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YY 1727-2020: Human immunodeficiency virus antibodies in human oral mucosal transudate detecting kits (Colloidal gold immuno-chromatography)
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 1727-2020 | English | 189 |
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Human immunodeficiency virus antibodies in human oral mucosal transudate detecting kits (Colloidal gold immuno-chromatography)
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YY 1727-2020
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Basic data | Standard ID | YY 1727-2020 (YY1727-2020) | | Description (Translated English) | Human immunodeficiency virus antibodies in human oral mucosal transudate detecting kits (Colloidal gold immuno-chromatography) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.040.30 | | Word Count Estimation | 10,146 | | Date of Issue | 2020-06-30 | | Date of Implementation | 2022-06-01 | | Issuing agency(ies) | State Drug Administration | YY 1727-2020: Human immunodeficiency virus antibodies in human oral mucosal transudate detecting kits (Colloidal gold immuno-chromatography)
---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.
Human immunodeficiency virus antibodies in human oral mucosal transudate detecting kits (Colloidal gold immuno-chromatography)
ICS 11.040.30
C30
People's Republic of China Pharmaceutical Industry Standard
Oral mucosa exudate human immunodeficiency virus antibody
Detection kit (colloidal gold immunochromatography)
2020-06-30 released
2022-06-01 implementation
Issued by the State Drug Administration
Foreword
This standard is a mandatory industry standard.
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that certain contents of this document may involve patents. The issuing agency 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 In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
Drafting organizations of this standard. China Institute for Food and Drug Control, Beijing Institute of Medical Device Inspection, Guangzhou Wanfu Biotechnology Co., Ltd.
Company, Beijing Manuo Biopharmaceutical Co., Ltd., Chengdu Xiehe Biotechnology Co., Ltd.
The main drafters of this standard. Xu Sihong, Zhang Chuntao, Song Aijing, Sun Li, Li Meilan, Tang Xiangjun, Xiao Ling.
Oral mucosa exudate human immunodeficiency virus antibody
Detection kit
(Colloidal gold immunochromatography)
1 Scope
This standard specifies the requirements for the human immunodeficiency virus antibody detection kit (colloidal gold immunochromatography) for oral mucosal exudate,
Test methods, labels and instructions for use, packaging, transportation and storage.
This standard is applicable to the detection of human immunodeficiency virus type 1 and human immunodeficiency virus in human oral mucosal exudate based on the principle of colloidal gold immunochromatography.
A human immunodeficiency virus antibody detection kit for qualitative detection of type 2 (HIV-1/2) antibodies (hereinafter referred to as "kit").
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 191 Packaging, storage and transportation pictorial signs
GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2.Professional in vitro diagnostic reagents
3 requirements
3.1 Appearance
The appearance should meet the following requirements.
a) Each component of the kit should be complete and complete, with no liquid leakage;
b) Chinese packaging labels should be clear and free from wear.
3.2 Physical inspection
The physical inspection should meet the following requirements.
a) The width of the film strip should be ≥2.5mm;
b) The liquid moving speed should be ≥10mm/min.
3.3 Compliance rate of antibody negative reference products
Use the national negative reference product for testing, the positive reaction should not be more than 2 copies, the negative reference product compliance rate (-/-) should be ≥18/20; or use
After the standardized negative reference product is tested, the result should meet the corresponding requirements.
3.4 Compliance rate of antibody positive reference products
Use national positive reference materials (see Appendix A) for testing, the HIV-1 positive reference product conformance rate (/) should be 18/18, HIV-
The conformity rate of type 2 positive reference product (/) should be 2/2; or use a standardized positive reference product for testing, and the result should meet the corresponding requirements.
3.5 Lowest detection limit
Use the national minimum detection limit reference product for detection, the positive reaction shall not be less than 3 (≥3/5) and the diluted matrix (S1) shall be a negative reaction;
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