GB/T 28639-2012General technical requirement for DNA microarray (English PDF)
DNA微阵列芯片通用技术条件
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
July 31, 2012
Implementation date
November 1, 2012
Scope
GB/T 28639-2012 is the English-translated version of DNA微阵列芯片通用技术条件.
GB/T 28639-2012 fixes the terms and definitions, performance requirements, test methods, marking, labelling, transport and storage for DNA microarray chips made by the spotting (printing) technique.
Clause 1 states that the standard applies to DNA microarray chip products that use a substrate as the carrier and serve qualitative detection.
Clause 3 adopts the definitions of GB/T 27990-2011 on basic terms for biochips and adds three of its own: the subarray, a micro-array unit formed by arranging a number of amplification products, oligonucleotides or DNA probes of one specific class within a defined area of the chip, with the note that one substrate may carry several such units and that each is generally used for one sample; the surface chemical modification QC probe, used to control the quality of the chemical modification of the substrate surface, being a labelled oligonucleotide with no homologous target sequence so that its signal depends only on the quality of that modification; and the internal standard QC probe, used to control whether nucleic acid extraction, the amplification reaction and the hybridization reaction have run normally, usually an oligonucleotide complementary to part of the nucleic acid sequence of the sample under test.
Clause 4 opens the performance requirements with 4.1 on appearance, which requires that within the valid area of the subarray the chip show no features affecting product quality and that the whole chip be intact.
The normative references are GB/T 191 on pictorial marking for packaging and GB/T 27990-2011.
The standard was drafted according to the rules of GB/T 1.1-2009, carries a notice that some of its content may involve patents which the issuing body does not undertake to identify, and is administered by the national biochip standardization technical committee, SAC/TC 421.
It was approved by AQSIQ and the Standardization Administration of China under National Standards Bulletin 2012 No. 17, and is classified under ICS 07.080 and Chinese classification A40.
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Document preview — GB/T 28639-2012
National Standard of the People's Republic of China
- ICS
- 07.080
- Classification
- A 40
Issued by: State Administration for Market Regulation; Standardization Administration of the PRC
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions GB/T 27990-2011 defined and the following
- 4 Performance Requirements
Foreword
This standard rule according to GB/T 1.1-2009 given draft.
1 Scope
This standard specifies the terms and definitions prepared print-legal DNA microarray chip, performance requirements, test methods, marking, labeling, transport Transport and storage.
This standard applies to the substrate as the carrier of DNA microarray chip products for the qualitative detection.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 191 Packing Pictorial marking
GB/T 27990-2011 biochip basic terms
3 Terms and Definitions
GB/T 27990-2011 defined and the following terms and definitions apply to this document.
3.1 Subarray
The DNA microarray chip in a specific area by a plurality of amplification product, an oligonucleotide or DNA probes to a specific class of arrangement by group A micro-array unit.
Note: Each of the substrate may be provided on a plurality of such units, each unit is generally used for detecting a sample to the array can be different or rubber. His fencing material is divided into different areas.
3.2 Surface chemical modification QC probe
QC substrate surface chemical modification of the probe on the quality of DNA microarray chip is used.
Note: The probe is non-existent relationship with the homologous target sequence oligonucleotide fragments with a detectable label, the signal is only surface chemical modification to the substrate Quality-related ornaments.
3.3 QC internal standard probe
DNA microarray quality control testing process used on nucleic acid extraction, amplification reaction, chip hybridization reaction process is normal Probes.
NOTE: Usually with a sample to be tested using nucleic acid sequence fragments from some complementary oligonucleotides as probes.
4 Performance Requirements
4.1 Appearance
No effect on product quality characteristics within the sub-array chip valid range, the whole chip intact.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
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