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Preparation, validation and clinical application of an automated test procedure for the determination of Covid-19 in clinical material

Publication

Abstract

he development of the viRNAtrap,V methodology, which ensures immediate deactivation of the viral particle, i.e. disinfection of the sample, which can be safely handled without risk of infection of medical and laboratory personnel. The solution will be designed to stabilize the RNA, so samples do not need to be refrigerated during transport and are stable at room temperature for several months. The functionality of the solution will then be verified on samples collected as part of the Covid19 diagnostic. Subsequently, the RNA isolation method will be optimised for manual and automated operation.

These methods will form the basis of the "viRNAtrapTM Extraction Kit 100", which will also be commercially available through GeneSpector https://gspector.cz) and will be routinely used in dozens of laboratories in the Czech Republic.

The viRNAtrap platform will be further tested and successfully used in conjunction with various qRT-PCR kits and has become part of a CE-IVD validated kit providing a comprehensive solution for Covid-19 diagnostics and a kit for joint testing for Covid-19 and influenza A and B.

The technology is currently operational and optimized for use on King Fisher, Bravo and Tecan platforms.