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YY/T 1223-2014: Totle T4 quantitative labelling immunoassay kit
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 1223-2014	English	209	Add to Cart	3 days [Need to translate]	Totle T4 quantitative labelling immunoassay kit

YY/T 1223-2014: Totle T4 quantitative labelling immunoassay kit

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Totle T4 quantitative labelling immunoassay kit ICS 11.100 C44 People's Republic of China pharmaceutical industry standards Total thyroxine labeled quantitative 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. Total thyroxine labeled quantitative immunoassay kit

1 Scope

This standard specifies the total thyroxine labeled immunosorbent assay kit for quantitative classification, requirements, test methods, marking, labeling, instructions for use Books, packaging, transportation and storage. This standard applies to the principles of competition law for the quantitative determination of total thyroxine (TT4) kit (hereinafter referred to as. TT4 kit). package Including enzyme markers (electric) chemiluminescent labels, (time-resolved) fluorescence labeling and other labeling methods, microplates, tubes, magnetic particles, beads and plastic beads As a quantitative determination of TT4 carrier immunoassay kits. This standard does not apply to. a) colloidal gold-labeled TT4 test strip; b) all kinds of TT4 with 125I-labeled and other radioisotope 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 TT4 immunoassay kit according to labeling methods can be divided into enzyme-labeled TT4 kit (electric) chemiluminescent labels TT4 test Kit, (time-resolved) fluorescence labeling kits TT4 etc; according to the solid support can be divided into microtiter plate, pipe, magnetic particle, microsphere beads And plastic beads as the carrier of TT4 kit; according to the procedure of the operation can be divided into manual method and automated method TT4 test instrument 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 20.0ng/mL ~ 240.0ng/mL range, with lg-logit mathematical model fitting or other appropriate mathematical model fitting, agent Amount - 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 20.0ng/mL, the upper limit of the linear range of not less than 240.0ng/mL. Note 2. The conversion between common units as follows. 1nmol/L × 0.0777 = 1μg/dL, 1μg/dL × 12.8720 = 1nmol/L, 1nmol/L × 0.7769 = 1μg/L, 1ng/mL × 1.0000 = 1μg/L. 4.3 The minimum detection limit Should not be higher than 10.0ng/mL. ...