GB/T 40369-2021 English PDF

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GB/T 40369-2021: General rules for determination of immunochromatographic test strip
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 40369-2021	119	Add to Cart	3 days	General rules for determination of immunochromatographic test strip	Valid

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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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