GB/T 36136-2018 in English

1. Background and significance of standard formulation

Tuberculosis is the second leading cause of death from infectious diseases after AIDS worldwide, and the problem of drug resistance is particularly prominent. With the abuse of antibiotics, the number of cases of multidrug-resistant and extensively drug-resistant tuberculosis has increased, and rapid and accurate detection of drug-resistant genes is crucial to guiding the selection of treatment options. Mycobacterium tuberculosis resistance gene chip detection technology uses microarray chips and PCR technology to achieve high-throughput and automated detection, significantly improving detection efficiency and accuracy.

2. Technical principles and evolution analysis

The standard is based on the principles of nucleic acid amplification and microarray hybridization: by designing specific PCR primers and probes, the target drug-resistant gene fragments are amplified and labeled, and then hybridized with the probes on the chip.

3. Instrument and reagent requirements

Microarray chip scanner and Nucleic acid amplifier are core equipment. PCR amplification reagents must comply with the YY/T1153 standard to ensure the stability of the reaction system.

4. Sample collection and processing

Sample processing steps include solid and liquid culture medium sampling, sputum liquefaction, etc. Strictly follow the operating procedures to ensure the quality of nucleic acid extraction.

5. Operation method and quality control requirements

The entire detection process is divided into four main steps: sample preparation, nucleic acid extraction, PCR amplification and chip hybridization analysis. Each step requires strict quality control measures, including the use of positive and negative controls.

6. Implementation suggestions