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YY/T 1611-2018: Human immunodeficiency virus antibodies detection kits (Immuno-chromatography)
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 1611-2018	English	139	Add to Cart	3 days [Need to translate]	Human immunodeficiency virus antibodies detection kits (Immuno-chromatography)

YY/T 1611-2018: Human immunodeficiency virus antibodies detection kits (Immuno-chromatography)

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(Human immunodeficiency virus antibody detection kit (immunochromatography)) ICS 11.040.30 C30 People's Republic of China Pharmaceutical Industry Standard Human immunodeficiency virus antibody detection kit Published on.2018-12-20 2020-01-01 implementation State Drug Administration issued

Content

Foreword III 1 Scope 1 2 Normative references 1 3 Requirements 1 4 Test method 2 5 Logo, label and instruction manual 2 6 Packaging, transportation and storage 3 Reference 4

Foreword

This standard was 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 issuing organization of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Medical Clinical Laboratory and the In vitro Diagnostic System Standardization Technical Committee (SAC/TC136). This standard was drafted. China Food and Drug Control Research Institute. The main drafters of this standard. Xu Sihong. Human immunodeficiency virus antibody detection kit (immunochromatography)

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 article. Pieces. 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. ...