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YY/T 1826-2021: Group B streptococcus nucleic acid detection kit (fluorescent PCR)
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1826-2021 | English | 179 |
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Group B streptococcus nucleic acid detection kit (fluorescent PCR)
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YY/T 1826-2021
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Basic data | Standard ID | YY/T 1826-2021 (YY/T1826-2021) | | Description (Translated English) | Group B streptococcus nucleic acid detection kit (fluorescent PCR) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Word Count Estimation | 9,927 | | Issuing agency(ies) | State Drug Administration | YY/T 1826-2021: Group B streptococcus nucleic acid detection kit (fluorescent PCR)---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
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
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