September 17, 2020 | News & Notices Acquisition of the approval for marketing the Novel Coronavirus (SARS-CoV-2) Detection Reagent Kit as an In Vitro Diagnostic Product
Ampdirect™ 2019-nCoV Detection Kit
On September 8, 2020, Shimadzu Corporation received the approval for for marketing the Ampdirect™ 2019-nCoV Detection Kit, a reagent kit for detection of the novel coronavirus (SARS-CoV-2) from biological samples, as an in vitro diagnostic product, from Japanese Ministry of Health, Labour and Welfare. Additionally, insurance coverage was announced on the same day, with sales starting on September 28 in Japan.
Since 1997, Shimadzu employs Ampdirect™ technology* to develop a number of reagents to enable quick and convenient PCR tests from biological samples, without the purification of nucleic acids. The reagents to detect the novel coronavirus (SARS-CoV-2) were developed by applying techniques cultivated through the development of reagents for detecting pathogens including the norovirus responsible for food poisoning as well as enterohemorrhagic E. coli, salmonella, and shigella.
The 2019 Novel Coronavirus Detection Reagent Kit, a collection of reagents for research purposes that was released in April, was described in “Regarding genetic testing methods for 2019-nCoV that have been evaluated using clinical specimens” (9 April 2020 edition by the National Institute of Infectious Diseases, Tuberculosis and Infectious Diseases Control Division, Health Service Bureau, Ministry of Health, Labour, and Welfare, Japan), and became subject to insurance coverage. The Ampdirect™ 2019-nCoV Detection Kit, which has now been released, is an in vitro diagnostic product, and was developed based on the 2019 Novel Coronavirus Detection Reagent Kit.
Shimadzu will strengthen its activities in the field of infectious diseases, so as to contribute to resolving social issues.
Note: This technology suppresses the action of PCR inhibitors such as the proteins and polysaccharides in biological samples, enabling the direct addition of PCR reaction liquids to biological samples, without the purification of DNA and RNA. Ampdirect is a trademark of Shimadzu Corporation.