Application experience of a rapid nucleic acid detection system for COVID-19 |
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| Affiliation: | 1. The Children''s Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, National Children''s Regional Medical Center, Hangzhou 310052, China;2. School of Life Science, Zhejiang Chinese Medical University, Hangzhou 310053, China;3. School of Medical Technology and Information Engineering, Zhejiang Chinese Medical University, Hangzhou 310053, China |
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| Abstract: | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is raging worldwide. The COVID-19 outbreak caused severe threats to the life and health of all humans caused by SARS-CoV-2. Clinically, there is an urgent need for an in vitro diagnostic product to detect SARS-CoV-2 nucleic acid quickly. Under this background, commercial SARS-CoV-2 nucleic acid POCT products came into being. However, how to choose these products and how to use these products in a standardized way have brought new puzzles to clinical laboratories. This paper focuses on evaluating the performance of these commercial SARS-CoV-2 nucleic acid POCT products and helps the laboratory make the correct choice. At the same time, to standardize the use of this kind of product, this paper also puts forward corresponding suggestions from six elements of total quality management, namely, human, machine, material, method, environment, and measurement. In addition, this paper also puts forward some ideas on the future development direction of POCT products. |
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| Keywords: | SARS-CoV-2 COVID-19 Point-of-care testing Quality control |
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