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YY/T 1483-2016: Anti-herpes-simplex-virus IgM antibody detection reageant(kit)
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1483-2016 | English | 139 |
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Anti-herpes-simplex-virus IgM antibody detection reageant(kit)
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YY/T 1483-2016
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Basic data | Standard ID | YY/T 1483-2016 (YY/T1483-2016) | | Description (Translated English) | Anti-herpes-simplex-virus IgM antibody detection reageant(kit) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Word Count Estimation | 7,779 | | Date of Issue | 2016-07-29 | | Date of Implementation | 2017-06-01 | | Quoted Standard | GB/T 191; YY/T 0466.1 | | Regulation (derived from) | State Food and Drug Administration Notice 2016 (No.129) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the technical requirements, test methods, labeling, labeling and instructions for the herpes simplex virus IgM antibody test kit (hereinafter referred to as "reagent"), packaging, transportation and storage. This standard is suitable for qualitative detection of human serum/plasma herpes simplex virus type 1 + 2 IgM antibody detection reagent (box), methodology for the enzyme-linked immunoassay, chemiluminescence, immunofluorescence, immunoblotting. | YY/T 1483-2016: Anti-herpes-simplex-virus IgM antibody detection reageant(kit)---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.
Anti-herpes-simplex-virus IgM antibody detection reageant (kit)
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Herpes simplex virus IgM antibody detection reagent (box)
2016-07-29 released
2017-06-01 implementation
State Food and Drug Administration issued
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The release of this document
The Agency does not assume responsibility for identifying these patents.
This standard is proposed by the State Food and Drug Administration.
This standard by the National Medical Laboratory Laboratory and in vitro diagnostic system Standardization Technical Committee (SAC/TC136) centralized.
The drafting unit of this standard. China Food and Drug Administration Research Institute.
The main drafters of this standard. Huang Jie, Qu Shoufang, Gao Shangxian
Herpes simplex virus IgM antibody detection reagent (box)
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 article
Pieces. 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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