YY/T 1514-2017Detection kit for antibodies to HIV-1 and HIV-2(western blotting) (English PDF)
人类免疫缺陷病毒（1+2型）抗体检测试剂盒（免疫印迹法）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
May 2, 2017
Implementation date
April 1, 2018
Scope
YY/T 1514-2017 is the English-translated version of 人类免疫缺陷病毒（1+2型）抗体检测试剂盒（免疫印迹法）.
YY/T 1514-2017 is the Chinese pharmaceutical industry standard for the kit that detects antibodies to HIV-1 and HIV-2 by western blotting, the confirmatory test run after a reactive screening result.
It sets the requirements, the test methods, the marking, labelling and instructions for use and the rules for packaging, transport and storage, covering the appearance of the strips, the bands that must appear with the controls, the agreement with national reference panels, the sensitivity and specificity, the repeatability and the stability. Issued on 2 May 2017, it has applied since 1 April 2018.
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Document preview — YY/T 1514-2017
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope4
- 2 Normative references4
- 3 Requirements4
- 4 Test method5
- 5 Marking, labelling and instructions for use6
- 6 Packaging, transportation and storage6
- Bibliography7
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.
4 Test method
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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 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
GB/T 29791.2-2013 — In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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