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Detection of genetically modified organisms and derived products-General requirements and definitions

Basic Information

Standard ID: GB/T 19495.1-2004

Standard Name:Detection of genetically modified organisms and derived products-General requirements and definitions

Chinese Name: 转基因产品检测 通用要求和定义

Standard category:National Standard (GB)

state:in force

Date of Release2004-04-21

Date of Implementation:2004-04-21

standard classification number

Standard ICS number:Food Technology >> 67.050 General methods of food testing and analysis

Standard Classification Number:Agriculture, Forestry>>Agriculture, Forestry Comprehensive>>B04 Basic Standards and General Methods

associated standards

Publication information

other information

Release date:2004-04-21

Review date:2004-10-14

Drafting unit:Shenzhen Entry-Exit Inspection and Quarantine Bureau of the People's Republic of China

Focal point unit:CNCA Certification and Accreditation Administration of China

Publishing department:General Administration of Quality Supervision, Inspection and Quarantine

competent authority:General Administration of Quality Supervision, Inspection and Quarantine

Introduction to standards:

This part of GB/T 19495 specifies the general technical requirements for the detection methods of genetically modified products. This part applies to the detection of genetically modified ingredients in genetically modified animals, plants, microorganisms and their processed products. GB/T 19495.1-2004 General requirements and definitions for the detection of genetically modified products GB/T19495.1-2004 Standard download decompression password: www.bzxz.net
This part of GB/T 19495 specifies the general technical requirements for the detection methods of genetically modified products. This part applies to the detection of genetically modified ingredients in genetically modified animals, plants, microorganisms and their processed products.


Some standard content:

1 Scope
Normative references
Terms, definitions and abbreviations
General requirements for laboratories
5. General requirements for materials, reagents and reference materials 6 General requirements for sampling
General requirements for sample preparation
General requirements for test methods
Expression and judgment of results
Test report
Sample preservation
References
GB/T 19495. 1--2004
GB/T19495 "Detection of genetically modified products" is a series of standards: GB/T 19495. 1-2004
GB/T 19495.2-2004
G/T 19495. 3-2004
GB/T 19495.42004
GB/T 19495.52004
GB/T 1H495, -2004
GB/T 15495. 7- 2004
GB/T 13495. 8--2004
Detection of genetically modified products
Detection of genetically modified products
Detection of genetically modified products
Detection of genetically modified products
Detection of genetically modified products
Detection of genetically modified products
Detection of genetically modified productswww.bzxz.net
This part quotes the contents of ENISO/DIS21276. General requirements and definitions; Laboratory technical requirements; Nucleic acid extraction and chemical methods; Nucleic acid qualitative PCR detection method: Nucleic acid quantitative PCR detection method; Gene chip detection method; Sampling and sample preparation methods; Protein detection method.
This part was proposed by the Certification and Accreditation Administration of the People's Republic of China and is officially approved by the Ministry of Agriculture and Rural Affairs: GR/T 19495. 1--2004
Drafting organizations of this part: Shenzhen Exit-Entry Inspection and Quarantine Bureau of the People's Republic of China, Animal and Plant Quarantine Laboratory of the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Guangzhou Exit-Entry Inspection and Quarantine Bureau of the People's Republic of China, Liaoning Exit-Entry Inspection and Quarantine Bureau of the People's Republic of China, Huisu Exit-Entry Inspection and Quarantine Bureau of the People's Republic of China, Institute of Plant Protection, Chinese Academy of Agricultural Sciences, China Agricultural University. Main drafters of this part: Yang Weidong, Zhu Shuifang, Jin Xianzhong, Zha Zhuming, Wu Jiyun, Qin Wen, Cao Jijuan, Chen Hongjun, Cheng Yinghui, Jiang Yuan, Xia Xifeng, Huang Kunlun
This part is the first national standard to be issued. 1 Scope
General requirements and definitions for detection of genetically modified products This part of GB/11995 specifies the general technical requirements for detection methods of genetically modified products. GB/T 19495.12004
This part applies to the risk detection of genetically modified ingredients in genetically modified animals, plants, particulates and their processed products. 2 Normative references
The clauses in the following documents become the clauses of this part through reference to this part of GB/T 19496. For all dated referenced documents, all subsequent amendments (excluding errors) or revisions are not applicable to this part. However, parties to agreements based on this part are encouraged to study whether the latest versions of these documents can be used. For undated referenced documents, the latest versions shall be used for this part.
GB/T 5682 -1992
GB/T15481
GB/T 19495.2-
GR/T 19495.
GB/T 19495.
Specifications and test methods for water used in analytical laboratories (evTSo3696:787)General requirements for the competence of testing and calibration laboratories200
Technical requirements for testing laboratories of transgenic productsNucleic acid extraction and purification methods for testing genetically modified products2004
2004 Testing of genetically modified products
Sampling and sample preparation methods
Xue Jiankang
ASTME 1342G1997
Preservation of bacteria, fungi, protozoa, viruses, genetic elements and preservation of animals and plants by freezing, freeze drying and low temperature preservation
3 Terms, definitions and abbreviations
The following terms, definitions and abbreviations apply to GB/TS
3.1 General terms
Species classification tt
This part of GB/TS 9495
The category to which genetically modified organisms belong, usually with species as the classification unit, but also with higher or lower classification units. 3.1.2
Laboratory sample
A certain number of samples obtained by mixing and reducing the original samples. Prepare the test samples and store the samples. 3.1.3
Test sample: test sample obtained by further homogenization of all or part of the laboratory sample for analysis or testing. 3.1.4
Sensitivity
The change in the result divided by the corresponding concentration standard curve is the analytical calibration curve. 3.1.5
Limit of detection
The limit of detection of a qualitative method refers to the lowest concentration or amount of the substance being tested that can be reliably detected. However, it is not necessary to conduct quantitative analysis and has been demonstrated by collaborative experiments or confirmed by a single laboratory. GB/T 19495. 1--2004
Limit of quantitative detection
Limit of quantitative detection
The limit of quantitative analysis process refers to the lowest amount or concentration of the sample being tested that can be detected at an appropriate level of precision and is based on ISO 5725 clauses [2] or [3]. It has been demonstrated by collaborative experiments or confirmed by a single laboratory. 3.1.7
Accuracy
The consistency between the test result and the recognized reference value. 3.1.8
Trueness
The consistency between the average value of a large number of experimental results and the recognized reference value. Note: The measurement standard of truthfulness (credibility) is usually expressed as a slope. Reliability is the correctness of the mean value mentioned. 3. 1.9
precision
the consistency between independent test results obtained under certain conditions. 3. 1. 10
repeatability
reproducibility
precision under repeated (reproducible; repeatable; accurate under repeated) conditions. 3. 1. 11
repeatability conditions
conditions under which unique test results are obtained by the same operator in the same laboratory at a short interval of time: using the same instruments, methods, execution and test items. 3. 1. 12
reproducihility conditions
Reproducibility conditions
The conditions under which different operators in different laboratories use different instruments and equipment to complete and obtain test results using the same method.
Repeatability standard deviation
repeatability standard deviationReproducibility standard deviation
reproducibility standard deviationThe standard deviation of the test results obtained under repeatability (reproducibility) conditions. Note: Repeatability (reproducibility) standard deviation is the limit standard of the dispersion of the test results obtained under repeatability (reproducibility) conditions. Similarly, "repeatability (reproducibility) variation\or\repeatability (reproducibility) coefficient of variation\can be defined or used" to measure the dispersion of the test results obtained under repeatability (reproducibility) conditions. 3. 1.14
repeatability limit
repeatability reprodueibility limit The value less than or equal to the absolute difference between two test results obtained under repeatability conditions can be considered as a probability.
Repeatability limit
When checking two independent test results obtained under repeatability conditions, compare to the repeatability threshold [R] -2. 8S, [57.
E collaborative trial or interlaboratory study A collaborative trial or interlaboratory study is a quantitative test performed on one or more stable, homogeneous raw materials in a documented manner. The guidelines for collaborative trials are described in detail in ISO 5725 and the ISO/AOAC/IUPAC draft protocol.
Fitness for purpose Applicability The range of matrix, analyte or species for which a method is suitable. The range of concentrations and types of study/monitoring for which it is suitable is determined by its performance characteristics. This is also referred to as the limitations of the method. 3.1.17 Practicality The simplicity of operation, the amount of sample and the cost required to achieve a specific performance standard necessary to meet the specified purpose. 3.1. 18
Applicability range
Quantification range linearity
Dynamic range dynamic range
Accuracy experiments demonstrate that the measurement intervals within the analytical process have an appropriate level of precision and accuracy. 3. 1. 19
Measurement uncertainty measurement uncertainty The parameter associated with a certain measurement result that can reasonably represent the distribution characteristics of the analytical results. 3.2 DNA extraction and purification terms
DNA and RNA extraction
DNA and RNA exiraclion
Separation of DNA and RNA from various components of the test sample 3.2.2
DNA purificationDNApurification
A method to obtain DNA of higher purity. In this context, purity refers to the reduction of the effects of observable or measurable PCR inhibitors.
PCR quality control DNA PCR quality DNAPCR grade DNA, that is, DNA template that can be used for PCR amplification. 3.3 Related terms for detection methods
polymerase chain reactionpolymerase chain reaction Template DNA is denatured into single strands by high temperature. Under the presence of DNA synthase and appropriate temperature, two primers anneal with complementary sequences on the two strands of template DNA respectively. Then, under the catalysis of A polymerase, tetradipamide is used as substrate to anneal the primers. This cycle of denaturation, annealing and IDNA synthesis is repeated. The DNA fragment between the two sequences is amplified geometrically.
Multiple PCR multiplex PCR
In the same tube PCR reaction system, there are more than two pairs of PCR primers, which can amplify multiple products at the same time: 3.3.3
gene-chip
DNA chip refers to a large number of specific nucleotide fragments or gene fragments arranged in an orderly and high-density manner and fixed on a carrier3
GB/T 19495. 1-2004
. The nucleic acid molecules of the test sample are labeled and hybridized with the DNA array fixed on the carrier at the same time according to the base pairing principle, and the chip is returned by the laser confocal fluorescence detection system. The hybridization signal intensity is analyzed by computer software to obtain the number and sequence information of the sample. Enzyme-linked immunosorbent assay enzyme-linked immunosorbent assay is a comprehensive technology that uses enzymes as markers or indicators for qualitative and quantitative determination of antigens or photons. 3.3.5
Identification of nucleic acid sequence Through hybridization, enzyme digestion and nucleic acid sequence determination, the sequence of the amplified fragment of the test sample is compared and identified with the reference nucleic acid fragment and/or sequence.
Screening
A method that can quickly and reliably remove (screen a large number of resistant (or positive) samples, requiring the use of strict methods to limit the number of samples to be tested.
The screening methods in this section refer to methods for detecting the same gene components of two genetically modified organisms. For example, methods for using PCR amplification to detect promoters, terminators or other controlled genetic components. 3.3.7
Junction region
The nucleic acid sequence that determines the junction between two consecutive sequences. For example, the junction region between a promoter and a gene! 3.3.8
Integration-boundary region
ategration-bond
The region near the insertion site of the exogenous gene. Including partial sequences of the exogenous gene and partial sequences of the target organism's gene. 3.3.9
Species-specific target sequence
Species-endogenous target sequence
Taxon specific larget sequencetaxon endogenous larget sequence can be used to specifically identify known sequences of a species, that is, sequences that always exist in this species and do not exist in other species. There are two types of species-specific sequences:
Sequences with variable numbers (and/or) multiple copies, which can be used to evaluate whether the nucleic acid of the species is sold in low-copy and/or single-linked sequences, and as reference sequences for the species base group for quantitative analysis. 3.3.10
Pre-processing process forward flow
Principles of operation of materials and (or) samples, used to ensure that laboratory samples, raw materials and processed test samples including DNA amplification maintain a natural separation state during the entire experimental process. 3.4 Terms about controls
Positive target DNA control positive DNA target control reference DNA or DNA extracted from traceable standard materials or DNA extracted from positive samples (or organisms) containing known short sequences. This control is used to prove that the analysis results of the sample contain the target sequence. 3.4.2
Negative target DNA control negative DNA target control DNA fragments that do not contain exogenous target nucleic acid sequences. Traceable negative standard substances can be used. 4
PCR inhibition control PCR inhibition control GB/T 19495.12004
This control adds a known amount of positive DNA template to the same reaction containing an equal amount of test sample DNA. Note: This control can detect whether there is a PCR inhibitor that is chromatographically active. It is necessary to perform a quantitative PCR in the case of a negative PCR amplification result. 3. 4.4
Amplification reagent control This control includes all the reaction reagents except the test sample DNA template. In the PCR reaction system, the template DNA is replaced by an alternate volume of water (without nucleic acid).
Extraction blank control This control is to complete all the steps of the extraction process with water instead of the test sample during the DNA extraction process to prove that there is no nucleic acid contamination during the extraction process.
When using DNA extracted from different batches and performing multiple PER analyses, the extraction blank control should also be included when doing the test sample PCR.
Positive extraction control
Extraction blank control
Extract DNA from a sample containing a known and labeled nucleic acid at the same time as the test sample to prove that the labeled nucleic acid is extracted by the same extraction method.
Environmental controlenvironnent control
Used to determine if the laboratory air is not contaminated by nucleic acids in a PCR control. This control is a volume of water without nucleic acids placed in a tube and is not exposed to air during the sample testing process, from mixing to amplification. 3.5 Terms related to standard material
Standard material
A raw material or substance, a true
test material.
ematerial
One or more properties of the same material are very similar and can be used to calibrate equipment, evaluate experimental methods or assess tests. Certified reference material can be traced back to the source (a certified standard material. One or more of its properties have been proven by an effective technical procedure and have a certificate or can be traced to the source or have other documents issued by a certified organization. 3.6 Terms related to quantification
Endogenous geneentlogenous gene
housekeeping genehousekeeping gene
Endogenous reference geneendogenous reference genereferencegenereferenccgene
A gene with a constant number of genes in cultivated species and no allele changes. This gene can be used for quantitative analysis of a gene in a certain month in the genome.
4 General requirements for laboratories
The genetically modified ingredient testing laboratory should comply with the provisions of GB/T15481 and (GB/T19495.2-20C4. The genetically modified product testing laboratory should participate in the horizontal test organized by the laboratory accreditation authority and pass the test results. It should also be authorized by the national laboratory accreditation authority to enjoy the qualification of testing genetically modified ingredients in animals, plants, microorganisms and their processed products. 5
GR/T19495.1—2C04
5 General requirements for materials, reagents and reference materials: The primers used should be of PCR grade and (or) IIPLC: grade, and the probes should be of IIPLC grade; During the analysis process, only analytically pure or purified reagents free of DNA and 13NA should be used in all experiments; The water used should meet the requirements of grade 1 water (13668-1992); The quality of key reagent components should be measured before use; The prepared solutions should be stored by autoclaving, and the name of the reagent, concentration, preparation time, storage conditions, expiration date and name of the preparer should be indicated on the container; Reagents that require autoclaving should be sterilized using a filtration device (pore diameter 0.22un); Bacteria should be checked for new products in the kit. Arrival period: Storage conditions: ICR reagents should be stored in a safe place to reduce contamination: Materials, containers and reagents should be protected against contamination: The storage and preservation of seeds and plasmids should comply with the provisions of SME1342-1997. The standard materials used should be prepared by a recognized institution, with certification and traceability, or with other documents issued by the certification body.
6 Sampling application requirements
The sampling method should be based on the corresponding national standards or international standards. The number of samples and the laboratory sample quantity should be based on the state and characteristics of the sample. The provisions of GB/T19195.7-2004 are adopted. General requirements for sample preparation
After receiving the sample in the laboratory, the laboratory shall confirm it. Check the sample report, verify the sample identification, and after confirming that there is no identification, proceed to the preparation of visual test products.
Mix the laboratory samples, take half as the retained sample, and use the other half for the following tests: The test sample preparation should be carried out in accordance with the provisions of GB/T1949.22001. The preparation method of the test sample should be based on the status and characteristics of the product. GB/T19499.3 and GB/T29495.7 methods should be used. 8 General requirements for test methods
The test method should be the most suitable for the customer, including the use of national standards or international standards. The test space should ensure that the latest and valid versions of international standards are used. When the method used is not specified in the "rate", the laboratory should choose a method that has been issued in an international standard or a national standard, a method developed by the laboratory, or other methods selected by the laboratory. They must be effectively verified before they can be used. Nucleic acid-based detection methods
Nucleic acid direct detection methods are applicable to the detection of foreign nucleic acid fragments introduced. 8.1.1 Extraction of nucleic acid from genetically modified products
The nucleic acid of the test product shall be extracted using the corresponding methods in this series of standards GB/T1S4195.3-2004. DNA extraction must be fully free of inhibitory factors. Protein, polysaccharide, fat, cellulose and DNA extraction reagents for PCR reaction: including EDTA, trioxane, isobutyl alcohol, sodium acetate, isoamyl alcohol, 7.5-ethanol, etc. The extracted DNA must be an excellent DNA template that can meet the requirements of downstream analysis.
Two extraction parallel samples must be set for each laboratory sample. Each time the nucleic acid is extracted from the test sample, an extraction blank control (water replaces the sample) must be set. If more than 19 samples are extracted, a protective control must be added regularly. The control must be done regularly or when a new batch of extraction reagents is used. To show whether the reagent is effective or whether there is an error in the extraction step. Environmental controls must also be set up throughout the experiment. 8.1.2 Qualitative PCR detection method
Qualitative PCR detection methods include conventional PCR, real fluorescence PCR and gene chip detection. The objects of qualitative detection include transgenic promoters, terminators, test screening transgenes, target genes and other exogenous genes: positive marker D-A control, negative marker LA control, rodenticide blank control and extraction blank control should be set up during detection. If necessary, CR inhibitor control must also be set up; endogenous genes of the species should be tested later. Therefore, the specificity of the qualitative method must be proved by effective experiments, and the qualitative error rate should be less than 35%. GB/T 19495. 1-2004
The detection limit of the qualitative method should meet the minimum content level of the substance, that is, at least 95% sensitivity (the quantitative error rate is less than or equal to 5%). The actual detection limit refers to the minimum content of the target DNA that can be detected. It is related to the test sample, the quality and (or) quantity of the template DNA and the absolute limit of the method.
8. 1. 3 Quantitative PCR Detection Method
The quantitative PCR detection method for transgenic genotypes should select one of the exogenous genes according to the situation and use the transgenic positive marker substance or positive standard molecule specified in the detection standard. Positive DNA control, negative DNA control, reagent blank control and extraction blank control should be set up during the detection. If necessary, PR inhibition control must also be set up. The detection limit of the quantitative method should meet the lowest content level of the analyte, that is, its RSLD, which is 25% or less. The actual detection limit of the quantitative method refers to the lowest amount of target DNA that can be reliably quantified: it is related to the test sample, the quality and (or) quantity of template DNA and the absolute limit of the method.
8.2 Protein-based detection method
The protein detection method is to detect the expression of transgenic exogenous genes, suitable antigenicity and undamaged transgenic products. The detection methods mainly include immunological methods and chemical analysis methods, and protein detection kits that meet national standards can be used. 9 Expression and judgment of results
9. 1 General requirements
Test results should not be expressed as "+" or "-". 9.2 Relationship between various control results and test results The PCR results of various controls are shown in Table 1. Table 1 can be used to analyze and report the test results of test samples. Table 1 Relationship between various control PCR test results and test result judgment Test sample
Positive last section control
. The expansion tower's slice marker section can be detected.
City, no increased marker fragments
Extraction of negative marker DNA and positive marker DNA control
Starting from the temperature range of nucleic acid re-test (may be contaminated) should choose to change the nucleic acid extraction method or reduce the extraction of nucleic acid to pure (may be inhibitory) 9. 3 Expression of negative results
Negative results cannot be expressed as "o" or "no GMO components (GMO not present)"
The test report of negative results should indicate "For the species, no GMO components were detected" and indicate the detection limit LOD of the detection method
9. 4 Expression of positive results
The test report of positive results should indicate "For the species, GMO components were detected". If possible, it can also include the confirmation of GMO components. 9.5 Statement of uncertain results
After repeated testing starting from nuclear extraction for more than two times, if the test results are suspicious or uncertain (negative results and positive results appear), and the reproducibility is poor, the test results of the blank sample in the experiment can be stated in the test report as negative, and the detection limits of the quantitative and qualitative detection methods can be indicated.
GB/T 19495. 12004
9.6 Test quality assurance
Test results should come from two test samples of the same laboratory blank. When the result of one test sample is positive and the result of the other test sample is negative, the test should be repeated. The amount of DNA template in the PCR reaction system can be increased to make the two samples get the same result. In addition, the quality of the plate LDNA needs to be tested. 10 Test report
After the sample is tested, the laboratory blank should make detailed experimental records according to the specific operating procedures and results of the experiment and issue a test report. The test report should at least include the following:
Description, status and clear identification of the laboratory sample; test basis;
Sampling method and schedule
|Date of sample collection:
Storage conditions;
Test start and end dates;
Test person in charge
Amount of laboratory samples and test samples:
Results obtained by specific methods, units used for results and calculation methods: Special circumstances observed during the test process;
Deviations, additions or modifications to the test party, Contents to be reported in a series of standards, 11 Sample preservation
Samples for inspection should be preserved in the appropriate manner depending on the state of the sample, and should be preserved for 5 months. If the sample is found to contain genetically modified ingredients, the sample preservation period is 1 year for re-inspection, negotiation and arbitration. After the expiration of the preservation period, it must be decontaminated, 8
References
GR/T 19495.i—20C4
[l] Codex Aliuensarius Commisaioa. X/MAS ol/A)_2] Codex Cominittec on Methods of Analysis and Sanplir: In Hsuse rieuhed vlidatien. lnHonsr: validatee: nethoes and thnirroic in mcuds of anelvsis for cdex puraoses. CocexAurntnierius Commission, ((x/MAS 9a/8), 109s, [ndapes:: Ilungary, 23 27Nuverrber1ss
Horwilz W. : Praiocol lor ihe design, r:onduct and i:ulerprelulior: of ne'sod perfertneurceL3
studies.Pure anid Appliel Chernistry,1993.67:33t-343AT Inhorir, SL : \Quelity Assu\ance Prs elies For fleaith Laborslories\ APHA, Washi-igtonlDC1973, p588
5-[ttp://euracenenm.han,de/guides/rival.am,IS13N -94a926-12-0[6] Thorupsor, M., Ellison. va.idalior of nthods o. anelysis. Terhricel reporl a' ihe Inlerrational Lnior n: Puretnd Applied Chemis.ry Sympusrun nn Hamonisatior. ef Quality Assurance Systems for Analytical Leboraturies. 1999, Budapest flurgary: 5 Noven-ucr i999i7l Arumuganathan K, and Earle E, D. : Nuciear content of soine iniportent planl species.Plnrt Mol. Biol. Rep, 1991, 9(3): 208-218The amount of DNA template in the PCR reaction system can be increased to make the two samples get the same results. In addition, the quality of the DNA in the plate needs to be tested. 10 Test report
After the sample is tested, the laboratory should make detailed experimental records according to the specific operating procedures and results of the experiment and issue a test report. The test report should at least contain the following contents:
Description, status and clear identification of laboratory samples; test basis;
Sampling method and date
Date of sample collection:
Storage conditions;
Start and end date of the test;
Test person in charge
Amount of laboratory samples and test samples:
Results obtained by specific methods, units used for results and calculation methods: Special circumstances observed during the test process;
Deviations, additions or adjustments to the test method, which need to be reported in the series of standards. 11 Sample preservation
Samples for inspection should be preserved in the corresponding way according to the status of the samples, and should be preserved for 5 months. If the sample is found to contain genetically modified ingredients, the sample shall be kept for one year for re-testing, negotiation and arbitration. After the expiration of the storage period, it shall be rendered harmless. 8
References
GR/T 19495.i—20C4
[l] Codex Aliuensarius Commisaioa. Proeedu:al Marua, Tweifth Edition fuy \Prineiples fo?-hc Lstablish-nen: s Corlex Meihoe:s ol Aualysis\: 2tnl. 3. 6-i ff. : \Guide.ines on the Ap-p.icazion af the Criteria Approach\(CX/MAS ol/A)_2] Codex Cominittec on Methods of Analysis and Sanplir: In Hsuse rieuhed vlidatien. lnHonsr: validatee: nethoes and thnir roic in mcuds of anelvsis for cdex puraoses. CocexAurntnierius Commission, ((x/MAS 9a/8), 109s, [ndapes:: Ilungary, 23 27Nuverrber1ss
Horwilz W. : Praiocol lor ihe design, r:onduct and i:ulerprelulior: of ne'sod perfertneurceL3|| tt | -94a926-12-0[6] Thorupsor, M., Ellison. S. -. , Hic. Weod: R. : Harnorised guide'tanes for single -shora.ory va.idalior of nthods o. anelysis. tical Leboraturies. 1999, Budapest flurgary: 5 Noven-ucr i999i7l Arumuganathan K, and Earle E, D. : Nuciear content of soine iniportent planl species.Plnrt Mol. Biol. Rep, 1991, 9(3): 208-218The amount of DNA template in the PCR reaction system can be increased to make the two samples get the same results. In addition, the quality of the DNA in the plate needs to be tested. 10 Test report
After the sample is tested, the laboratory should make detailed experimental records according to the specific operating procedures and results of the experiment and issue a test report. The test report should at least contain the following contents:
Description, status and clear identification of laboratory samples; test basis;
Sampling method and date
Date of sample collection:
Storage conditions;
Start and end date of the test;
Test person in charge
Amount of laboratory samples and test samples:
Results obtained by specific methods, units used for results and calculation methods: Special circumstances observed during the test process;
Deviations, additions or adjustments to the test method, which need to be reported in the series of standards. 11 Sample preservation
Samples for inspection should be preserved in the corresponding way according to the status of the samples, and should be preserved for 5 months. If the sample is found to contain genetically modified ingredients, the sample shall be kept for one year for re-testing, negotiation and arbitration. After the expiration of the storage period, it shall be rendered harmless. 8
References
GR/T 19495.i—20C4
[l] Codex Aliuensarius Commisaioa. Proeedu:al Marua, Tweifth Edition fuy \Prineiples fo?-hc Lstablish-nen: s Corlex Meihoe:s ol Aualysis\: 2tnl. 3. 6-i ff. : \Guide.ines on the Ap-p.icazion af the Criteria Approach\(CX/MAS ol/A)_2] Codex Cominittec on Methods of Analysis and Sanplir: In Hsuse rieuhed vlidatien. lnHonsr: validatee: nethoes and thnir roic in mcuds of anelvsis for cdex puraoses. CocexAurntnierius Commission, ((x/MAS 9a/8), 109s, [ndapes:: Ilungary, 23 27Nuverrber1ss
Horwilz W. : Praiocol lor ihe design, r:onduct and i:ulerprelulior: of ne'sod perfertneurceL3|| tt | -94a926-12-0[6] Thorupsor, M., Ellison. S. -. , Hic. Weod: R. : Harnorised guide'tanes for single -shora.ory va.idalior of nthods o. anelysis. tical Leboraturies. 1999, Budapest flurgary: 5 Noven-ucr i999i7l Arumuganathan K, and Earle E, D. : Nuciear content of soine iniportent planl species.Plnrt Mol. Biol. Rep, 1991, 9(3): 208-218ry Sympusrun nn Hamonisatior. ef Quality Assurance Systems for Analytical Leboraturies. 1999, Budapest flugary: 5 Noven-ucr i999i7l Arumuganathan K, and Earle E, D. : Nuciear content of soine iniportent planl species. Plnrt Mol. Biol. Rep, 1991, 9 (3): 208-218ry Sympusrun nn Hamonisatior. ef Quality Assurance Systems for Analytical Leboraturies. 1999, Budapest flugary: 5 Noven-ucr i999i7l Arumuganathan K, and Earle E, D. : Nuciear content of soine iniportent planl species. Plnrt Mol. Biol. Rep, 1991, 9 (3): 208-218
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