新型冠状病毒快速与普通核酸检测系统的临床组合应用研究

将新型冠状病毒（COVID-19）的快速与普通核酸检测系统不同组合单元混搭应用，分析新冠核酸检测的最优化组合应用。方法 将新冠核酸液体质控品稀释到浓度为200 cp/mL、500 cp/mL、1000 cp/mL和2000 cp/mL。将普通检测系统（核酸提取法、普通扩增试剂和普通荧光定量PCR仪）和快速检测系统（直接裂解法、快速扩增试剂和快速荧光定量PCR仪）中的不同单元，进行混搭组合。通过扩增以上不同浓度的稀释质控品，验证不同混搭组合应用的检测效果。结果 全部使用普通检测系统组合单元，其敏感性较好但检测时间较慢（134 min）。全部使用快速检测系统组合单元，其敏感性较差但检测时间较快（56 min），其中直接裂解法是造成敏感性较差的主要原因。 进一步的研究发现，使用普通检测系统中的普通核酸提取法，搭配快速检测系统中的快速扩增试剂和快速荧光定量PCR仪，该混搭组合系统敏感性较好，且时间较快（59 min）。结论 在临床实践中，不建议使用直接裂解法提取核酸，但可使用快速扩增试剂和快速荧光定量PCR仪提高检测效率，缩短检测时间

Clinical application of rapid and common COVID-19 nucleic acid detection system

To explore the optimal detection method for COVID-19 by comparing different combinations of fast and common nucleic acid detection system. Methods COVID-19 nucleic acid liquid quality control reference was diluted to the concentration of 200 cp/mL, 500 cp/mL, 1000 cp/mL and 2000 cp/mL. The common detection system (nucleic acid extraction method, common amplification reagent and common RT PCR instrument) and rapid detection system (direct pyrolysis release method, rapid amplification reagent and rapid RT PCR instrument) were used. The units of common and rapid detection system were mixed and matched to explore the best detection system. Results Using the common detection system, the time was the slowest (134 min), but the sensitivity was the best. Using the rapid detection system, the time was the fastest (56 min), but the sensitivity was worst. The reason for the poor sensitivity may be attributed to the direct pyrolysis release method. Further research found that the common nucleic acid extraction, the rapid amplification reagent and rapid RT PCR instrument were the best combined application in COVID-19 nucleic detection. The combination of the detection time was fast (59 min), and the sensitivity was better. Conclusion It is not recommended to use the direct lysis-release method to extract nucleic acid. However, the efficiency and time can be improved by using rapid amplification reagent and rapid RT PCR instrument