Search result: GB/T 37871-2019
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Technical specification for quality evaluation of nucleic acid test kit
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GB/T 37871-2019
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| Standard ID | GB/T 37871-2019 (GB/T37871-2019) | | Description (Translated English) | Technical specification for quality evaluation of nucleic acid test kit | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | G00 | | Classification of International Standard | 07.080 | | Word Count Estimation | 10,134 | | Date of Issue | 2019-08-30 | | Date of Implementation | 2019-08-30 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration |
GB/T 37871-2019
(Nucleic acid detection kit quality evaluation technical specification)
ICS 07.080
G00
National Standards of People's Republic of China
Nucleic acid detection kit quality evaluation technical specification
Technicalspecificationforqualityevaluationofnucleicacidtestkit
Published on.2019-08-30
2019-08-30 implementation
State market supervision and administration
China National Standardization Administration issued
Content
Foreword III
1 range 1
2 Normative references 1
3 Terms and definitions, abbreviations 1
3.1 Terms and Definitions 1
3.2 Abbreviations 2
4 Quality evaluation requirements 2
5 Quality evaluation indicators and methods 2
5.1 Quality Evaluation Indicator 2
5.2 Quantitative test kit quality evaluation method 3
5.3 Qualitative test kit quality evaluation method 4
6 Document Requirements 4
6.1 Packing Mark 4
6.2 Guidance Document 4
6.3 Traceability Document 4
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard is proposed and managed by the National Standards Research Center.
This standard was drafted. China Institute of Metrology, Beijing Kangwei Century Biotechnology Co., Ltd., Beijing Medical Device Inspection Institute.
The main drafters of this standard. Dong Lianhua, Wang Jing, Wang Chunxiang, Wang Jun, Fu Boqiang, Niu Chunyan, Gao Yunhua.
Nucleic acid detection kit quality evaluation technical specification
1 Scope
This standard specifies the terms and definitions, evaluation requirements, evaluation indicators and evaluation methods for the quality evaluation of nucleic acid test kits.
This standard applies to nucleic acid testing kit products and services.
This standard does not apply to high-throughput sequencing nucleic acid detection kits.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 21415 in vitro diagnostic medical device biological sample medium quantity measurement calibrator and control substance evaluation
Source
GB/T 37868 Nucleic Acid Detection Kit Traceability Technical Specification
3 terms and definitions, abbreviations
3.1 Terms and definitions
The following terms and definitions apply to this document.
3.1.1
Accuracy
The degree of agreement between test results or measurement results and true values.
[GB/T 20001.4-2015, definition 3.4]
3.1.2
Repetitive repeatability
Precision under repetitive conditions.
Note. Repeatability can be quantified using discrete properties of the results.
[GB/T 20001.4-2015, definition 3.5]
3.1.3
Precision precision
The degree of agreement between the independent test/measurement results obtained under specified conditions.
[GB/T 20001.4-2015, definition 3.3]
3.1.4
Repeatability condition repeatabilityconditions
In order to obtain independent test/measurement results, the same operator, using the same test/measurement facility, in a short time
Observation conditions for testing/measuring the same test/measurement object within the compartment.
[GB/T 20001.4-2015, definition 3.6]
3.1.5
Analytical specificity
A measurement program only has the ability to confirm the measurability of the measurement it is intended to measure.
[GB/T 19702-2005, definition 3.8]
GB/T 37871-2019
(Nucleic acid detection kit quality evaluation technical specification)
ICS 07.080
G00
National Standards of People's Republic of China
Nucleic acid detection kit quality evaluation technical specification
Technicalspecificationforqualityevaluationofnucleicacidtestkit
Published on.2019-08-30
2019-08-30 implementation
State market supervision and administration
China National Standardization Administration issued
Content
Foreword III
1 range 1
2 Normative references 1
3 Terms and definitions, abbreviations 1
3.1 Terms and Definitions 1
3.2 Abbreviations 2
4 Quality evaluation requirements 2
5 Quality evaluation indicators and methods 2
5.1 Quality Evaluation Indicator 2
5.2 Quantitative test kit quality evaluation method 3
5.3 Qualitative test kit quality evaluation method 4
6 Document Requirements 4
6.1 Packing Mark 4
6.2 Guidance Document 4
6.3 Traceability Document 4
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard is proposed and managed by the National Standards Research Center.
This standard was drafted. China Institute of Metrology, Beijing Kangwei Century Biotechnology Co., Ltd., Beijing Medical Device Inspection Institute.
The main drafters of this standard. Dong Lianhua, Wang Jing, Wang Chunxiang, Wang Jun, Fu Boqiang, Niu Chunyan, Gao Yunhua.
Nucleic acid detection kit quality evaluation technical specification
1 Scope
This standard specifies the terms and definitions, evaluation requirements, evaluation indicators and evaluation methods for the quality evaluation of nucleic acid test kits.
This standard applies to nucleic acid testing kit products and services.
This standard does not apply to high-throughput sequencing nucleic acid detection kits.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 21415 in vitro diagnostic medical device biological sample medium quantity measurement calibrator and control substance evaluation
Source
GB/T 37868 Nucleic Acid Detection Kit Traceability Technical Specification
3 terms and definitions, abbreviations
3.1 Terms and definitions
The following terms and definitions apply to this document.
3.1.1
Accuracy
The degree of agreement between test results or measurement results and true values.
[GB/T 20001.4-2015, definition 3.4]
3.1.2
Repetitive repeatability
Precision under repetitive conditions.
Note. Repeatability can be quantified using discrete properties of the results.
[GB/T 20001.4-2015, definition 3.5]
3.1.3
Precision precision
The degree of agreement between the independent test/measurement results obtained under specified conditions.
[GB/T 20001.4-2015, definition 3.3]
3.1.4
Repeatability condition repeatabilityconditions
In order to obtain independent test/measurement results, the same operator, using the same test/measurement facility, in a short time
Observation conditions for testing/measuring the same test/measurement object within the compartment.
[GB/T 20001.4-2015, definition 3.6]
3.1.5
Analytical specificity
A measurement program only has the ability to confirm the measurability of the measurement it is intended to measure.
[GB/T 19702-2005, definition 3.8]
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