Abstract

Objective: To describe the results of implementing Digital PCR (dPCR) in detecting gene mutations in lung cancer patients and to summarize the experience of quality management according to ISO 15189:2022 standards at the National Lung Hospital. Method: A descriptive cross-sectional study combining the experience of implementation and operational data of Digital PCR at the National Lung Hospital. Results: Digital PCR (dPCR) testing was performed from August 2025 to April 2026: 1) Gene mutation rate - EGFR gene mutation rate in plasma samples: 56%; EGFR gene mutation rate in FFPE samples: 52%; Gene mutation rate of FFPE samples across all three lung cancer panels: 29%. 2) Results: Results of Method Approval and Interlaboratory Comparison on 10 FFPE samples showed consistency with reference methods. 3) 12 errors were recorded in the total of 441 Digital PCR tests performed (2.7%) Conclusion: Digital PCR has the ability to detect and quantify gene mutations at a highly sensitive level (VAF < 0. 1%), improving the ability to identify mutations in small biopsy and plasma samples. Implementing the ISO 15189:2022 standard ensures the reliability of the test; major technical issues can be controlled through standardization of pre-analytical and operational procedures.