YY/T 1465.7-2021Immunogenic evaluation method of medical devices - Part 7: Liquid phase multiplex protein quantification technique by flow cytometry (English PDF)

Foreword

YY/T 1465 "Methods for Evaluation of Immunogenicity of Medical Devices" is divided into the following parts.

---Part 1: In vitro T lymphocyte transformation test;

---Part 2: Determination of serum immunoglobulin and complement components (ELISA method);

---Part 3: Plaque forming cell determination agar solid phase method;

---Part 4: Mouse peritoneal macrophages phagocytize chicken red blood cells in vivo method;

---Part 5: Use M86 antibody to determine the clearance rate of alpha-Gal antigen in animal-derived medical devices;

---Part 6: Determination of animal spleen lymphocyte subsets by flow cytometry;

---Part 7: Flow cytometry multiple protein quantification technology. This part is part 7 of YY/T 1465.

This section was drafted in accordance with the rules given in GB/T 1.1-2009.

Introduction

Immune response is an important defense mechanism of the body. As an exogenous substance, medical devices pass through various ways after being in contact with the human body.

It affects the immune response of the body's immune system, especially for animal-derived medical products, allogeneic products, and tissue-engineered medical products Wait. Although the interaction between medical devices/materials and the immune system may produce different immune responses, they can be roughly divided into two types.

That is, humoral immune response and cell-mediated immune response. At present, it is still impossible to determine whether the immune response generated by medical devices or materials stimulates the host.

It is beneficial or harmful. Therefore, it is very important to use medical devices/materials to conduct immune response research to obtain relevant information.

GB/T 16886.20 gives guidelines for possible immune reactions and potential immune toxic reactions that may occur when medical devices come into contact with the human body.

But there is no specific test method. YY/T 1465 series standards are expected to provide specific test methods for the implementation of GB/T 16886.20.

This part of YY/T 1465 provides the simultaneous quantitative detection of multiple soluble proteins in samples using the flow-type liquid phase multiple protein quantification technology The method provides specific test methods for evaluating the potential of medical devices/materials to stimulate the body's immune response, which can be used as GB/T 16886.20 An alternative method standard in immunotoxicology tests. Other methods confirmed to be applicable can also be used.

1 Scope

This part of YY/T 1465 stipulates the quantitative detection of a variety of soluble proteins in samples using flow cytometry multiple protein quantification technology. experiment method.

This section is suitable for evaluating the immune response induced by medical devices/materials.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document. For undated reference documents, the latest version (including all amendments) is applicable to this document.

GB/T 16886.2 Biological Evaluation of Medical Devices Part 2: Animal Welfare Requirements

GB/T 16886.12 Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Samples

3 Flow-type liquid phase multiple protein quantification technology