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－ Supporting Clinical Research from Testing to Therapeutic Agent Development －
Shimadzu Review 77[1・2] (2020.6)
Abstract
PCR testing is used for rapid verification of infection with SARS-CoV2. One of the factors preventing increased use of PCR testing in Japan has been that many of the PCR tests currently in use require a complicated RNA purification step. To resolve this issue, we developed the 2019 Novel Coronavirus Detection Kit that requires no RNA purification. Also, to support clinical research into remdesivir, a drug that has received special approval as a treatment for COVID-19, we developed a simultaneous analysis method for remdesivir and its metabolite (GS-441524) that reduces the risk of specimen exposure by using an LC/MS/MS system with a fully automated sample preparation unit. As technology that is relevant to measures against SARS-CoV2 infection, this article describes the principle of the 2019 Novel Coronavirus Detection Kit and an evaluation of this kit using clinical specimens. This article also describes a simple and safe assay method for remdesivir and its metabolite using LC/MS/MS and a fully automated sample preparation unit.
1Clinical & Biotechnology Business Unit, Life Science Business Department, Analytical & Measuring Instruments Division, Shimadzu Corporation, Kyoto, Japan
2Global Application Development Center, Analytical & Measuring Instruments Division, Shimadzu Corporation, Kyoto, Japan
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