| With the outbreak of the COVID-19 pandemic in early 2020,nucleic acid testing technology has entered a rapidly developing era.Traditional nucleic acid amplification testing devices have encountered issues such as operational difficulties and large size.In order to make nucleic acid amplification testing more immediate,this study focuses on the principle of loop-mediated isothermal amplification(LAMP)and designs a portable rapid detection device.This device is capable of simultaneously performing nucleic acid isothermal amplification rapid testing on 8 samples,with a testing time of 15 to 30 minutes.It mainly consists of hardware modules,software modules,isothermal control algorithm modules,and an optical acquisition system module.The study designs a fuzzy PID control algorithm and an optical acquisition system,which,in conjunction with the hardware,maintains the temperature at 65 ± 0.3 ℃.The optical acquisition system tests the FAM and HEX fluorescence channels with a linear fitting degree of R^2 greater than 0.99,and the repeatability test CV value is less than 0.1%.A novel coronavirus pseudo-virus and LAMP reagents are used,and the device is designed and performance validated according to the industry standards of a polymerase chain reaction(PCR)analyzer.The results show that the device has strong stability and high specificity in biological performance testing.It has a sensitivity of up to1250copies/ml,and the detection results are consistent with those of digital PCR testing.The device achieves on-site real-time detection of nucleic acid amplification,with strong reliability,stability,and low cost,making it suitable for promotion in primary healthcare testing institutions. |