GB/T 39730-2020 in English
VALIDGeneral requirements for cell counting—Flow cytometry
- Issued on:2020-12-14
- Implemented on:2021-07-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
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《GB/T 39730-2020细胞计数通用要求 流式细胞测定法》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
Standard Overview and Technical Background
GB/T39730-2020, as my country's first national standard specifically for flow cytometry technology, was issued in December 2020 and officially implemented in July 2021. The standard was formulated by the China Institute of Metrology and filled the gap in my country's standardization of cell counting methods.
Definition of core terms
| Terms | Key points of definition | Traceability standards |
|---|---|---|
| Cell counting | Measurement process of cell number | ISO20391-1:2018 |
| Certified reference materials | Characteristic quantity values with uncertainty and traceability | JJF1001-2018 |
| Measurement precision | The degree of consistency of repeated measurement results | JJF1001-2018 |
Detailed explanation of the principle of the method
The standard specifies two core methods:
- Counting standard microsphere method: Calculate the concentration by detecting the ratio of target cells to microspheres through flow cytometer
- Volume method: Directly measure the number of cells in a known volume
Key technical parameter requirements:
- Cell signal collection volume ≥ 10,000
- Microsphere collection volume ≥ 1,000
- Voltage adjustment needs to make the signal located in the middle of the scatter plot
Instrument and equipment specifications
The standard puts forward clear requirements for flow cytometer:
Case study: A laboratory used an uncalibrated micropipette which resulted in a 15% deviation in cell concentration determination. After regular calibration according to standard requirements, the deviation was reduced to less than 3%.
Implementation Suggestions
Key Points for Quality Control
- Establish a daily startup calibration system
- Perform method performance verification (precision, accuracy, etc.) on a regular basis
- Implement standardized training for operators
Solutions to Common Problems
| Problem phenomenon | Possible cause | Solution measures |
|---|---|---|
| Cell aggregation | Vortex speed is too high | Adjust to ≤3000r/min |
| Fluorescence signal offset | Improper voltage setting | Adjust according to standard Figure 2 |

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