YY/T 1664-2019Parathyroid hormone 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, and standards for the parathyroid hormone (PTH) assay kit. Sign and use instructions, packaging, transportation, storage.

This standard is applicable to the kit for quantitative determination of whole parathyroid hormone (1~84) by double antibody sandwich method, including enzyme labeling, An immunoassay kit for labeling methods such as (electro) chemiluminescent labeling, (time-resolved) fluorescent labeling.

This standard does not apply to semi-quantitative determination of whole parathyroid hormone (1~84) reagents by colloidal gold or other methods (eg. test Paper strips, etc.; radioimmunoassay or immunoradiometric kits of various parathyroid hormones labeled with radioisotopes such as 125I.

2 Normative references

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

GB/T 191 packaging storage and transportation icon

GB/T 29791.2 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 2. Professional in vitro diagnostic reagents

3 Classification

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

The same can be divided into microplate type, tube type, magnetic particles, microspheres and plastic beads; can be divided into manual operation methods and instruments according to different operating procedures Automatic operation method.

4 Requirements