Key Aspects of Performance Evaluation on Droplet Digital PCR Instrument.
10.12455/j.issn.1671-7104.240426
- Author:
Wen BAO
1
Author Information
1. Center for Medical Device Evaluation, NMPA, Beijing,
- Publication Type:Journal Article
- Keywords:
droplet digital PCR instrument;
performance evaluation;
quality control
- MeSH:
Polymerase Chain Reaction/methods*;
Quality Control;
Software;
Humans
- From:
Chinese Journal of Medical Instrumentation
2025;49(3):340-343
- CountryChina
- Language:Chinese
-
Abstract:
From the perspective of performance evaluation, this paper describes briefly the concerns of study on each component module and the entire instrument, clinical items, software, and product testing on droplet digital PCR instruments, including the study methods and quality control requirements. The increase of the research and development efficiency of products and contribute to the promotion of application of digital PCR instruments in clinical laboratories are expected.
