere with the diagnostic equipment and analysis.”
Proprietary to Porvair Sciences, Vyon® is a highly versatile porous plastic which can be modified give hydrophilic or hydrophobic properties, or enhanced to achieve specific chemical and biochemical separations. Vyon® can also be combined with other materials to create a composite product. These and other desirable properties have made Vyon® the material of choice of porous plastic for medical device / healthcare companies looking to produce drug filters, vents for catheters and medical fluid collection vessels with a competitive advantage. Vyon® is available in a range of shapes and sizes to suit your needs.
More information online:
ilmt.co/PL/AjKv and
ilmt.co/PL/va29 52690pr@reply-direct.com
New Antibodies for COVID-19 Virus Detection
The nucleocapsid of COVID-19 virus is ideal for antigen detection for two major reasons: 1) It is produced abundantly in infected cells.
2) It is a highly conserved protein and therefore not prone to mutation.
The cytoplasm of infected cells fills with the nucleocapsid antigen. These cells can be collected on a NP swab and added to a specimen buffer to lyse and release this antigen for detection by immunoassay.
ViroStat has developed and just released a set of new monoclonal antibodies to the nucleocapsid of the COVID-19 virus. These final 5 antibodies were selected from an initial group of 60 based upon highest binding affinity and best ELISA pairing for detection of native viral antigen.
Download the data sheet for these new monoclonal antibodies. More information online:
ilmt.co/PL/VkWE
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Breakthrough 25-minute COVID-19 Test set for Launch
A breakthrough test for COVID-19 which works in just 25 minutes, with high accuracy and requiring only routine laboratory equipment, is currently in the final stages of clinical validation by British biotech firm MicrosensDx. The test, called MicrosensDx COVID-19, has been used successfully in large scale testing programs with BAE Systems in Cumbria over the last few months, where it has been deployed to test more than 8,000 people a week. MicrosensDx is now planning to scale up for wider availability, both in the UK and across Europe. Crucially, the test uses fewer of the globally limited reagents that other COVID-19 test technologies require and which have been in short supply across Europe in recent months.
It can be used within mass testing laboratories, but is also available for use in a ‘near patient’ mini-lab format, by healthcare staff with basic laboratory training, to enable rapid real-time testing. Crucially the result is available in less than a third of the time required by the widespread Public Health England PCR test [90 minutes]. The test can analyse multiple types of sample (throat and nasal swabs, in addition to saliva and sputum) and, crucially, the virus is neutralised once it is captured in a vial, making it safe for the operator administering the test. The sample is placed in a solution containing the company’s highly-sensitive magnetic beads which attract RNA from the virus, even at the lowest of levels. This allows the RNA to be extracted from the patient’s sample ready for amplification.
The detection technology is based on the biotech’s loop-mediated isothermal amplification (LAMP) technology. MicrosensDx COVID-19 is a refined version of a prototype test which was originally designed earlier this year and validated in collaboration with Kings College London’s Professor Tim Spector OBE, the world-leading epidemiologist. The sensitivity of the test has improved markedly since the early- stage assay, with validation data due later this month to coincide with full CE marking accreditation.
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