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March 26, 2020

G&Ds team fastracks kit for COVID-19 diagnostic testing

By Gabriel Fernandez de Pierola, General Manager, Genomics and Diagnostic Solutions, GE Healthcare Life Sciences

Our Genomics and Diagnostic Solutions (G&Ds) team introduces the Sera-Xtracta Virus/Pathogen Kit to isolate DNA/RNA viruses such as COVID-19 from a variety of sample types, including swabs and blood.

In response to the Coronavirus pandemic, molecular diagnostic laboratories and their test developers urgently need to design, manufacture, and validate assays for these pathogenic agents. In addition to the usual challenges in developing a suitable and successful diagnostic assay, there is a shortage of kits to meet the increased demand for reagents to address the need on a global level.

To help address this urgent need, members of our Genomics and Diagnostic Solutions (G&Ds) team have been working hard to fastrack the development and testing of a solution for the purification of DNA/RNA viruses such as COVID-19 from a variety of sample types (swabs, blood and samples in universal transport media). Testing was also conducted on our existing RNASpin Kits.

Our R&D team, together with our Field Application Scientist and Product Manager, has developed a buffer formulation that can be used in conjunction with our SeraSil-Mag silica coated superparamagnetic beads to accelerate the development of test kits. This buffer ensures that total nucleic acid is selectively bound to the bead while impurities are efficiently removed during the quick wash steps. The buffer and SeraSil-Mag beads are packaged into the the Sera-Xtracta Virus/Pathogen Kit.

Luke T. Daum, Ph.D., tested the Sera-Xtracta Virus/Pathogen Kit using both human and murine blood samples, and compared the results with RNASpin Kits. The tests were given high priority to ensure results could be presented without delay in the hope of finding a solution to help address the limited supply of current COVID-19 test kits. Tests which typically take months to run were completed in less than two weeks. The G&Ds team works with Dr. Daum on an ongoing basis and are hugely grateful for speed and extra hours he dedicated to delivering the test results so quickly.

The testing methods and results are documented in an application note to provide kit developers with the reference data they need to feel confident that the kit will work to detect viruses and pathogens.

Our custom solutions team has worked around the clock to prepare this new kit for manufacture, and are now poised to talk with kit developers about their needs for the Sera-Xtracta Virus/Pathogen Kit. The kit will be made to order initially and following with further validation over the coming weeks it will be launched as a fully stocked commercial kit under the Sera-Xtracta brand.

To turn this project around is such a short time is truly commendable, and we would like to thank our Field Application Scientist, Product Managers as well as our R&D, Custom Solutions and Marketing teams within the Genomics and Diagnostic Solutions business for their hard work, commitment and dedication to this project.

For further information on the Sera-Xtracta Virus/Pathogen Kit, please contact our custom services team at or speak to your modality specialist.