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YY/T 1514-2017 English PDF (YYT1514-2017)

YY/T 1514-2017 English PDF (YYT1514-2017)

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YY/T 1514-2017: Detection kit for antibodies to HIV-1 and HIV-2(western blotting)

This Standard specifies the requirements, test method, marking, labelling, instructions for use, packaging, transportation, storage, etc. of detection kit for antibodies to HIV-1 and HIV-2 (western blotting). This Standard applies to reagents for qualitative detection of antibodies to HIV-1 and HIV-2 using the western blotting method (including the recombinant immunoblotting method), to fix the multicomponent antigens or recombinant expression multicomponent antigens to the different locations of nitrocellulose membrane using the SDS-PAGA method or the direct sample application method, i.e. detection kits for antibodies to HIV-1 and HIV-2 (western blotting).
YY/T 1514-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.100
C 44
Detection kit for antibodies to HIV-1 and HIV-2
(western blotting)
ISSUED ON. MARCH 28, 2017
IMPLEMENTED ON. APRIL 1, 2018
Issued by. China Food And Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Requirements... 4
4 Test method ... 5
5 Marking, labelling and instructions for use ... 6
6 Packaging, transportation and storage ... 6
Bibliography ... 7
Detection kit for antibodies to HIV-1 and HIV-2
(western blotting)
1 Scope
This Standard specifies the requirements, test method, marking, labelling, instructions for use, packaging, transportation, storage, etc. of detection kit for antibodies to HIV-1 and HIV-2 (western blotting).
This Standard applies to reagents for qualitative detection of antibodies to HIV-1 and HIV-2 using the western blotting method (including the recombinant immunoblotting method), to fix the multicomponent antigens or recombinant expression
multicomponent antigens to the different locations of nitrocellulose membrane using the SDS-PAGA method or the direct sample application method, i.e. detection kits for antibodies to HIV-1 and HIV-2 (western blotting).
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition dated applies to this document. For undated references, the latest edition of the referenced documents (including all amendments) applies to this document.
GB/T 191, Packaging ?€? Pictorial marking for handling of goods
GB/T 29791.2, In vitro diagnostic medical devices ?€? Information supplied by the manufacturer (labelling) ?€? Part 2. In vitro diagnostic reagents for professional use 3 Requirements
3.1 Appearance
Appearance shall comply with the following requirements.
a) all components of kits shall be complete and there is no leakage of liquid; b) packaging labels in Chinese shall be clear without wear.
3.2 Compliance of positive references for antibodies
4.3 Compliance of negative references for antibodies
Use national negative references or standardized negative references for testing, operate as specified in the instructions for use, and the results shall comply with the requirements of 3.3.
4.4 Compliance of uncertain references for antibodies
Use national uncertain references or standardized uncertain references for testing, operate as specified in the instructions for use, and the results shall comply with the requirements of 3.4.
4.5 Stability
Use the following methods.
a) validity stability. obtain kits of a certain time within validity, operate as specified in the instructions for use, and the results shall comply with the requirements of 3.5.2; b) thermal stability. place kits aside for a certain time at certain temperature (normally 37??C), operate as specified in the instructions for use, and the results shall comply with the requirements of 3.5.2.
5 Marking, labelling and instructions for use
As specified in GB/T 29791.2-2013.
6 Packaging, transportation and storage
6.1 Packaging
The pictorial marks for packaging, storage and transportation shall be as specified in GB/T 191-2008. The packaging containers shall well sealed and complete without leakage or damage.
6.2 Transportation
Kits shall be transported as required by the manufacturer. During the process of transportation, protect them from exposure to damp, heavy loads, direct sunlight, rain and snow and acid-base materials and damage of exterior and interior packaging. 6.3 Storage
Kits shall be stored under the conditions specified by the manufacturer.

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