YY/T 1717-2020_English: PDF (YY/T1717-2020)
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Nucleic acid extraction kit(magnetic beads method)
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YY/T 1717-2020
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Standard ID | YY/T 1717-2020 (YY/T1717-2020) | Description (Translated English) | Nucleic acid extraction kit(magnetic beads method) | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | Classification of Chinese Standard | C44 | Classification of International Standard | 11.040 | Word Count Estimation | 7,760 | Date of Issue | 2020 | Date of Implementation | 2021-04-01 | Summary | This standard specifies the terms and definitions, classification, technical requirements, test methods, identification, labels and instructions for use, packaging, transportation and storage of nucleic acid extraction kits (magnetic beads method) (hereinafter referred to as "kits"). This standard applies to the extraction and purification of human genomic nucleic acids from various clinical samples such as serum, plasma, whole blood, cerebrospinal fluid, milk, saliva, urine, sputum, swab, tissue or paraffin-embedded tissue by magnetic bead method. Its fragments, kits for pathogen nucleic acids. Pathogen nucleic acid includes deoxyribonucleic acid (DNA), ribonucleic acid (RNA), etc. This standard does not apply to nucleic acid extraction reagents contained in closed systems where the nucleic acid extraction product cannot be taken out for detection. |
YY/T 1717-2020
Nucleic acid extraction kit(magnetic beads method)
ICS 11.040
C44
People's Republic of China Pharmaceutical Industry Standard
Nucleic acid extraction kit (magnetic bead method)
2020-03-31 released
Implementation on 2021-04-01
Issued by the State Drug Administration
Preface
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that certain contents of this document may involve patents. Publication of this document
The agency is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
Drafting organizations of this standard. Xi'an Tianlong Technology Co., Ltd., Anhui Provincial Hospital, Beijing Medical Device Inspection Institute, China Food and Drug Inspection
Research Institute, Guangzhou Darui Biotechnology Co., Ltd., Hunan Shengxiang Biotechnology Co., Ltd., Shanghai Fosun Long March Medical Science
Co., Ltd., Shanghai Kehua Biological Engineering Co., Ltd., Suzhou Beaver Biomedical Engineering Co., Ltd.
The main drafters of this standard. Peng Niancai, Shen Zuojun, Wang Ruixia, Liu Donglai, Liang Zhikun, Deng Zhongping, Xia Yi, Fang Qin, Ren Hui, Li Hongdong.
Nucleic acid extraction kit (magnetic bead method)
1 Scope
This standard specifies the terms and definitions, classification, technical requirements, and tests of nucleic acid extraction kits (magnetic bead method) (hereinafter referred to as "kits")
Method, identification, label and instruction manual, packaging, transportation and storage, etc.
This standard is applicable to the use of magnetic bead method from serum, plasma, whole blood, cerebrospinal fluid, breast milk, saliva, urine, sputum, swab, tissue or paraffin pack
A kit for extracting and purifying human genome nucleic acid and its fragments, pathogen nucleic acid from various clinical samples such as buried tissue. Pathogen nucleic acid contains
Deoxyribonucleic acid (DNA), ribonucleic acid (RNA), etc.
This standard does not apply to nucleic acid extraction reagents contained in a closed system where the nucleic acid extraction product cannot be taken out for testing.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2.Professional in vitro diagnostic reagents
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Nucleic Acid
A class of biological macromolecules connected by nucleotides or deoxynucleotides through 3',5'-phosphodiester bonds, which have very important biological
The function is mainly to store and transmit genetic information, including ribonucleic acid (RNA) and deoxyribonucleic acid (DNA).
3.2
Magnetic beads
The surface of superparamagnetic nanoparticles has been improved and modified to make it bind with nucleic acid molecules specifically and efficiently under different conditions.
Combining and dissociating, such superparamagnetic nanoparticles are called magnetic beads. Using this feature of magnetic beads, under the action of an external magnetic field,
Separation and purification of nucleic acid DNA and RNA from the sample.
3.3
Extraction yield
A nucleic acid extraction kit (magnetic bead method) is used to extract the total amount of nucleic acid from a biological sample of a certain mass or volume.
3.4
Nucleic acid purity
The amount of nucleic acid relative to other impurities in the product extracted from a certain amount of biological sample with a nucleic acid extraction kit (magnetic bead method).
3.5
Precision
Under specified conditions, repeat measurements on the same or similar measured objects to obtain the measured values or the degree of agreement between the measured values.
Note 1.Measurement precision is usually represented by imprecision in numbers, such as standard deviation, variance and coefficient of variation under specified measurement conditions.
Note 2.Prescribed conditions such as measurement repeatability conditions, measurement intermediate precision conditions or measurement reproducibility conditions.
Note 3.Measurement precision is used to define measurement repeatability, intermediate measurement precision and measurement reproducibility.
Note 4.Repeated measurement refers to the results obtained on the same or similar samples in a way that is not affected by previous results.
[GB/T 29791.1-2013, A.3 Supplementary Statistics and Analysis Terms]
4 categories
4.1 Classification by extraction target type
According to the different types of extraction targets, it can be divided into human genomic DNA extraction kits, pathogen nucleic acid extraction kits and other nuclear
There are three types of acid extraction kits; pathogen nucleic acid extraction kits can be divided into bacterial nucleic acid extraction kits and virus nucleic acid extraction reagents
Boxes etc.
Note. Other types of nucleic acid extraction kits refer to multi-purpose kits that can extract both human genomic DNA and pathogen nucleic acid.
4.2 Classification by extraction target nucleic acid type
According to different types of extraction target nucleic acid, it can be divided into deoxyribonucleic acid (DNA) extraction kit and ribonucleic acid (RNA) extraction kit.
5 Technical requirements
5.1 Appearance
The appearance should meet the following conditions.
a) The kit should meet the appearance requirements specified by the manufacturer;
b) The kit should have complete components, clean packaging, no leakage, and no damage; signs and labels should be clearly written.
5.2 Quantity
The amount of liquid reagents should not be less than the value indicated on the label.
5.3 Extraction yield
The extraction yield of the kit should meet the extraction yield requirements specified by the manufacturer. The manufacturer shall stipulate the detection method for the extracted output. mention
The yield should be described for a certain amount of samples. The certain amount of samples referred to here should be classified and expressed for different types of kits, such as liquids.
Sample application volume representation, tissue and other solid samples application quality representation, dried blood slice sample application area size expression, paraffin slice sample should be
Use the slice thickness and the cell area to express together.
5.4 Nucleic acid purity
The purity of the nucleic acid extracted by the kit should meet the nucleic acid purity requirements specified by the manufacturer. Manufacturers should stipulate nucleic acid purity testing
method.
5.5 Extraction efficiency
The extraction efficiency of the kit should meet the extraction efficiency requirements specified by the manufacturer. Manufacturers should specify extraction efficiency testing
method.
5.6 Intra-run precision
The precision within the batch should be classified according to the following different categories.
a) Human genomic DNA (except serum or plasma free kit) extraction kit. use the kit to extract the company's self-calibration
For the reference product, the repeatability error CV of the concentration value should not be greater than 15%;
b) Pathogen type nucleic acid extraction kit and serum or plasma free DNA extraction kit. use the kit to extract the company's own label
The Ct value is obtained by using the fluorescence PCR reagent specified by the company to amplify the extract for the specified reference product, and the repeatability error CV is not large
Less than 5%;
c) Other kits. the intra-assay precision of other kits that cannot be classified into the above two categories or whose concentration and Ct values cannot be obtained
Meet the requirements of intra-run precision specified by the manufacturer. The manufacturer shall specify the testing method for the precision within the batch.
6 Test method
6.1 Appearance
Under natural light, visually inspect the appearance with normal vision or corrected vision, and the result should meet the requirements of 5.1.
6.2 Quantity
Use a universal measuring tool corresponding to the amount of liquid to measure, and the result should meet the requirements of 5.2.
6.3 Extraction yield
Use the kit to extract a certain amount of reference products calibrated by the company, and test the extraction yield according to the detection method specified by the company, and the results should match
Meet the requirements of 5.3.
6.4 Nucleic acid purity
Use the kit to extract a certain amount of reference materials calibrated by the company, and detect the purity of the extracted nucleic acid according to the detection method specified by the company.
The results should meet the requirements of 5.4.
6.5 Extraction efficiency
Use the kit to extract a certain amount of reference products calibrated by the company, and test the extraction efficiency according to the detection method specified by the company, and the results should match
Meet the requirements of 5.5.
6.6 Intra-run precision
The intra-assay precision should be tested according to the following different categories.
a) Human genomic DNA (except serum or plasma free kit) extraction kit. use the kit to compare the same
The company’s self-calibrated reference product was subjected to nucleic acid extraction, a total of 10 times, and the concentration value was measured with an ultraviolet spectrophotometer. According to the data
Calculate the repeatability error CV value, and the result should meet the requirements of 5.6a);
b) Pathogen-based nucleic acid extraction kit and serum or plasma free DNA extraction kit. use pathogen-based nucleic acid extraction reagents
The kit and serum or plasma free DNA extraction kit are used to extract nucleic acid from the reference products calibrated by the same company according to the instructions.
Take, a total of 10 times, use the same fluorescent PCR instrument and the fluorescent PCR reagent designated by the company to amplify the detection extract, and detect
Ct value, calculate the repeatability error CV value based on the data, and the result should meet the requirements of 5.6b);
c) Other types of kits. use the kit to extract a certain amount of reference materials calibrated by the company, and test in accordance with the detection method specified by the company
The precision within the batch should meet the requirements of 5.6c).
7 Logo, label and instruction manual
Should meet the requirements of GB/T 29791.2.
8 Packaging, transportation and storage
8.1 Packaging
The kit should be packaged as required by the manufacturer.
8.2 Transportation
The kit should be transported as required by the manufacturer.
8.3 Storage
The kit should be stored as required by the manufacturer.
references
[1] GB/T 29791.1-2013 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 1.Terminology, definitions
Yihe General Requirements (ISO 118113-1.2009, IDT)
[2] YY/T 0316-2016 Application of medical device risk management to medical devices (ISO 14971.2007, IDT)
[3] YY 0466.1-2016 Medical devices are used for medical device labeling, marking and providing information symbols. Part 1.General
Application requirements (ISO 15223-1.2012, IDT)
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