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YY/T 1224-2014: Detection kit for analysis of related chromosome and gene abnormalities in bladder cancer (Fluorescent in situ hybridization)
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1224-2014 | English | 209 |
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Detection kit for analysis of related chromosome and gene abnormalities in bladder cancer (Fluorescent in situ hybridization)
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YY/T 1224-2014
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Basic data | Standard ID | YY/T 1224-2014 (YY/T1224-2014) | | Description (Translated English) | Detection kit for analysis of related chromosome and gene abnormalities in bladder cancer (Fluorescent in situ hybridization) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 9,950 | | 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 CSP3, CSP7, CSP17, GLP9 corresponding sites of four kinds of fluorescence in situ hybridization probes and re-dye composition, by detecting a sample (usually urine smears) on the 3rd, 7th, 17 chromosome aneuploidy increases an | YY/T 1224-2014: Detection kit for analysis of related chromosome and gene abnormalities in bladder cancer (Fluorescent in situ hybridization)
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Detection kit for analysis of related chromosome and gene abnormalities in bladder cancer (Fluorescent in situ hybridization)
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Bladder cancer and related chromosome
Gene abnormality detection kit (fluorescence in situ hybridization)
geneabnormalitiesinbladdercancer (Fluorescentinsituhybridization)
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, Shen Shu, Zhangchun Tao, noble first.
Bladder cancer and related chromosome
Gene abnormality detection kit (fluorescence in situ hybridization)
1 Scope
This standard specifies the bladder cancer-related chromosomal abnormality detection kit (fluorescence in situ hybridization) the definition and composition, to
Requirements, test methods, marking, labeling, instructions, packaging, transport and storage.
This standard applies to the CSP3, CSP7, CSP17, GLP9 corresponding sites of four kinds of fluorescence in situ hybridization probe and counterstain composed by
Test sample (usually urine smears) on the 3rd, 7th, 17th chromosome aneuploidy increases and P16 gene locus on chromosome 9
Missing the point, so the diagnosis of bladder cancer kits.
This standard does not apply to.
a) In immunohistochemistry diagnostic methods as the basic principle for bladder cancer diagnosis kit;
Labeled Immunoassays b) by ELISA analysis as the basic principle for bladder cancer diagnosis 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
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Fluorescence in situ hybridization fluorescentinsituhybridization; FISH
According to the principle of complementary base pairing with the target nucleic acid fragment DNA pairing (probe) on the labeling fluorescent dye, and the probe is to be tested
Nucleic acid fragments corresponding materials under certain conditions specific binding (hybridizing) to form a double-stranded nucleic acid, fluorescence microscopy and recorded by means of shape
A type of hybrid duplexes, the number, the sample to be tested to determine whether or not the normal method for detecting target DNA.
3.2
Bladder cancer-related chromosomal abnormalities and gene detection kit (fluorescence in situ hybridization) detectionkitforanalysisof
relatedchromosomeandgeneabnormalitiesinbladdercancer (fluorescentinsituhybridization)
By the CSP3, CSP7, CSP17 and GLP9 corresponding sites of a total of four kinds of fluorescence in situ hybridization probes (hereinafter referred to as. Probe) and counterstain
And other auxiliary agents composed by the 3rd detected sample to be tested, No. 7, No. 17 chromosome aneuploidy and increased chromosome 9 P16 group
Due to lack of sites for bladder cancer diagnosis kit (hereinafter. the kit).
4 Requirements
4.1 Appearance
The kit packaging should be complete, no damage, marked complete, clear; each liquid reagent should be clearly labeled, leak-free, color should be consistent with the manufacturer
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