YY/T 1214-2019 (YY/T1214-2019, YYT 1214-2019, YYT1214-2019) & related versions
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Human chorionic gonadotrophin detection kit
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YY/T 1214-2019
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YYT 1214-2019
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| YY/T 1214-2013 | English | 160 |
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Human chorionic gonadotrophin quantitative labelling immunoassay kit
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YY/T 1214-2019: PDF in English (YYT 1214-2019)
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
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
......
| Standard ID | YY/T 1214-2019 (YY/T1214-2019) | | Description (Translated English) | Human chorionic gonadotrophin detection kit | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.040.30 | | Word Count Estimation | 10,130 | | Date of Issue | 2019 | | Date of Implementation | 2020-08-01 | | Summary | This standard specifies the classification, requirements, test methods, labels and instructions for use, packaging, transportation and storage of human chorionic gonadotropin assay kits. This standard applies to kits for quantitative determination of human chorionic gonadotropin based on the double-antibody sandwich method, including immunoassay kits using enzyme labeling, (electro)chemiluminescence labeling, (time-resolved) fluorescent labeling and other labeling methods. This standard does not apply to reagents (such as test strips, etc.) for the semi-quantitative determination of human chorionic gonadotropin labeled with colloidal gold or other methods; or immunoradiation kits. This standard replaces YY/T 1214-2013 "Human Chorionic Gonadotropin Quantitative Labeling Immunoassay Kit". |
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