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GB/T 36136-2018 English PDF

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GB/T 36136-2018: General requirements of DNA array-based M. tuberculosis drug resistance detection
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GB/T 36136-2018119 Add to Cart 3 days General requirements of DNA array-based M. tuberculosis drug resistance detection Valid

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Basic data

Standard ID: GB/T 36136-2018 (GB/T36136-2018)
Description (Translated English): General requirements of DNA array-based M. tuberculosis drug resistance detection
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C30
Classification of International Standard: 11.040.55
Word Count Estimation: 6,640
Date of Issue: 2018-05-14
Date of Implementation: 2018-12-01
Regulation (derived from): National Standards Announcement No. 6 of 2018
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

GB/T 36136-2018: General requirements of DNA array-based M. tuberculosis drug resistance detection


---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
(The basic requirements for detection of Mycobacterium tuberculosis drug-resistance gene chips) ICS 11.040.55 C30 National Standards of People's Republic of China Mycobacterium tuberculosis drug resistance gene chip detection basic requirements Published on.2018-05-14 2018-12-01 implementation State market supervision and administration China National Standardization Administration issued

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard is proposed and managed by the National Biochip Standardization Technical Committee (SAC/TC421). This standard was drafted. Boao Biological Group Co., Ltd., China Center for Disease Control and Prevention. The main drafters of this standard. Guo Yong, Zhu Lingxiang, Zhao Yanlin, Liu Yingying, Wang Wei, Xiang Guangxin, Hao Yu. Mycobacterium tuberculosis drug resistance gene chip detection basic requirements

1 Scope

This standard specifies the basic requirements for detection of M. tuberculosis drug resistance gene chips. This standard is applicable to the detection of resistance-related genes of common first- and second-line anti-tuberculosis drugs from Mycobacterium tuberculosis derived from clinical samples.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. YY/T 1153 DNA microarray chip for in vitro diagnosis YY/T 1154 laser confocal scanner Management Measures for Clinical Gene Amplification in Medical Institutions (Wei Ban Medical Administration [2010] No. 194)

3 Abbreviations

The following abbreviations apply to this document. DNA. Deoxyribonucleic Acid PCR. Polymerase Chain Reaction (PolymeraseChainReaction)

4 Principle

Design specific PCR amplification primers and phases based on the specific conserved nucleic acid sequences of clinically common M. tuberculosis resistance genes The oligonucleotide probe should be. Using the DNA of Mycobacterium tuberculosis isolated from clinical samples as a template, adding primers with terminal luminescent markers, using PCR technology The target fragment of the drug resistance gene is amplified, and the amplified DNA to be tested carries a luminescent marker. The PCR amplification product labeled with the luminescent label is hybridized with the probe on the chip under certain conditions, according to the mutual base Complementing the principle, the sequence-matched PCR amplification product forms a stable secondary structure with the probe. According to the specific arrangement of the probe on the chip By setting, the relevant information of the corresponding test DNA can be detected, and the drug resistance gene information of the sample is inferred.

5 Instrument materials and reagents

5.1 Instruments and materials Microarray chip scanner, microarray chip hybridization cassette, nucleic acid that should meet the requirements of YY/T 1154 and obtain medical device registration certificate Amplifier, chip hybridization instrument (optional), chip washer (optional), refrigerator (-20 ° C), micro sampler and sampler tip, constant temperature water bath Pots, microcentrifuges, centrifuge tubes, constant temperature shakers, chip washing containers and slide holders.
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