YY 1727-2020Human immunodeficiency virus antibody detection kit for oral mucosal transudate (colloidal gold immunochromatography) (English PDF)
口腔黏膜渗出液人类免疫缺陷病毒抗体检测试剂盒（胶体金免疫层析法）
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
June 30, 2020
Implementation date
June 1, 2022
Scope
YY 1727-2020 is the English-translated version of 口腔黏膜渗出液人类免疫缺陷病毒抗体检测试剂盒（胶体金免疫层析法）.
YY 1727-2020 is the Chinese standard "Human immunodeficiency virus antibody detection kit for oral mucosal transudate (colloidal gold immunochromatography)".
Its scope clause reads: 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"). Its clauses include requirements.
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Document preview — YY 1727-2020
National Standard of the People's Republic of China
- ICS
- 11.040.30
- Classification
- C30
Issued by: National Medical Products Administration
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 requirements
- 3.1 Appearance
- 3.2 Physical inspection
- 3.3 Compliance rate of antibody negative reference products
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;
......
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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