YY/T 1249-2014 English PDF (YYT1249-2014)

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YY/T 1249-2014: Free prostate specific antigen quantitative labelling immunoassay kit
YY/T 1249-2014
Free prostate specific antigen quantitative labelling immunoassay kit
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Free prostate specific antigen 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. Release mechanism of the present document does not assume responsibility for the identification of 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.
Free prostate specific antigen quantitative marker
Immunoassay kit
1 Scope
This standard specifies the free prostate specific antigen labeled immunosorbent assay kit for quantitative classification, requirements, test methods, marking, marking
Sign, instructions, packaging, transport and storage.
This standard applies to the double antibody sandwich method for the quantitative determination of the principles of free prostate-specific antigen (fPSA) kit (hereinafter
He said. fPSA kit). Including enzyme-labeled, (electro) chemiluminescent labels, (time-resolved) fluorescent labels as capture antibody labeling method,
In microplates, tubes, magnetic particles, beads and plastic beads coated with an antibody to the carrier, the quantitative determination of fPSA immunoassay kits.
This standard does not apply to.
a) with colloidal gold or other qualitative or semi-quantitative determination of labeled fPSA agents (such as. test strip, etc.);
b) all kinds of fPSA 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
fPSA kit in accordance with the labeling methods can be divided into enzyme-labeled fPSA kit (electric) chemiluminescent labels fPSA kit
(Time-resolved) fluorescence labeling fPSA kit and the like; according to the solid support can be divided into microtiter plate, pipe, magnetic particles, plastic beads and microspheres
Beads and other materials as the carrier fPSA kit; depending on the operation process can be divided into manual method and automated method fPSA 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
At 0.5μg/L ~ 10μg/L range, double logarithmic or other appropriate mathematical model fitting, the dose - response curve linear correlation coefficient
Number (r) shall not be less than 0.9900.
Note. The lower limit of the linear range of not more than 0.5μg/L, the upper limit of the linear range of not less than 10μg/L.
4.3 The minimum detection limit
It should not be higher than 0.20μg/L.