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YY/T 1222-2014: Totle 73 quantitative labelling immunoassay kit
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1222-2014 | English | 209 |
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Totle 73 quantitative labelling immunoassay kit
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YY/T 1222-2014
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Basic data | Standard ID | YY/T 1222-2014 (YY/T1222-2014) | | Description (Translated English) | Totle 73 quantitative labelling immunoassay kit | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 9,999 | | Date of Issue | 6/17/2014 | | Date of Implementation | 7/1/2015 | | Quoted Standard | GB/T 191 | | Regulation (derived from) | China Food and Drug Administration in 2014 Bulletin No. 30 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard applies to the principles of competition law for three quantitative determination of total triiodothyronine (TT3) kit, including enzyme-labeled, (electric) chemiluminescent markers (time-resolved) fluorescence labeling methods such as labeli | YY/T 1222-2014: Totle 73 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.
Totle 73 quantitative labelling immunoassay kit
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
The total three triiodothyronine quantitative marker
Immunoassay kit
Issued on. 2014-06-17
2015-07-01 implementation
China Food and Drug Administration released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
Please note that some of the content of this document may involve patents. Distribution of this document
Institutions do not assume the responsibility to identify these patents.
This standard was proposed by the China Food and Drug Administration.
This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) centralized.
This standard was drafted. Chinese Academy of Food and Drug test.
The main drafters of this standard. Zhangchun Tao, Huang Ying, Liu Yan, Shen Shu, noble first.
The total three triiodothyronine quantitative marker
Immunoassay kit
1 Scope
This standard specifies the total three triiodothyronine labeled immunosorbent assay kit for quantitative classification, requirements, test methods, marking, labeling,
Manual, packaging, transportation and storage.
This standard applies to the principles of competition law for the quantitative determination of total three triiodothyronine (TT3) kit (hereinafter referred to as. TT3 reagent
box). Including enzyme-labeled, (electro) chemiluminescent labels, (time-resolved) fluorescence label and the like methods, microplates, tubes, magnetic particles, microbeads, and
Plastic beads and other carriers as a quantitative measurement TT3 immunoassay kits.
This standard does not apply to.
a) colloidal gold-labeled TT3 test strip;
b) all kinds of TT3 and other radiolabelled with 125I RIA or IRMA kit.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 191 Packaging - Pictorial signs
Category 3
TT3 immunoassay kit according to different labeling methods can be divided into enzyme-labeled TT3 kit (electric) chemiluminescent label TT3 test
Kit, (time-resolved) fluorescence-labeled TT3 kit and the like; according to the solid support can be divided into microtiter plate, pipe, magnetic particle, microsphere beads
And plastic beads as the carrier of the TT3 kit; according to the procedure of the operation can be divided into manual method and the automatic operation of the instrument test method TT3
Cartridge.
4 Requirements
4.1 appearance and physical examination
The kit components should be complete, and outside packaging should be complete, clear labels, no leakage of liquid reagent, lyophilized component was loose body, adding purified
After re-solvent such as water should be within 10min to dissolve, no sediment or floc.
4.2 Linear
In 0.8ng/mL ~ 6.0ng/mL range, with lg-logit mathematical model fitting or other appropriate mathematical model fitting dose - Anti
Response curve linear correlation coefficient absolute value (︱r︱) shall not be less than 0.9900.
Note 1. The lower limit of the linear range of not more than 0.8ng/mL, the upper limit of the linear range of not less than 6.0ng/mL.
Note 2. The conversion relationship with other units as follows. 1nmol/L × 0.651 = 1ng/mL, 1nmol/L × 65.100 = 1ng/dL, 1ng/mL × 1.536 =
1nmol/L, 1ng/mL × 1.000 = 1μg/L.
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