转基因定量检测结果测量不确定度的自上而下评定方法研究及应用

doi:10.3864/j.issn.0578-1752.2023.22.002

中国农业科学 ›› 2023, Vol. 56 ›› Issue (22): 4371-4385.doi: 10.3864/j.issn.0578-1752.2023.22.002

• 作物遗传育种·种质资源·分子遗传学 • 上一篇下一篇

转基因定量检测结果测量不确定度的自上而下评定方法研究及应用

李俊¹(), 赵新², 陈红³, 李飞武⁴, 梁晋刚³, 李允静¹, 王颢潜³, 高鸿飞¹, 张华³, 陈子言³, 吴刚¹, 沈平³, 徐利群³(), 武玉花¹()

¹ 中国农业科学院油料作物研究所/农业农村部农业转基因生物溯源重点实验室，武汉 430062
² 天津市农业科学院，天津 300384
³ 农业农村部科技发展中心，北京 100025
⁴ 吉林省农业科学院，长春 130033

收稿日期:2023-04-30 接受日期:2023-07-27 出版日期:2023-11-16 发布日期:2023-11-17
通信作者: 徐利群，E-mail：gmotest@126.com。武玉花，E-mail：wuyuhua@oilcrops.cn
联系方式: 李俊，E-mail：lijuner@caas.cn。
基金资助:
科技创新2030—重大项目(2022ZD0402010)

Development and Application of Top-Down Approaches for Estimating Measurement Uncertainty of GMO Quantitative Results

LI Jun¹(), ZHAO Xin², CHEN Hong³, LI FeiWu⁴, LIANG JinGang³, LI YunJing¹, WANG HaoQian³, GAO HongFei¹, ZHANG Hua³, CHEN ZiYan³, WU Gang¹, SHEN Ping³, XU LiQun³(), WU YuHua¹()

¹ Oil Crops Research Institute, Chinese Academy of Agricultural Sciences/Key Laboratory of agricultural genetically modified organism traceability, Ministry of Agriculture and Rural Affairs, Wuhan 430062
² Tianjin Academy of Agricultural Sciences, Tianjin 300384
³ Development Center of Science and Technology, Ministry of Agriculture and Rural Affairs, Beijing 100025
⁴ Jilin Academy of Agricultural Sciences, Changchun 130033

Received:2023-04-30 Accepted:2023-07-27 Published:2023-11-16 Online:2023-11-17

摘要/Abstract

摘要：

【目的】定量检测标准体系是实施转基因定量标识的基础，而不确定度评定是定量检测标准体系的重要组成部分。急需建立适合一般实验室采用的标准化转基因定量检测结果不确定度的自上而下评定方法，以便检测实验室自行评定定量检测结果的测量不确定度。【方法】测量方法精密度不确定度评定有2种方法，一种是根据“不确定度函数”的一般概念，利用15个不同浓度的常规样品，建立测量方法精密度引入的不确定度评定公式；另一种是重复测量有证标准物质，根据检测数据的中间精密度，计算方法精密度引入的不确定度。用有证标准物质或实验室配制样品作阳性定量质控品进行偏倚不确定度评定，实验室配制样品标称值的不确定度由实验室根据制备过程采用简易程序自行评定。将测量方法精密度引入的不确定度和测量过程的偏倚不确定度合成，评定试样定量结果的标准不确定度，然后乘以包含因子k，获得扩展不确定度。【结果】以转基因玉米DBN9936定量检测方法为例，分别用模拟的DBN9936常规样品和有证基体标准物质（GBW（E）100901）评定测量方法精密度引入的不确定度，分别为0.76%和0.33%，与常规样品相比，用有证标准物质评定的测量方法精密度不确定度显著偏小。用有证标准物质（GBW（E）100901）评定的偏倚不确定度为0.26%；用实验室配制粉末样品和基因组DNA样品（标称值均为3.0%）评定的偏倚不确定度分别为0.20%和0.19%。采用简易程序评定实验室配制样品标称值引入的不确定度时，部分不确定度分量被忽略，评定的偏倚不确定度偏小。将测量方法精密度不确定度和偏倚不确定度分别合成，用常规样品评定的扩展不确定度为1.26%、1.20%和1.20%；用有证标准物质评定的扩展不确定度为0.84%、0.78%和0.76%。【结论】建立了转基因定量检测结果自上而下的不确定度评定方法，检测实验室要优先选择用常规样品评定测量方法精密度引入的不确定度。在评定偏倚不确定度时，检测实验室原则上要优先选择有证标准物质作阳性定量质控品。

关键词: 转基因定量结果, 测量不确定度, 自上而下, 有证标准物质, 阳性定量质控品

Abstract:

【Objective】The enforcement of labeling regulations on genetically modified organisms (GMOs) requires establishing a standard system for accurate quantification of GMOs that includes the standard or guide for estimating measurement uncertainty (MU). It is urgent to establish a standardized top-down approach for estimating MU of quantitative results, which is conveniently adopted by the general testing laboratories. 【Method】There are two approaches for estimating the MU introduced by precision of quantitative method, one is to establish the equation of MU estimation using data obtained on 15 routine samples based on the "uncertainty function", the other is to evaluate the MU by repeatedly measuring a certified reference material (CRM) and calculating the intermediate precision. The uncertainty introduced by bias is evaluated using a CRM or a sample prepared by laboratory as bias control. The uncertainty of the nominal value of the sample prepared by laboratory is evaluated by using a simplified program based on the preparation process. The MU contributed by method precision and bias are combined into the standard uncertainty of the quantitative results, and then multiplied by the coverage factor k to obtain the expanded uncertainty. 【Result】The event-specific PCR method of genetically modified maize DBN9936 was took as an example. The MU of method precision was evaluated to be 0.76% using simulated DBN9936 routine samples, and to be 0.33% using a CRM (GBW (E) 100901). Compared with routine samples, the MU of method precision evaluated using a CRM is significantly underestimated. The uncertainty introduced by bias was evaluated to be 0.26% using a CRM (GBW (E) 100901) as a bias control. Using a laboratory prepared powder sample and a genomic DNA sample (nominal values of 3.0%) as bias control, the bias uncertainty was evaluated to be 0.20% and 0.19%, respectively. Since the simplified program ignored some uncertainty components, the uncertainty of the nominal value of laboratory prepared samples was estimated to be smaller. By combining the MU of method precision and bias, the expanded uncertainty using routine samples was obtained to be 1.26%, 1.20%, and 1.20%, respectively, the expanded uncertainty using a CRM was 0.84%, 0.78%, and 0.76%, respectively. 【Conclusion】This study established the top-down approaches for MU estimation of quantitative results, testing laboratories should prioritize routine samples to estimate the MU contributed by the method precision, and select CRMs as bias control in principle to evaluate bias uncertainty during GMO quantification.

Key words: quantitative results of GMO content, measurement uncertainty, top-down approach, certified reference materials, bias control

李俊, 赵新, 陈红, 李飞武, 梁晋刚, 李允静, 王颢潜, 高鸿飞, 张华, 陈子言, 吴刚, 沈平, 徐利群, 武玉花. 转基因定量检测结果测量不确定度的自上而下评定方法研究及应用[J]. 中国农业科学, 2023, 56(22): 4371-4385.

LI Jun, ZHAO Xin, CHEN Hong, LI FeiWu, LIANG JinGang, LI YunJing, WANG HaoQian, GAO HongFei, ZHANG Hua, CHEN ZiYan, WU Gang, SHEN Ping, XU LiQun, WU YuHua. Development and Application of Top-Down Approaches for Estimating Measurement Uncertainty of GMO Quantitative Results[J]. Scientia Agricultura Sinica, 2023, 56(22): 4371-4385.

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转化体（基因） Event (gene)	引物/探针名称及序列 Sequences of primer/probe (5′-3′)	扩增片段大小 Amplicon size (bp)
DBN9936	LF51：CAGGGGCAAGAAAACATC	76
	LR126：TCTTGTGTGCCCATGAGCCTA
	LP79：FAM-TCTTGTGTGCCCATGAGCCTA-BHQ1
zSSIIb	F：CGGTGGATGCTAAGGCTGATG	88
	R：AAAGGGCCAGGTTCATTATCCTC
	P：Hex-TAAGGAGCACTCGCCGCCGCATCTG-BHQ1

样品类型 Sample type	样品编号 Sample code	预期浓度 Expected concentration (%)	测量值 Measured value (%)		${{\bar{c}}_{j}}$(%)	SD (%)	RSD (%)
样品类型 Sample type	样品编号 Sample code	预期浓度 Expected concentration (%)	c_1,_j	c_2,_j	${{\bar{c}}_{j}}$(%)	SD (%)	RSD (%)
低浓度样品 Low level sample	R1	0.10	0.119	0.096	0.107	0.021	19.20
	R2	0.12	0.126	0.100	0.113	0.023	20.53
	R3	0.15	0.135	0.142	0.139	0.006	4.13
	R4	0.20	0.215	0.192	0.204	0.020	9.81
	R5	0.25	0.249	0.311	0.280	0.054	19.41
	R6	0.30	0.331	0.385	0.358	0.048	13.48
高浓度样品 High level sample	R7	0.35	0.439	0.330	0.385	0.097	25.28
	R8	0.40	0.561	0.474	0.518	0.077	14.86
	R9	0.50	0.524	0.590	0.557	0.058	10.45
	R10	0.70	0.788	0.609	0.699	0.159	22.70
	R11	1.00	0.978	0.946	0.962	0.028	2.88
	R12	2.00	2.270	2.181	2.226	0.079	3.55
	R13	2.50	2.238	2.854	2.546	0.546	21.43
	R14	3.00	2.974	3.543	3.258	0.505	15.48
	R15	4.00	4.320	4.151	4.236	0.150	3.55

样品分类 Sample type	样品编号 Sample code	测量值 Measured value (%)		分析结果 Analytical result (%)
样品分类 Sample type	样品编号 Sample code	c_1,_j	c_2,_j	$\left\| \text{ }{{d}_{j}} \right\|$	$\left\| \text{ }\bar{d} \right\|$	α
低浓度样品 Low level sample	R1	0.119	0.096	0.023	0.032	0.029
	R2	0.126	0.100	0.026
	R3	0.135	0.142	0.006
	R4	0.215	0.192	0.023
	R5	0.249	0.311	0.061
	R6	0.331	0.385	0.054

样品分类 Sample type	样品编号 Sample code	测量值 Measured value (%)		数据分析结果 Analytical result
样品分类 Sample type	样品编号 Sample code	c_1,_j	c_2,_j	$\left\| \text{ }{{d}_{j}} \right\|$(%)	${{\bar{c}}_{j}}$(%)	${{\left\| \text{ }{{d}_{j}} \right\|}_{rel}}$	$\text{ }{{\left\| \text{ }\bar{d} \right\|}_{rel}}$	β
高浓度样品 High level sample	R7	0.439	0.330	0.110	0.385	0.278	0.155	0.137
	R8	0.561	0.474	0.087	0.518	0.181
	R9	0.524	0.590	0.066	0.557	0.128
	R10	0.788	0.609	0.179	0.699	0.240
	R11	0.978	0.946	0.031	0.962	0.032
	R12	2.270	2.181	0.089	2.226	0.042
	R13	2.238	2.854	0.616	2.546	0.260
	R14	2.974	3.543	0.569	3.258	0.191
	R15	4.320	4.151	0.170	4.236	0.041

平行子样 Subsample	检测结果 Measured result (%)					分析结果 Analytical result (%)
平行子样 Subsample	第1天 Day 1	第2天 Day 2	第3天 Day 3	第4天 Day 4	第5天 Day 5	组内均方 MS_w	组间均方 MS_b	重复性方差 $s_{r}^{2}$	组间方差 $s_{b}^{2}$
子样1 Subsample 1	3.95	3.90	3.47	3.30	3.96	0.171	0.412	0.171	0.048
子样2 Subsample 2	3.60	3.14	4.04	3.40	3.93
子样3 Subsample 3	3.06	2.33	3.25	3.02	3.62
子样4 Subsample 4	3.85	2.87	2.87	2.58	3.14
子样5 Subsample 5	3.51	2.94	3.08	3.02	3.60

转基因定量检测结果测量不确定度的自上而下评定方法研究及应用

Development and Application of Top-Down Approaches for Estimating Measurement Uncertainty of GMO Quantitative Results

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质控品 Control	标准值 C_CRM	测量结果 Measured result (%)			分析结果Analytical result (%)
质控品 Control	标准值 C_CRM	C₁	C₂	C₃	$\bar{c}$	\|bias\|	s	$u(\bar{c})$	u_CRM(u_E)	u_bias	RSD
GBW（E）100901	3.49%	3.13	3.05	3.64	3.273	0.217	0.348	0.201	0.165^a	0.260	10.65
实验室配制粉末质控品 Laboratory prepared matrix control	0.03	3.21	3.35	2.81	3.123	0.123	0.319	0.184	0.060^b	0.194	10.21
实验室配制基因组DNA质控品 Laboratory prepared genomic DNA control	0.03	2.90	3.30	3.40	3.200	0.200	0.295	0.171	0.070^b	0.184	9.23

DNA	测量浓度（拷贝(μL)）			平均值 $\bar{c}$	平均值标准差 ${{u}_{{\bar{c}}}}$	平均值相对标准差 ${{u}_{\bar{c}1}}$
DNA	1	2	2	平均值 $\bar{c}$	平均值标准差 ${{u}_{{\bar{c}}}}$	平均值相对标准差 ${{u}_{\bar{c}1}}$
转基因DNA GM DNA	34000	33100	33700	33600	307	0.0091
非转基因DNA Non-GM DNA	33300	33400	34700	33800	477	0.0141

试样检测平均值 Mean of test sample	精密度不确定度评定 Estimation of precision uncertainty		偏倚不确定度评定 Estimation of bias uncertainty		合成不确定度 Combined uncertainty (%)	扩展不确定度 Expanded uncertainty (%)	定量结果 Expression of quantitative result (%)
试样检测平均值 Mean of test sample	评定方法 Method	精密度不确定度 Precision uncertainty (%)	质控品类型 Control type	偏倚不确定度 Bias uncertainty (%)	合成不确定度 Combined uncertainty (%)	扩展不确定度 Expanded uncertainty (%)	定量结果 Expression of quantitative result (%)
4.15%	常规样品 Routine sample	0.57	有证标准物质CRM	0.260	0.63	1.26	4.15±1.26
			实验室配制粉末样品 Laboratory prepared matrix sample	0.194	0.60	1.20	4.15±1.20
			实验室配制基因组DNA样品 Laboratory prepared genomic DNA sample	0.184	0.60	1.20	4.15±1.20
	有证标准物质 CRM	0.33	有证标准物质CRM	0.260	0.42	0.84	4.15±0.84
			实验室配制粉末样品 Laboratory prepared matrix sample	0.194	0.39	0.78	4.15±0.78
			实验室配制基因组DNA样品 Laboratory prepared genomic DNA sample	0.184	0.38	0.76	4.15±0.76