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YY/T 1826-2021: Group B streptococcus nucleic acid detection kit (fluorescent PCR)
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 1826-2021	English	179	Add to Cart	3 days [Need to translate]	Group B streptococcus nucleic acid detection kit (fluorescent PCR)

YY/T 1826-2021: Group B streptococcus nucleic acid detection kit (fluorescent PCR)

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Group B streptococcus nucleic acid detection kit (fluorescent PCR) ICS 11:100:10 CCSC44 People's Republic of China Pharmaceutical Industry Standard Group B Streptococcus Nucleic Acid Detection Kit (Fluorescent PCR Method) Published on 2021-12-06 2022-12-01 Implementation Released by the State Drug Administration directory Preface I 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Requirement 1 5 Test method 3 6 Labels and Instructions for Use 4 7 Packaging, transport and storage4 Appendix A (Informative) Group B Streptococcus Nucleic Acid Detection Reagent National Reference Information 5 Reference 6

foreword

This document is in accordance with the provisions of GB/T 1:1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents" drafted: Please note that some content of this document may be patented: The issuing agency of this document assumes no responsibility for identifying patents: This document is proposed by the State Drug Administration: This document is under the jurisdiction of the National Standardization Technical Committee for Medical Clinical Laboratory and In Vitro Diagnostic Systems (SAC/TC136): This document is drafted by: China National Institute for Food and Drug Control, Jiangsu Shuoshi Biotechnology Co:, Ltd:, Suzhou Baiyuan Gene Technology Co:, Ltd:, Sun Yat-Sen University Daan Gene Co:, Ltd: The main drafters of this document: Shen Shu, Xu Sihong, Tu Xiaobao, Che Tuanjie, Jiang Xiwen: Group B Streptococcus Nucleic Acid Detection Kit (Fluorescent PCR Method)

1 Scope

This document specifies the requirements, test methods, labeling and instructions for use, packaging, transportation and storage: This document is suitable for the qualitative detection of specific parts of neonates or vaginal and rectal secretions of women and their culture through the principle of fluorescent PCR method: A diagnostic kit for group B streptococcus nucleic acid in :

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text: Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document: GB/T 29791:1 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 1: Terms, definitions and general Require GB/T 29791:2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) - Part 2: In vitro diagnostic reagents for professional use

3 Terms and Definitions

The terms and definitions defined in GB/T 29791:1 and the following terms and definitions apply to this document: 3:1 polymerase chain reaction polymerase chain reaction; PCR A method for rapid amplification of specific DNA or RNA fragments in vitro, which consists of three basic reactions of denaturation-annealing-extension Step composition: 3:2 group B streptococcus groupBstreptococcus; GB S A beta-hemolytic, gram-positive Streptococcus pyogenes, arranged in pairs or short chains: Can cause maternal endometritis and fever, is a The leading cause of bacterial sepsis and meningitis infections in neonates: Note: Group B Streptococcus is also known as Group B Streptococcus or Streptococcus agalactiae (Streptococcusagalactiae):

4 Requirements

4:1 Appearance The outer packaging should meet the manufacturer's requirements: The composition of the kit should be complete and meet the manufacturer's requirements: 4:2 Nucleic acid extraction function The nucleic acid extraction function should meet the following requirements: a) For reagents containing nucleic acid extraction components, the manufacturer shall make appropriate requirements for nucleic acid extraction and verify the nucleic acid extraction function; b) Reagents that require extraction of samples but do not contain nucleic acid extraction components shall be specified or specified by the manufacturer and provide verification or ...