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SN/T 4800-2017 | English | 149 |
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Protocols for assessment on ELISA commercial diagnostic kits used in entry-exit animal quarantine
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SN/T 4800-2017
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Basic data Standard ID | SN/T 4800-2017 (SN/T4800-2017) | Description (Translated English) | Protocols for assessment on ELISA commercial diagnostic kits used in entry-exit animal quarantine | Sector / Industry | Commodity Inspection Standard (Recommended) | Classification of Chinese Standard | B41 | Word Count Estimation | 5,524 | Date of Issue | 2017-07-21 | Date of Implementation | 2018-03-01 | Regulation (derived from) | State-Quality-Inspection-Accreditation (2017) 337 | Issuing agency(ies) | General Administration of Customs |
SN/T 4800-2017: Protocols for assessment on ELISA commercial diagnostic kits used in entry-exit animal quarantine ---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.
(Technical specification for quality evaluation of ELISA kit for entry and exit animal quarantine)
People's Republic of China entry and exit inspection and quarantine industry standards
In and out animal quarantine ELISA test kit quality
Evaluation technical specification
Protocolsforassessmenton ELISAcommercialdiagnostickits
Released on.2017-07-21
2018-03-01 implementation
People's Republic
The General Administration of Quality Supervision, Inspection and Quarantine issued
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 Certification and Accreditation Administration.
This standard was drafted. China Academy of Inspection and Quarantine, Beijing Entry-Exit Inspection and Quarantine Bureau of the People's Republic of China, the Chinese People
Heguo Shenzhen Entry-Exit Inspection and Quarantine Bureau, Shanghai Entry-Exit Inspection and Quarantine Bureau of the People's Republic of China.
The main drafters of this standard. Wang Qin, Liu Wei, Lin Xiangmei, Liu Jian, Liu Xiaofei, Ma Guiping, Qin Zhifeng, Li Jian, Wu Shaoqiang, Li Xiaolin,
Qiu Songyu, Feng Chunyan, Mei Lin, Liu Dandan.
In and out animal quarantine ELISA test kit quality
Evaluation technical specification
1 Scope
This standard specifies the technical specifications for the evaluation of quarantine ELISA kits for entry and exit animals.
This standard is applicable to the evaluation of animal quarantine ELISA kits for entry and exit.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
SN/T 2435-2010 Quality Assessment Procedure for Entry-Exit Animal Quarantine Diagnostic Kit
General procedure and requirements for quality evaluation of SN/T 4738 animal and quarantine kits for entry and exit
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Analytical sensitivity analyticalsensitivity
The minimum amount of analyte in the sample that can be detected, the lowest detection limit.
3.2
Analytical specificity
The ability to distinguish the target factor from other virulence factors in the experiment.
3.3
Repetitive repeatability
Consecutive test of the same analyte under the same conditions (equipment, operator, laboratory, and time interval)
Consistency with independent results. It is mainly achieved by evaluating the coefficient of variation between intra-assay and inter-batch replicates.
3.4
Diagnostic sensitivity diagnosticsensitivity
The proportion of positive results of infected animals at the time of detection is known.
3.5
Diagnostic specificity
It is known that no infected animals get a negative result at the time of detection.
3.6
Coefficient of variation coefficientofvariation; CV
The ratio of the standard deviation of each replicate to the average of each replicate.
3.7
Validity robustness
The performance of the different states of the kit reagents maintained their assay accuracy after storage under different conditions. Use the kit validity period as
Indicators to evaluate.
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