Key Aspects of Performance Evaluation on Droplet Digital PCR Instrument

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 i...

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Main Author: Wen BAO
Format: Article
Language:zho
Published: Editorial Office of Chinese Journal of Medical Instrumentation 2025-05-01
Series:Zhongguo yiliao qixie zazhi
Subjects:
Online Access:https://zgylqxzz.xml-journal.net/article/doi/10.12455/j.issn.1671-7104.240426
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author Wen BAO
author_facet Wen BAO
author_sort Wen BAO
collection DOAJ
description 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.
format Article
id doaj-art-efc1d77b45c847c786aa0e26b8374cc6
institution Kabale University
issn 1671-7104
language zho
publishDate 2025-05-01
publisher Editorial Office of Chinese Journal of Medical Instrumentation
record_format Article
series Zhongguo yiliao qixie zazhi
spelling doaj-art-efc1d77b45c847c786aa0e26b8374cc62025-08-20T03:47:19ZzhoEditorial Office of Chinese Journal of Medical InstrumentationZhongguo yiliao qixie zazhi1671-71042025-05-0149334034310.12455/j.issn.1671-7104.2404262024-0426Key Aspects of Performance Evaluation on Droplet Digital PCR InstrumentWen BAO0Center for Medical Device Evaluation, NMPA, Beijing, 100081From 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.https://zgylqxzz.xml-journal.net/article/doi/10.12455/j.issn.1671-7104.240426droplet digital pcr instrumentperformance evaluationquality control
spellingShingle Wen BAO
Key Aspects of Performance Evaluation on Droplet Digital PCR Instrument
Zhongguo yiliao qixie zazhi
droplet digital pcr instrument
performance evaluation
quality control
title Key Aspects of Performance Evaluation on Droplet Digital PCR Instrument
title_full Key Aspects of Performance Evaluation on Droplet Digital PCR Instrument
title_fullStr Key Aspects of Performance Evaluation on Droplet Digital PCR Instrument
title_full_unstemmed Key Aspects of Performance Evaluation on Droplet Digital PCR Instrument
title_short Key Aspects of Performance Evaluation on Droplet Digital PCR Instrument
title_sort key aspects of performance evaluation on droplet digital pcr instrument
topic droplet digital pcr instrument
performance evaluation
quality control
url https://zgylqxzz.xml-journal.net/article/doi/10.12455/j.issn.1671-7104.240426
work_keys_str_mv AT wenbao keyaspectsofperformanceevaluationondropletdigitalpcrinstrument