GB/T 35533-2017 in English

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General technical requirement for chromosomal abnormality detection microarray

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Standard No:	GB/T 35533-2017
Document status:	VALID
Title in English:	General technical requirement for chromosomal abnormality detection microarray
Title in Chinese:	染色体异常检测基因芯片通用技术要求
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
ICS Classification:	11.040.55-Diagnostic equipment
Chinese Classification:	C30-Medical apparatus and devices in general
Professional Classification:	GB-National Standard
Related Keywords:	chromosomal abnormality detection microarray introduction chromosome abnormality detection gene chips chromosome abnormality detection field detection principle cnv detection
Related Topics:	chip genetic abnormality How long does the gene chip test biological autosome baseline abnormalities Detection of isomers biological autosome gene chip technology How to detect isomers Isomer detection Outlier Curve Detection Isomer detection Gene chip general technical requirements for chromosomal abnormality detection The following about the gene chip Bladder cancer cell chromosome and gene abnormality detection kit Abnormal water flow detection "General Technical Requirements for Gene Chips for Chromosomal Abnormality Detection" Gene detection analysis technology Detection of isomers Chromosomal Abnormality Detection Gene Core Sheet Dyeing Instrument detection gene Gene detection gene Gene chip instrument The main technology of the chip Abnormal chromatographic carrier gas gene detection gene chip gene chip detected by gene chip Chromosomal abnormalities genes and chromosomes The future of genetic testing technology chromosome technology gene chip one gene chip portable within gene technology Sound Anomaly Detection heterologous gene Gene chip + instrument heterologous gene microarray gene Abnormal sound detection Abnormal methylation detection Abnormal sound detection Abnormal use of the instrument Gene Technology Gold gene chip technology precursor gene about gene chips The Past and Present of Gene Chips Chromatographic Detector Technology precursor gene Abnormal water color gene low frequency technology Biology + Autosomal Abnormal Detection chip Detection chip pathway abnormalities First frame genetic detection technology Analysis of genetic testing technology conventional staining bipolar detection chip bipolar detection chip conventional staining First frame genetic detection technology Mandrel technical requirements Curve Anomaly Detection Abnormal chromosome 15 Abnormal detection ability base chip Mandrel Technical Requirements secretory gene Device Anomaly Detection abnormal chromosome 12 Abnormal chromosome 13 Chromosomal abnormality 17 Chromosome 17 abnormality Chromosome 14 abnormality 15th chromosome abnormality 16th chromosome abnormality Stainer Abnormal discharge of human body Chromosomal gene hybridization abnormal chromosomal methylation Chromosomal methylation What about chromosomal abnormalities Chromosomal Abnormalities and Occupation Genetic testing application Gene detection analysis technology transient gene technology Regular 6 Factors gene precursor Applications of Genetic Testing Chip testing at home and abroad Chip main technology Chip Test Requirements chromosome technology Detection of dyeing method Abnormal dispersion foreign gene chip Signal Anomaly Detection Genetic detection of primary and secondary variants Due to objection detection base gene chip chain Techniques for Detecting GMOs GBT35533 GB/T 35533-2017 Chemokine chip Mitochondrial genome chip How much does a ceRNA chip test cost? Aligent gene chip gene pathways The NLPR3 gene is located on the chromosome Is the genetic test for angiomatous nematodes a specific test? Affygene chip Human disease susceptibility gene chip Chip testing technology What detection method is used for isomer detection? Standard requirements for testing mandrels Genetic testing data specification requirements Bose detection method The most commonly used staining method for bone marrow smear staining Gene low-frequency variant detection method Chip testing industry testing Gene chip standard code Common cell staining methods

《GB/T 35533-2017染色体异常检测基因芯片通用技术要求》由TC421（全国生物芯片标准化技术委员会）归口，主管部门为国家标准化管理委员会。

Introduction

1. Standard Overview

GB/T 35533-2017 General Technical Requirements for Chromosome Abnormality Detection Gene Chips is my country's first national standard for chromosome abnormality detection gene chips, providing normative guidance for product development, production and application.

2. Background of Standard Formulation

With the development of biotechnology, gene chips are increasingly used in the medical field. This standard fills the gap in my country's chromosome abnormality detection field and ensures product quality and the reliability of test results.

Dimensions	Technical indicators	Standard requirements
Chip type	aCGH, SNP, etc.	Clearly define the detection principle and scope of application
Resolution	Probe coverage	Minimum abnormal fragment length is not less than 1kb
Repeatability	Aneuploidy detection: more than 95%; CNV detection: more than 90%	Ensure the reliability of the results

3. Implementation Suggestions

Sample processing:Establish standardized sampling and pretreatment processes to ensure sample quality.

Quality control measures:Set up multi-level quality control probes (QC, HC, BC) to monitor the hybridization process and data quality.

Performance verification:Use positive/negative samples for verification to ensure that the positioning overlap rate with the reference method is not less than 50%.

More samples: DL/T 5154-2012 GB 50021-2001(2009) GB 18306-2015

Sample only — not a preview of GB/T 35533-2017

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