Clinical, Medical & Diagnostic Products
Inactivation Media for Highly Infectious Clinical Specimens
Designed and manufactured in the UK by MWE, Σ–MM™ solution rapidly kills all microorganisms, including bacteria, mycobacteria and viruses, rendering specimens safe for transport, whilst preserving and stabilising RNA/DNA for accurate molecular analysis across diagnostic platforms.
The Σ–MM™ device is a highly effective single step collection. The medium disturbs and lyses lipid membranes, destroys proteins including DNase and RNase, leaving stable intact DNA or RNA. Specimens collected into Σ–MM™ can be transported at ambient temperatures, no freezing or refrigeration is required. Specimens can be collected using any microbiology swabs, including MWE Transwab® and all MWE Dryswab™ products.
Σ–MM™ has been on the market for a number of years and has consistently been shown to effectively eliminate infectious microorganisms from specimens. During the pandemic, Σ–MM™ has demonstrated compatibility on numerous PCR platforms, where samples were rendered safe for handling and viral RNA was preserved, resulting in accurate diagnostic reporting.
A study was designed in cooperation with the Medical Research Council & University of Glasgow’s Centre for Virus Research to measure the inactivation of SARS-CoV-2 achieved in specimens collected using Σ–MM™. Σ–MM™ Molecular Medium was tested for the ability to inactivate SARS- CoV-2-Gla-1 isolate.
BS EN 14476 requires that there should be a titre reduction of more than 4 log10 for virucidal suspension tests. Σ–MM™ consistently exceeded this requirement for both the time points and concentrations used in the study. In fact, in 1 minute of inoculation there was no detectable virus at all in 6 out of 6 samples tested. Given that the test concentrations were higher than would be the case for clinical specimens, the study demonstrates that Σ–MM™ can be used as a safe transport system for SARS-CoV-2 specimens, offering rapid inactivation. The results are consistent with other studies using different inactivation reagents and methods.
More information online:
ilmt.co/PL/50m0 56270pr@reply-direct.com
Stabilised Saliva Collection Kit for Safe Sample Collection
The Thermo Scientific SpeciMAX Stabilized Saliva Collection Kit* is designed to securely collect saliva for research. The SpeciMAX Stabilized Saliva Collection Kit preserves viral nucleic acids in a non- hazardous stabilisation solution that inactivates common respiratory viruses for safer sample collection. The kit comes with an easy-to-use, spill-resistant funnel, a screw cap to secure the sample after collection, and a standardised size tube that fits seamlessly into viral RNA extraction automation workflows for high throughput sample processing.
“Labs need a non-invasive and non-hazardous collection kit that works with their current instruments,” said Ellie Mahjubi, Vice President and General Manager of Sample Preparation at Thermo Fisher Scientific. “SpeciMAX Stabilized Saliva Collection Kits are compatible with downstream automation workflows to help reduce the costs and time of viral research.”
The stabilised solution is non-hazardous, does not contain guanidinium to avoid interaction with bleach and is compatible with all disinfection protocols. The stabilisation agent preserves nucleic acid in saliva samples at ambient temperature for up to 14 days for RNA and viral nucleic acid, and up to two years for gDNA.
The new kit complements Thermo Fisher’s recently launched SpeciMAX Saliva Collection Kit for raw saliva. Both products come individually packaged and barcoded, require just 1 mL of saliva and are a standardised 6 mL size to fit into downstream automation workflows.
The SpeciMAX Stabilized Saliva Collection Kit contains components that are manufactured under a license from Isohelix, a division of Cell Projects Limited. More information online:
ilmt.co/PL/0DGZ
56404pr@reply-direct.com
New Clinical MDR and Study Automation Platform Accelerates Clinical Trial Design and Build
Formedix announces the launch of ryze, an innovative all-in-one cloud-based clinical metadata repository (MDR) and study automation platform. ryze has been specifically developed to accelerate and streamline the design, build and submission of clinical trials, in compliance with the Clinical Data Interchange Standards Consortium (CDISC) and NCI Controlled Terminology.
As a fully-integrated software suite, ryze enables the design and build of the full spectrum of case report forms (CRFs), study data tabulation models (SDTMs) and analysis data models (ADaMs), while also automating SDTM mappings and conversions. Built with compliance at its core, the platform features metadata templates with embedded CDISC standards and NCI Controlled Terminology. This enables pharmaceutical, biotechnology and CRO organisations to effortlessly meet their regulatory objectives. Importantly, ryze facilitates metadata standardisation, expediting clinical trial set up, enabling data reuse, and improving data quality and consistency.
ryze is the only platform that allows seamless integration with a wide selection of leading electronic data capture (EDC) systems, including support for the individual functionality of each system. As such, clinical data professionals can use ryze to design CRFs and make any necessary changes before automatically exporting the designs into the EDC of their choice to build their clinical trial. As a result, clinical trial build can take as little as 6 weeks.
Furthermore, ryze is a commercial off-the-shelf system, meaning it is available for use immediately and can be rapidly configured to meet specific application needs.
SDTM conversion is enabled at the click of a button, significantly reducing time-to-data and providing clinicians instant visibility of patient data as soon as it starts flowing in from the EDC system. This allows clinicians to gain actionable data insights to drive well-informed, data- based decision making. Owing to this unique capability, an early release of ryze has already been used with great success to rapidly roll-out COVID-19 vaccine clinical trials.
More information online:
ilmt.co/PL/AEaO 54973pr@reply-direct.com
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