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GB/T 42076.1-2022: Biotechnology - Cell counting - Part 1: General guidance on cell counting methods
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| GB/T 42076.1-2022 | English | 334 |
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Biotechnology - Cell counting - Part 1: General guidance on cell counting methods
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GB/T 42076.1-2022
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Basic data | Standard ID | GB/T 42076.1-2022 (GB/T42076.1-2022) | | Description (Translated English) | Biotechnology - Cell counting - Part 1: General guidance on cell counting methods | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | A40 | | Classification of International Standard | 07.080 | | Word Count Estimation | 18,190 | | Date of Issue | 2022-12-30 | | Date of Implementation | 2022-12-30 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 42076.1-2022: Biotechnology - Cell counting - Part 1: General guidance on cell counting methods
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 07.080
CCSA40
National Standards of People's Republic of China
Biotechnology Cell Counting
Part 1.General rules for cell counting methods
(ISO 20391-1.2018, IDT)
Posted on 2022-12-30
2022-12-30 implementation
State Administration for Market Regulation
Released by the National Standardization Management Committee
table of contents
Preface I
Introduction II
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 General principles of cell counting4
4.1 Overview 4
4.2 Total Cell Count 4
4.3 Differential counting of cells 4
4.4 Direct cell counting4
4.5 Indirect cell counting4
5 Considerations for Cell Counting 4
5.1 Choice of cell counting method 4
5.2 Considerations for choosing a cell counting method5
5.3 Sampling 5
5.4 Sample preparation for cell counting6
5.4.1 Environmental factors 6
5.4.2 Procedure 6
5.4.3 Reagents and quality stability 6
5.5 Measurement 7
6 Confirmation and verification7
6.1 Instrument qualification 7
6.2 Method validation and validation7
6.3 Reference material 7
6.3.1 Certified reference materials7
6.3.2 Internal standard substance 8
6.3.3 Use of reference materials 8
7 Data processing, analysis and reporting 8
7.1 Data processing and analysis 8
7.1.1 General 8
7.1.2 Image processing and analysis 8
7.1.3 Gate setting 8
7.1.4 Coincidence correction 8
7.2 Report 8
Appendix A (Informative) Common Cell Counting Methods 10
Appendix B (informative) Common cell counting methods for different measurement purposes12
Reference 13
foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules for Standardization Documents"
drafting.
This document is Part 1 of GB/T 42076 "Biotechnology Cell Counting". GB/T 42076 has issued the following parts.
--- Part 1.General rules for cell counting methods.
This document is equivalent to ISO 20391-1.2018 "Cell Counting in Biotechnology Part 1.General Rules for Cell Counting Methods".
Please note that some contents of this document may refer to patents. The issuing agency of this document assumes no responsibility for identifying patents.
This document was proposed and managed by the National Biochemical Testing Standardization Technical Committee (SAC/TC387).
This document was drafted by. China Institute of Testing Technology, West China Stomatological Hospital of Sichuan University, China Institute of Metrology, Innovent Biological
Pharmaceutical (Suzhou) Co., Ltd., Shanghai Institute of Metrology and Testing Technology, Sichuan Stem Cell Technology and Cell Therapy Association, Qingdao Reside Biotech
Technology Co., Ltd., General Biology (Anhui) Co., Ltd., Sichuan New Life Stem Cell Technology Co., Ltd., Shanghai Jiaotong University, Complex
Dan University, Institute of Zoology, Chinese Academy of Sciences, Shenzhen Inspection Group (Shenzhen) Medical Laboratory.
The main drafters of this document. Yang Jiebin, Zhou Lihua, Ye Deping, Tian Weidong, Wang Jing, Tang Xiangkai, Qiao Qian, Wang Dongming, Fu Boqiang, Xiao Weimin,
Ran Dan, Sun Dengfeng, Zhao Tongbiao, Liu Gang, Jiang Zijing, Guo Yanhong, Jiang Zhanyue, Li Yan, Wang Yue, Ma Lixia, Sun Jielin, Duojia, Li Xuelian, Chen Mengmeng,
Yu Mingjun, Fan Chunhai, Qian Feng, Yang Guowu.
Introduction
Cell counting is a fundamental measurement that broadly impacts many aspects of biotechnology, from biomanufacturing to advanced medicine. thin
The number of cells (or number of discrete cells) is usually expressed as the concentration of cells in suspension (ie, the number of cells per unit volume) and the number of cells adhered to a certain surface
Bulk density (that is, the number of cells per unit area). Cell counts are critical in assessing the efficacy and efficacy of cell-based therapies. Bioreactor
The concentration of cells in can be used as an indicator for quality assurance in the cell-based manufacturing process. Many cell-based bioassays require
Normalize the respective cell count results to ensure that the data are comparable to each other.
GB/T 42076 is proposed to be composed of two parts.
--- Part 1.General rules for cell counting methods. Part 1 provides the theoretical basis for Part 2, which aims to provide cell counts
General principles and considerations to be followed.
--- Part 2.Experimental design and statistical analysis to quantify the performance of counting methods. Part 2 is the expansion and specific operation of Part 1
and implementation details.
Biotechnology Cell Counting
Part 1.General rules for cell counting methods
1 Scope
This document defines terms related to cell counting in the field of biotechnology, and describes cell counts (usually cell concentrations) and viscose counts in suspension.
Cell counts attached to the matrix (usually cell area density), providing cell counting methods (including total and differential counts, direct counts
and indirect counting), as well as key considerations for the choice of method and measurement process, specify the guidelines for data processing, analysis, and reporting.
Require.
This document is applicable to the enumeration of all cell types, including mammalian and non-mammalian (e.g. bacteria, yeast) cell counts.
This document is not intended for cell counting in tissue sections or biomaterial matrices.
There are international and national standards related to cell counting in different fields/specific application scenarios. If applicable, the user can operate within its range
Reference to existing standards within the scope (specific measurement technique and/or application scenario).
2 Normative references
This document has no normative references.
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Accuracyaccuracy
The degree of agreement between the measured value of a measurand and its true value.
Note 1."Measurement accuracy" is not a quantitative concept, nor is it a quantitative value. When a measurement gives a smaller measurement error, it indicates that the measurement is more accurate.
Note 2 to entry. "Measurement accuracy" is sometimes understood as giving the degree of agreement between measured values to be measured.
[Source. ISO /IEC Guide 99.2007, 2.13, with modifications]
3.2
Cell mass agglomerate
Two or more cells are faintly clustered together and detected as one larger object.
NOTE. Cell clumps can often be dissociated into individual cells without significant damage to the cells.
3.3
cell aggregate aggregate
Two or more cells come together (closely or loosely) and are detected as larger objects.
NOTE. Cell aggregates are generally more difficult to separate into individual cells.
3.4
area density
The number of adherent cells per unit surface, usually expressed as the number of cells per unit area.
3.5
attribute attribute
Physical, chemical, biological or microbiological properties or characteristics.
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