GB/T 40268-2021 English PDF

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GB/T 40268-2021: Determination of performance on immunomagnetic material
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Basic data

Standard ID: GB/T 40268-2021 (GB/T40268-2021)
Description (Translated English): Determination of performance on immunomagnetic material
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: A40
Word Count Estimation: 14,149
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

GB/T 40268-2021: Determination of performance on immunomagnetic material

---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.
Determination of performance on immunomagnetic material ICS 07.080 CCSA40 National Standards of People's Republic of China Immunomagnetic material performance testing method Released on 2021-05-21 2021-12-01 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). Drafting organizations of this document. Beijing Physical and Chemical Analysis and Testing Center, China Academy of Inspection and Quarantine Sciences, Shenzhen Yirui Biotechnology Co., Ltd. Co., Ltd., China Research Institute of Testing Technology, Sichuan University, Beijing Niuniu Gene Technology Co., Ltd., Ministry of Ecology and Environment Solid Waste and Chemicals Management Technology Center. The main drafters of this document. Du Meihong, Li Jingwen, Liu Qingjun, Zhou Lihua, Yang Yin, Yin Na, Chen Erning, Zhu Hai, Zou Mingqiang, Yang Yongzhe, Tang Jiangwen, Guo Gang, Wang Yanfei, Wang Bingzhi, Niu Gang, Yan Yiyong, Fu Hui.

Introduction

The immunomagnetic materials applicable to this document have two characteristics. one is superparamagnetic, and the other is that a certain amount of anti-magnetic material is immobilized on the surface. Bioactive molecules such as bodies or antigens can specifically bind to the target. This document contains information on materials, magnetics, and biology. Content and analysis technology. The immunomagnetic materials involved in this document are mainly used in the separation, separation, etc. of biomedicine, food safety, in vitro diagnostics, etc. Processes such as purification and detection. This document proposes various indicators of the basic performance of immunomagnetic materials, and determines the method to detect the performance of the material. The main indicators include Material concentration, particle size, dispersion stability, superparamagnetism, magnetic recovery rate, target saturation binding capacity, target capture rate, capture specificity Stability and capture rate stability. Immunomagnetic material performance testing method

1 Scope

This document describes the mass concentration, particle size, dispersion stability, superparamagnetism, magnetic recovery rate, and saturation binding of target materials for immunomagnetic materials Detection methods for the amount, target capture rate, capture specificity and capture rate stability. This document is applicable to the particle size range of 50nm~100μm, which is superparamagnetic and has biologically active components such as antibodies or antigens immobilized on the surface. Performance testing of composite materials.

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/T 6682 Analytical laboratory water specifications and test methods GB/T 13888 Method for measuring the coercivity of magnetic materials in an open magnetic circuit GB/T 15445.6 Expression of particle size analysis results Part 6.Qualitative and quantitative expression of particle shape and morphology GB/T 19077 Particle Size Analysis Laser Diffraction Method GB/T 21649.1 Particle Size Analysis Image Analysis Method Part 1.Static Image Analysis Method GB /Z 26082 DC magnetic susceptibility (magnetic moment) measurement method for nanomaterials GB/T 29022 Particle Size Analysis Dynamic Light Scattering Method (DLS) GB/T 38431 Stability Evaluation of Particle Dispersion System Static Multiple Light Scattering Method

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Immunomagneticmaterial Bioactive molecules such as antibodies or antigens are immobilized on the surface, which can specifically bind to the target under certain conditions. Magnetic composite material. 3.2 Dispersion stability The change of the dispersion state of the immunomagnetic material in the dispersion system over time. 3.3 Superparamagnetism The magnetization properties of ferromagnetic materials with a single domain structure smaller than the critical size. Note. When the temperature is lower than the Curie temperature and higher than the transition temperature, it is characterized by paramagnetism, but under the action of an external magnetic field, its paramagnetic susceptibility is much higher than that of general paramagnetism. Material; when the external magnetic field is removed, there is no hysteresis. 3.4 Saturation magnetization The maximum magnetization that the immunomagnetic material can achieve at a given temperature. ......

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