GB/T 37872-2019 in English
VALIDGuidelines for validation of next-generation target region sequencing
- Issued on:2019-08-30
- Implemented on:2019-08-30
- File Format:PDF
- Delivery:Via email within 1~3 business days
$117.00
《GB/T 37872-2019目标基因区域捕获质量评价通则》由424-nrccrm（国家标准物质研究中心）归口，主管部门为国家市场监督管理总局。
Introduction
Interpretation of GB/T 37872—2019 National Standard of the People's Republic of China
Background and significance of standard formulation
This standard was jointly drafted by Shenzhen BGI Life Sciences Institute and other authoritative institutions to standardize the quality evaluation method of target gene region capture based on liquid phase capture technology. With the rapid development of high-throughput sequencing technology, precision medicine and biological research have increasingly higher requirements for the quality of target gene region capture.
Comparison of standard frameworks
| Standard dimensions | GB/T 37872—2019 requirements | International comparison |
|---|---|---|
| Sequencing depth | Germline mutation ≥60 times, somatic mutation ≥200 times (frequency ≥5%) | In line with international standards, some indicators are higher than those of European and American counterparts |
| Sequencing coverage | Coverage depths reach 99%, 98% and 97% respectively (depending on different multiples) | Meet the requirements of high-precision sequencing |
| Capture specificity | ≥45% (greater than 10Mb) and ≥12% (≤10Mb) | Optimized probe design and specificity control |
Detailed explanation of quality requirements
Average sequencing depth: According to the mutation type and detection target, the minimum requirements are set at 60x, 200x and 500x respectively.
Sequencing coverage: Tables 1, 2 and 3 specify the coverage requirements at different sequencing depths in detail to ensure data reliability.
Capture specificity: By comparing the amount of base data, the probe design is optimized to improve the capture efficiency.
Evaluation methods and implementation suggestions
Implementation steps and precautions
- Preparation of experimental materials: Use human genomic DNA to ensure sample quality.
- Library preparation: Perform standardized operations according to the requirements of the high-throughput sequencing platform.
- Data processing: Use local alignment algorithms and filtering parameters to optimize raw data.
- Result calculation: Perform depth and coverage statistics based on the aligned data, and use formulas (1), (2) and (3) to calculate the average sequencing depth, coverage and capture specificity respectively.
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