The BSI CH/212 IVDs group is responsible for standardization in the field of in vitro diagnostics (IVDs). They have put forward a proposal to develop a new technical specification, ISO/PWI TS 8219: Sequencing and clinical application to infectious diseases.
The document covers the essential requirements for advanced sequencing procedure for detecting the microbes directly, without the need for microbial culture. It aims to address the challenges associated with sampling, processing, sequencing, and analysis for accurate diagnosis of infectious diseases. It also provides guidance on improving the quality, safety, and overall performance of these sequencing approaches.
Members who are interested in this proposal are encouraged to respond directly by 24 September or through BIVDA (regulatory@bivda.org.uk).
