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YY/T 1594-2018: Anti-TG quantitative labelling immunoassay kit
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1594-2018 | English | 159 |
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Anti-TG quantitative labelling immunoassay kit
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YY/T 1594-2018
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Basic data | Standard ID | YY/T 1594-2018 (YY/T1594-2018) | | Description (Translated English) | Anti-TG quantitative labelling immunoassay kit | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Word Count Estimation | 8,859 | | Date of Issue | 2018-04-11 | | Date of Implementation | 2019-05-01 | | Regulation (derived from) | China Drug Administration Announcement No. 4 of 2018 | | Issuing agency(ies) | State Drug Administration | YY/T 1594-2018: Anti-TG quantitative labelling immunoassay 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.
(Human anti-thyroglobulin antibody assay kit)
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Human anti-thyroglobulin antibody assay kit
Published on.2018-04-11
2019-05-01 implementation
State Drug Administration issued
Content
Foreword III
1 Scope 1
2 Normative references 1
3 Category 1
4 Requirements 1
5 Test method 2
6 Labels and instruction manual 4
7 Packaging, transportation and 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 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 Research Institute, Abbott Trade (Shanghai) Co., Ltd., Zhengzhou Antu Bioengineering Co., Ltd.
Limited company, Boao Biological Co., Ltd.
The main drafters of this standard. Sun Nan, Liu Yan, Gao Shangxian, Zhang Lihong, Wang Xuefeng, Guan Rui.
Human anti-thyroglobulin antibody assay kit
1 Scope
This standard specifies the scope of application of human anti-thyroglobulin antibody assay kits, normative references, classification, requirements, test methods
Law, label and instruction manual, packaging, transportation and storage.
This standard is applicable to the labeled immunoassay kit for quantitative determination of human anti-thyroglobulin antibodies (hereinafter referred to as Anti-TG test).
Kit) This includes quantitative determination of the Anti-TG kit by labeling methods such as enzymatic labeling and chemiluminescent labeling.
This standard does not apply to.
a) colloidal gold labeled Anti-TG test strip;
b) Various types of radioimmunoassay or immunoradiation kits 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 article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191-2008 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; according to different operating procedures can be divided into manual methods and instruments
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 Blank limit
The blank limit should not be higher than 15.0 IU/mL.
4.3 Linear
Within the linear range given by the manufacturer (lower limit not higher than 20 IU/mL, upper limit not lower than 1000 IU/mL), correlation coefficient (r) should be
Not less than 0.9900.
4.4 Accuracy
Accuracy should meet one of the following requirements.
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