Canon Medical Systems Corporation working with Nagasaki University has now completed the progress of the Genelyzer Kit for SARS-COV-2 RNA. The fluorescent LAMP method is based on a gene amplification technique. In a report labelled “Validation of 2019-nCoV gene testing method in which clinical evaluation results were obtained using clinical specimens”. These results were reported on March 26, 2020, by Japan’s Ministry of Health, Labour and Welfare, and the National Institute of Infectious Disease.
This study reveals a 100% specificity and 90% or more sensitivity. A piece of administrative information released by the Ministry of Health, Labour and Welfare states that the rapid genetic testing system has been approved practical application in conducting testing.
In positive samples, the testing system can detect more than 15 viral genome copies per reaction with 100% sensitivity in 10 minutes. The entire examination from processing the sample to obtaining the test findings can be accomplished in 40 minutes. To utilize the maximum ability of the testing system, Canon Medical Systems Corporation will continue evaluating its practical application at clinical sites, airports, and other locations that require the testing.
This research project is part of a research program focusing on risk evaluation of emerging and re-emerging infectious diseases. Also, the effort focuses on the implementation of emergency management functions, which is being conducted under Health and Labour Science Research Grants. The system is entering the practical approach phase under the industry-academia-government with compliance from the Ministry of Health, Labour and Welfare of Japan.
Canon Medical Systems Corporation is hoping that the testing systems can assist those in need at a wide range of clinical sites in Japan. This will help control the spread of coronavirus (COVID-19). At the same time, the main goal is the expansion of effective measures from the spread of any infectious diseases around the world.