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GB/T 40999-2021: Quality assessment requirements for Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) total antibody detection kit
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 40999-2021 | English | 189 |
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Quality assessment requirements for Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) total antibody detection kit
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GB/T 40999-2021
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Basic data | Standard ID | GB/T 40999-2021 (GB/T40999-2021) | | Description (Translated English) | Quality assessment requirements for Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) total antibody detection kit | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C44 | | Word Count Estimation | 10,197 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 40999-2021: Quality assessment requirements for Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) total antibody detection kit
---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.
Quality assessment requirements for Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) total antibody detection kit
ICS 11.100.10
CCSC44
National Standards of People's Republic of China
Novel coronavirus antibody detection kit
Quality evaluation requirements
Released on 2021-11-26
2022-03-01 implementation
State Administration for Market Regulation
Issued by the National Standardization Management Committee
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 of Standardization Documents"
Drafting.
Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying patents.
This document was 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).
Drafting organizations of this document. China Institute for Food and Drug Control, Chinese People's Liberation Army General Hospital, National Medical Products Administration
Instrument Technology Evaluation Center, Beijing Medical Device Inspection Institute, Chongqing Public Health Medical Treatment Center, Guangzhou Wanfu Biotechnology Co., Ltd.
Company, Shanghai Xinchao Biotechnology Co., Ltd., Beijing Wantai Biopharmaceutical Co., Ltd.
The main drafters of this document. Xia Deju, Shi Dawei, Hu Jinjun, Xu Sihong, Yang Zhen, He Kunlun, Zhang Ying, Li Hongran, Bi Chunlei, Wang Jing,
Kang Keren, Zhang Xiaoyan, Sun Xudong, Qiao Shan.
Novel coronavirus antibody detection kit
Quality evaluation requirements
1 Scope
This document specifies the quality requirements, test methods, labels and specifications involved in the quality evaluation of new coronavirus (total) antibody detection kits.
Instructions, packaging, transportation and storage.
This document is suitable for the use of immunochromatography, enzyme-linked immunoassay and chemiluminescence method to detect the new type of coronavirus in human serum, plasma and whole blood.
A kit for in vitro qualitative detection of virus-specific antibodies (including IgM, IgG and other antibody types).
2 Normative references
The content of the following documents constitutes an indispensable clause of this document through normative references in the text. Among them, dated quotations
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 pictorial signs
GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2.In vitro diagnostic reagents for professional use
3 Terms and definitions
There are no terms and definitions that need to be defined in this document.
4 Quality requirements
4.1 Physical properties
4.1.1 Appearance
The appearance should at least conform to but not limited to.
a) The components of the kit should be complete and complete, and there should be no liquid leakage;
b) The packaging label should be clear and free from wear.
4.1.2 Film strip width
The width of the film strip should not be less than 2.5mm.
Note. This clause only applies to immunochromatography.
4.1.3 Liquid moving speed
The liquid moving speed should not be lower than 10mm/min.
Note. This clause only applies to immunochromatography.
4.2 Performance
4.2.1 Compliance rate of positive reference products
When using a national positive reference product or a standardized positive reference product for testing, the results should meet the corresponding requirements.
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