YY/T 1483-2016Anti-herpes simplex virus IgM antibody detection reagent (kit) (English PDF)
单纯疱疹病毒IgM抗体检测试剂（盒）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
July 29, 2016
Implementation date
June 1, 2017
Scope
YY/T 1483-2016 is the English-translated version of 单纯疱疹病毒IgM抗体检测试剂（盒）.
YY/T 1483-2016 is the Chinese pharmaceutical industry standard for the reagent kit that detects IgM antibody to herpes simplex virus, the marker of a recent infection.
It specifies the technical requirements, the test methods, the labelling, the instructions and the rules for packaging, transport and storage, covering the appearance, the agreement with the national reference materials for positive and negative sera, the detection limit, the specificity, the repeatability and the stability of the reagent. Issued on 29 July 2016, it has applied since 1 June 2017.
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Document preview — YY/T 1483-2016
National Standard of the People's Republic of China
- Classification
- C 44
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative reference documents
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the technical requirements for herpes simplex virus IgM antibody detection reagent (box) [hereinafter referred to as "reagent (box)"], the test method Law, labeling, labeling and instructions, packaging, transportation and storage.
This standard is suitable for qualitative detection of human serum/plasma herpes simplex virus type 1 IgM antibody detection reagent (box), methodology Enzyme immunoassay, chemiluminescence, immunofluorescence, immunoblotting, and the like.
2 Normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 191 Packaging and storage icon (ISO 780)
YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements (ISO 15223-1)
3 herpes simplex virus type 1 IgM antibody test reagent (box) requirements
3.1 Appearance
Appearance should meet the following requirements.
a) kit components should be complete, complete, liquid without leakage;
b) Chinese packaging labels should be clear, no wear.
3.2 Positive reference product compliance rate
With the herpes simplex virus type 1 IgM antibody detection reagents on the national positive reference material or standardized positive reference material for testing, The results should meet the requirements.
3.3 Negative reference product compliance rate
The use of herpes simplex virus type 1 IgM antibody detection reagent for the detection of national negative reference material or standardized negative reference material, The results should meet the requirements.
3.4 Minimum detection limit
Use the herpes simplex virus type 1 IgM antibody assay reagent to the national minimum detection limit reference or the standard minimum detection limit Product for testing, the results should meet the requirements.
3.5 Repeatability
Depending on the product characteristics, one of the following methods a) or b) can be verified.
a) Use the herpes simplex virus type 1 IgM antibody assay reagent to the national repeat reference or the standard repeatable reference The coefficient of variation (CV,%) should not exceed 15.0%.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
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Related Standards
GB/T 191-2025 — Graphical symbols marking for handling and storage of packages
YY/T 0466.1-2009 — Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
YY/T 0466.1-2016 — Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
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YY/T 1483-2016
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