Clinical, Medical & Diagnostic Products
Monkeypox Assay Granted Emergency Use Authorization
Thermo Fisher Scientific’s Applied Biosystems TaqPath Monkeypox/Orthopox Virus DNA Kit, a polymerase chain reaction (PCR) test designed to detect non-variola Orthopoxviruses, including monkeypox virus, in approximately three-and-a-half hours, has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA).
The test is intended for the qualitative detection of DNA from monkeypox virus (clade I/II) and screening for non-variola Orthopoxviruses in human lesion swab specimens from individuals suspected of monkeypox (mpox) infection by their healthcare provider.
The TaqPath Monkeypox/Orthopox Virus DNA Kit is also designed for identification of other non-variola Orthopoxvirus DNA. While positive results are indicative of the presence of DNA from monkeypox virus or other non-variola Orthopoxvirus, clinicians must correlate PCR results with patient history and other diagnostic information to determine infection status.
“Ensuring that all US laboratories have access to monkeypox PCR testing is a critical part of the response to this public health emergency,” said
Manoj Gandhi, Senior Medical Director for Genetic Testing Solutions, Thermo Fisher Scientific. “This helps expedite availability of results so that patients can receive the appropriate treatment quickly. Authorised testing also enables public health agencies to stay one step ahead of the virus by monitoring viral spread and addressing affected populations accordingly.”
In early 2020, Thermo Fisher was among the first companies to distribute an emergency use authorised assay to identify active SARS-CoV-2 infections with the TaqPath COVID-19 Combo Kit. The TaqPath Monkeypox/Orthopox Virus DNA Kit builds off that technology and reflects Thermo Fisher’s continued commitment to develop diagnostic tools designed to address pressing public health emergencies as soon as possible.
More information online:
ilmt.co/PL/ABQZ 59495pr@reply-direct.com
Multimode Reader Streamlines Quantitative Endotoxin Detection
The Nebula® Multimode Reader from Lonza is qualified for use with Lonza’s turbidimetric, chromogenic and recombinant endotoxin detection methods. Users can now directly compare results from absorbance-based and fluorescence-based endotoxin assays in one reader, reducing the variables and training required for endotoxin detection. Powered by WinKQCL® Software, the reader also streamlines maintenance and validation procedures with a single data management system while maintaining data integrity compliance. This multimode reader expands Lonza’s Complete Testing Solutions, helping customers increase the efficiency of their endotoxin testing program.
Designed to meet the demands of current QC labs, the Nebula® Multimode Reader provides users with a single solution for use with multiple endotoxin assay types. Its customised plate movement technology and tunable wavelength capability allow users the choice of the turbidimetric, chromogenic or recombinant Factor C methods. As a result, the selection of the best-suited assay for specific samples will be significantly easier.
Full integration of the Nebula® Multimode Reader with Lonza’s WinKQCL® Endotoxin Detection and Analysis Software means data integrity compliance is more easily maintained. The audit trail, trends analysis and other key features from the WinKQCL® Software are available from one instrument, allowing users to realise a reduction in the time and documentation required to validate new test methods.
Janet Yancey-Wrona, Head of Marketing for Testing Solutions, Lonza, commented: “The flexibility that the Nebula® Multimode Reader provides in a single, compact unit will help ease the workload and minimise space consumed in the QC lab. Developed to work with all of Lonza’s quantitative endotoxin tests, the new reader enables our customers to evaluate and compare results more easily when adopting new test methods. We look forward to supporting our customers as they implement this new technology and improve the efficiency of their endotoxin testing programs.”
Employing a single reader that can accommodate multiple testing types means that end-user training, system maintenance, and software analysis are significantly simplified. Laboratories that need to test multiple sample types or validate new testing methods can benefit from more streamlined workflows and greater testing flexibility.
More information online:
ilmt.co/PL/XAJ9 59350pr@reply-direct.com Liquid Nitrogen Generator for Laboratories and Medical Applications
Liquid Nitrogen (LN2) is commonly used for a variety of applications across a wide range of industry sectors, including IVF (storage of samples), food packaging, cryotherapy, dermatology, lab applications and metal treatment to name just a few. In most cases, customers are reliant on deliveries of liquid nitrogen in the form of cylinders or Dewars, which gives rise to a number of pain points. It could be that you’re paying too much for LN2, with prices subject to fluctuation and controlled by your gas supplier.
Offering up to 240L/day, CRYOGEN from F-DGSi is a range of stand-alone LN2 generators. With CRYOGEN, there is no need for regular refilling or dependence on your LN2 vendor. No bulk storage is required, and installation can be confined to compact space in your premises. CRYOGEN enables you to take back control of LN2 production and eliminate some of the headaches associated with traditional methods of delivery. Moreover, you can achieve an ROI within a relatively short time period, depending on
usage levels and price you are currently paying for LN2.
Proven technology and innovative product features set F-DGSi apart from their competitors. Using PSA Technology for nitrogen production, F-DGSi gas generators can deliver a much drier and higher purity nitrogen than produced using hollow fibre membranes, which are susceptible to humidity and can deplete over time resulting in costly replacement. The CRYOGEN is produced with helium compressor air cooled or water cooled depending on your needs.
F-DGS generators use touch-screen technology with remote access monitoring, a unique feature not available with other generators in the field. Remote Access Monitoring allows you to access the generator remotely, offering the ability to set parameters, view activities and diagnose faults in the event of a breakdown. This is really useful in
remote locations where you do not have a local FSE or when access to labs is restricted. The control system gives the user all the information necessary to ensure an efficient and consistent supply of liquid nitrogen and nitrogen gas are always available. From the process to flow and alarms, including automatic operation, Trend graphs, service alarm and service records page, there is simply no other liquid nitrogen system with this amount of information.
CRYOGEN Generators are your reliable and efficient alternative to conventional liquid nitrogen supplies. Taking away the on-going costs, safety considerations of deliveries, transportation of traditional liquid gas supplies. Your on-site liquid nitrogen systems will be some of the most advanced and intelligent available.
F-DGSi is a French manufacturer and world leader in the innovation of gas generators (Hydrogen, Air Zero, Nitrogen) and liquid nitrogen generators. The company are meeting the needs of different analytical instruments, such as, LC-MS, GC, GC-MS, cryotherapy and other applications used in laboratories around the world. Reliability and a high product quality, combined with French creativity and design, allow you to lower your operating costs, reduce environmental impact and eliminate the inconvenience of bottled gas supply.
More information online:
ilmt.co/PL/VEwm 58930pr@reply-direct.com
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