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YY/T 1674-2019: Insulin-like growth gactor Ⅰ testing kit
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 1674-2019	English	159	Add to Cart	3 days [Need to translate]	Insulin-like growth gactor Ⅰ testing kit

YY/T 1674-2019: Insulin-like growth gactor Ⅰ testing kit

---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.
Insulin-like growth gactor Ⅰ testing kit ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standard Insulin-like growth factor Ⅰ assay kit Published on October 23,.2019 2020-10-01 implementation Published by the State Drug Administration

Contents

Foreword III 1 Scope 1 2 Normative references 1 3 Classification 1 4 Requirement 1 5 Test method 2 6 Labels and instruction manuals 4 7 Packaging, transportation, storage 4 Reference 5

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some elements of this document may involve patents. The issuer of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Medical Clinical Laboratory and the Standardization Technical Committee for In vitro Diagnostic Systems (SAC/TC136). This standard was drafted. China Food and Drug Inspection Institute, Henan Medical Device Inspection Institute, Zhengzhou Antu Biological Engineering Co., Ltd. Company, Shenzhen New Industry Biomedical Engineering Co., Ltd., Siemens Medical Diagnostic Products (Shanghai) Co., Ltd. The main drafters of this standard. Yu Ting, Qu Shoufang, Sun Nan, Huang Jie, Zhang Juanli, Li Xiaoxia, Wei Wenfeng, Yuan Jinyun, Wang Shaoying, Nangang. Insulin-like growth factor Ⅰ assay kit

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 article Pieces. 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

4.1 Appearance Manufacturers should specify appropriate appearance requirements based on the packaging characteristics of their products. Generally should have the composition and properties of each component of the kit; inside and outside Requirements for clear packaging and labels. 4.2 Detection limit Should not be higher than 20ng/mL. 4.3 Linear Within the linear range given by the manufacturer (the lower limit should not be higher than 40ng/mL, and the upper limit should not be lower than 1000ng/mL), the correlation coefficient (r) Should not be lower than 0.9900. 4.4 Accuracy Accuracy should meet one of the following requirements. a) Detection of insulin-like growth factor Ⅰ national (or international) standard in the linear range specified by the kit ...