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: | , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Taylor & Francis Group
2025-12-01
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| Series: | GM Crops & Food |
| Subjects: | |
| Online Access: | https://www.tandfonline.com/doi/10.1080/21645698.2025.2548053 |
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| Summary: | 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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| ISSN: | 2164-5698 2164-5701 |