Objective: To establish a new digital polymerase chain reaction (dPCR) system for the detection of fusion gene in patients with chronic myeloid leukemia (CML), and explore its analytical performance and clinical applicability in the detection of .

Methods: A new dPCR system for detecting was successfully developed, and its sensitivity difference with qPCR and improvement of drug side effects in patients with CML during drug reduction or withdrawal were compared.

Results: Among 176 samples, qPCR and dPCR showed high consistency in the sensitivity of detecting (82.39%), and the positive rate of dPCR was about 5 times higher that of qPCR (20.45% 3.98%). During follow-up, blood routine (25% 10%), kidney/liver/stomach (25% 20%) and cardiac function (10% 0) were significantly improved after drug reduction or withdrawal in patients with initial dPCR negative compared with before drug reduction or withdrawal.

Conclusions: This new dPCR detection system can be applied to the detection of . It has better consistency and higher positive detection rate than qPCR. Drug withdrawal or dose reduction guided by dPCR has a certain effect on improving drug side effects.

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http://dx.doi.org/10.19746/j.cnki.issn.1009-2137.2023.06.008DOI Listing

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