转基因定量检测量值转换系数的研究进展

doi:10.3969/j.issn.1000-1158.2024.06.19

摘要
图/表
参考文献(46)
相关文章 (15)

全文: PDF (457 KB) HTML (1 KB)
输出: BibTeX | EndNote (RIS)

摘要基于PCR技术测定的转基因成分定量结果主要是拷贝数比值,而“产品标识”规定检测结果必须以质量分数表示。量值单位的不统一,造成无法根据检测结果直接进行标识与否的判定。因此亟须研究转基因含量2种单位间的量值关系,建立实现量值转换的“转换系数”定值方法,从而保障检测结果与标识阈值的直接可比。通过对国际转基因“产品标识”制度进行总结,系统分析了影响“转换系数”量值的关键因素和欧盟建立的定值方法,并就我国开展相关研究的重要性进行了论述,为我国转基因“产品标识”制度的有效执行提供参考。

	服务

	把本文推荐给朋友
	加入我的书架
	加入引用管理器
	E-mail Alert
	RSS
	作者相关文章
	刘圆圆
	李佳丽
	吉帅帅
	高运华
	刘旦梅
	王迪

关键词 ：生物计量, 转基因产品, 标准物质, 转换系数, 数字PCR, 产品标识制度

Abstract：The quantitative results of GM content determined by PCR-based technology are mainly copy number ratio, whereas the labeling regulation specified that the quantitative result must be expressed in the form of a mass fraction. The lack of consistency in measurement unit hinders direct decision-making based on test results. It is urgent to investigate the quantity value relationship between the two measurement scales, and establish a methodology for determining the “conversion factor” value, thus ensuring the direct comparison between quantitative results and labeling threshold. The international labeling systems of genetically modified product are summarized, key affect factors for determining the “conversion factor” and characterization method established by the European Union are systematically analyzed, and the importance of conducting the relevant study in China is also discussed. This review can provide reference for the effective implementation of the labeling system in China.

Key words： biometrology genetically modified product reference material conversion factor digital PCR;product labeling system

收稿日期: 2023-10-08 发布日期: 2024-06-06

PACS:

TB99

基金资助:国家农业生物育种重大项目(2022ZD04020)

作者简介: 刘圆圆(1998- ),安徽阜阳人,山西大学硕士研究生,主要研究方向为生物核酸计量。Email:202223119013@email.sxu.edu.cn

引用本文:

刘圆圆,李佳丽,吉帅帅,高运华,刘旦梅,王迪. 转基因定量检测量值转换系数的研究进展[J]. 计量学报, 2024, 45(6): 922-928.
LIU Yuanyuan,LI Jiali,JI Shuaishuai,GAO Yunhua,LIU Danmei,WANG Di. Research Progress on the Conversion Factor of Quantity Value for Genetically Modified Organism Quantification. Acta Metrologica Sinica, 2024, 45(6): 922-928.

链接本文:

http://jlxb.china-csm.org:81/Jwk_jlxb/CN/10.3969/j.issn.1000-1158.2024.06.19 或 http://jlxb.china-csm.org:81/Jwk_jlxb/CN/Y2024/V45/I6/922

［21］	张忠民. 转基因食品标识阈值问题研究［J］. 食品科学, 2015, 36(9): 254-263.
［3］	LI Y, PENG Y, HALLERMAN E M, et al. Biosafety management and commercial use of genetically modified crops in China ［J］. Plant Cell Rep, 2014; 33(4): 565-573.
［10］	康宇立, 朱涛, 麻晓春. 中美转基因生物安全监管体系对比［J］. 生命世界, 2018 (9): 6-7.
［25］	王迪, 王志栋, 吴枭, 等. SARS-CoV-2基因组RNA标准物质的研制［J］. 计量学报, 2021, 42(2): 259-264.
	YU T, CAO S L, ZHANG J G, et al. Global overview of commercial cultivation of genetically modified crops (1996—2018)［J］. China Seed Industry, 2020(1): 13-16.
［40］	International Organization for Standardization. General requirements for the competence of testing and calibration laboratories: ISO/IEC 17025: 2005 ［S］. 2015.
［4］	POTT A, OTTO M, SCHULZ R. Impact of genetically modified organisms on aquatic environments: Review of available data for the risk assessment ［J］. Sci Total Environ, 2018, 635: 687-698.
［7］	汪筱苏. 转基因技术发展进程与法规问题探析［J］. 分子植物育种, 2022, 20(24): 8134-8137.
	CHE L C. Research on the Legal Regulation of International Trade in Genetically Modified Foods: A Review of International Research on Genetically Modified Food Safety Legislation［J］. Journal of Food Safety and Quality Testing, 2022, 13(20): 6791-6793.
	KANG Y L, ZHU T, MA X C. Comparison of genetically modified organism safety regulatory systems between China and the United States［J］. Life World, 2018 (9): 6-7
［13］	农业部. 转基因植物及其产品成分检测基体标准物质定值技术规范:2259号公告-1—2015［S］. 北京,2015.
［18］	BORGES B J P, ARANTES O M N, FERNANDES A A R, et al. Genetically Modified Labeling Policies: Moving Forward or Backward?［J］. Front Bioeng Biotechnol, 2018, 6: 181.
	ZHANG Z M. Research on labeling threshold issues of genetically modified foods［J］. Food Science, 2015, 36(9): 254-263.
	LIU B Q, WEI T. An overview of genetically modified food safety issues and management mode ［J］. Modern Food, 2019, (21): 154-156.
	LAN Q K, LI W L, SUN Z J, et al. Current status and revelation of domestic and international GM testing standard system［J］. Agricultural Science and Technology Management, 2020, 39(3): 27-32.
［15］	CANTRILL R C. International development of methods of analysis for the presence of products of modern biotechnology［J］. Asia Pac J Clin Nutr, 2008, 17(1): 233-239.
［20］	MCFADDEN B R, LUSK J L, POLLACK A, et al. A randomized group approach to identifying label effects［J］. Journal of Choice Modelling, 2023, 48.
	YANG D Y, YANG Y C, LI H. Overview of the current status of data analysis and uncertainty assessment for quantitative testing of genetically modified ingredients［J］. Journal of Food Safety and Quality Testing, 2016, 7(8): 3025-3033.
	WANG D, WANG Z D, WU X, et al. Development of SARS-CoV-2 genomic RNA standards［J］. Acta Metrologica Sinica, 2021, 42(2): 259-264.
	FAN H B, CAI Y H, LI Y Y, et al. Application of digital PCR in the development of food testing standards［J］. Acta Metrologica Sinica, 2023, 44(3): 472-478.
［28］	QUAN P L, SAUZADE M, BROUZES E. dPCR: A Technology Review［J］. Sensors (Basel, Switzerland), 2018, 18(4): 1271.
［31］	XU W T, HUANG K L, DENG A K, et al. Variations of tissue DNA density and nuclear DNA content in soybean lines and their impacts on the GMO quantification［J］. Food Control, 2007, 18(10): 1300-1306.
［34］	王颢潜, 李夏莹, 张丽, 等. 转基因产品检测标准物质量值一致性研究进展［J］. 生物技术通报, 2020, 36(5): 2-8.
［35］	VAN H F, KARCZMARCZYK M, SCHIMMEL H, et al. Influence of primer & probe chemistry and amplification target on reverse transcription digital PCR quantification of viral RNA［J］. Biomol Detect Quantif. 2016, 9: 20-28.
［42］	农业部. 转基因植物及其产品成分检测. 基体标准物质制备技术规范:1782号公告-8—2012［S］. 北京,2012.
［46］	农业部. 转基因植物及其产品成分检测油菜内标准基因定性PCR方法:2031号公告-9—2013［S］. 北京,2013.
［2］	XIAO Z, KERR W A. Biotechnology in China—regulation, investment, and delayed commercialization［J］. GM Crops Food, 2022, 13(1): 86-96.
［9］	LIANG J, YANG X, JIAO Y, et al. The evolution of Chinas regulation of agricultural biotechnology［J］. aBIOTECH, 2022, 3(4): 237-249.
［16］	CASTELLARI E, SOREGAROLI C, VENUS J T, et al. Food processor and retailer non-GMO standards in the US and EU and the driving role of regulations［J］. Food Policy, 2018, 78: 26-37.
［24］	VOGELSTEIN B, KINZLER K W. Digital PCR［J］. Proc Natl Acad Sci U S A, 1999, 96(16): 9236-9241.
［32］	COSTEA P I, ZELLER G, SUNAGAWA S, et al. Towards standards for human fecal sample processing in metagenomic studies［J］. Nat Biotechnol, 2017, 35(11): 1069-1076.
［37］	DOBNIK D, DEMAR T, HUBER I, et al. Inter-laboratory analysis of selected genetically modified plant reference materials with digital PCR［J］. Anal Bioanal Chem. 2018, 410(1): 211-221.
［41］	林鹰, 杨文莉, 周玲艳, 等. 农业转基因核酸标准物质研究进展［J］. 生物技术通报, 2022, 38(8): 52-61.
［44］	FOTI N, PRICE S, MAZZARA M. Event-specific method for the quantitation of maize line MON 863 using real-time PCR: JRC 21830［R］. EU, Institute for Health and Consumer Protection (Joint Research Centre), 2006.
［1］	于滔, 曹士亮, 张建国, 等. 全球转基因作物商业化种植概况(1996—2018年)［J］. 中国种业, 2020(1): 13-16.
［5］	刘培琴, 韦婷. 浅谈转基因食品安全问题及管理模式［J］. 现代食品, 2019, (21): 154-156.
	WANG X S. Exploration of the development process and regulatory issues of transgenic technology［J］. Molecular Plant Breeding, 2022, 20(24): 8134-8137.
［8］	车流畅. 转基因食品国际贸易法律规制研究—评《国际转基因食品安全立法研究》［J］. 食品安全质量检测学报, 2022, 13(20): 6791-6793.
［11］	兰青阔, 李文龙, 孙卓婧, 等. 国内外转基因检测标准体系现状与启示［J］. 农业科技管理, 2020, 39(3): 27-32.
［14］	黄耀辉, 樊殿峰, 焦悦, 等. 浅谈多国转基因产品标识制度对我国的启示［J］. 生物技术进展, 2022, 12(4): 516-522.
	HUANG Y H, FAN D F, JIAO Y, et al. Implications of the labeling system of genetically modified products in many countries for China［J］. Biotechnology Progress, 2022, 12(4): 516-522.
［19］	MOGHISSI A A, JAEGER L M, SHAFEI D, et al. Regulatory science requirements of labeling of genetically modified food［J］. Crit Rev Biotechnol, 2018, 38(3): 386-393.
［22］	FRAITURE M A, HERMAN P, TAVERNIERS I, et al. Current and new approaches in GMO detection: challenges and solutions［J］. Biomed Res Int, 2015, 2015: 392872.
［23］	杨冬燕, 杨永存, 李浩. 转基因成分定量检测数据分析及不确定度评估现状概述［J］. 食品安全质量检测学报, 2016, 7(8): 3025-3033.
［26］	范宏博, 蔡永洪, 李月玥, 等. 数字PCR法在食品检测标准物质研制中的应用［J］. 计量学报, 2023, 44(3): 472-478.
［29］	PHILIPPE C, GERHARD B, CRISYIAN S, et al. Expression of GM content in mass fraction from digital PCR data［J］. Food Control, 2022, 133(PB): 108626.
［30］	CORBISIER P, EMONS H. Towards metrologically traceable and comparable results in GM quantification［J］. Anal Bioanal Chem, 2019, 411(1): 7-11.
［39］	VYNCK M, VANDESOMPELE J, THAS O. Quality control of digital PCR assays and platforms［J］. Anal Bioanal Chem. 2017, 409(25): 5919-5931.
［43］	国家市场监督管理总局. 转基因产品检测实时荧光定性聚合酶链式反应(PCR)检测方法:GB/T 19495. 4—2018［S］. 北京:中国标准出版社,2018.
［6］	TRAVIS R, BENJAMIN R, ISABELLE C, et al. Ethical aspects of GMO regulation in the EU: Regulating new plant breeding techniques as GM has negative effects on sustainability, diversity and inclusion: Regulating new plant breeding techniques as GM has negative effects on sustainability, diversity and inclusion［J］. EMBO reports, 2022, 23(9): 1-5.
［12］	TRAPMANN S, CORBISIER P, SCHIMMEL H, et al. Towards future reference systems for GM analysis［J］. Anal Bioanal Chem, 2010, 396(6): 1969-1975.
［17］	HAKIM M P, ZANETTA L D, DE OLIVEIRA J M, et al. The mandatory labeling of genetically modified foods in Brazil: Consumers knowledge, trust, and risk perception［J］. Food Res Int. 2020, 132: 109053.
［27］	BURNS M J, BURRELL A M, FOY C A. The applicability of digital PCR for the assessment of detection limits in GMO analysis［J］. European Food Research and Technology, 2010, 231(3): 353-362.
［33］	DEMEKE T, MALABANAN J, HOLIGROSKI M, et al. Effect of Source of DNA on the Quantitative Analysis of Genetically Engineered Traits Using Digital PCR and Real-Time PCR［J］. J AOAC Int. 2017, 100(2): 492-498.
	WANG H Q, LI X Y, ZHANG L, et al. Progress on the consistency of standardized substances for the detection of genetically modified products［J］. Biotechnology Bulletin, 2020, 36(5): 2-8.
［36］	JACCHIA S, KAGKLI D M, LIEVENS A, et al. Identification of single target taxon-specific reference assays for the most commonly genetically transformed crops using digital droplet PCR［J］. Food Control, 2018, 93: 191-200.
［38］	PAVICˇ J, DEVONSHIRE A, BLEJEC A, et al. Inter-laboratory assessment of different digital PCR platforms for quantification of human cytomegalovirus DNA［J］. Anal Bioanal Chem. 2017, 409(10): 2601-2614.
	LIN Y, YANG W L, ZHOU L Y, et al. Progress of agricultural transgenic nucleic acid standards［J］. Biotechnology Bulletin, 2022, 38(8): 52-61.
［45］	SAVINI C, BOGNI A, MAZZARA M. Event-specific method for the quantification of oilseed rape MON88302 by real-time PCR: EUR 26388 ［R］. Institute for Health and Consumer Protection (Joint Research Centre), 2013.