GB/T 42080.3-2024 in English
VALIDMolecular in vitro diagnostic examinations—Specifications for pre-examination processes for frozen tissue—Part 3: Isolated DNA
- Issued on:2024-09-29
- Implemented on:2025-04-01
- File Format:PDF
- Delivery:Via email within 5 business days
$301.00
| Standard No: | GB/T 42080.3-2024 |
| Document status: | VALID |
| Title in English: | Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for frozen tissue—Part 3: Isolated DNA |
| Title in Chinese: | 分子体外诊断检验 冷冻组织检验前过程的规范 第3部分:分离DNA |
| Language: | English |
| File Format: | Electronic (PDF) |
| Delivery: | Via email within 5 business days |
| Issued on: | 2024-09-29 |
| Implemented on: | 2025-04-01 |
| Chinese Classification: | C30-Medical apparatus and devices in general |
| Professional Classification: | GB-National Standard |
| Related Keywords: | frozen tissue part
vitro diagnostic examinations specifications frozen tissue samples dna isolation process dna introduction |
| Related Topics: | Precursor ion
Tissue Separator Cadmium ion test Precursor ion frozen tissue precursor ion mode Cadmium ion test Precursor ion |
《GB/T 42080.3-2024分子体外诊断检验 冷冻组织检验前过程的规范 第3部分:分离DNA》由TC136(全国医用临床检验实验室和体外诊断系统标准化技术委员会)归口,主管部门为国家药监局。
Introduction
This standard, GB/T 42080.3-2024, is issued by the National Standardization Administration Committee and is scheduled to come into effect on April 1, 2025. It specifically addresses the pre-processing steps for DNA isolation in molecular diagnostics involving frozen tissue samples. The third part of this series focuses on methodologies and best practices for extracting high-quality DNA from cryopreserved specimens, ensuring consistency and reliability across various diagnostic applications.
The standard outlines detailed protocols for handling frozen tissues to minimize degradation of nucleic acids during the thawing and processing stages. It also includes recommendations for equipment calibration, reagent selection, and quality control measures that are crucial for maintaining sample integrity throughout the DNA isolation process.
By adhering to these guidelines, laboratories can enhance their diagnostic accuracy in molecular pathology tests, particularly those involving genetic mutations or infectious agents detected through nucleic acid amplification techniques. This standard aims to promote standardized procedures across different institutions and regions, facilitating better comparability of results and advancing research efforts in the field.
*** Please note: This description may not be accurate, please refer to the official documentation.

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