YY/T 1674-2019Insulin-like growth factor I testing kit (English PDF)

Foreword

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

1 Scope

This standard specifies the classification, requirements, test methods, labels and instruction manuals, packaging, Transportation and storage.

This standard applies to the kit for the quantitative determination of insulin-like growth factor I based on the double antibody sandwich method, including enzyme-labeled, (electrical)

Immunoassay kit for labeling methods such as chemiluminescent labeling and (time-resolved) fluorescent labeling.

This standard does not apply to reagents (such as test strips) for semi-quantitative determination of insulin-like growth factor I labeled with colloidal gold or other methods.

Etc.); Radioimmunity or immunoradiation kits of various insulin-like growth factor I labeled with 125I and other radioisotopes.

2 Normative references

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

GB/T 191 Packaging, storage and transportation icon

GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2. In vitro diagnostic reagents for professional use

3 Categories

According to the different labeling methods, it can be divided into enzyme labels, (electro) chemiluminescence labels, (time-resolved) fluorescent labels, etc.

It can be divided into microwell plate type, tube type, magnetic particles, microsphere beads and plastic beads, etc.; it can be divided into manual operation methods and instruments according to different operating processes. Automatic method.

4 Requirements