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YY/T 1868-2023: (Hepatitis B virus core antibody detection kit (luminescence immunoassay))
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1868-2023 | English | 279 |
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(Hepatitis B virus core antibody detection kit (luminescence immunoassay))
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YY/T 1868-2023
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Standard similar to YY/T 1868-2023
Basic data | Standard ID | YY/T 1868-2023 (YY/T1868-2023) | | Description (Translated English) | (Hepatitis B virus core antibody detection kit (luminescence immunoassay)) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of International Standard | 11.100.10 | | Word Count Estimation | 13,196 | | Date of Issue | 2023-01-13 | | Date of Implementation | 2024-01-15 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the technical requirements, test methods, signs, labels, instructions for use, packaging, transportation and storage of the hepatitis B virus core antibody detection kit (luminescent immunoassay method). This standard is applicable to kits for the qualitative or quantitative detection of hepatitis B virus core antibody in human serum and plasma by using the principle of competition method, indirect method and sandwich method, and using luminescent immunoassay technology. Including chemiluminescence, microparticle chemiluminescence, electrochemiluminescence, photochemiluminescence, and time-resolved fluorescence methods. This standard does not apply to: a) Hepatitis B virus core antibody calibrators and hepatitis B virus core antibody quality control products intended to be sold separately; b) Biochips based on the principle of luminescence immunoassay. | YY/T 1868-2023: (Hepatitis B virus core antibody detection kit (luminescence immunoassay))---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 Standard of the People's Republic of China
Hepatitis B virus core antibody detection kit
(luminescence immunoassay)
Released on 2023-01-13
2024-01-15 Implementation
Released by the State Drug Administration
foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules for Standardization Documents"
to be drafted.
Please note that some contents of this document may refer to patents. The issuing agency of this document assumes no responsibility for identifying patents.
This document is proposed by the State Drug Administration.
This document is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
This document was drafted by. China National Institutes for Food and Drug Control, Zhengzhou Antu Bioengineering Co., Ltd., Abbott Trading (Shanghai)
Co., Ltd., Siemens Medical Diagnostic Products (Shanghai) Co., Ltd., Shanghai Clinical Laboratory Center, Mike Biological Co., Ltd.
The main drafters of this document. Li Kejian, Zhang Lihong, Wu Xiaojun, Wang Ruirong, Zhu Yuqing, Long Tengxiang.
Hepatitis B virus core antibody detection kit
(luminescence immunoassay)
1 Scope
This document specifies the technical requirements, test methods, signs,
Labels, instructions for use, packaging, transportation and storage, etc.
This document is applicable to the qualitative or quantitative detection of human serum,
Kits for hepatitis B virus core antibody (hereinafter referred to as "HBcAb") in plasma, including chemiluminescence, microparticle chemiluminescence, electrochemical
Luminescence, photoinduced chemiluminescence, and time-resolved fluorescence.
This document does not apply to.
a) Hepatitis B virus core antibody calibrator and hepatitis B virus core antibody quality control to be sold separately;
b) Biochip based on the principle of luminescent immunoassay.
2 Normative references
The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references
For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to
this document.
GB/T 191 Packaging, storage and transportation icon marks
GB/T 21415-2008 In vitro diagnostic medical devices, measuring calibrators and control substances in biological samples, and assigning values
Traceability
GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labelling) Part 2.In vitro diagnostic reagents for professional use
3 Terms and Definitions
This document does not have terms and definitions that need to be defined.
4 Technical Requirements
4.1 Quantitative detection kit
4.1.1 Appearance
The following requirements should be met.
a) The components of the kit should be complete and complete without liquid leakage;
b) The package is not damaged, and the Chinese label should be clear.
4.1.2 Traceability
According to GB/T 21415-2008 and relevant regulations, the manufacturer shall provide the source, assignment method and uncertainty of the calibration products used, etc.
content.
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