YY/T 1826-2021Group B streptococcus nucleic acid detection kit (fluorescent PCR) (English PDF)
B群链球菌核酸检测试剂盒（荧光PCR法）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 6, 2021
Implementation date
December 1, 2022
Scope
YY/T 1826-2021 is the English-translated version of B群链球菌核酸检测试剂盒（荧光PCR法）.
YY/T 1826-2021 is the Chinese pharmaceutical industry standard for the kit that detects group B streptococcus nucleic acid by fluorescent PCR, the test used to screen for the organism that can be passed to a newborn during birth.
It sets the requirements, the test methods, the labels and instructions for use and the rules for packaging, transport and storage, covering the detection limit, the specificity against other streptococci and common flora, the accuracy against reference materials, the repeatability, the internal control and the stability.
It applies to kits for the qualitative detection of the organism in specimens from newborns and in vaginal and rectal swabs from women, directly or after enrichment culture. Issued on 6 December 2021, it has applied since 1 December 2022.
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Document preview — YY/T 1826-2021
National Standard of the People's Republic of China
- Classification
- C 44
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Requirement
- 5 Test method
- 6 Labels and Instructions for Use
- 7 Packaging, transport and storage
- Appendix A (Informative) Group B Streptococcus Nucleic Acid Detection Reagent National Reference Information
- Reference
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.
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
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 29791.1In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 1: Terms, definitions and general requirements
- GB/T 29791.2In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use
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Related Standards
GB/T 29791.1-2013 — In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 1: Terms, definitions and general requirements
GB/T 29791.2-2013 — In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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