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YY/T 1250-2014 English PDF

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YY/T 1250-2014: Insulin quantitative labelling immunoassay kit
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YY/T 1250-2014English209 Add to Cart 3 days [Need to translate] Insulin quantitative labelling immunoassay kit Valid YY/T 1250-2014

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Basic data

Standard ID YY/T 1250-2014 (YY/T1250-2014)
Description (Translated English) Insulin 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 9,919
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 principle of double-antibody sandwich assay for the quantitative determination of human insulin (h-INS) kit, including enzyme-labeled, (electric) chemiluminescent markers (time-resolved) fluorescence labeling and other labelin

YY/T 1250-2014: Insulin 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.
Insulin quantitative labelling immunoassay kit ICS 11.100 C44 People's Republic of China pharmaceutical industry standards Labeled insulin 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. Huang Ying, Zhangchun Tao, Shen Shu Ting, noble first. Labeled insulin quantitative immunoassay kit

1 Scope

This standard specifies the quantitative insulin labeled immunosorbent assay kit for the classification, requirements, test methods, marking, labeling, manual, package Loading, transport and storage. This standard applies to the double antibody sandwich method for the quantitative determination of the principles of human insulin (h-INS) kit (hereinafter referred to as. INS agents box). Including enzyme-labeled, (electro) chemiluminescent labels, (time-resolved) fluorescent labels as capture antibody labeling method, in microplates, tubes, magnetic Granules, beads and plastic beads coated with an antibody to the carrier, the quantitative determination of human insulin immunoassay kit. This standard does not apply to. Human insulin agents (such as a) with colloidal gold or other qualitative or semi-quantitative determination mark. strip, etc.); b) the categories of persons with 125I and other radiolabeled insulin 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 INS kit according to different labeling methods can be divided into INS enzyme labeling kit (electro) chemiluminescent labels INS kit (time Resolved) fluorescence labeled INS kit etc; according to the solid support can be divided into microtiter plate, pipe, magnetic particle, microsphere beads and plastic beads As carrier INS kit; it can be divided according to the different operating procedures manual method and apparatus for automatic operation of law INS kit.

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 5.0mIU/L ~ 160mIU/L range, double logarithmic or other appropriate mathematical model fitting, the dose - response curve linear phase Relationship Number (r) shall not be less than 0.9900. Note. The lower limit of the linear range of not more than 5.0mIU/L, the upper limit of the linear range of not less than 160mIU/L. 4.3 The minimum detection limit Should not be higher than 2.0mIU/L. 4.4 accuracy Kit calibrator with the corresponding concentrations of insulin national (or international) standards were analyzed simultaneously determined double logarithmic or other appropriate

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