YY/T 1611-2018Human immunodeficiency virus antibodies detection kits(Immuno-chromatography) (English PDF)
人类免疫缺陷病毒抗体检测试剂盒（免疫层析法）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 20, 2018
Implementation date
January 1, 2020
Scope
YY/T 1611-2018 is the English-translated version of 人类免疫缺陷病毒抗体检测试剂盒（免疫层析法）.
YY/T 1611-2018 is the Chinese pharmaceutical industry standard for kits that detect antibody to human immunodeficiency virus by immunochromatography, the rapid strip test.
It sets the requirements, the test methods, the identification, labelling and instructions for use and the rules for packaging, transport and storage, covering the appearance of the strip, the agreement with national reference panels for negative and positive results, the detection limit, the specificity against potentially cross-reacting sera, the repeatability and the stability.
It applies to kits used on human serum and plasma. Issued on 20 December 2018, it has applied since 1 January 2020.
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Document preview — YY/T 1611-2018
National Standard of the People's Republic of China
- ICS
- 11.040.30
- Classification
- C 30
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Requirements
- 4 Test method
- 5 Logo, label and instruction manual
- 6 Packaging, transportation and storage
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the requirements, test methods, identification, labeling, and use of the human immunodeficiency virus antibody detection kit (Immunochromatography). Instructions, packaging, transportation and storage.
This standard applies to human immunodeficiency virus (humanimmunodefi- in human serum or plasma) based on immunochromatography.
Citing gold method, colloidal selenium method, immunochromatography, latex for qualitative detection of ciencyvirus, HIV) type 1 and type 2 (HIV-1/2) antibodies Human immunodeficiency virus antibody detection kit (hereinafter referred to as "kit") such as chromatography.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 packaging storage and transportation icon
GB/T 29791.2 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 2. Professional in vitro diagnostic reagents
3 Requirements
3.1 Appearance
The appearance should meet the following requirements.
a) The components of the kit should be complete and complete, and the liquid should be free of leakage;
b) Chinese packaging labels should be clear and free of wear.
3.2 Antibody negative reference product compliance rate
Test with a national negative reference or a standardized negative reference, the results should meet the requirements.
3.3 Antibody positive reference product compliance rate
Test with a national positive reference or a standardized positive reference, the results should meet the requirements.
3.4 Minimum detection limit
Test with the national minimum detection limit reference or the standard minimum detection limit reference, the results should meet the requirements.
3.5 Repeatability
Testing with national repetitive reference products or standardized repetitive reference products should meet the requirements.
3.6 Stability
The following performance should be verified.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 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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YY/T 1611-2018
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