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SN/T 4800-2017: Protocols for assessment on ELISA commercial diagnostic kits used in entry-exit animal quarantine
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SN/T 4800-2017: Protocols for assessment on ELISA commercial diagnostic kits used in entry-exit animal quarantine

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(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. ...