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RB/T 032-2020: (Guidelines for Validation and Verification of Gene Amplification Testing Methods)
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(Guidelines for Validation and Verification of Gene Amplification Testing Methods)
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RB/T 032-2020
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Basic data | Standard ID | RB/T 032-2020 (RB/T032-2020) | | Description (Translated English) | (Guidelines for Validation and Verification of Gene Amplification Testing Methods) | | Sector / Industry | Chinese Industry Standard (Recommended) | | Classification of Chinese Standard | A00 | | Word Count Estimation | 13,166 | | Date of Issue | 2020-08-26 | | Date of Implementation | 2020-12-01 | | Regulation (derived from) | National Certification and Accreditation Administration Announcement No. 21 of 2020 | | Issuing agency(ies) | National Certification and Accreditation Administration | RB/T 032-2020: (Guidelines for Validation and Verification of Gene Amplification Testing Methods)
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(Guidelines for Validation and Verification of Gene Amplification Testing Methods)
ICS 03:120:00
A00
The People's Republic of China Certification and Accreditation Industry Standard
Guidelines for Validation and Verification of Gene Amplification Testing Methods
2020-08-26 released
2020-12-01 implementation
Issued by the National Certification and Accreditation Administration Commission
Table of contents
Foreword Ⅰ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Method confirmation 3
4:1 General 3
4:2 Selection of characteristic parameters 3
4:3 Confirmation method 4
4:3:1 Method validation in the laboratory 4
4:3:2 Inter-laboratory method validation 4
4:4 Confirmation of characteristic parameters 5
4:4:1 Specificity 5
4:4:2 Detection limit 5
4:4:3 Precision 5
4:4:4 Linear range 6
4:4:5 Limit of quantification 6
4:4:6 Reality 6
4:4:7 Robustness 7
4:4:8 Measurement uncertainty 7
4:5 Record 7
5 Method verification 7
5:1 General 7
5:2 Selection of verification parameters 8
Appendix A (informative appendix) Detection of inhibitors in DNA extract 9
Reference 10
Foreword
This standard was drafted in accordance with the rules given in GB/T 1:1-2009:
This standard was proposed and managed by the National Certification and Accreditation Administration Committee:
Drafting organizations of this standard: China National Accreditation Center for Conformity Assessment, Dalian Customs Technology Center, Shenzhen Huada Gene Technology Co:, Ltd:, Zhejiang
Jiangtianke High-tech Development Co:, Ltd:, Shenyang Customs Technology Center, Liaoning Provincial Center for Disease Control and Prevention:
The main drafters of this standard: Li Hong, Liu Shuyan, Shan Geng, Zhang Na, Tang Danzhou, Jiang Huayan, Fu Hongkun, Chen Huan, Fu Haibin, Wu Weiwei,
Sun Xiaochen, Qu Xiaoming, Wang Yanbin:
Guidelines for Validation and Verification of Gene Amplification Testing Methods
1 Scope
This standard provides guidelines for the validation and verification of gene amplification detection methods:
This standard applies to methods developed by laboratories in the field of gene amplification, standard methods used beyond the predetermined scope, and other modifications
The method confirmation of the standard method and the method verification of the laboratory before the formal use of the newly introduced standard method:
2 Normative references
The following documents are indispensable for the application of this document: For dated reference documents, only the dated version applies to this article
Pieces: For undated references, the latest version (including all amendments) applies to this document:
GB/T 6379:2 Accuracy of measurement methods and results (accuracy and precision) Part 2: Determine the repeatability of standard measurement methods
Basic methods of sex and reproducibility
ISO /IEC 17025:2017 General requirements for the competence of testing and calibration laboratories (General requirements for thecompe-
tenceoftestingandcalibrationlaboratories)
ISO /IEC Guide 99:2007 Basic and general concepts and related terms of international metrology vocabulary [Internationalvocabulary
ofmetrology-Basicandgeneralconceptsandassociateterms(VIM)]
3 Terms and definitions
The following terms and definitions defined in ISO /IEC Guide 99:2007 and ISO /IEC 17025:2017 apply to this document: in order to
For ease of use, some terms and definitions in ISO /IEC Guide 99 are listed repeatedly below:
3:1
Method verification
The laboratory provides objective evidence to prove that it meets the requirements of the testing method through verification or testing: That is to provide objective evidence to prove
The laboratory can use the method correctly to ensure that the required method performance is achieved:
Note 1: When applicable, the measurement uncertainty should be considered:
Note 2: Modified from ISO /IEC Guide 99:2007, definition 2:44:
3:2
Methodvalidation
Through experiments, the laboratory provides objective evidence to prove that the method to be determined meets the intended use:
Note 1: Method validation should identify the factors that affect the performance of the method and the degree of influence, verify the performance characteristics of the method, and determine the applicable matrix and the used method
limitation factor:
Note 2: Confirmation can include confirmation of sampling, disposal of test items and transportation procedures:
Note 3: Modified from ISO /IEC Guide 99:2007, definition 2:45:
3:3
Qualitativemethod
An analytical method that directly or indirectly detects the presence of an analyte:
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