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GB/T 40369-2021: General rules for determination of immunochromatographic test strip
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 40369-2021 | English | 119 |
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General rules for determination of immunochromatographic test strip
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GB/T 40369-2021
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Basic data | Standard ID | GB/T 40369-2021 (GB/T40369-2021) | | Description (Translated English) | General rules for determination of immunochromatographic test strip | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | A40 | | Word Count Estimation | 6,649 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 40369-2021: General rules for determination of immunochromatographic test strip---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.
General rules for determination of immunochromatographic test strip
ICS 07.080
CCSA40
National Standards of People's Republic of China
General rules for the detection of immunochromatographic test strips
Released on 2021-08-20
2022-03-01 implementation
State Administration of Market Supervision and Administration
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 and managed by the National Standardization Technical Committee for Biochemical Testing (SAC/TC387).
This document was drafted by. Beijing Technology and Business University, China Jiliang University, South China Agricultural University, Shenzhen Yirui Biotechnology Co., Ltd.
Division, Institute of Biology, China Academy of Testing Technology.
The main drafters of this document. Ma Aijin, Zhang Yafen, Ye Zihong, Xia Wenqiang, Lei Hongtao, Zhou Lihua, Feng Dejian, Cui Haifeng, Zhu Hai, Wu Wei,
Wang Bingzhi.
General rules for the detection of immunochromatographic test strips
1 Scope
This document describes the general requirements, testing process and result report of immunochromatographic test strips.
This document is applicable to the detection of immunochromatographic test strips.
2 Normative references
The contents of the following documents constitute the indispensable clauses of this document through normative references in the text. Among them, dated quotations
Only the version corresponding to that date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to
This document.
GB 19489 Laboratory Biosafety General Requirements
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Detection limit limitofdetection
At a given confidence level, the lowest concentration or content of the target analyte that can be reliably distinguished between a positive sample and a negative sample.
3.2
Sensitivity
At the detection limit level of the method under the test conditions, the number of positive samples with positive results as a percentage of the total number of positive samples.
3.3
Specificity
When the method is at the detection limit level under the test conditions, the number of negative samples with negative results is the percentage of the total number of negative samples.
3.4
False negative rate
When the method is at the detection limit level under the test conditions, the percentage of negative results detected in positive samples.
3.5
False positive rate
When the method is at the detection limit level under the test conditions, the percentage of positive results detected in negative samples.
4 General requirements
4.1 Product
Test strip products should be accompanied by product instructions or equivalent guidance documents.
4.2 Laboratory
The biosafety management of the laboratory shall meet the corresponding requirements in GB 19489.
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