Testing To Nucleic Acid Isothermal Amplification Analyzer Of Microfluidic Chip And Studying Of Its Quality Checking Standards

In recent years, the continuous development of blood screening test, the sensitivityof blood serum virus detection method can be greatly improved. However, due to thebody’s immune system will inevitably appear immune silence, Seroconversion period,the window period, the virus mutation so on, virus positive blood donors occasionallywere missed.The polymerase chain reaction method has the advantages of highsensitivity, good specificity, is one of the most accurate test method of gene diagnosis.Therefore, in the field of life sciences, nucleic acid amplification technique has played adecisive role position. With the rapid development of molecular biology diagnosistechnology, domestic and foreign researchers continue to explore new methods. Sincethe advent of PCR technology, various kinds of nucleic acid amplification techniqueshave been invented, these new gene amplification technologies have entered thecommercialization stage, including isothermal nucleic acid amplification.Isothermal nucleic amplification technology by virtue of its amplification atconstant temperature, greatly reduces the requirements of the experimental apparatus,shorts the reaction time, optimizes the efficiency of the experiment, and can bring highbusiness gain. At home and abroad, the diagnostic product of nucleic acid isothermalamplification has been developed for many years, and has been used widely in the fieldof biological gene diagnosis.This paper introduces a new Rtisochip isothermal amplification microfluidicchip nucleic acid analyzer, belonging to the technical field of isothermal amplification,and is one of the leading technology products. And then, following the implementationof different national or industry standards, the thesis systematically studied theregistration inspection method of Rtisochip isothermal amplification analyzer ofmicrofluidic chip in nucleic acid molecular diagnostics, including Environment,Performance, Electrical safety and Electromagnetic Compatibility Aspects, respectively.At the end, in order to further improve the safety and effectiveness of the analyzer,based on the technical characteristics of the constant temperature nucleic acid analysisequipment, and the requirement of production quality inspection of the equipment, anew model checking standard of isothermal amplification analyzer was developed for enhancing the accuracy of test results and objective.