GB/T 40268-2021Determination of performance on immunomagnetic material (English PDF)

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.

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.

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.