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Disease Diagnosis

Digital PCR is well suited for clinical diagnostic applications because of its high sensitivity, relatively simple workflow, visual readout of data in the result graph, achievement of true absolute quantification, tolerance to factors affecting amplification efficiency during PCR, and high reproducibility of test results.

Digital PCR is used in a wide range of disease diagnostic applications, including: early diagnosis of tumors, targeted drug use, efficacy monitoring, micro-residue monitoring; pathogen detection; birth defect testing; organ transplant rejection monitoring, etc. Examples are as follows:

Liquid biopsy of tumors, which provides reliable data for concomitant diagnosis, efficacy monitoring and prognosis of tumors by detecting circulating tumor DNA (ctDNA) in plasma;
Detection of a small number of pathogens in specimens, such as cerebrospinal fluid infections, postoperative bacteremia, and HBV and HIV following drug administration;
Testing for birth defects due to changes in chromosome number or gene copy number;
Surveillance for organ transplant rejection, which allows earlier detection of acute rejection and urgent intervention.

The digital PCR has very obvious advantages in the above mentioned tests, such as:

The digital PCR can detect rare mutations in complex backgrounds and is suitable for detecting tumor-associated mutations in various body fluid specimens (e.g. blood, pleural fluid, cerebrospinal fluid, urine), which helps to understand the full picture of tumor mutations in patients and overcome tumor heterogeneity to some extent;
The load of viruses and other pathogens is crucial for the interpretation of disease course, subsequent treatment and efficacy assessment, and therefore requires highly accurate and stable analysis by digital PCR;
The high sensitivity of digital PCR determines that clinical specimens can be tested without going through the pathogenic microbial culture process, which greatly shortens the reporting cycle and makes it possible to rapidly detect potential pathogenic microorganisms, greatly advancing the window period for disease detection and allowing better early diagnosis and treatment.