Upscaled version of two assays validated according to regulatory standards

Upscaled versions of the assays should be developed, for broader use. The quality of all reagents used for these assays should be extensively tested and documented according to CLSI criteria. We will initiate the validation in order to obtain the directive 98/79/EC for in vitro diagnostic (IVD) label, including development of harmonised standards and statistical approaches to optimise reagents in collaboration with LGC.