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vitro diagnostic examinations specifications frozen tissue part2 vitro diagnostic testing isolated proteins introduction specifications molecular diagnostic technology public security risk levels table items canned ham industrial reuse water treatment facilities introduction
GB/T 42080.2-2022 in English

GB/T 42080.2-2022 in English

VALID

Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for frozen tissue—Part2:Isolated proteins

  • Issued on:2022-12-30
  • Implemented on:2023-07-01
  • File Format:PDF
  • Delivery:Via email within 1~3 business days
Price(USD): $250.00
$243.00
Standard No: GB/T 42080.2-2022
Document status: VALID
Title in English: Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for frozen tissue—Part2:Isolated proteins
Title in Chinese: 分子体外诊断检验 冷冻组织检验前过程的规范 第2部分:分离蛋白质
Language: English
File Format: Electronic (PDF)
Delivery: Via email within 1~3 business days
Issued on: 2022-12-30
Implemented on: 2023-07-01
Chinese Classification: C30-Medical apparatus and devices in general
Professional Classification: GB-National Standard
Related Keywords: vitro diagnostic examinations specifications
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《GB/T 42080.2-2022分子体外诊断检验 冷冻组织检验前过程的规范 第2部分:分离蛋白质》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

Specifications for frozen tissues for molecular in vitro diagnostic testing: Interpretation of protein separation standards


1. Background and purpose of the standard

With the rapid development of molecular diagnostic technology, protein detection in frozen tissues plays an important role in medical research and clinical diagnosis. GB/T42080.2-2022 "Specifications for pre-testing processes of frozen tissues for molecular in vitro diagnostic testing Part 2: Protein separation" is based on the international standard ISO201842:2018, aiming to standardize the operation process of frozen tissues before protein detection to ensure the reliability and consistency of experimental results.

The core goal of this standard is to reduce changes and modifications in the protein spectrum during the pre-test process. By standardizing the collection, transportation, processing and storage of specimens, the original state of the samples can be maintained to the maximum extent, providing high-quality protein samples for subsequent analysis.


2. Comparison of standard frameworks

Standard dimensions GB/T42080.1-2022 (RNA separation) GB/T42080.2-2022 (Protein separation) GB/T42080.3-2022 (DNA separation)
Applicable analytes mRNA Protein DNA
Key steps Total RNA extraction and purification Protein separation and quantification Genomic DNA extraction
Main Challenges RNA degradation, contamination control Protein modification, cold ischemia effect Nucleic acid shearing, extraction efficiency

3. External Laboratory Requirements

Specimen Collection

Specimen collection should select appropriate tissue type and size according to the purpose of the test. The collection information should include the donor's health status, medication history and surgical records.

Isopentane (C5H12) is used for rapid freezing to reduce the risk of protein degradation.

Fresh Tissue Transportation

Use a cooling box or vacuum packaging to maintain the ambient temperature at 2℃~8℃. Record the transportation time and the temperature change around the container.

Reference studies have shown that maintaining 0℃~4℃ conditions can significantly improve protein stability (see Appendix A for examples).


4. Laboratory internal requirements

Specimen processing and freezing

Pathological evaluation should be performed immediately after specimen receipt, and suitable tissue areas should be selected for protein isolation.

Use liquid nitrogen or dry ice to quickly freeze sections to avoid the effects of warm ischemia and cold ischemia on protein spectra.

Protein separation and detection

Proteins should be separated using commercial kits or laboratory-developed procedures. Western blot or Bradford method is recommended for quantitative analysis.

The separated proteins should be tested as soon as possible. If long-term storage is required, it is recommended to be dispensed into cryogenic vials (≤-70℃).


5. Implementation Recommendations

Quality Control

Validate the entire workflow, including specimen collection, freezing, and protein separation steps. Document variables that cannot be fully controlled (e.g., cold ischemia time) and develop risk mitigation measures.

Staff Training

Ensure that operators are familiar with standardized procedures, especially those involving hazardous chemicals such as isopentane.

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