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GB/T 42077-2022: Biotechnology - Requirements for evaluating the performance of quantification methods for nucleic acid target sequences - qPCR and dPCR
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 42077-2022 | English | 834 |
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Biotechnology - Requirements for evaluating the performance of quantification methods for nucleic acid target sequences - qPCR and dPCR
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GB/T 42077-2022
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Basic data | Standard ID | GB/T 42077-2022 (GB/T42077-2022) | | Description (Translated English) | Biotechnology - Requirements for evaluating the performance of quantification methods for nucleic acid target sequences - qPCR and dPCR | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | A40 | | Classification of International Standard | 07.080 | | Word Count Estimation | 46,462 | | Date of Issue | 2022-12-30 | | Date of Implementation | 2022-12-30 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 42077-2022: Biotechnology - Requirements for evaluating the performance of quantification methods for nucleic acid target sequences - qPCR and dPCR
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ICS 07.080
CCSA40
National Standards of People's Republic of China
Performance of Biotech Nucleic Acid Target Quantification Methods
Evaluation requirements qPCR method and dPCR method
(ISO 20395.2019, IDT)
Posted on 2022-12-30
2022-12-30 implementation
State Administration for Market Regulation
Released by the National Standardization Management Committee
table of contents
Preface I
1 Scope 1
2 Normative references 1
3 Terms and Definitions 2
4 Measurement program design 7
5 Sample quality control --- nucleic acid total amount, integrity and purity 11
6 Method design and optimization for nucleic acid target sequence quantification 13
7 Data Quality Control and Analysis 16
8 Validation of Nucleic Acid Quantitative Measurement Methods 18
9 Traceability and comparability of nucleic acid quantitative measurement methods 20
10 Measurement Uncertainty of qPCR and dPCR Measurements 21
11 report 22
Appendix A (Informative) Spectrophotometry 23
Appendix B (Informative) Nucleic Acid Integrity 25
Appendix C (Informative) PCR Amplification Efficiency 27
Appendix D (Informative) Measurement Uncertainty 29
Appendix E (informative) MIQE and dMIQE checklist 31
Reference 38
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 for Standardization Documents"
drafting.
This document is equivalent to ISO 20395.2019 "Performance Evaluation Requirements for Biotechnology Nucleic Acid Target Sequence Quantitative Methods qPCR method and
dPCR method.
Please note that some contents of this document may refer to patents. The issuing agency of this document assumes no responsibility for identifying patents.
This document was proposed and managed by the National Biochemical Testing Standardization Technical Committee (SAC/TC387).
This document was drafted by. China Institute of Testing Technology, China Institute of Metrology, West China Hospital of Sichuan University, Shenzhen Analysis and Testing
Association, Academy of Military Medical Sciences, Institute of Agricultural Quality Standards and Testing Technology, Chinese Academy of Agricultural Sciences, Qingdao Ruisid Biotechnology Co., Ltd.
Division, General Biology (Anhui) Co., Ltd., Chengdu World Union Health Biotechnology Co., Ltd.
The main drafters of this document. Zhou Lihua, Ma Lixia, Zhang Yi, Gao Yunhua, Sun Yujie, Li Liang, Zhang Chen, Tian Weidong, Sun Dengfeng, Yu Mingjun,
Jiang Zhanyue, Zhang Bingqiang, Ye Deping, Men Jingtao, Jiang Zijing, Yang Guowu, Yang Jiebin.
Performance of Biotech Nucleic Acid Target Quantification Methods
Evaluation requirements qPCR method and dPCR method
1 Scope
This document specifies general requirements for the performance evaluation and quality assurance of methods for the quantification of nucleic acid target sequences.
This document applies to digital PCR (dPCR) or real-time quantitative PCR (qPCR) amplification techniques for DNA (deoxyribonucleic acid) and
Quantitative determination of RNA (ribonucleic acid) target sequences. Suitable target nucleic acid molecules, including double-stranded DNA (dsDNA), such as genomic
DNA (gDNA) and plasmid DNA; single-stranded DNA (ssDNA), complementary DNA (cDNA), single-stranded RNA (ssRNA) including ribosomes
RNA (rRNA), messenger RNA (mRNA); double-stranded RNA, including long and short non-coding RNA [microRNA (miRNA) and
small interfering RNA (siRNA), etc.].
This document applies to nucleic acids of biological origin (such as viruses, prokaryotic and eukaryotic cells), cell-free biological fluid samples (such as plasma or cell
cellular matrix); in vitro extracted from nucleic acids of non-biological origin [such as oligonucleotides, synthetic gene fragments, and in vitro transcribed (IVT) RNA]
nucleic acid.
This document is not intended for the quantification of DNA oligonucleotides that are too short (< 50 bases).
This document contains.
---Assay design, including quantitative strategies (qPCR standard curve method, dPCR molecular counting method, qPCR relative quantification method, dPCR ratio
value quantification method) and usage control;
--- Quantification of total nucleic acid mass concentration and quality control of nucleic acid samples, including assessment of nucleic acid quality (purity and integrity);
---PCR assay design, optimization, bioinformatics and in vitro specificity testing;
---Data quality control and analysis, including acceptance criteria, threshold setting and normalization method;
--- Method validation according to the specific requirements of qPCR/dPCR (precision, linearity, limit of quantification, limit of detection, correctness and robustness);
--- Methods for establishing metrological traceability and evaluating uncertainty of measurement.
This document does not provide advice on the sampling of biological material or the handling of biological samples (e.g. collection, preservation, transport, storage, handling, and nucleic acid extraction).
requirements or acceptance criteria. There are also no requirements and requirements for special applications (such as food or clinical applications where special matrix problems may arise)
Acceptance Criteria.
2 Normative references
The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references
For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to
this document.
ISO /IEC Guide 98-3.2008 Uncertainty of Measurement Part 3.Guidelines for the Expression of Uncertainty in Measurement (GUM.1995)
1995)]
Note. GB/T 27418-2017 Evaluation and Expression of Measurement Uncertainty (ISO /IEC Guide 98-3.2008, MOD).
ISO /IEC Guide 99 Basic and general concepts of the international vocabulary of metrology and related terms (VIM) [International
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