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YY/T 1217-2013: Luteinizing hormone quantitative labelling immunoassay kit
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1217-2013 | English | 209 |
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Luteinizing hormone quantitative labelling immunoassay kit
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YY/T 1217-2013
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Basic data | Standard ID | YY/T 1217-2013 (YY/T1217-2013) | | Description (Translated English) | Luteinizing hormone 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 | 9,914 | | Quoted Standard | YY/T 0466.1 | | Regulation (derived from) | State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies: luteinizing hormone quantitative labeled immunoassay kit classification, requirements, test methods, marking, labeling and instructions for use, packaging, transportation and storage. This standard applies to: a double-antibody sa | YY/T 1217-2013: Luteinizing hormone 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.
Luteinizing hormone quantitative labelling immunoassay kit
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Luteinizing hormone quantitative labeled immunosorbent assay kit
Issued on. 2013-10-21
2014-10-01 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 standard may involve patents. The standard release
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 testing laboratory and diagnostic systems in vitro Standardization Technical Committee.
This standard was drafted. Chinese Academy of Food and Drug test.
The main drafters of this standard. Huang Ying, Li Lili, Yu Ting, noble first.
Luteinizing hormone quantitative labeled immunosorbent assay kit
1 Scope
This standard specifies the luteinizing hormone labeled immunosorbent assay kit for quantitative classification, requirements, test methods, marking, labeling and use of said
Specification, packaging, transportation and storage.
This standard applies to the double antibody sandwich method for the quantitative determination of the principles of luteinizing hormone (LH) kit (hereinafter referred to as. LH Reagents
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 as the carrier coating antibody, quantitative measurement of LH immunoassay kit.
This standard does not apply to.
a) various types of colloidal gold-labeled LH test strips;
b) all kinds of LH RIA or IRMA kit and other radiolabelled with 125I.
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.
Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements
Category 3
LH kit according to different labeling methods can be classified into the enzyme-labeled LH kit (electro) chemiluminescent labels LH kit (time
Resolved) fluorescence labeled LH kits etc; according to the solid support can be divided into microtiter plate, pipe, magnetic particle, microsphere beads and plastic beads
As the carrier of the LH kits; it can be divided according to the different operating procedures manual method and apparatus for automatic operation of law LH kits.
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 loose body component was added deionized
Once the sub-water complex solvent should be completely dissolved within 20min.
4.2 The minimum detection limit
Should not be higher than 1.0IU/L.
4.3 accuracy
Kit calibrator with the corresponding concentration of national measurement standards were analyzed simultaneously, double logarithmic or other appropriate mathematical model proposed
Together, it requires two dose - response curve does not deviate significantly from the parallel; LH to national standards as reference, the measured value with the kit calibrator
Flag titer values should be between 0.900 to 1.100.
4.4 dose - response curve is linear
In [2.0,100] IU/L range, double logarithmic or other appropriate mathematical model fitting, the dose - response curve linear correlation coefficient (r)
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