{"title":"[两种典型护理点检测技术的核心原理及关键设计开发控制因素分析]。","authors":"You Zhou, Xin Liu","doi":"10.12455/j.issn.1671-7104.240318","DOIUrl":null,"url":null,"abstract":"<p><p>Point-of-care testing (POCT), as an emerging diagnostic technology, is gradually becoming an important part of the clinical diagnostic field due to its advantages, such as ease of operation, rapid response, and portability. This paper primarily introduces two mainstream technologies in POCT: lateral flow assays and nucleic acid amplification. It covers the basic principles, applications, and quality control points in design and development of the two mainstream technologies, aiming to provide a technical reference for device manufacturers, researchers, and regulatory agencies.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 2","pages":"230-236"},"PeriodicalIF":0.0000,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"[Analysis of the Core Principles and Key Design and Development Control Factors of Two Typical Point-of-Care Testing Technologies].\",\"authors\":\"You Zhou, Xin Liu\",\"doi\":\"10.12455/j.issn.1671-7104.240318\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Point-of-care testing (POCT), as an emerging diagnostic technology, is gradually becoming an important part of the clinical diagnostic field due to its advantages, such as ease of operation, rapid response, and portability. This paper primarily introduces two mainstream technologies in POCT: lateral flow assays and nucleic acid amplification. It covers the basic principles, applications, and quality control points in design and development of the two mainstream technologies, aiming to provide a technical reference for device manufacturers, researchers, and regulatory agencies.</p>\",\"PeriodicalId\":52535,\"journal\":{\"name\":\"中国医疗器械杂志\",\"volume\":\"49 2\",\"pages\":\"230-236\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-03-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"中国医疗器械杂志\",\"FirstCategoryId\":\"1087\",\"ListUrlMain\":\"https://doi.org/10.12455/j.issn.1671-7104.240318\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"中国医疗器械杂志","FirstCategoryId":"1087","ListUrlMain":"https://doi.org/10.12455/j.issn.1671-7104.240318","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"Medicine","Score":null,"Total":0}
[Analysis of the Core Principles and Key Design and Development Control Factors of Two Typical Point-of-Care Testing Technologies].
Point-of-care testing (POCT), as an emerging diagnostic technology, is gradually becoming an important part of the clinical diagnostic field due to its advantages, such as ease of operation, rapid response, and portability. This paper primarily introduces two mainstream technologies in POCT: lateral flow assays and nucleic acid amplification. It covers the basic principles, applications, and quality control points in design and development of the two mainstream technologies, aiming to provide a technical reference for device manufacturers, researchers, and regulatory agencies.
期刊介绍:
Chinese Journal of Medical Instrumentation mainly reports on the development, progress, research and development, production, clinical application, management, and maintenance of medical devices and biomedical engineering. Its aim is to promote the exchange of information on medical devices and biomedical engineering in China and turn the journal into a high-quality academic journal that leads academic directions and advocates academic debates.