GB/T 36136-2018General requirements of DNA array-based M.tuberculosis drug resistance detection (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

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 document. 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

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