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GB/T 41185-2021 English PDF

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GB/T 41185-2021: Specification of preparation and quality control of reference materials for DNA detection of aquatic animals pathogen - Plasmid
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Basic data

Standard ID GB/T 41185-2021 (GB/T41185-2021)
Description (Translated English) Specification of preparation and quality control of reference materials for DNA detection of aquatic animals pathogen - Plasmid
Sector / Industry National Standard (Recommended)
Classification of Chinese Standard B41
Word Count Estimation 11,179
Issuing agency(ies) State Administration for Market Regulation, China National Standardization Administration

GB/T 41185-2021: Specification of preparation and quality control of reference materials for DNA detection of aquatic animals pathogen - Plasmid


---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.
Specification of preparation and quality control of reference materials for DNA detection of aquatic animals pathogen -- Plasmid ICS 65:020:30 CCSB41 National Standards of People's Republic of China Preparation of reference material for the detection of aquatic animal pathogenic DNA and Quality Control Specification Plasmids Published on 2021-12-31 2022-07-01 Implementation State Administration for Market Regulation Released by the National Standardization Administration

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 Ministry of Agriculture and Rural Affairs of the People's Republic of China: This document is under the jurisdiction of the National Aquatic Products Standardization Technical Committee (SAC/TC156): This document is drafted by: China Academy of Inspection and Quarantine, Beijing Customs, Lianyungang Customs: The main drafters of this document: Lin Xiangmei, Zhang Min, Wang Na, Wu Shaoqiang, Jing Hongli, Gu Qiang, Ren Tong, Zhou Yi, Jiang Yulin: Preparation of reference material for the detection of aquatic animal pathogenic DNA and Quality Control Specification Plasmids

1 Scope

This document gives the plasmid as a positive reference material for the detection of aquatic animal pathogenic DNA, its quality control standard terms and definitions, abbreviations Abbreviations, principles, reagents or materials, instruments and equipment, specifies general requirements for plasmid preparation, quality control of plasmids, validation of plasmids, and quality A method for evaluating the quality of pellets: This document is applicable to the preparation and quality control of plasmids in the detection of aquatic animal pathogenic DNA nucleic acids:

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 6682 Analysis Laboratory Water Specifications and Test Methods SC/T 7019 Laboratory Preservation Specification for Aquatic Animal Pathogenic Microorganisms

3 Terms and Definitions

The following terms and definitions apply to this document: 3:1 coefficient of variation coefficientofvariation A normalized measure of the degree of dispersion of a probability distribution, which is defined as the ratio of the standard deviation of the data to the mean of the data: 3:2 initial sample frontsample According to the order of preparation, the first 1/3 batch of products are prepared: 3:3 uniformity The plasmids of the same production batch, each containing the same amount of target gene: 3:4 traceability The consistency of the target gene sequence in the plasmid with the sequence of the pathogen reference strain: 3:5 stability Plasmids have the ability to ensure positive test results within specific storage conditions and storage time ranges: 3:6 positive reference material It has some identical characteristics with the pathogen, such as the same target gene sequence, antigenicity, sensitivity, etc:, and is used for the detection of the pathogen: An ideal positive test result will be obtained, which is usually used as a positive control to determine whether the sample to be tested is pathogen-positive:

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