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SN/T 2435-2010: Protocol of quality assessment on the diagnostic kits used in entry-exit animal quarantine
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| SN/T 2435-2010 | English | 159 |
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Protocol of quality assessment on the diagnostic kits used in entry-exit animal quarantine
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SN/T 2435-2010
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Basic data | Standard ID | SN/T 2435-2010 (SN/T2435-2010) | | Description (Translated English) | Protocol of quality assessment on the diagnostic kits used in entry-exit animal quarantine | | Sector / Industry | Commodity Inspection Standard (Recommended) | | Classification of Chinese Standard | B41 | | Classification of International Standard | 11.220 | | Word Count Estimation | 6,698 | | Date of Issue | 2010-01-10 | | Date of Implementation | 2010-07-16 | | Quoted Standard | Terrestrial animal diagnostic tests and vaccines Manual (OIE); Aquatic Manual of diagnostic tests and vaccines (OIE) | | Regulation (derived from) | National Quality Inspection (2010) No. 13 | | Issuing agency(ies) | General Administration of Customs | | Summary | This standard specifies the entry and exit animal quarantine diagnostic kit quality evaluation procedures. This standard applies to conduct animal disease antigen, antibody detection diagnostic kit used quality evaluation. | SN/T 2435-2010: Protocol of quality assessment on the diagnostic kits used in entry-exit animal quarantine
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Protocol of quality assessment on the diagnostic kits used in entry-exit animal quarantine
Exit inspection and quarantine industry standard book People's Republic of China
Entry-exit animal quarantine diagnostic kit
Quality evaluation procedures
Issued on. 2010-01-10
2010-07-16 implementation
People's Republic of China
The State Administration of Quality Supervision, Inspection and Quarantine released
Foreword
Appendix A of this standard is an informative annex.
This standard is proposed and managed by the National Certification and Accreditation Administration Committee.
This standard is drafted by. China Inspection and Quarantine Science Research Institute.
Participated in the drafting of this standard. People's Republic of China Shanghai Entry-Exit Inspection and Quarantine Bureau, People's Republic of China Tianjin Entry-Exit Inspection and
Quarantine Bureau, People's Republic of China Jiangsu Entry-Exit Inspection and Quarantine of Guangdong People's Republic of China, People's Republic of China
State Hunan Entry-Exit Inspection and Quarantine Beijing People's Republic of China, People's Republic of China Entry-Exit Inspection and Shanxi
Quarantine Bureau, People's Republic of China Zhuhai Entry-Exit Inspection and Quarantine Shandong People's Republic of China, People's Republic of China
Inner Mongolia National Entry-Exit Inspection and Quarantine, Shenzhen People's Republic of China, People's Republic of China Zhejiang Entry-Exit Inspection
Quarantine Bureau.
The main drafters of this standard. Linxiang Mei, Liu, Li Shuqing, Dong Zhizhen, Jia Guang Yue Kwok-keung, Wushao Jiang, Lin Zhixiong, Zhuzhong Wu,
Yan Xin Li, Hui Feng Lian, clear as thin beam into beads, Zhaolin Li, Fan Wan Hong, He Yongqiang, Wang Yiqin.
This standard is the first release of the entry-exit inspection and quarantine industry standards.
Entry-exit animal quarantine diagnostic kit
Quality evaluation procedures
1 Scope
This standard specifies the entry-exit animal quarantine diagnostic kit of quality evaluation procedures.
This standard applies to evaluate the quality of animal disease antigen/antibody detection of selected diagnostic kit.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research
Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
Terrestrial animal diagnostic tests and vaccines Manual (OIE)
Aquatic diagnostic tests and vaccines Manual (OIE)
3 Terms and Definitions
The following terms and definitions apply to this standard.
3.1
A variety of chemical or biological products for the diagnosis or for some or all of the principal reagents required for certain types of animal diseases in general, including, as
Antibody, antigen, conjugate dilution buffer, etc., especially in this standard immunological detection methods used in commercially available diagnostic kits.
3.2
Animals and animal products in international trade recommended by the authoritative international organization for animal health may be an optimum test method to determine. this
Mainly refers to the standard specified test OIE "Terrestrial Animals Manual of diagnostic tests and vaccines" or "aquatic animal diagnostic tests and vaccines Manual" set out in
Inspection or alternative tests.
3.3
Known incidence of animal samples positive rate to represent. For unknown samples, with the results accepted reference method for detecting ratio
Compared to determine the sensitivity, but to determine the limit of detection of the kit.
3.4
The detection rate with the known negative health animal samples to represent. For unknown samples, with the results accepted reference method for detecting ratio
Compared to determine their specificity.
3.5
To represent the coefficient of variation. The coefficient of variation, also known as dispersion coefficient, also known as standard deviation coefficient, is a set of data and its standard deviation
Corresponding mean ratio. Use kit known negative, weak positive and strong positive samples were repeatedly measured and calculated measurement result becomes
Coefficient of variation, determine the repeatability of the test.
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