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KMID : 1142220200150010001
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Regulatory Research on Food, Drug & Cosmetic
2020 Volume.15 No. 1 p.1 ~ p.7
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A Study on Development of Guideline to Establish Performance Evaluation for Automated Blood Cell Analyzer
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Lee Seung-Ro
kwak Joung-In
Kim Ji-Eun
Yang Da-Hae
Lee Woon-Hyoung
Park Ki-Dae
Park Ki-Sook
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Abstract
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Complete blood cell count is the most commonly performed blood test from medical checkups and basic tests before surgery to follow-up observation of malignant blood disease. The automated blood cell analyzer is used in combination with analysis ‘hematology analyser’ and test reagents ‘blood cell test reagents’. Although blood cell test reagents account for a high percentage of the number of approvals. However, currently relevant guideline and standards are not clearly presented. In this study, evaluation items and methods were derived for essential performance of automated blood cell analyzers, such as imprecision, correlation, linearity, carry-over and sensitivity for each item of white blood cells, red blood cells, platelets and hemoglobin. Finally, we developed a guideline for performance evaluation of automated blood cell analyzers. The newly developed guideline is expected to contribute to the enhancement of international competitiveness by securing reliability and an improvement of technology and quality of IVD medical device industry.
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KEYWORD
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automated blood cell analyzer, haematology analyser, IVD reagents for Hematology, complete blood count
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