Development of a duplex chamber digital PCR to quantify twelve genetically modified maize events

Accurate quantification of genetically modified organisms (GMOs) is essential for regulatory compliance, especially under threshold-based labeling policies. In this study, we developed and validated twelve event-specific duplex chamber- or chip-based digital PCR (cdPCR) methods using microfluidic ar...

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Main Authors: Eun-Ha Kim, Youn-Sung Cho, Byeori Kim, Yelinn Yoo, Jae-In Lee, Young Soon Kim, Tae-Sung Park
Format: Article
Language:English
Published: Taylor & Francis Group 2025-12-01
Series:GM Crops & Food
Subjects:
Online Access:https://www.tandfonline.com/doi/10.1080/21645698.2025.2548053
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author Eun-Ha Kim
Youn-Sung Cho
Byeori Kim
Yelinn Yoo
Jae-In Lee
Young Soon Kim
Tae-Sung Park
author_facet Eun-Ha Kim
Youn-Sung Cho
Byeori Kim
Yelinn Yoo
Jae-In Lee
Young Soon Kim
Tae-Sung Park
author_sort Eun-Ha Kim
collection DOAJ
description Accurate quantification of genetically modified organisms (GMOs) is essential for regulatory compliance, especially under threshold-based labeling policies. In this study, we developed and validated twelve event-specific duplex chamber- or chip-based digital PCR (cdPCR) methods using microfluidic array plates to quantify GM maize events approved in South Korea. In contrast to conventional real-time PCR, the cdPCR approach allows for absolute quantification without standard curve calibration and incorporates event-specific zygosity ratio correction to improve accuracy of the measurement. The method was evaluated at GMO content levels of 0.9%, 3.0%, and 5.0%. It demonstrated high sensitivity and robustness, with trueness, precision, and reproducibility satisfying the minimum performance criteria recommended by international guidelines. Comparative analysis with real-time quantitative PCR (qPCR) showed comparable accuracy; however, cdPCR provided advantages in cost-efficiency and operational simplicity. These findings support the applicability of duplex cdPCR as a practical and reliable tool for GMO quantification, particularly in national regulatory laboratories and for enforcement of labeling thresholds such as Korea’s 3.0% rule.
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institution Kabale University
issn 2164-5698
2164-5701
language English
publishDate 2025-12-01
publisher Taylor & Francis Group
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series GM Crops & Food
spelling doaj-art-5cd9cd3d98d74c60aae8939027f9fc4e2025-08-22T06:06:20ZengTaylor & Francis GroupGM Crops & Food2164-56982164-57012025-12-0116152753810.1080/21645698.2025.2548053Development of a duplex chamber digital PCR to quantify twelve genetically modified maize eventsEun-Ha Kim0Youn-Sung Cho1Byeori Kim2Yelinn Yoo3Jae-In Lee4Young Soon Kim5Tae-Sung Park6Biosafety Division, National Institute of Agricultural Sciences, Jeonju, KoreaPlanning & Coordination Division, National Institute of Agricultural Sciences, Jeonju, KoreaBiosafety Division, National Institute of Agricultural Sciences, Jeonju, KoreaBiosafety Division, National Institute of Agricultural Sciences, Jeonju, KoreaBiosafety Division, National Institute of Agricultural Sciences, Jeonju, KoreaBiosafety Division, National Institute of Agricultural Sciences, Jeonju, KoreaBiosafety Division, National Institute of Agricultural Sciences, Jeonju, KoreaAccurate quantification of genetically modified organisms (GMOs) is essential for regulatory compliance, especially under threshold-based labeling policies. In this study, we developed and validated twelve event-specific duplex chamber- or chip-based digital PCR (cdPCR) methods using microfluidic array plates to quantify GM maize events approved in South Korea. In contrast to conventional real-time PCR, the cdPCR approach allows for absolute quantification without standard curve calibration and incorporates event-specific zygosity ratio correction to improve accuracy of the measurement. The method was evaluated at GMO content levels of 0.9%, 3.0%, and 5.0%. It demonstrated high sensitivity and robustness, with trueness, precision, and reproducibility satisfying the minimum performance criteria recommended by international guidelines. Comparative analysis with real-time quantitative PCR (qPCR) showed comparable accuracy; however, cdPCR provided advantages in cost-efficiency and operational simplicity. These findings support the applicability of duplex cdPCR as a practical and reliable tool for GMO quantification, particularly in national regulatory laboratories and for enforcement of labeling thresholds such as Korea’s 3.0% rule.https://www.tandfonline.com/doi/10.1080/21645698.2025.2548053Chamber digital PCRgenetically modified maizequantitative method
spellingShingle Eun-Ha Kim
Youn-Sung Cho
Byeori Kim
Yelinn Yoo
Jae-In Lee
Young Soon Kim
Tae-Sung Park
Development of a duplex chamber digital PCR to quantify twelve genetically modified maize events
GM Crops & Food
Chamber digital PCR
genetically modified maize
quantitative method
title Development of a duplex chamber digital PCR to quantify twelve genetically modified maize events
title_full Development of a duplex chamber digital PCR to quantify twelve genetically modified maize events
title_fullStr Development of a duplex chamber digital PCR to quantify twelve genetically modified maize events
title_full_unstemmed Development of a duplex chamber digital PCR to quantify twelve genetically modified maize events
title_short Development of a duplex chamber digital PCR to quantify twelve genetically modified maize events
title_sort development of a duplex chamber digital pcr to quantify twelve genetically modified maize events
topic Chamber digital PCR
genetically modified maize
quantitative method
url https://www.tandfonline.com/doi/10.1080/21645698.2025.2548053
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