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YY/T 1214-2019 PDF English

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YY/T 1214-2019: Human chorionic gonadotrophin detection kit
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Status: Valid

YY/T 1214: Historical versions

Standard IDUSDBUY PDFDeliveryStandard Title (Description)Status
YY/T 1214-2019199 Add to Cart 3 days Human chorionic gonadotrophin detection kit Valid
YY/T 1214-2013160 Add to Cart Auto, 9 seconds. Human chorionic gonadotrophin quantitative labelling immunoassay kit Obsolete

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YY/T 1214-2019: Human chorionic gonadotrophin detection kit

---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1214-2019
Human chorionic gonadotrophin detection kit ICS 11.040.30 C30 People's Republic of China Pharmaceutical Industry Standard Replacing YY/T 1214-2013 Human chorionic gonadotropin assay kit Published on.2019-07-24 2020-08-01 implementation State Drug Administration issued

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY/T 1214-2013 "Human chorionic gonadotropin quantitative labeling immunoassay kit", and YY/T 1214- Compared with.2013, the main changes are as follows. --- Increased the method of calculating the relative deviation in the accuracy experiment; --- Eliminated the precision within the analysis and the inter-analytical precision items, and merged into the intra-batch precision; --- Cancel the measurement item of the quality control item. Please note that some of the contents of this document may involve patents. The issuing organization 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 In vitro Diagnostic System Standardization Technical Committee (SAC/TC136). This standard was drafted. China Food and Drug Control Institute, Roche Diagnostics (Shanghai) Co., Ltd., Siemens medical diagnostic products (Shanghai) Co., Ltd., Abbott Trading (Shanghai) Co., Ltd. The main drafters of this standard. Yu Ting, Huang Ying, Qu Shoufang, Sun Nan, Huang Jie, Cai Xiaorong, Ge Yawen, Wang Shaoying, Xiao Wei, Wang Xuefeng, Zhang Hong. Human chorionic gonadotropin assay kit

1 Scope

This standard specifies the classification, requirements, test methods, labels and instructions for use of human chorionic gonadotropin determination kits, packaging, Transportation, storage. This standard applies to the kit for the quantitative determination of human chorionic gonadotropin by the double antibody sandwich method, including enzyme labeling, (electric) Immunoassay kit for labeling methods such as chemiluminescent labeling, (time-resolved) fluorescent labeling. This standard does not apply. semi-quantitative determination of human chorionic gonadotropin reagents by colloidal gold or other methods (eg, test strips) Etc.); a variety of human chorionic gonadotropin radioimmunoassay or immunoradiometric kits labeled with a radioisotope 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 article. Pieces. 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

4.1 Appearance Manufacturers should specify appropriate appearance requirements based on the packaging characteristics of their products. Generally, there should be components and traits of each component of the kit; internal and external Requirements for packaging, labeling, etc. 4.2 Detection limit Should not be higher than 5.0 IU/L. 4.3 Linear Within the linear range given by the manufacturer (the lower limit should not be higher than 5.0 IU/L, and the upper limit should be no less than 1000 IU/L; enzyme-linked immunosorbent assay The upper limit of the kit should be no less than.200 IU/L), and the correlation coefficient (r) should be no less than 0.9900. 4.4 Accuracy Accuracy should meet one of the following requirements. a) Detection of human chorionic gonadotropin national (or international) standards within the linear range specified in the kit, relative to the results of the assay YY/T 1214-2019 Human chorionic gonadotrophin detection kit ICS 11.040.30 C30 People's Republic of China Pharmaceutical Industry Standard Replacing YY/T 1214-2013 Human chorionic gonadotropin assay kit Published on.2019-07-24 2020-08-01 implementation State Drug Administration issued

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY/T 1214-2013 "Human chorionic gonadotropin quantitative labeling immunoassay kit", and YY/T 1214- Compared with.2013, the main changes are as follows. --- Increased the method of calculating the relative deviation in the accuracy experiment; --- Eliminated the precision within the analysis and the inter-analytical precision items, and merged into the intra-batch precision; --- Cancel the measurement item of the quality control item. Please note that some of the contents of this document may involve patents. The issuing organization 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 In vitro Diagnostic System Standardization Technical Committee (SAC/TC136). This standard was drafted. China Food and Drug Control Institute, Roche Diagnostics (Shanghai) Co., Ltd., Siemens medical diagnostic products (Shanghai) Co., Ltd., Abbott Trading (Shanghai) Co., Ltd. The main drafters of this standard. Yu Ting, Huang Ying, Qu Shoufang, Sun Nan, Huang Jie, Cai Xiaorong, Ge Yawen, Wang Shaoying, Xiao Wei, Wang Xuefeng, Zhang Hong. Human chorionic gonadotropin assay kit

1 Scope

This standard specifies the classification, requirements, test methods, labels and instructions for use of human chorionic gonadotropin determination kits, packaging, Transportation, storage. This standard applies to the kit for the quantitative determination of human chorionic gonadotropin by the double antibody sandwich method, including enzyme labeling, (electric) Immunoassay kit for labeling methods such as chemiluminescent labeling, (time-resolved) fluorescent labeling. This standard does not apply. semi-quantitative determination of human chorionic gonadotropin reagents by colloidal gold or other methods (eg, test strips) Etc.); a variety of human chorionic gonadotropin radioimmunoassay or immunoradiometric kits labeled with a radioisotope 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 article. Pieces. 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

4.1 Appearance Manufacturers should specify appropriate appearance requirements based on the packaging characteristics of their products. Generally, there should be components and traits of each component of the kit; internal and external Requirements for packaging, labeling, etc. 4.2 Detection limit Should not be higher than 5.0 IU/L. 4.3 Linear Within the linear range given by the manufacturer (the lower limit should not be higher than 5.0 IU/L, and the upper limit should be no less than 1000 IU/L; enzyme-linked immunosorbent assay The upper limit of the kit should be no less than.200 IU/L), and the correlation coefficient (r) should be no less than 0.9900. 4.4 Accuracy Accuracy should meet one of the following requirements. a) Detection of human chorionic gonadotropin national (or international) standards within the linear range specified in the kit, relative to the results of the assay ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.

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