Technical Guideline on the Registration of Group B Streptococcus Nucleic Acid Detection Reagents (draft)
On August 13, 2020, CMDE announced its preparation of Technical Guideline on the Registration of Group B Streptococcus Nucleic Acid Detection Reagents (draft). The Group B Streptococcus Nucleic Acid Detection Reagents mentioned in this guideline refers to the nucleic acid detection technology based on molecular biological methods. This method takes group B streptococcus nucleic acid sequence as the detection target, and it is a reagent for qualitative detection of group B Streptococcus in vitro from human samples (such as rectal swabs and vaginal swabs of pregnant women) or bacteria cultured with human samples. All kinds of opinions are welcome to be filled in the information collection form and submit it to CMDE before September 4, 2020 via email.
