GB/T 40172-2021 in English
VALIDGeneral guidance on detection methods of mammalian cell cross-contamination
- Issued on:2021-05-21
- Implemented on:2021-12-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$243.00
《GB/T 40172-2021哺乳动物细胞交叉污染检测方法通用指南》由TC387(全国生化检测标准化技术委员会)归口,主管部门为国家标准化管理委员会。
Introduction
Interpretation of the core content of the standard
GB/T40172-2021 is my country's first special standard for mammalian cell cross-contamination detection. It systematically standardizes the full chain of technical requirements from detection principles to implementation process. This standard places special emphasis on ensuring the purity of cell culture through a multi-dimensional detection strategy. The main technical highlights include:
- Establishing a two-level detection system between species and within species
- Clarifying the applicable scenarios of 9 types of detection methods
- Specifying the 9 core loci that must be included in STR typing
- Proposing key detection nodes in the early culture stage (first week)
Comparative analysis of detection methods
| Detection methods | Applicable scenarios | Sensitivity | Key technical indicators |
|---|---|---|---|
| STR genotyping | Intra-species contamination | High (1%) | 9 core loci including D13S317 must be tested |
| PCR detection method | Inter-species contamination | High (0.1%) | CYTB/CO1 gene difference analysis |
| Isozyme spectrum | Inter-species contamination | Low (10%) | Four enzyme spectra of G6PD/LDH/MD/NP |
Key points for the implementation of key technologies
STR typing detection specifications
When identifying human cells, a composite amplification system containing 9 STR loci including D13S317, TH01, D5S818 is required, and data analysis is performed according to the ATCC ASN ANSI 0002-2011 standard. A typical example is the identification of HeLa cells, which needs to match the standard STR profile provided by ATCC.
Identification of interspecies contamination
When using chromosome karyotype analysis, please note:
- Human cells are diploid (2n=46)
- Mouse cells have 40 chromosomes (2n=40)
- Aneuploidy needs to be confirmed in combination with STR typing
Laboratory quality management
Key control links
- Staff training: Need to pass the dual-module assessment of cell culture technology and molecular detection technology
- Equipment verification: PCR instrument needs to be calibrated with temperature gradient regularly
- Control setting: Each batch of testing must include positive/negative controls of known origin
Test cycle recommendation
| Cell type | Test frequency |
|---|---|
| Primary cells | Culture day 3 + before freezing |
| Passaged cell lines | Every 3 months or every 10 generations |

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