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YY/T 1890-2023: Hepatitis B virus surface antigen (HBsAg) detection kit(Immunochromatographic method)
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1890-2023 | English | 179 |
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Hepatitis B virus surface antigen (HBsAg) detection kit(Immunochromatographic method)
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YY/T 1890-2023
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Basic data | Standard ID | YY/T 1890-2023 (YY/T1890-2023) | | Description (Translated English) | Hepatitis B virus surface antigen (HBsAg) detection kit(Immunochromatographic method) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100.10 | | Word Count Estimation | 9,937 | | Date of Issue | 2023-09-05 | | Date of Implementation | 2024-09-15 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the requirements, test methods, identification, labeling and instructions for use, packaging, transportation and storage of hepatitis B virus surface antigen detection kits (immunochromatographic method). This standard applies to hepatitis B virus surface antigen detection reagents for the qualitative detection of hepatitis B virus surface antigen (hereinafter referred to as HBsAg) in human serum, plasma or whole blood using immunochromatographic methods such as colloidal gold method and latex method. box. This document does not apply to hepatitis B virus surface antigen detection kits using enzyme-linked immunoassay, chemiluminescence immunoassay, time-resolved immunofluorescence and other methodologies. | YY/T 1890-2023: Hepatitis B virus surface antigen (HBsAg) detection kit(Immunochromatographic method)
---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.
ICS 11.100.10
CCSC44
Pharmaceutical Industry Standards of the People's Republic of China
Hepatitis B virus surface antigen detection kit
Published on 2023-09-05
Implemented on 2024-09-15
Released by the State Drug Administration
Foreword
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents"
Drafting.
Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents.
This document is proposed by the National Medical Products Administration.
This document is under the jurisdiction of the National Standardization Technical Committee for Medical Clinical Laboratory and In Vitro Diagnostic Systems (SAC/TC136).
This document was drafted by. China Institute of Food and Drug Control, Beijing Institute of Medical Device Inspection (Beijing Medical Biological Protective Equipment
Medical Equipment Inspection Research Center), Guangdong Medical Device Quality Supervision and Inspection Institute, Beijing Wantai Biopharmaceutical Co., Ltd., Zhuhai Livzon Reagent Co., Ltd.
Co., Ltd., Yingke Xinchuang (Xiamen) Technology Co., Ltd.
The main drafters of this document. Liu Yan, Li Kejian, Zhou Cheng, Liu Yanchun, Pan Xiaofang, Xianyang Ling, Zhou Xin, Qin Rong.
Hepatitis B virus surface antigen detection kit
1 Scope
This document specifies the requirements, test methods, identification, labeling and use of hepatitis B virus surface antigen detection kit (immunochromatographic method)
Instructions for use, packaging, transportation and storage, etc.
This document is applicable to the detection of hepatitis B virus surface in human serum, plasma or whole blood using immunochromatographic methods such as colloidal gold method and latex method.
Hepatitis B virus surface antigen detection kit for qualitative detection of antigen (hereinafter referred to as HBsAg).
This document does not apply to hepatitis B virus expression using enzyme-linked immunoassay, chemiluminescence immunoassay, time-resolved immunofluorescence, etc.
Facial antigen detection kit.
2 Normative reference documents
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations
For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to
this document.
GB/T 191 Packaging, storage and transportation pictorial mark
GB/T 29791.1 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 1.Terms, definitions and general
Require
GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2.Professional in vitro diagnostic reagents
3 Terms and definitions
The terms and definitions defined in GB/T 29791.1 apply to this document.
4 requirements
4.1 Physical inspection
4.1.1 Appearance
The appearance of the kit should be neat, the text and labels should be clear, and the liquid components should be clear.
4.1.2 Membrane strip width
The width of the membrane strip should be no less than 2.5mm.
4.1.3 Liquid migration speed
The liquid migration speed should not be less than 10mm/min.
4.2 Compliance rate of negative reference products
Twenty copies of HBsAg national negative reference materials were used for testing, and the results were all negative, and the compliance rate of the negative reference materials was 100%. or use sutra mark
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