YY/T 1213-2013 English PDF (YYT1213-2013)

Delivery: 3 seconds. Download true-PDF + Invoice.
Get Quotation: Click YY/T 1213-2013 (Self-service in 1-minute)
Historical versions (Master-website): YY/T 1213-2013
Preview True-PDF (Reload/Scroll-down if blank)

YY/T 1213-2013: Follicle stimulating hormone quantitative labelling immunoassay kit
YY/T 1213-2013
Follicle stimulating hormone quantitative labelling immunoassay kit
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
FSH 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 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, Shen Shu Ting, Zhangchun Tao, noble first.
FSH quantitative labeled immunosorbent assay kit
1 Scope
This standard specifies the FSH labeled immunosorbent assay kit for quantitative classification, requirements, test methods, marking, labeling, the 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 follicle stimulating hormone (FSH) kit (hereinafter referred to as. FSH test
Cartridge). Including enzyme-labeled, (electro) chemiluminescent labels, (time-resolved) fluorescent labels as capture antibody labeling method, in microplates, tubes,
Magnetic particles, beads and plastic beads as the carrier coating antibody, quantitative measurement of FSH immunoassay kit.
This standard does not apply to.
a) colloidal gold-labeled FSH test strip;
b) all kinds of FSH 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.
Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements
Category 3
FSH kit according to different labeling methods can be divided into enzyme-labeled FSH kit (electric) chemiluminescent labels FSH kit (when
Inter-resolved) fluorescence labeled FSH kit etc; according to the solid support can be divided into microtiter plate, pipe, magnetic particle, microsphere beads and plastic beads
As the carrier of FSH kit; it can be divided according to the different operating procedures manual method and apparatus for automatic operation of law FSH 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 loose body component was added deionized
Once the sub-water complex solvent should be completely dissolved within 10min.
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; FSH to national standards as reference, the measured value of the kit calibrator
And indicated value of cost-effectiveness should be between 0.900 to 1.100.
4.4 Linear
In [2.0,50] IU/L range, double logarithmic or other appropriate mathematical model fitting, the dose - response curve linear correlation coefficient (r)