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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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2025-12-01
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| Series: | GM Crops & Food |
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| 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. |
| format | Article |
| id | doaj-art-5cd9cd3d98d74c60aae8939027f9fc4e |
| institution | Kabale University |
| issn | 2164-5698 2164-5701 |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| 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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