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Evaluation of a Point-of-Care Testing Analyzer for Measuring Peripheral Blood Leukocytes
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[Analysis of the Core Principles and Key Design and Development Control Factors of Two Typical Point-of-Care Testing
1Shanghai Medical Device and Cosmetics Evaluation and Verification Center, Shanghai, 200020.
Abstract:
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.
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